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Original Articles
Association between Tumor Size at the Time of Disease Progression and Survival Outcomes
Chi Hoon Maeng, Bum Jun Kim, Myung-Ju Ahn, In Sil Choi, Dae Young Zang, Bo-Hyung Kim, Minji Kwon, Dae Seog Heo, Bhumsuk Keam
Received July 24, 2024  Accepted October 20, 2024  Published online October 22, 2024  
DOI: https://doi.org/10.4143/crt.2024.690    [Accepted]
AbstractAbstract PDF
Purpose
This study evaluates the prognostic significance of tumor size at disease progression (PD) and depth of response (DOR) in cancer patients.
Materials and Methods
We performed post hoc analysis using data from six prospective clinical trials conducted by the Korean Cancer Study Group. Patients with tumor size at PD was categorized into ‘Mild PD’ and ‘Significant PD’ based on the cutoff values of relative change from baseline using maximally selected rank statistics. The overall survival (OS) and progression-free survival (PFS) were compared between PD and DOR categories.
Results
Among the 194 evaluable patients, 130 experienced PD. A 35.48% decrease from baseline in tumor size at PD was chosen for the cutoff between mild and significant PD for OS (mild PD: tumor size from the baseline ≤ −35.48%; significant PD > −35.48%). The mild PD had superior OS compared to the significant PD (25.8 vs. 12.8 months; Hazard ratio [HR] 0.47, 95% CI 0.266-0.843, p=0.009). When using an exploratory cutoff based on whether the tumor size was below vs. exceeded from the baseline (mild PD: tumor size from the baseline ≤ 0%; significant PD > 0%), OS remained significantly longer in the mild PD (17.1 vs. 11.8 months; HR 0.60, 95% CI 0.392-0.932, p=0.021). The greatest DOR was associated with the longest OS and PFS (p<0.001 for both).
Conclusion
Tumor size at PD and DOR were significant prognostic factors for progressive disease. Maintaining a sufficiently reduced tumor size even during PD was associated with better survival outcomes.
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Sarcoma
Whole-Genome and Transcriptome Sequencing Identified NOTCH2 and HES1 as Potential Markers of Response to Imatinib in Desmoid Tumor (Aggressive Fibromatosis): A Phase II Trial Study
Joonha Kwon, Jun Hyeong Lee, Young Han Lee, Jeeyun Lee, Jin-Hee Ahn, Se Hyun Kim, Seung Hyun Kim, Tae Il Kim, Kum-Hee Yun, Young Suk Park, Jeong Eun Kim, Kyu Sang Lee, Jung Kyoon Choi, Hyo Song Kim
Cancer Res Treat. 2022;54(4):1240-1255.   Published online January 17, 2022
DOI: https://doi.org/10.4143/crt.2021.1194
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
Desmoid tumor, also known as aggressive fibromatosis, is well-characterized by abnormal Wnt/β-catenin signaling. Various therapeutic options, including imatinib, are available to treat desmoid tumor. However, the molecular mechanism of why imatinib works remains unclear. Here, we describe potential roles of NOTCH2 and HES1 in clinical response to imatinib at genome and transcriptome levels.
Materials and Methods
We identified somatic mutations in coding and noncoding regions via whole-genome sequencing. To validate the genetic interaction with expression level in desmoid-tumor condition, we utilized large-scale whole-genome sequencing and transcriptome datasets from the Pan-Cancer Analysis of Whole Genomes project. RNA-sequencing was performed using prospective and retrospective cohort samples to evaluate the expressional relevance with clinical response.
Results
Among 20 patients, four (20%) had a partial response and 14 (66.7%) had stable disease, 11 of which continued for ≥ 1 year. With gene-wise functional analyses, we detected a significant correlation between recurrent NOTCH2 noncoding mutations and clinical response to imatinib. Based on Pan-Cancer Analysis of Whole Genomes data analyses, NOTCH2 mutations affect expression levels particularly in the presence of CTNNB1 missense mutations. By analyzing RNA-sequencing with additional desmoid tumor samples, we found that NOTCH2 expression was significantly correlated with HES1 expression. Interestingly, NOTCH2 had no statistical power to discriminate between responders and non-responders. Instead, HES1 was differentially expressed with statistical significance between responders and non-responders.
Conclusion
Imatinib was effective and well tolerated for advanced desmoid tumor treatment. Our results show that HES1, regulated by NOTCH2, as an indicator of sensitivity to imatinib, and an important therapeutic consideration for desmoid tumor.

Citations

Citations to this article as recorded by  
  • The Notch signaling pathway in desmoid tumor: Recent advances and the therapeutic prospects
    Chuanxi Zheng, Jianghong Huang, Gang Xu, Wei Li, Xin Weng, Shiquan Zhang
    Biochimica et Biophysica Acta (BBA) - Molecular Basis of Disease.2024; 1870(1): 166907.     CrossRef
  • Long‐term result of 125I seed brachytherapy for pediatric desmoid tumor in the head and neck
    Yi‐Wei Zhong, Xiao‐Ming Lyu, Yan Shi, Chuan‐Bin Guo, Jian‐Guo Zhang, Lei Zheng
    Pediatric Blood & Cancer.2023;[Epub]     CrossRef
  • Update on Familial Adenomatous Polyposis-Associated Desmoid Tumors
    Wanjun Yang, Pei-Rong Ding
    Clinics in Colon and Rectal Surgery.2023; 36(06): 400.     CrossRef
  • Multimodality Imaging Assessment of Desmoid Tumors: The Great Mime in the Era of Multidisciplinary Teams
    Igino Simonetti, Federico Bruno, Roberta Fusco, Carmen Cutolo, Sergio Venanzio Setola, Renato Patrone, Carlo Masciocchi, Pierpaolo Palumbo, Francesco Arrigoni, Carmine Picone, Andrea Belli, Roberta Grassi, Francesca Grassi, Antonio Barile, Francesco Izzo,
    Journal of Personalized Medicine.2022; 12(7): 1153.     CrossRef
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Impact of Prior Cancer History on the Clinical Outcomes in Advanced Breast Cancer: A Propensity Score–Adjusted, Population-Based Study
Caijin Lin, Jiayi Wu, Shuning Ding, Chihwan Goh, Lisa Andriani, Kunwei Shen, Li Zhu
Cancer Res Treat. 2020;52(2):552-562.   Published online November 18, 2019
DOI: https://doi.org/10.4143/crt.2019.210
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
Despite the rapid growing of cancer survivors, prior cancer history is a commonly adopted exclusion criterion. Whether prior cancer will impact the survival of patients with advanced breast cancer (ABC) remains uncertain.
Materials and Methods
Patients with ABC diagnosed between 2004 and 2010 were identified using Surveillance, Epidemiology, and End Results (SEER) database. Timing, stage, and type were used to characterize prior cancer. Multivariable analyses using propensity score–adjusted Cox regression and competing risk regression were conducted to evaluate the prognostic effect of prior cancer on overall survival (OS) and breast cancer-specific survival (BCSS).
Results
A total of 14,176 ABC patients were identified, of whom 10.5% carried a prior cancer history. The most common type of prior cancer was female genital cancer (32.4%); more than half (51.7%) were diagnosed at localized stage; most were diagnosed more than 5 years (42.9%) or less than 1 year (28.3%) prior to the index cancer. In multivariate analyses, patients with prior cancer presented a slightly worse OS (hazard ratio, 1.18; 95% confidence interval [CI], 1.07 to 1.30; p=0.001) but a better BCSS (subdistribution hazard ratio, 0.64; 95% CI, 0.56 to 0.74; p < 0.001). In subset analyses, no survival detriment was observed in patients with prior malignancy from head and neck or endocrine system, at in situ or localized stage, or diagnosed more than 4 years.
Conclusion
Prior cancer provides an inferior OS but a superior BCSS for patients with ABC. It does not affect the survival adversely in some subgroups and these patients should not be excluded from clinical trials.

Citations

Citations to this article as recorded by  
  • Impact of childhood/adolescent cancer history on prognosis in parotid mucoepidermoid carcinoma
    Hefeng Gu, Sunyi Tu, Lan Ma, Kuiwei Su, Yeqing Zhou
    British Journal of Oral and Maxillofacial Surgery.2024; 62(7): 612.     CrossRef
  • Clinical characteristics and prostate-cancer-specific mortality of competitive risk nomogram in the second primary prostate cancer
    Chaojie Xu, Dongchen Pei, Yi Liu, Jianhua Guo, Nan Liu, Qian Wang, Yang Yu, Zhengjun Kang
    Frontiers in Oncology.2023;[Epub]     CrossRef
  • The Impact of a History of Different Other Cancers on the Long-Term Outcomes of Patients with Gallbladder Cancer: A Propensity Score–Adjusted, Population-Based Study
    Jing Wang, Chan Zhang, Dong Yan
    Technology in Cancer Research & Treatment.2023;[Epub]     CrossRef
  • Second primary malignancies in oral tongue cancer: A Surveillance, Epidemiology, and End Result–based analysis evaluating the basic characteristics, survival outcomes, and predictive factors
    Zicheng Xu, Jianxing Wang, Hongzhou Cai, Feng Qi, Qing Zou
    Precision Medical Sciences.2022; 11(1): 4.     CrossRef
  • Better Prognosis and Survival in Esophageal Cancer Survivors After Comorbid Second Primary Malignancies: A SEER Database-Based Study
    Jiayue Ye, Sheng Hu, Wenxiong Zhang, Deyuan Zhang, Yang Zhang, Dongliang Yu, Jinhua Peng, Jianjun Xu, Yiping Wei
    Frontiers in Surgery.2022;[Epub]     CrossRef
  • Effect of Previous Cancer History on Survival of Patients with Different Subtypes of Breast Cancer
    Weixun Lin, Yaokun Chen, Zeqi Ji, Lingzhi Chen, Jinyao Wu, Yexi Chen, Zhiyang Li, Nauman Rahim Khan
    BioMed Research International.2022; 2022: 1.     CrossRef
  • Association between a prior cancer history and prognosis in adult patients with high‑grade glioma
    Dongjie He, Peiwen Wu, Gaiyan Li, Siying Zhu, Qiming Wang, Qiuju Shao, Hao Chang
    Journal of Clinical Neuroscience.2022; 106: 20.     CrossRef
  • Impact of prior cancer history on survival of patients with gastric cancer
    Li Wen, Kun Yu, Hongjiang Lu, Guansheng Zhong
    European Journal of Surgical Oncology.2021; 47(9): 2286.     CrossRef
  • Effect of prior cancer on survival outcomes for patients with advanced prostate cancer
    Yechen Wu, Xi Chen, Duocheng Qian, Wei Wang, Yiping Zhang, Jinxin Hu, Jun Zhu, Qiang Wu, Tinghu Cao
    BMC Urology.2021;[Epub]     CrossRef
  • Survival of women diagnosed with breast cancer and who have survived a previous cancer
    Sandi L. Pruitt, Hong Zhu, Daniel F. Heitjan, Asal Rahimi, Bhumika Maddineni, Anna Tavakkoli, Ethan A. Halm, David E. Gerber, Danyi Xiong, Caitlin C. Murphy
    Breast Cancer Research and Treatment.2021; 187(3): 853.     CrossRef
  • Trends in the proportion of second or later primaries among all newly diagnosed malignant cancers
    Chelsea Anderson, Deborah K. Mayer, Hazel B. Nichols
    Cancer.2021; 127(15): 2736.     CrossRef
  • Survival analysis of patients with primary breast duct carcinoma and lung adenocarcinoma: a population-based study from SEER
    Fengyuan Lv, Mingliang Cheng, Liang Jiang, Xiaoping Zhao
    Scientific Reports.2021;[Epub]     CrossRef
  • Research on Effectiveness of Prior Cancer on Survival Outcomes for Patients with Nonmetastatic Triple-Negative Breast Cancer: A Competing Risk Analysis and Propensity Score Matching Analysis of the SEER Database
    Heyan Chen, Lutong Yan, Shengyu Pu, Lizhe Zhu, Huimin Zhang, Can Zhou, Raffaele Palmirotta
    Journal of Oncology.2021; 2021: 1.     CrossRef
  • Risk of breast cancer-related death in women with a prior cancer
    Fei Ji, Ci-Qiu Yang, Xiao-Ling Li, Liu-Lu Zhang, Mei Yang, Jie-Qing Li, Hong-Fei Gao, Teng Zhu, Min-Yi Cheng, Wei-Ping Li, Si-Yan Wu, Ai-Ling Zhong, Kun Wang
    Aging.2020; 12(7): 5894.     CrossRef
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Osimertinib in Patients with T790M-Positive Advanced Non-small Cell Lung Cancer: Korean Subgroup Analysis from Phase II Studies
Myung-Ju Ahn, Ji-Youn Han, Dong-Wan Kim, Byoung Chul Cho, Jin-Hyoung Kang, Sang-We Kim, James Chih-Hsin Yang, Tetsuya Mitsudomi, Jong Seok Lee
Cancer Res Treat. 2020;52(1):284-291.   Published online July 23, 2019
DOI: https://doi.org/10.4143/crt.2019.200
AbstractAbstract PDFPubReaderePub
Purpose
Osimertinib is a third-generation, irreversible, oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that potently and selectively inhibits both EGFR sensitizing mutation and EGFR T790M and has demonstrated efficacy in non-small cell lung cancer (NSCLC) central nervous system (CNS) metastases. We present results of a subgroup analysis of Korean patients from the pooled data of two global phase II trials: AURA extension (NCT01802632) and AURA2 (NCT02094261).
Materials and Methods
Enrolled patients had EGFR T790M-positive NSCLC and disease progression during or after EGFR-TKI therapy. Patients received osimertinib 80 mg orally once daily until disease progression. The primary endpoint was objective response rate (ORR).
Results
In total, 66 Korean patients received osimertinib treatment with a median treatment duration of 19 months. In the evaluable-for-response population (n=62), ORR was 74% (95% confidence interval [CI], 61.5 to 84.5) and median duration of response was 9.8 months (95% CI, 7.1 to 16.8). In the full analysis set (n=66), median progression-free survival was 10.9 months (95% CI, 8.3 to 15.0; data cutoff November 1, 2016), and median overall survival was 29.2 months (95% CI, 24.8 to 35.7; data cutoff May 1, 2018). Eight patients with CNS metastases were evaluable for response, none of whom showed CNS progression. The most common adverse events were rash (53%), cough (33%), paronychia, diarrhea, and decreased appetite (each 32%).
Conclusion
Efficacy and safety profiles of osimertinib in this subgroup are consistent with the global phase II pooled population, which supports osimertinib as a recommended treatment for Korean patients with T790M positive NSCLC.

Citations

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  • Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with oncogene-addicted metastatic non-small-cell lung cancer
    S.-H. Lee, J. Menis, T.M. Kim, H.R. Kim, C. Zhou, S.A. Kurniawati, K. Prabhash, H. Hayashi, D.D.-W. Lee, M.S. Imasa, Y.L. Teh, J.C.-H. Yang, T. Reungwetwattana, V. Sriuranpong, C.-E. Wu, Y. Ang, M. Sabando, M. Thiagarajan, H. Mizugaki, V. Noronha, M. Yuli
    ESMO Open.2024; 9(12): 103996.     CrossRef
  • The role of brain radiotherapy for EGFR- and ALK-positive non-small-cell lung cancer with brain metastases: a review
    Valerio Nardone, Caterina Romeo, Emma D’Ippolito, Pierpaolo Pastina, Maria D’Apolito, Luigi Pirtoli, Michele Caraglia, Luciano Mutti, Giovanna Bianco, Antonella Consuelo Falzea, Rocco Giannicola, Antonio Giordano, Pierosandro Tagliaferri, Claudia Vincigue
    La radiologia medica.2023; 128(3): 316.     CrossRef
  • The Relationship Between Short-Term Surrogate Endpoint Indicators and mPFS and mOS in Clinical Trials of Malignant Tumors: A Case Study of Approved Molecular Targeted Drugs for Non-Small-Cell Lung Cancer in China
    Mingjun Rui, Zijing Wang, Zhengyang Fei, Yao Wu, Yingcheng Wang, Lei Sun, Ye Shang, Hongchao Li
    Frontiers in Pharmacology.2022;[Epub]     CrossRef
  • Efficacy and Safety of SH-1028 in Patients With EGFR T790M-Positive NSCLC: A Multicenter, Single-Arm, Open-Label, Phase 2 Trial
    Anwen Xiong, Shengxiang Ren, Huaimin Liu, Liyun Miao, Lei Wang, Jianhua Chen, Wei Li, Runpu Li, Xiang Wang, Zhiwei Lu, Donglin Wang, Xiaohong Wu, Zhihua Liu, Ligang Xing, Yimin Mao, Chunling Liu, Aiping Zeng, Hongrui Niu, Yingying Du, Yuping Sun, Yueyin P
    Journal of Thoracic Oncology.2022; 17(10): 1216.     CrossRef
  • Treatment of Brain Metastases of Non-Small Cell Lung Carcinoma
    Agnieszka Rybarczyk-Kasiuchnicz, Rodryg Ramlau, Katarzyna Stencel
    International Journal of Molecular Sciences.2021; 22(2): 593.     CrossRef
  • 9,249 View
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  • 5 Web of Science
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Korean First Prospective Phase II Study, Feasibility of Prone Position in Postoperative Whole Breast Radiotherapy: A Dosimetric Comparison
Yoonsun Chung, Jeong Il Yu, Won Park, Doo Ho Choi
Cancer Res Treat. 2019;51(4):1370-1379.   Published online February 18, 2019
DOI: https://doi.org/10.4143/crt.2018.423
AbstractAbstract PDFPubReaderePub
Purpose
This first Korean prospective study is to evaluate the feasibility of prone breast radiotherapy after breast conserving surgery for left breast cancer patients who have relatively small breast size and we present dosimetric comparison between prone and supine positions.
Materials and Methods
Fifty patients underwent two computed tomography (CT) simulations in supine and prone positions. Whole breast, ipsilateral lung, heart, and left-anterior-descending coronary artery were contoured on each simulation CT images. Tangential-fields treatment plan in each position was designed with total 50 Gy in 2-Gy fractions, and then one of the positions was designated for the treatment by comparing target coverage and dose to normal organs. Also, interfractional and intrafractional motion was evaluated using portal images.
Results
In total 50 patients, 32 cases were decided as prone-position–beneficial group and 18 cases as supine-position–beneficial group based on dosimetric advantage. Target dose homogeneity was comparable, but target conformity in prone position was closer to optimal than in supine position. For both group, prone position significantly increased lung volume. However, heart volumewas decreased by prone position for prone-position–beneficial group but was comparable between two positions for supine-position–beneficial group. Lung and heart doses were significantly decreased by prone position for prone-position–beneficial group. However, prone position for supine-position–beneficial group increased heart dose while decreasing lung dose. Prone position showed larger interfractional motion but smaller intra-fractional motion than supine position.
Conclusion
Prone breast radiotherapy could be beneficial to a subset of small breast patients since it substantially spared normal organs while achieving adequate target coverage.

Citations

Citations to this article as recorded by  
  • Чи є положення лежачи на животі безпечним для органів ризику при променевій терапії молочної залози? Клінічний випадок та огляд літератури
    Sumeyra Oz, Aslı Sabah, Ilyas Anıl Kılınc, Oguzhan Bascik, Yunus Babayigit, Ipek Sucak, Yasemin Celik, Cengiz Kurtman
    Practical oncology.2024; 6(2): 22.     CrossRef
  • Dosimetric analysis of six whole-breast irradiation techniques in supine and prone positions
    Dong Wook Kim, Chae-Seon Hong, Junyoung Son, Se Young Kim, Ye-In Park, Mijoo Chung, Weon Kuu Chung, Min Cheol Han, Jihun Kim, Hojin Kim, Jin Sung Kim
    Scientific Reports.2024;[Epub]     CrossRef
  • Current Cardioprotective Strategies for the Prevention of Radiation-Induced Cardiotoxicity in Left-Sided Breast Cancer Patients
    Vasiliki Nikovia, Evangelos Chinis, Areti Gkantaifi, Maria Marketou, Michalis Mazonakis, Nikolaos Charalampakis, Dimitrios Mavroudis, Kornilia Vasiliki Orfanidou, Antonios Varveris, Chrysostomos Antoniadis, Maria Tolia
    Journal of Personalized Medicine.2023; 13(7): 1038.     CrossRef
  • Prone versus supine free-breathing for right-sided whole breast radiotherapy
    Odile Fargier-Bochaton, Xinzhuo Wang, Giovanna Dipasquale, Mohamed Laouiti, Melpomeni Kountouri, Olena Gorobets, Nam P. Nguyen, Raymond Miralbell, Vincent Vinh-Hung
    Scientific Reports.2022;[Epub]     CrossRef
  • Long-term follow-up results of intensity-modulated radiotherapy with helicoïdal tomotherapy for non-metastatic breast cancers: Single centre experience
    Z. Zolcsak, P. Loap, A. Fourquet, Y.M. Kirova
    Cancer/Radiothérapie.2022; 26(5): 654.     CrossRef
  • A study of skin marker alignment using different diamond‐shaped light fields for prone breast external‐beam radiation therapy
    Huijun Xu, Sally B. Cheston, Arun Gopal, Baoshe Zhang, Shifeng Chen, Suhong Yu, Andrea Hall, Sara Dudley
    Journal of Applied Clinical Medical Physics.2022;[Epub]     CrossRef
  • Comparative analysis of dosimetry and predictive somatotype parameters of prone and supine whole-breast irradiation among Chinese women after breast-conserving surgery
    Yi Gao, Li Wang, Han Bai, Xiang Pan, Lan Li, Li Chang, Yaoxiong Xia, Wenhui Li, Yu Hou
    Frontiers in Oncology.2022;[Epub]     CrossRef
  • Prone position versus supine position in postoperative radiotherapy for breast cancer
    Junming Lai, Fangyan Zhong, Jianxiong Deng, Shuang Hu, Ruoyan Shen, Hui Luo, Yongbiao Luo
    Medicine.2021; 100(20): e26000.     CrossRef
  • The cardiac toxicity of radiotherapy – a review of characteristics, mechanisms, diagnosis, and prevention
    Tianhui Wei, Yufeng Cheng
    International Journal of Radiation Biology.2021; 97(10): 1333.     CrossRef
  • Evaluation of critical organ dosimetry with focus on heart exposure in supine versus prone patient positioning for breast irradiation
    Sager Omer, Beyzadeoglu Murat, Dincoglan Ferrat, Demiral Selcuk, Uysal Bora, Gamsiz Hakan, Ozcan Fatih, Colak Onurhan, Dirican Bahar
    Journal of Surgery and Surgical Research.2020; 6(1): 087.     CrossRef
  • Setup uncertainties and the optimal imaging schedule in the prone position whole breast radiotherapy
    Shengyu Yao, Yin Zhang, Ke Nie, Bo Liu, Bruce G. Haffty, Nisha Ohri, Ning J. Yue
    Radiation Oncology.2019;[Epub]     CrossRef
  • 7,870 View
  • 168 Download
  • 9 Web of Science
  • 11 Crossref
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Investigating the Feasibility of Targeted Next-Generation Sequencing to Guide the Treatment of Head and Neck Squamous Cell Carcinoma
Sun Min Lim, Sang Hee Cho, In Gyu Hwang, Jae Woo Choi, Hyun Chang, Myung-Ju Ahn, Keon Uk Park, Ji-Won Kim, Yoon Ho Ko, Hee Kyung Ahn, Byoung Chul Cho, Byung-Ho Nam, Sang Hoon Chun, Ji Hyung Hong, Jung Hye Kwon, Jong Gwon Choi, Eun Joo Kang, Tak Yun, Keun-Wook Lee, Joo-Hang Kim, Jin Soo Kim, Hyun Woo Lee, Min Kyoung Kim, Dongmin Jung, Ji Eun Kim, Bhumsuk Keam, Hwan Jung Yun, Sangwoo Kim, Hye Ryun Kim
Cancer Res Treat. 2019;51(1):300-312.   Published online May 9, 2018
DOI: https://doi.org/10.4143/crt.2018.012
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
Head and neck squamous cell carcinoma (HNSCC) is a deadly disease in which precision medicine needs to be incorporated. We aimed to implement next-generation sequencing (NGS) in determining actionable targets to guide appropriate molecular targeted therapy in HNSCC patients.
Materials and Methods
Ninety-three tumors and matched blood samples underwent targeted sequencing of 244 genes using the Illumina HiSeq 2500 platform with an average depth of coverage of greater than 1,000×. Clinicopathological data from patients were obtained from 17 centers in Korea, and were analyzed in correlation with NGS data.
Results
Ninety-two of the 93 tumors were amenable to data analysis. TP53 was the most common mutation, occurring in 47 (51%) patients, followed by CDKN2A (n=23, 25%), CCND1 (n=22, 24%), and PIK3CA (n=19, 21%). The total mutational burden was similar between human papillomavirus (HPV)–negative vs. positive tumors, although TP53, CDKN2A and CCND1 gene alterations occurred more frequently in HPV-negative tumors. HPV-positive tumors were significantly associated with immune signature-related genes compared to HPV-negative tumors. Mutations of NOTCH1 (p=0.027), CDKN2A (p < 0.001), and TP53 (p=0.038) were significantly associated with poorer overall survival. FAT1 mutations were highly enriched in cisplatin responders, and potentially targetable alterations such as PIK3CA E545K and CDKN2A R58X were noted in 14 patients (15%).
Conclusion
We found several targetable genetic alterations, and our findings suggest that implementation of precision medicine in HNSCC is feasible. The predictive value of each targetable alteration should be assessed in a future umbrella trial using matched molecular targeted agents.

Citations

Citations to this article as recorded by  
  • Personalized Biomarker-Based Umbrella Trial for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: KCSG HN 15-16 TRIUMPH Trial
    Bhumsuk Keam, Min Hee Hong, Seong Hoon Shin, Seong Gu Heo, Ji Eun Kim, Hee Kyung Ahn, Yun-Gyoo Lee, Keon-Uk Park, Tak Yun, Keun-Wook Lee, Sung-Bae Kim, Sang-Cheol Lee, Min Kyoung Kim, Sang Hee Cho, So Yeon Oh, Sang-Gon Park, Shinwon Hwang, Byung-Ho Nam, S
    Journal of Clinical Oncology.2024; 42(5): 507.     CrossRef
  • A Phase II Trial of Nintedanib in Patients with Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma: In-Depth Analysis of Nintedanib Arm from the KCSG HN 15-16 TRIUMPH Trial
    Kyoo Hyun Kim, Sun Min Lim, Hee Kyung Ahn, Yun-Gyoo Lee, Keun-Wook Lee, Myung-Ju Ahn, Bhumsuk Keam, Hye Ryun Kim, Hyun Woo Lee, Ho Jung An, Jin-Soo Kim
    Cancer Research and Treatment.2024; 56(1): 37.     CrossRef
  • Extracellular vesicles as tools and targets in therapy for diseases
    Mudasir A. Kumar, Sadaf K. Baba, Hana Q. Sadida, Sara Al. Marzooqi, Jayakumar Jerobin, Faisal H. Altemani, Naseh Algehainy, Mohammad A. Alanazi, Abdul-Badi Abou-Samra, Rakesh Kumar, Ammira S. Al-Shabeeb Akil, Muzafar A. Macha, Rashid Mir, Ajaz A. Bhat
    Signal Transduction and Targeted Therapy.2024;[Epub]     CrossRef
  • Impact of PIK3CA and cell cycle pathway genetic alterations on durvalumab efficacy in patients with head and neck squamous cell carcinoma: Post hoc analysis of TRIUMPH study
    Dong Hyun Kim, Seung Taek Lim, Hye Ryun Kim, Eun Joo Kang, Hee Kyung Ahn, Yun-Gyoo Lee, Der Sheng Sun, Jung Hye Kwon, Sang-Cheol Lee, Hyun Woo Lee, Min Kyoung Kim, Bhumsuk Keam, Keon-Uk Park, Seong-Hoon Shin, Hwan Jung Yun
    Oral Oncology.2024; 151: 106739.     CrossRef
  • Characterization of macrophages in head and neck squamous cell carcinoma and development of MRG-based risk signature
    Lei Liu, Qiang Liu
    Scientific Reports.2024;[Epub]     CrossRef
  • The Next Chapter in Cancer Diagnostics: Advances in HPV-Positive Head and Neck Cancer
    Antea Krsek, Lara Baticic, Tamara Braut, Vlatka Sotosek
    Biomolecules.2024; 14(8): 925.     CrossRef
  • Biomarkers in head and neck squamous cell carcinoma: unraveling the path to precision immunotherapy
    Kamal S. Saini, Sasikala Somara, Heidi C. Ko, Purva Thatai, Angela Quintana, Zachary D. Wallen, Michelle F. Green, Ravi Mehrotra, Sandra McGuigan, Lingjuan Pang, Soma Das, Kavita Yadav, Dobrica Neric, Luca Cantini, Chinmayee Joshi, Kazuya Iwamoto, Sudha D
    Frontiers in Oncology.2024;[Epub]     CrossRef
  • Massive parallel sequencing of head and neck conventional squamous cell carcinomas: A comprehensive review
    Alfons Nadal, Antonio Cardesa, Abbas Agaimy, Alhadi Almangush, Alessandro Franchi, Henrik Hellquist, Ilmo Leivo, Nina Zidar, Alfio Ferlito
    Virchows Archiv.2024;[Epub]     CrossRef
  • FAT1 expression in T-cell acute lymphoblastic leukemia (T-ALL) modulates proliferation and WNT signaling
    Sven Liebig, Martin Neumann, Patricia Silva, Jutta Ortiz-Tanchez, Veronika Schulze, Konstandina Isaakidis, Cornelia Schlee, Michael P. Schroeder, Thomas Beder, Luc G. T. Morris, Timothy A. Chan, Lorenz Bastian, Thomas Burmeister, Stefan Schwartz, Nicola G
    Scientific Reports.2023;[Epub]     CrossRef
  • Short-term immune-checkpoint inhibition partially rescues perturbed bone marrow hematopoiesis in mismatch-repair deficient tumors
    Paula Krone, Annabell Wolff, Julia Teichmann, Johanna Maennicke, Julia Henne, Leonie Engster, Inken Salewski, Wendy Bergmann, Christian Junghanss, Claudia Maletzki
    OncoImmunology.2023;[Epub]     CrossRef
  • Genetic Mutations Associated with Inflammatory Response Caused by HPV Integration in Oropharyngeal Squamous Cell Carcinoma
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    Biomedicines.2023; 12(1): 24.     CrossRef
  • New Treatment Development for Larynx Preservation
    Susumu Okano
    Koutou (THE LARYNX JAPAN).2023; 35(2): 98.     CrossRef
  • Current Trends in Precision Medicine and Next-Generation Sequencing in Head and Neck Cancer
    Roberto N. Solis, Dustin A. Silverman, Andrew C. Birkeland
    Current Treatment Options in Oncology.2022; 23(2): 254.     CrossRef
  • EGFR Mutation and 11q13 Amplification Are Potential Predictive Biomarkers for Immunotherapy in Head and Neck Squamous Cell Carcinoma
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    Frontiers in Immunology.2022;[Epub]     CrossRef
  • Diagnostics of HNSCC Patients: An Analysis of Cell Lines and Patient-Derived Xenograft Models for Personalized Therapeutical Medicine
    Ramona Gabriela Ursu, Ionut Luchian, Costin Damian, Elena Porumb-Andrese, Nicolae Ghetu, Roxana Gabriela Cobzaru, Catalina Lunca, Carmen Ripa, Diana Costin, Igor Jelihovschi, Florin Dumitru Petrariu, Luminita Smaranda Iancu
    Diagnostics.2022; 12(5): 1071.     CrossRef
  • Unraveling most abundant mutational signatures in head and neck cancer
    Michaela Plath, Johanna Gass, Mario Hlevnjak, Qiaoli Li, Bohai Feng, Xavier Pastor Hostench, Matthias Bieg, Lea Schroeder, Dana Holzinger, Marc Zapatka, Kolja Freier, Wilko Weichert, Jochen Hess, Karim Zaoui
    International Journal of Cancer.2021; 148(1): 115.     CrossRef
  • Worldwide prevalence of PI3K-AKT-mTOR pathway mutations in head and neck cancer: A systematic review and meta-analysis
    Adriana Castelo de Moura, Daniele Xavier Assad, Juliana Amorim dos Santos, Isabela Porto de Toledo, Gustavo Barcelos Barra, Rogerio Moraes Castilho, Cristiane Helena Squarize, Eliete Neves Silva Guerra
    Critical Reviews in Oncology/Hematology.2021; 160: 103284.     CrossRef
  • Immuno-Oncological Biomarkers for Squamous Cell Cancer of the Head and Neck: Current State of the Art and Future Perspectives
    Stijn J. De Keukeleire, Tijl Vermassen, Elien Hilgert, David Creytens, Liesbeth Ferdinande, Sylvie Rottey
    Cancers.2021; 13(7): 1714.     CrossRef
  • Comprehensive Analysis of Mutation-Based and Expressed Genes-Based Pathways in Head and Neck Squamous Cell Carcinoma
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    Processes.2021; 9(5): 792.     CrossRef
  • Prognostic and Predictive Factors in Advanced Head and Neck Squamous Cell Carcinoma
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    International Journal of Molecular Sciences.2021; 22(9): 4981.     CrossRef
  • A phase II study of poziotinib in patients with recurrent and/or metastatic head and neck squamous cell carcinoma
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    Cancer Medicine.2021; 10(20): 7012.     CrossRef
  • Therapeutic implications of activating noncanonical PIK3CA mutations in head and neck squamous cell carcinoma
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    Journal of Clinical Investigation.2021;[Epub]     CrossRef
  • Understanding the Pattern of Oropharyngeal Cancers from North-East Romanian Patients
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  • Immunologic and immunogenomic aspects of tumor progression
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  • Prospective assessment of the clinical benefit of a tailored cancer gene set built on a next-generation sequencing platform in patients with recurrent or metastatic head and neck cancer
    Thomas C. Westbrook, Ian S. Hagemann, Jessica Ley, Kevin Chen, Kevin Palka, Jingxia Liu, Ling Chen, Peter Oppelt, Douglas Adkins
    Medical Oncology.2020;[Epub]     CrossRef
  • Biological Determinants of Chemo-Radiotherapy Response in HPV-Negative Head and Neck Cancer: A Multicentric External Validation
    Martijn van der Heijden, Paul B. M. Essers, Monique C. de Jong, Reinout H. de Roest, Sebastian Sanduleanu, Caroline V. M. Verhagen, Olga Hamming-Vrieze, Frank Hoebers, Philippe Lambin, Harry Bartelink, C. René Leemans, Marcel Verheij, Ruud H. Brakenhoff,
    Frontiers in Oncology.2020;[Epub]     CrossRef
  • Molecular subtypes of oropharyngeal cancer show distinct immune microenvironment related with immune checkpoint blockade response
    Min Hwan Kim, Jae-Hwan Kim, Ji Min Lee, Jae Woo Choi, Dongmin Jung, Hojin Cho, Hyundeok Kang, Min Hee Hong, Su Jin Heo, Se Heon Kim, Eun Chang Choi, Da Hee Kim, Young Min Park, Sangwoo Kim, Sun Och Yoon, Yoon Woo Koh, Byoung Chul Cho, Hye Ryun Kim
    British Journal of Cancer.2020; 122(11): 1649.     CrossRef
  • Establishment and characterization of patient-derived xenografts as paraclinical models for head and neck cancer
    Han Na Kang, Jae-Hwan Kim, A-Young Park, Jae Woo Choi, Sun Min Lim, Jinna Kim, Eun Joo Shin, Min Hee Hong, Kyoung-Ho Pyo, Mi Ran Yun, Dong Hwi Kim, Hanna Lee, Sun Och Yoon, Da Hee Kim, Young Min Park, Hyung Kwon Byeon, Inkyung Jung, Soonmyung Paik, Yoon W
    BMC Cancer.2020;[Epub]     CrossRef
  • Impact of genetic variants in clinical outcome of a cohort of patients with oropharyngeal squamous cell carcinoma
    Ana Carolina de Carvalho, Sandra Perdomo, Wellington dos Santos, Gabriela Carvalho Fernandes, Lais Machado de Jesus, Raiany Santos Carvalho, Cristovam Scapulatempo-Neto, Gisele Caravina de Almeida, Bruna Pereira Sorroche, Lidia Maria Rebolho Batista Arant
    Scientific Reports.2020;[Epub]     CrossRef
  • Prognostic Value of CD200R1 mRNA Expression in Head and Neck Squamous Cell Carcinoma
    Hyun Chang, Yun-Gyoo Lee, Yoon Ho Ko, Jang Ho Cho, Jong-Kwon Choi, Keon Uk Park, Eun Joo Kang, Keun-Wook Lee, Sun Min Lim, Jin-Soo Kim, Hyun Woo Lee, Min Kyoung Kim, In Gyu Hwang, Sangwoo Kim, Byung-Ho Nam, Hye Ryun Kim
    Cancers.2020; 12(7): 1777.     CrossRef
  • Mouse–human co-clinical trials demonstrate superior anti-tumour effects of buparlisib (BKM120) and cetuximab combination in squamous cell carcinoma of head and neck
    Hye Ryun Kim, Han Na Kang, Mi Ran Yun, Kwon Young Ju, Jae Woo Choi, Dong Min Jung, Kyoung Ho Pyo, Min Hee Hong, Myoung-Ju Ahn, Jong-Mu Sun, Han Sang Kim, Jinna Kim, Jinseon Yoo, Kyu Ryung Kim, Yoon Woo Koh, Se Heon Kim, Eun Chang Choi, Sun Ock Yoon, Hyo S
    British Journal of Cancer.2020; 123(12): 1720.     CrossRef
  • Mutationssignaturen beim Kopf- und Hals-Tumor
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  • BAMixChecker: an automated checkup tool for matched sample pairs in NGS cohort
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  • Diagnostic Tumor Markers in Head and Neck Squamous Cell Carcinoma (HNSCC) in the Clinical Setting
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  • A Review of HPV-Related Head and Neck Cancer
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    Journal of Clinical Medicine.2018; 7(9): 241.     CrossRef
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Randomized Open Label Phase III Trial of Irinotecan Plus Capecitabine versus Capecitabine Monotherapy in Patients with Metastatic Breast Cancer Previously Treated with Anthracycline and Taxane: PROCEED Trial (KCSG BR 11-01)
In Hae Park, Seock-Ah Im, Kyung Hae Jung, Joo Hyuk Sohn, Yeon Hee Park, Keun Seok Lee, Sung Hoon Sim, Kyong-Hwa Park, Jee Hyun Kim, Byung Ho Nam, Hee-Jun Kim, Tae-Yong Kim, Kyung-Hun Lee, Sung-Bae Kim, Jin-Hee Ahn, Suee Lee, Jungsil Ro
Cancer Res Treat. 2019;51(1):43-52.   Published online February 14, 2018
DOI: https://doi.org/10.4143/crt.2017.562
AbstractAbstract PDFPubReaderePub
Purpose
We investigated whether irinotecan plus capecitabine improved progression-free survival (PFS) compared with capecitabine alone in patients with human epidermal growth factor 2 (HER2) negative and anthracycline and taxane pretreated metastatic breast cancer (MBC).
Materials and Methods
A total of 221 patients were randomly assigned to irinotecan (80 mg/m2, days 1 and 8) and capecitabine (1,000 mg/m2 twice a day, days 1-14) or capecitabine alone (1,250 mg/m2 twice a day, days 1-14) every 3 weeks. The primary endpoint was PFS.
Results
There was no significant difference in PFS between the combination and monotherapy arm (median, 6.4 months vs. 4.7 months; hazard ratio [HR], 0.84; 95% confidence interval [CI], 0.63 to 1.11; p=0.84). In patients with triple-negative breast cancer (TNBC, n=90), the combination significantly improved PFS (median, 4.7 months vs. 2.5 months; HR, 0.58; 95% CI, 0.37 to 0.91; p=0.02). Objective response rate was numerically higher in the combination arm, though it failed to reach statistical significance (44.4% vs. 33.3%, p=0.30). Overall survival did not differ between arms (median, 20.4 months vs. 24.0 months; p=0.63). While grade 3 or 4 neutropenia was more common in the combination arm (39.6% vs 9.0%), hand-foot syndrome was more often observed in capecitabine arm. Quality of life measurements in global health status was similar. However, patients in the combination arm showed significantly worse symptom scales especially in nausea/vomiting and diarrhea.
Conclusion
Irinotecan plus capecitabine did not prove clinically superior to single-agent capecitabine in anthracycline- and taxane-pretreated HER2 negative MBC patients. Toxicity profiles of the two groups differed but were manageable. The role of added irinotecan in patients with TNBC remains to be elucidated.

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  • Targeting EMSY-mediated methionine metabolism is a potential therapeutic strategy for triple-negative breast cancer
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    Cell Reports Medicine.2024; 5(2): 101396.     CrossRef
  • Efficacy and safety of nanoparticle albumin‐bound paclitaxel in taxane‐pretreated metastatic breast cancer patients
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    BMC Cancer.2024;[Epub]     CrossRef
  • Subgroup analyses from the phase 3 ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer
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    npj Breast Cancer.2024;[Epub]     CrossRef
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    Tingting Tang, Naiyu Liu, Lingjuan Wang, Kaiyue Zuo, Xinjie Zhu
    ChemBioChem.2024;[Epub]     CrossRef
  • Synergizing Immunotherapy and Antibody–Drug Conjugates: New Horizons in Breast Cancer Therapy
    Antonello Pinto, Chiara Guarini, Marianna Giampaglia, Valeria Sanna, Assunta Melaccio, Laura Lanotte, Anna Natalizia Santoro, Francesca Pini, Antonio Cusmai, Francesco Giuliani, Gennaro Gadaleta-Caldarola, Palma Fedele
    Pharmaceutics.2024; 16(9): 1146.     CrossRef
  • Preliminary results from ASCENT-J02: a phase 1/2 study of sacituzumab govitecan in Japanese patients with advanced solid tumors
    Yoichi Naito, Seigo Nakamura, Nobuko Kawaguchi-Sakita, Takanori Ishida, Takahiro Nakayama, Yutaka Yamamoto, Norikazu Masuda, Koji Matsumoto, Takahiro Kogawa, Kazuki Sudo, Akihiko Shimomura, Catherine Lai, Danjie Zhang, Yuki Iwahori, Dianna Gary, Danh Huyn
    International Journal of Clinical Oncology.2024; 29(11): 1684.     CrossRef
  • A Phase IIb, single arm, multicenter trial of sacituzumab govitecan in Chinese patients with metastatic triple‐negative breast cancer who received at least two prior treatments
    Binghe Xu, Fei Ma, Tao Wang, Shusen Wang, Zhongsheng Tong, Wei Li, Xinhong Wu, Xiaojia Wang, Tao Sun, Yueyin Pan, Herui Yao, Xian Wang, Ting Luo, Jin Yang, Xiaohua Zeng, Weihong Zhao, Xiuyu Julie Cong, Jiongjie Chen
    International Journal of Cancer.2023; 152(10): 2134.     CrossRef
  • Update on Classic and Novel Approaches in Metastatic Triple-Negative Breast Cancer Treatment: A Comprehensive Review
    Salvatore Greco, Nicolò Fabbri, Riccardo Spaggiari, Alfredo De Giorgi, Fabio Fabbian, Antonio Giovine
    Biomedicines.2023; 11(6): 1772.     CrossRef
  • Cost-effectiveness of sacituzumab govitecan versus chemotherapy in patients with relapsed or refractory metastatic triple-negative breast cancer
    Jiao Xie, SiNi Li, YaMin Li, JianHe Li
    BMC Health Services Research.2023;[Epub]     CrossRef
  • Triple negative breast cancer: second and successive lines of treatment
    Fernando Henao Carrasco, Sara Leal Sánchez
    Revisiones en Cáncer.2023;[Epub]     CrossRef
  • TROPION-Breast02: Datopotamab deruxtecan for locally recurrent inoperable or metastatic triple-negative breast cancer
    Rebecca A Dent, David W Cescon, Thomas Bachelot, Kyung Hae Jung, Zhi-Ming Shao, Shigehira Saji, Tiffany A Traina, Petra Vukovic, Darlington Mapiye, Micah J Maxwell, Peter Schmid, Javier Cortés
    Future Oncology.2023; 19(35): 2349.     CrossRef
  • An integrated analysis of Sacituzumab govitecan in relapsed or refractory metastatic triple-negative breast cancer
    Shao-Xian Cheng, Qiu-Chi Chen, Guo-He Lin, Yan-Hong Han, Bi-Cheng Wang, Yi Dai, Yan-Xia Zhao
    Medicine.2023; 102(30): e34486.     CrossRef
  • Post-marketing safety surveillance of sacituzumab govitecan: an observational, pharmacovigilance study leveraging FAERS database
    Wensheng Liu, Qiong Du, Zihan Guo, Xuan Ye, Jiyong Liu
    Frontiers in Pharmacology.2023;[Epub]     CrossRef
  • Effects of Sacituzumab on Breast Cancer: Target Therapy
    Elina Armani Khatibi, Tooba Gholikhani, Balam Jimenez Brito, Nastaran Farshbaf Moghimi
    Biomedical Research Bulletin.2023; 1(4): 141.     CrossRef
  • The Place of Chemotherapy in The Evolving Treatment Landscape for Patients With HR-positive/HER2-negative MBC
    Chris Twelves, Rupert Bartsch, Noa Efrat Ben-Baruch, Simona Borstnar, Luc Dirix, Petra Tesarova, Constanta Timcheva, Lyudmila Zhukova, Xavier Pivot
    Clinical Breast Cancer.2022; 22(3): 223.     CrossRef
  • Quality-of-life methodology in hormone receptor–positive advanced breast cancer: Current tools and perspectives for the future
    Fatima Cardoso, David Cella, Galina Velikova, Victoria Harmer, Eva Schumacher-Wulf, Julie Rihani, Ana Casas, Nadia Harbeck
    Cancer Treatment Reviews.2022; 102: 102321.     CrossRef
  • Comprehensive metabolomics expands precision medicine for triple-negative breast cancer
    Yi Xiao, Ding Ma, Yun-Song Yang, Fan Yang, Jia-Han Ding, Yue Gong, Lin Jiang, Li-Ping Ge, Song-Yang Wu, Qiang Yu, Qing Zhang, François Bertucci, Qiuzhuang Sun, Xin Hu, Da-Qiang Li, Zhi-Ming Shao, Yi-Zhou Jiang
    Cell Research.2022; 32(5): 477.     CrossRef
  • Major advancements in metastatic breast cancer treatment: when expanding options means prolonging survival
    F. Miglietta, M. Bottosso, G. Griguolo, M.V. Dieci, V. Guarneri
    ESMO Open.2022; 7(2): 100409.     CrossRef
  • Association of Quality-of-Life Outcomes in Cancer Drug Trials With Survival Outcomes and Drug Class
    Joseph N. Samuel, Christopher M. Booth, Elizabeth Eisenhauer, Michael Brundage, Scott R. Berry, Bishal Gyawali
    JAMA Oncology.2022; 8(6): 879.     CrossRef
  • Analysis of patients without and with an initial triple-negative breast cancer diagnosis in the phase 3 randomized ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer
    Joyce O’Shaughnessy, Adam Brufsky, Hope S. Rugo, Sara M. Tolaney, Kevin Punie, Sagar Sardesai, Erika Hamilton, Delphine Loirat, Tiffany Traina, Roberto Leon-Ferre, Sara A. Hurvitz, Kevin Kalinsky, Aditya Bardia, Stephanie Henry, Ingrid Mayer, Yanni Zhu, S
    Breast Cancer Research and Treatment.2022; 195(2): 127.     CrossRef
  • Sacituzumab govitecan as second-line treatment for metastatic triple-negative breast cancer—phase 3 ASCENT study subanalysis
    Lisa A. Carey, Delphine Loirat, Kevin Punie, Aditya Bardia, Véronique Diéras, Florence Dalenc, Jennifer R. Diamond, Christel Fontaine, Grace Wang, Hope S. Rugo, Sara A. Hurvitz, Kevin Kalinsky, Joyce O’Shaughnessy, Sibylle Loibl, Luca Gianni, Martine Picc
    npj Breast Cancer.2022;[Epub]     CrossRef
  • Safety analyses from the phase 3 ASCENT trial of sacituzumab govitecan in metastatic triple-negative breast cancer
    Hope S. Rugo, Sara M. Tolaney, Delphine Loirat, Kevin Punie, Aditya Bardia, Sara A. Hurvitz, Joyce O’Shaughnessy, Javier Cortés, Véronique Diéras, Lisa A. Carey, Luca Gianni, Martine J. Piccart, Sibylle Loibl, David M. Goldenberg, Quan Hong, Martin Olivo,
    npj Breast Cancer.2022;[Epub]     CrossRef
  • Apatinib plus vinorelbine versus vinorelbine for metastatic triple-negative breast cancer who failed first/second-line treatment: the NAN trial
    Dou-Dou Li, Zhong-hua Tao, Bi-Yun Wang, Lei-Ping Wang, Jun Cao, Xi-Chun Hu, Jian Zhang
    npj Breast Cancer.2022;[Epub]     CrossRef
  • Combination treatment of radiofrequency ablation and peptide neoantigen vaccination: Promising modality for future cancer immunotherapy
    Jiawei Shou, Fan Mo, Shanshan Zhang, Lantian Lu, Ning Han, Liang Liu, Min Qiu, Hongseng Li, Weidong Han, Dongying Ma, Xiaojie Guo, Qianpeng Guo, Qinxue Huang, Xiaomeng Zhang, Shengli Ye, Hongming Pan, Shuqing Chen, Yong Fang
    Frontiers in Immunology.2022;[Epub]     CrossRef
  • A prospective, open-label, multicenter phase IV clinical trial on the safety and efficacy of lobaplatin-based chemotherapy in advanced breast cancer
    Min Yan, Peng Yuan, Quchang Ouyang, Ying Cheng, Guohui Han, Dewei Wang, Li Ran, Tao Sun, Da Zhao, Yuju Bai, Shun’e Yang, Xiaojia Wang, Rong Wu, Xiaohua Zeng, Herui Yao, Xuening Ji, Jun Jiang, Xiaohua Hu, Haifeng Lin, Liping Zheng, Zhitu Zhu, Wei Ge, Junla
    Therapeutic Advances in Medical Oncology.2022;[Epub]     CrossRef
  • Phase I study of liposomal irinotecan in patients with metastatic breast cancer: findings from the expansion phase
    Jasgit C. Sachdev, Pamela Munster, Donald W. Northfelt, Hyo Sook Han, Cynthia Ma, Fiona Maxwell, Tiffany Wang, Bruce Belanger, Bin Zhang, Yan Moore, Arunthathi Thiagalingam, Carey Anders
    Breast Cancer Research and Treatment.2021; 185(3): 759.     CrossRef
  • Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer
    Aditya Bardia, Sara A. Hurvitz, Sara M. Tolaney, Delphine Loirat, Kevin Punie, Mafalda Oliveira, Adam Brufsky, Sagar D. Sardesai, Kevin Kalinsky, Amelia B. Zelnak, Robert Weaver, Tiffany Traina, Florence Dalenc, Philippe Aftimos, Filipa Lynce, Sami Diab,
    New England Journal of Medicine.2021; 384(16): 1529.     CrossRef
  • Glembatumumab vedotin for patients with metastatic, gpNMB overexpressing, triple-negative breast cancer (“METRIC”): a randomized multicenter study
    Linda T. Vahdat, Peter Schmid, Andres Forero-Torres, Kimberly Blackwell, Melinda L. Telli, Michelle Melisko, Volker Möbus, Javier Cortes, Alberto J. Montero, Cynthia Ma, Rita Nanda, Gail S. Wright, Yi He, Thomas Hawthorne, Rebecca G. Bagley, Abdel-Baset H
    npj Breast Cancer.2021;[Epub]     CrossRef
  • Occult triple negative male breast cancer. The usefulness of molecular platforms. A case report
    Angelats L, Estival A, Martinez-Cardús A, Musulen E, Margelí M
    Current Problems in Cancer: Case Reports.2021; : 100097.     CrossRef
  • A Retrospective Analysis of the Effect of Irinotecan-Based Regimens in Patients With Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes
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  • Impact of Value Frameworks on the Magnitude of Clinical Benefit: Evaluating a Decade of Randomized Trials for Systemic Therapy in Solid Malignancies
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    Current Oncology.2021; 28(6): 4894.     CrossRef
  • High Antitumor Activity of the Dual Topoisomerase Inhibitor P8-D6 in Breast Cancer
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    Cancers.2021; 14(1): 2.     CrossRef
  • Clinical outcomes of breast cancer patients treated in phase I clinical trials at University of Colorado Cancer Center
    Jennifer A. Weiss, Andrew Nicklawsky, Jodi A. Kagihara, Dexiang Gao, Christine Fisher, Anthony Elias, Virginia F. Borges, Peter Kabos, Sarah L. Davis, Stephen Leong, Sue Gail Eckhardt, Jennifer R. Diamond
    Cancer Medicine.2020; 9(23): 8801.     CrossRef
  • Chemotherapy Options beyond the First Line in HER-Negative Metastatic Breast Cancer
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    Journal of Oncology.2020; 2020: 1.     CrossRef
  • Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer
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    New England Journal of Medicine.2019; 380(8): 741.     CrossRef
  • An open label phase 1 study evaluation safety, tolerability, and maximum tolerated dose of oral administration of irinotecan in combination with capecitabine
    I. Kümler, R. L. Eefsen, Peter Grundtvig Sørensen, S. Theile, A. Fullerton, P. G. Nielsen, Benny Vittrup Jensen, D. L. Nielsen
    Cancer Chemotherapy and Pharmacology.2019; 84(2): 441.     CrossRef
  • Exploiting DNA repair defects in breast cancer: from chemotherapy to immunotherapy
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  • Sacituzumab govitecan: breakthrough targeted therapy for triple-negative breast cancer
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    Expert Review of Anticancer Therapy.2019; 19(8): 673.     CrossRef
  • The role of capecitabine and eribulin in the treatment of metastatic HER2-negative metastatic breast cancer
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    Journal of Modern Oncology.2018; 20(3): 26.     CrossRef
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TAK-264 (MLN0264) in Previously Treated Asian Patients with Advanced Gastrointestinal Carcinoma Expressing Guanylyl Cyclase C: Results from an Open-Label, Non-randomized Phase 1 Study
Yung-Jue Bang, Toshimi Takano, Chia-Chi Lin, Adedigbo Fasanmade, Huyuan Yang, Hadi Danaee, Takayuki Asato, Thea Kalebic, Hui Wang, Toshihiko Doi
Cancer Res Treat. 2018;50(2):398-404.   Published online May 10, 2017
DOI: https://doi.org/10.4143/crt.2017.074
AbstractAbstract PDFPubReaderePub
Purpose
This phase 1 dose-escalation portion of the study evaluated the safety, pharmacokinetics (PK), and antitumor activity of TAK-264 in Asian patients with advanced gastrointestinal (GI) carcinoma or metastatic or recurrent gastric or gastroesophageal junction adenocarcinoma expressing guanylyl cyclase C (GCC).
Materials and Methods
Adult patients with advanced GI malignancies expressing GCC (H-score ≥ 10) received TAK-264 on day 1 of 3-week cycles as 30-minute intravenous infusions for up to 1 year or until disease progression or unacceptable toxicity. The primary objectives were to evaluate the safety profile including dose-limiting toxicities (DLTs) during cycle 1, determine the maximum tolerated dose (MTD), and characterize the PK profile of TAK-264.
Results
Twelve patients were enrolled and treated with 1.2 mg/kg (n=3), 1.5 mg/kg (n=3), or 1.8 mg/kg TAK-264 (n=6). Median number of treatment cycles received was two (range, 1 to 10). None of the patients experienced a DLT and the MTD was not determined. Ten patients (83%) experienced adverse events (AEs). The most common were neutropenia, anorexia, and nausea (each reported by four patients). Five patients (42%) experienced grade ≥ 3 AEs consisting of tumor hemorrhage and hypertension, ascites, adrenal insufficiency, neutropenia and asthenia. Serum exposure to TAK-264 increased proportionally with the dose and the median half-life was approximately 5.5-6.6 days. No patients experienced an objective response.
Conclusion
TAK-264 demonstrated a manageable safety profile with limited antitumor activity consistent with studies conducted in Western patients with advanced GI malignancies. TAK-264 exposure increased proportionally with the dose.

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  • Antibody–drug conjugates in gastric cancer: from molecular landscape to clinical strategies
    Jia-Lin Hao, Xin-Yun Li, Yu-Tong Liu, Ji-Xuan Lang, Di-Jie Liu, Chun-Dong Zhang
    Gastric Cancer.2024; 27(5): 887.     CrossRef
  • Asia‐Inclusive Clinical Research and Development Enabled by Translational Science and Quantitative Clinical Pharmacology: Toward a Culture That Challenges the Status Quo
    Karthik Venkatakrishnan, Neeraj Gupta, Patrick F. Smith, Tiffany Lin, Neil Lineberry, Tatiana Ishida, Lin Wang, Mark Rogge
    Clinical Pharmacology & Therapeutics.2023; 113(2): 298.     CrossRef
  • A phase I, first-in-human study of TAK-164, an antibody–drug conjugate, in patients with advanced gastrointestinal cancers expressing guanylyl cyclase C
    Richard Kim, Alexis D. Leal, Aparna Parikh, David P. Ryan, Shining Wang, Brittany Bahamon, Neeraj Gupta, Aaron Moss, Joanna Pye, Harry Miao, Haig Inguilizian, James M. Cleary
    Cancer Chemotherapy and Pharmacology.2023; 91(4): 291.     CrossRef
  • Guanylate cyclase-C Signaling Axis as a theragnostic target in colorectal cancer: a systematic review of literature
    Moein Piroozkhah, Ali Aghajani, Pooya Jalali, Arvin Shahmoradi, Mobin Piroozkhah, Younes Tadlili, Zahra Salehi
    Frontiers in Oncology.2023;[Epub]     CrossRef
  • Antibody-drug conjugates: Resurgent anticancer agents with multi-targeted therapeutic potential
    Claudia Ceci, Pedro Miguel Lacal, Grazia Graziani
    Pharmacology & Therapeutics.2022; 236: 108106.     CrossRef
  • Research Progress of Antibody–Drug Conjugate Therapy for Advanced Gastric Cancer
    Na Wang, Qingyun Mei, Ziwei Wang, Lu Zhao, Dou Zhang, Dongying Liao, Jinhui Zuo, Hongxia Xie, Yingjie Jia, Fanming Kong
    Frontiers in Oncology.2022;[Epub]     CrossRef
  • Antibody drug conjugates in gastrointestinal cancer: From lab to clinical development
    Davinder Singh, Divya Dheer, Abhilash Samykutty, Ravi Shankar
    Journal of Controlled Release.2021; 340: 1.     CrossRef
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Korean Cancer Patients’ Awareness of Clinical Trials, Perceptions on the Benefit and Willingness to Participate
Yoojoo Lim, Jee Min Lim, Won Jae Jeong, Kyung-Hun Lee, Bhumsuk Keam, Tae-Yong Kim, Tae Min Kim, Sae-Won Han, Do Youn Oh, Dong-Wan Kim, Tae-You Kim, Dae Seog Heo, Yung-Jue Bang, Seock-Ah Im
Cancer Res Treat. 2017;49(4):1033-1043.   Published online April 7, 2017
DOI: https://doi.org/10.4143/crt.2016.413
AbstractAbstract PDFPubReaderePub
Purpose
The purpose of this study was to assess current levels of awareness of clinical trials (CTs), perceptions regarding their benefits and willingness to participate to CTs among Korean cancer patients.
Materials and Methods
From December 2012 to August 2015, we distributed questionnaires to cancer patients receiving systemic anti-cancer therapy at Seoul National University Hospital, Seoul, Korea.
Results
A total of 397 out of 520 requested patients (76.3%) responded to the survey. Among the 397 patients, 62.5% were female and the median age was 52 years. Overall, 97.4% (387/397) answered that they have at least heard of CTs. When asked about their level of awareness, 23.8% (92/387) answered that they could more than roughly explain about CTs. The average visual analogue scale score of CT benefit in all patients was 6.43 (standard deviation, 2.20). Patients who were only familiar with the term without detailed knowledge of the contents had the least expectation of benefit from CTs (p=0.015). When asked about their willingness to participate in CTs, 56.7% (225/397) answered positively. Patients with higher levels of awareness of CTs showed higher willingness to participate (p < 0.001). Heavily treated patients and patients with previous experience regarding CTs also showed a higher willingness to participate (p < 0.001). The perceived benefit of CTs was higher in the group willing to participate (p=0.026).
Conclusion
The patient’s level of awareness regarding CTs was positively related to the positive perception and willingness to participate. Although the general awareness of CTs was high, a relatively large proportion of patients did not have accurate knowledge; therefore, proper and accurate patient education is necessary.

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  • Depression and anxiety among hemophilia patients enrolled in clinical trials: a multi-center cohort study
    Zhen Peng, Xiaoyu Zhu, Chongwei Wang, Mingfeng Zhou, Xiaoling Xu, Yin Chen
    Annals of Hematology.2023; 102(7): 1927.     CrossRef
  • Depression and anxiety in cancer patient enrolled in clinical trials with serious adverse events
    Zhen Peng, Chongwei Wang, Yubei Sun, Yan Ma, Jumei Wang, Fei Xu, Xiaoling Xu, Yin Chen
    Cancer Medicine.2023; 12(19): 20015.     CrossRef
  • Acceptance Factors and Psychological Investigation of Clinical Trials in Cancer Patients
    Jiangjie Sun, Jingyi Fang, Chenchen Zhang, Nannan Jia, Weiming Zhao, Jinjian Gao, Yingying Huang, Jiqing Hao, Liping Zhang, Carmen M Galvez-Sánchez
    Behavioural Neurology.2023; 2023: 1.     CrossRef
  • Understanding and attitudes of the Jordanian public about clinical research ethics
    Mera A Ababneh, Sayer I Al-Azzam, Karem Alzoubi, Abeer Rababa’h, Saddam Al Demour
    Research Ethics.2021; 17(2): 228.     CrossRef
  • A patient-focused, theory-guided approach to survey design identified barriers to and drivers of clinical trial participation
    Jamie C. Brehaut, Kelly Carroll, Justin Presseau, Dawn P. Richards, Jenn Gordon, Angèle Bénard, Natasha Hudek, Ian D. Graham, Dean A. Fergusson, Susan Marlin
    Journal of Clinical Epidemiology.2021; 132: 106.     CrossRef
  • Awareness of breast cancer patients in Poland about clinical trials as available treatment options
    Mikołaj Bartoszkiewicz, Joanna Kufel-Grabowska, Maria Litwiniuk
    Breast Disease.2021; 40(1): 33.     CrossRef
  • Results from a Theory-Guided Survey to Support Breast Cancer Trial Participation: Barriers, Enablers, and What to Do about them
    Jamie C. Brehaut, Kelly Carroll, Jenn Gordon, Justin Presseau, Dawn P. Richards, Dean A. Fergusson, Ian D. Graham, Susan Marlin
    Current Oncology.2021; 28(3): 2014.     CrossRef
  • Regional Differences in Access to Clinical Trials for Cancer in Korea
    Woorim Kim, Seongkyeong Jang, Yoon Jung Chang
    Quality Improvement in Health Care.2021; 27(1): 20.     CrossRef
  • How Cancer Patients Perceive Clinical Trials (CTs) in the Era of CTs: Current Perception and Its Differences Between Common and Rare Cancers
    Ji Hyun Park, Ji Sung Lee, HaYeong Koo, Jeong Eun Kim, Jin-Hee Ahn, Min-Hee Ryu, Sook-ryun Park, Shin-kyo Yoon, Jae Cheol Lee, Yong-Sang Hong, Sun Young Kim, Kyo-Pyo Kim, Chang-Hoon Yoo, Jung Yong Hong, Jae Lyun Lee, Kyung Hae Jung, Baek-Yeol Rhyoo, Tae W
    Journal of Cancer Education.2020; 35(3): 545.     CrossRef
  • Colorectal cancer survivors’ willingness to participate in a hypothetical clinical trial of Korean medicine: A cross-sectional study
    Yown Hwangbo, Gyung Mo Son, Kyung Hee Kim, Myeong Sook Kwon, Kun Hyung Kim
    European Journal of Integrative Medicine.2020; 33: 101033.     CrossRef
  • Perception and Satisfaction of Anticancer Drug Clinical Trials in Cancer Patients
    Ju Kyung Jeon, Jeong Hye Kim
    Asian Oncology Nursing.2019; 19(1): 18.     CrossRef
  • Challenges in informed consent decision-making in Korean clinical research: A participant perspective
    Im-Soon Choi, Eun Young Choi, Iyn-Hyang Lee, Dermot Cox
    PLOS ONE.2019; 14(5): e0216889.     CrossRef
  • Clinical Trials: What, Where, When?
    Olga S. Kobyakova, Ivan A. Deev, Evgeny S. Kulikov, Roman I. Shtykh, Igor D. Pimenov, Olga I. Zvonareva, Igor V. Mareev
    Annals of the Russian academy of medical sciences.2018; 73(5): 314.     CrossRef
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  • 11 Web of Science
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Topotecan-Vincristine-Doxorubicin in Stage 4 High-Risk Neuroblastoma Patients Failing to Achieve a Complete Metastatic Response to Rapid COJEC: A SIOPEN Study
Loredana Amoroso, Giovanni Erminio, Guy Makin, Andrew D. J. Pearson, Penelope Brock, Dominique Valteau-Couanet, Victoria Castel, Marlène Pasquet, Genevieve Laureys, Caroline Thomas, Roberto Luksch, Ruth Ladenstein, Riccardo Haupt, Alberto Garaventa, SIOPEN Group
Cancer Res Treat. 2018;50(1):148-155.   Published online March 21, 2017
DOI: https://doi.org/10.4143/crt.2016.511
AbstractAbstract PDFPubReaderePub
Purpose
Metastatic response to induction therapy for high-risk neuroblastoma is a prognostic factor. In the International Society of Paediatric Oncology Europe Neuroblastoma (SIOPEN) HR-NBL-1 protocol, only patients with metastatic complete response (CR) or partial response (PR) with ≤ three abnormal skeletal areas on iodine 123-metaiodobenzylguanidine ([123I]mIBG) scintigraphy and no bone marrow disease proceed to high dose therapy (HDT). In this study, topotecan-vincristine-doxorubicin (TVD) was evaluated in patients failing to achieve these criteria, with the aim of improving the metastatic response rate.
Materials and Methods
Patients with metastatic high-risk neuroblastoma who had not achieved the SIOPEN criteria for HDT after induction received two courses of topotecan 1.5 mg/m2/day for 5 days, followed by a 48-hour infusion of vincristine, 2 mg/m2, and doxorubicin, 45 mg/m2.
Results
Sixty-three patients were eligible and evaluable. Following two courses of TVD, four (6.4%) patients had an overall CR, while 28 (44.4%) had a PR with a combined response rate of 50.8% (95% confidence interval [CI], 37.9 to 63.6). Of these, 23 patients achieved a metastatic CR or a PR with ≤ 3 mIBG skeletal areas and no bone marrow disease (36.5%; 95% CI, 24.7 to 49.6) and were eligible to receive HDT. Toxicity was mostly haematological, affecting 106 of the 126 courses (84.1%; 95% CI, 76.5 to 90.0), and dose reduction was necessary in six patients. Stomatitis was the second most common nonhematological toxicity, occurring in 20 patients (31.7%).
Conclusion
TVD was effective in improving the response rate of high-risk neuroblastoma patients after induction with COJEC enabling them to proceed to HDT. However, the long-term benefits of TVD needs to be determined in randomized clinical trials.

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  • ALK signaling primes the DNA damage response sensitizing ALK-driven neuroblastoma to therapeutic ATR inhibition
    Marcus Borenäs, Ganesh Umapathy, Dan E. Lind, Wei-Yun Lai, Jikui Guan, Joel Johansson, Eva Jennische, Alexander Schmidt, Yeshwant Kurhe, Jonatan L. Gabre, Agata Aniszewska, Anneli Strömberg, Mats Bemark, Michael N. Hall, Jimmy Van den Eynden, Bengt Hallbe
    Proceedings of the National Academy of Sciences.2024;[Epub]     CrossRef
  • Development of red blood cell-derived extracellular particles as a biocompatible nanocarrier of microRNA-204 (REP-204) to harness anti-neuroblastoma effect
    Wararat Chiangjong, Jirawan Panachan, Sujitra Keadsanti, David S. Newburg, Ardythe L. Morrow, Suradej Hongeng, Somchai Chutipongtanate
    Nanomedicine: Nanotechnology, Biology and Medicine.2024; 60: 102760.     CrossRef
  • Elevated Expression of LGR5 and WNT Signaling Factors in Neuroblastoma Cells With Acquired Drug Resistance
    John Clark-Corrigall, Svetlana Myssina, Martin Michaelis, Jindrich Cinatl, Shafiq Ahmed, Jane Carr-Wilkinson
    Cancer Investigation.2023; 41(2): 173.     CrossRef
  • Computational intelligence analysis of high-risk neuroblastoma patient health records reveals time to maximum response as one of the most relevant factors for outcome prediction
    Davide Chicco, Riccardo Haupt, Alberto Garaventa, Paolo Uva, Roberto Luksch, Davide Cangelosi
    European Journal of Cancer.2023; 193: 113291.     CrossRef
  • Dinutuximab beta combined with chemotherapy in patients with relapsed or refractory neuroblastoma
    Aleksandra Wieczorek, Anna Zaniewska-Tekieli, Karoline Ehlert, Katarzyna Pawinska-Wasikowska, Walentyna Balwierz, Holger Lode
    Frontiers in Oncology.2023;[Epub]     CrossRef
  • Adaptation of the Th-MYCN Mouse Model of Neuroblastoma for Evaluation of Disseminated Disease
    Seyed M. Rahavi, Maryam Aletaha, Ali Farrokhi, Amanda Lorentzian, Philipp F. Lange, Christopher A. Maxwell, Chinten James Lim, Gregor S. D. Reid
    International Journal of Molecular Sciences.2023; 24(15): 12071.     CrossRef
  • Challenging diagnosis of Mycolicibacterium cosmeticum/canariasense infection: A case report and literature review
    Daniel Grupel, Orly Sagi, Israel Nissan, Rona Grossman, Motro Yair, Jacob Moran-Gilad, Dana Danino
    Journal of Clinical Tuberculosis and Other Mycobacterial Diseases.2023; 33: 100393.     CrossRef
  • Dinutuximab Beta Maintenance Therapy in Patients with High-Risk Neuroblastoma in First-Line and Refractory/Relapsed Settings—Real-World Data
    Aleksandra Wieczorek, Urszula Żebrowska, Marek Ussowicz, Agnieszka Sokół, Marzena Stypińska, Bożenna Dembowska-Bagińska, Katarzyna Pawińska-Wąsikowska, Walentyna Balwierz
    Journal of Clinical Medicine.2023; 12(16): 5252.     CrossRef
  • Characterization and therapeutic perspectives of differentiation-inducing therapy in malignant tumors
    Kangwei Zhu, Yuren Xia, Xindi Tian, Yuchao He, Jun Zhou, Ruyu Han, Hua Guo, Tianqiang Song, Lu Chen, Xiangdong Tian
    Frontiers in Genetics.2023;[Epub]     CrossRef
  • Early Salvage Chemo-Immunotherapy with Irinotecan, Temozolomide and Naxitamab Plus GM-CSF (HITS) for Patients with Primary Refractory High-Risk Neuroblastoma Provide the Best Chance for Long-Term Outcomes
    Juan Muñoz, Cristina Larrosa, Saray Chamorro, Sara Perez-Jaume, Margarida Simao, Nazaret Sanchez-Sierra, Amalia Varo, Maite Gorostegui, Alicia Castañeda, Moira Garraus, Sandra Lopez-Miralles, Jaume Mora
    Cancers.2023; 15(19): 4837.     CrossRef
  • Sustained Response to Entrectinib in an Infant With a Germline ALKAL2 Variant and Refractory Metastatic Neuroblastoma With Chromosomal 2p Gain and Anaplastic Lymphoma Kinase and Tropomyosin Receptor Kinase Activation
    Diana Treis, Ganesh Umapathy, Susanne Fransson, Jikui Guan, Patricia Mendoza-García, Joachim T. Siaw, Sandra Wessman, Lena Gordon Murkes, Jakob J. E. Stenman, Anna Djos, Lotta H. M. Elfman, John Inge Johnsen, Bengt Hallberg, Ruth H. Palmer, Tommy Martinss
    JCO Precision Oncology.2022;[Epub]     CrossRef
  • High-Risk Neuroblastoma: Poor Outcomes Despite Aggressive Multimodal Therapy
    Adil Abdelhamed Abbas, Alaa Mohammed Noor Samkari
    Current Cancer Therapy Reviews.2022; 18(1): 14.     CrossRef
  • Multi-omics integration reveals a six-malignant cell maker gene signature for predicting prognosis in high-risk neuroblastoma
    Zijun Yan, Qiming Liu, Ziyang Cao, Jinxia Wang, Hongyang Zhang, Jiangbin Liu, Lin Zou
    Frontiers in Neuroinformatics.2022;[Epub]     CrossRef
  • Dinutuximab beta plus conventional chemotherapy for relapsed/refractory high-risk neuroblastoma: A single-center experience
    Nur Olgun, Emre Cecen, Dilek Ince, Deniz Kizmazoglu, Birsen Baysal, Ayse Onal, Ozhan Ozdogan, Handan Guleryuz, Riza Cetingoz, Ayse Demiral, Mustafa Olguner, Ahmet Celik, Serra Kamer, Erdener Ozer, Zekiye Altun, Safiye Aktas
    Frontiers in Oncology.2022;[Epub]     CrossRef
  • Central nervous system relapse in high-risk stage 4 neuroblastoma: The HR-NBL1/SIOPEN trial experience
    P. Berlanga, C. Pasqualini, U. Pötschger, C. Sangüesa, M.R. Castellani, A. Cañete, R. Luksch, M. Elliot, G. Schreier, M. Kropf, D. Morgenstern, V. Papadakis, S. Ash, E. Ruud, P. Brock, A. Wieczorek, P. Kogner, T. Trahair, P. Ambros, T. Boterberg, V. Caste
    European Journal of Cancer.2021; 144: 1.     CrossRef
  • Survival in patients with high-risk neuroblastoma treated without autologous stem cell transplant or dinutuximab beta
    Richa Jain, Amita Trehan, Prema Menon, Rakesh Kapoor, Nandita Kakkar, Srinivasan Radhika, Akshay Kumar Saxena, Bhagwant Rai Mittal, Neelam Varma, Ram Samujh, Deepak Bansal
    Pediatric Hematology and Oncology.2021; 38(4): 291.     CrossRef
  • Neuroblastoma
    Christine Chung, Tom Boterberg, John Lucas, Joseph Panoff, Dominique Valteau‐Couanet, Barbara Hero, Rochelle Bagatell, Christine E. Hill‐Kayser
    Pediatric Blood & Cancer.2021;[Epub]     CrossRef
  • Effect of high-dose chemotherapy plus stem cell rescue on the survival of patients with neuroblastoma modified by MYCN gene gain/amplification and remission status: a nationwide registration study in Japan
    Yuya Saito, Mitsuyoshi Urashima, Yoshiyuki Takahashi, Atsushi Ogawa, Chikako Kiyotani, Yuki Yuza, Katsuyoshi Koh, Kenichiro Watanabe, Yoshiyuki Kosaka, Hiroaki Goto, Atsushi Kikuta, Keiko Okada, Yuhki Koga, Junya Fujimura, Masami Inoue, Atsushi Sato, Yosh
    Bone Marrow Transplantation.2021; 56(9): 2173.     CrossRef
  • Connectivity Map Analysis Indicates PI3K/Akt/mTOR Inhibitors as Potential Anti-Hypoxia Drugs in Neuroblastoma
    Paolo Uva, Maria Carla Bosco, Alessandra Eva, Massimo Conte, Alberto Garaventa, Loredana Amoroso, Davide Cangelosi
    Cancers.2021; 13(11): 2809.     CrossRef
  • Off-label drug use in paediatric haemato-oncology patients: financial implications and proposed solutions for Belgian patients
    T. Bauters, D. Heenen, K. Norga, A. Van Damme, A. Uyttebroeck, G. Laureys
    European Journal of Pediatrics.2021; 180(9): 3067.     CrossRef
  • Early Use of Dinutuximab Beta in Patients with High-Risk Neuroblastoma
    Neofit Spasov, Mariya Spasova, Stella Stabouli
    Case Reports in Pediatrics.2021; 2021: 1.     CrossRef
  • Randomized Trial of Two Induction Therapy Regimens for High-Risk Neuroblastoma: HR-NBL1.5 International Society of Pediatric Oncology European Neuroblastoma Group Study
    Alberto Garaventa, Ulrike Poetschger, Dominique Valteau-Couanet, Roberto Luksch, Victoria Castel, Martin Elliott, Shifra Ash, Godfrey C. F. Chan, Geneviève Laureys, Maja Beck-Popovic, Kim Vettenranta, Walentyna Balwierz, Henrik Schroeder, Cormac Owens, Ma
    Journal of Clinical Oncology.2021; 39(23): 2552.     CrossRef
  • Vincristine in Combination Therapy of Cancer: Emerging Trends in Clinics
    Jan Škubník, Vladimíra Svobodová Pavlíčková, Tomáš Ruml, Silvie Rimpelová
    Biology.2021; 10(9): 849.     CrossRef
  • Extending the Applicability of In Ovo and Ex Ovo Chicken Chorioallantoic Membrane Assays to Study Cytostatic Activity in Neuroblastoma Cells
    Miguel Angel Merlos Rodrigo, Berta Casar, Hana Michalkova, Ana Maria Jimenez Jimenez, Zbynek Heger, Vojtech Adam
    Frontiers in Oncology.2021;[Epub]     CrossRef
  • ATR inhibition enables complete tumour regression in ALK-driven NB mouse models
    Joanna Szydzik, Dan E. Lind, Badrul Arefin, Yeshwant Kurhe, Ganesh Umapathy, Joachim Tetteh Siaw, Arne Claeys, Jonatan L. Gabre, Jimmy Van den Eynden, Bengt Hallberg, Ruth H. Palmer
    Nature Communications.2021;[Epub]     CrossRef
  • Association of PARP1 polymorphisms with response to chemotherapy in patients with high‐risk neuroblastoma
    Marianna Avitabile, Vito Alessandro Lasorsa, Sueva Cantalupo, Antonella Cardinale, Flora Cimmino, Annalaura Montella, Dalila Capasso, Riccardo Haupt, Loredana Amoroso, Alberto Garaventa, Alessandro Quattrone, Maria Valeria Corrias, Achille Iolascon, Mario
    Journal of Cellular and Molecular Medicine.2020; 24(7): 4072.     CrossRef
  • Investigation of the Role of Dinutuximab Beta-Based Immunotherapy in the SIOPEN High-Risk Neuroblastoma 1 Trial (HR-NBL1)
    Ruth Ladenstein, Ulrike Pötschger, Dominique Valteau-Couanet, Roberto Luksch, Victoria Castel, Shifra Ash, Genevieve Laureys, Penelope Brock, Jean Marie Michon, Cormac Owens, Toby Trahair, Godfrey Chi Fung Chan, Ellen Ruud, Henrik Schroeder, Maja Beck-Pop
    Cancers.2020; 12(2): 309.     CrossRef
  • Extended induction chemotherapy does not improve the outcome for high-risk neuroblastoma patients: results of the randomized open-label GPOH trial NB2004-HR
    F. Berthold, A. Faldum, A. Ernst, J. Boos, D. Dilloo, A. Eggert, M. Fischer, M. Frühwald, G. Henze, T. Klingebiel, C. Kratz, B. Kremens, B. Krug, I. Leuschner, M. Schmidt, R. Schmidt, R. Schumacher-Kuckelkorn, D. von Schweinitz, F.H. Schilling, J. Theisse
    Annals of Oncology.2020; 31(3): 422.     CrossRef
  • Novel therapeutic strategies targeting telomere maintenance mechanisms in high-risk neuroblastoma
    S. L. George, V. Parmar, F. Lorenzi, L. V. Marshall, Y. Jamin, E. Poon, P. Angelini, L. Chesler
    Journal of Experimental & Clinical Cancer Research.2020;[Epub]     CrossRef
  • Influence of Surgical Excision on the Survival of Patients With Stage 4 High-Risk Neuroblastoma: A Report From the HR-NBL1/SIOPEN Study
    Keith Holmes, Ulrike Pötschger, Andrew D. J. Pearson, Sabine Sarnacki, Giovanni Cecchetto, Javier Gomez-Chacon, Roly Squire, Enrique Freud, Adam Bysiek, Lucas E. Matthyssens, Martin Metzelder, Tom Monclair, Jakob Stenman, Michal Rygl, Lars Rasmussen, Jean
    Journal of Clinical Oncology.2020; 38(25): 2902.     CrossRef
  • Development of differentiation modulators and targeted agents for treating neuroblastoma
    Zegao Jin, Yang Lu, Yizhe Wu, Jinxin Che, Xiaowu Dong
    European Journal of Medicinal Chemistry.2020; 207: 112818.     CrossRef
  • A promoter-driven assay for INSM1-associated signaling pathway in neuroblastoma
    Chiachen Chen, Michael S. Lan
    Cellular Signalling.2020; 76: 109785.     CrossRef
  • Evolving treatments in high-risk neuroblastoma
    Abhinav Kumar, John P J Rocke, B Nirmal Kumar
    Expert Opinion on Orphan Drugs.2020; 8(12): 497.     CrossRef
  • Drug Targeting the Actin Cytoskeleton Potentiates the Cytotoxicity of Low Dose Vincristine by Abrogating Actin-Mediated Repair of Spindle Defects
    Yao Wang, Jeffrey H. Stear, Ashleigh Swain, Xing Xu, Nicole S. Bryce, Michael Carnell, Irina B. Alieva, Vera B. Dugina, Timothy P. Cripe, Justine Stehn, Edna C. Hardeman, Peter W. Gunning
    Molecular Cancer Research.2020; 18(7): 1074.     CrossRef
  • Cardiac MRI: a Promising Diagnostic Tool to Detect Cancer Therapeutics–Related Cardiac Dysfunction
    Jasmin D. Haslbauer, Sarah Lindner, Gesine Bug, Eike Nagel, Valentina O. Puntmann
    Current Cardiovascular Imaging Reports.2019;[Epub]     CrossRef
  • Therapy intensification in high-risk neuroblastoma patients with poor response to standard induction: experience of Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology, Immunology
    T. V. Shamanskaya, D. Y. Kachanov, A. V. Dumacheva, M. V. Teleshova, D. V. Shevtcov, T. V. Sergeeva, A. M. Syleimanova, R. A. Moiseenko, Y. N. Likar, . Kailash, S. R. Varfolomeeva
    Pediatric Hematology/Oncology and Immunopathology.2019; 18(4): 19.     CrossRef
  • Molecular mechanisms and therapeutic targets in neuroblastoma
    John Inge Johnsen, Cecilia Dyberg, Susanne Fransson, Malin Wickström
    Pharmacological Research.2018; 131: 164.     CrossRef
  • Updated clinical and biological information from the two-stage phase II study of imatinib mesylate in subjects with relapsed/refractory neuroblastoma
    Fabio Morandi, Loredana Amoroso, Alessandra Dondero, Roberta Castriconi, Stefano Parodi, Roberto Luksch, Fiorina Casale, Aurora Castellano, Alberto Garaventa, Alessandro Moretta, Cristina Bottino, Mirco Ponzoni, Maria Valeria Corrias
    OncoImmunology.2018; 7(9): e1468953.     CrossRef
  • Dual BRD4 and AURKA Inhibition Is Synergistic against MYCN-Amplified and Nonamplified Neuroblastoma
    Joshua Felgenhauer, Laura Tomino, Julia Selich-Anderson, Emily Bopp, Nilay Shah
    Neoplasia.2018; 20(10): 965.     CrossRef
  • Prise en charge des neuroblastomes de haut risque : l’expérience du groupe européen SIOPEN
    Dominique Valteau-Couanet, Gudrun Schleiermacher, Sabine Sarnacki, Claudia Pasqualini
    Bulletin du Cancer.2018; 105(10): 918.     CrossRef
  • Novel Therapies for Relapsed and Refractory Neuroblastoma
    Peter E. Zage
    Children.2018; 5(11): 148.     CrossRef
  • Investigational drugs in phase II clinical trials for the treatment of neuroblastoma
    Loredana Amoroso, Riccardo Haupt, Alberto Garaventa, Mirco Ponzoni
    Expert Opinion on Investigational Drugs.2017; 26(11): 1281.     CrossRef
  • 11,652 View
  • 577 Download
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Feasibility and Efficacy of Eribulin Mesilate in Korean Patients with Metastatic Breast Cancer: Korean Multi-center Phase IV Clinical Study Results
Yeon Hee Park, Tae Yong Kim, Young-Hyuck Im, Keun-Seok Lee, In Hae Park, Joohyuk Sohn, Soo-Hyeon Lee, Seock-Ah Im, Jee Hyun Kim, Se Hyun Kim, Soo Jung Lee, Su-Jin Koh, Ki Hyeong Lee, Yoon Ji Choi, Eun Kyung Cho, Suee Lee, Seok Yun Kang, Jae Hong Seo, Sung-Bae Kim, Kyung Hae Jung
Cancer Res Treat. 2017;49(2):423-429.   Published online August 3, 2016
DOI: https://doi.org/10.4143/crt.2016.191
AbstractAbstract PDFPubReaderePub
Purpose
Eribulin mesilate was approved for the treatment of patients with locally advanced or metastatic breast cancer (MBC),who had received at least two chemotherapeutic regimens, including anthracycline and taxane. On the other hand, the efficacy and safety information of eribulin in Korean patients is limited by the lack of clinical trials.
Materials and Methods
In this multicenter, open-label, single-arm, phase IV study, locally advanced or MBC patients were enrolled between June 2013 and April 2014 from 14 centers in Korea. One point four mg/m2 dose of eribulin was administered on days 1 and 8 of every 21 days. The primary endpoint was the frequency and intensity of the treatment emergent adverse event. The secondary endpoint was the disease control rate, which included the rate of complete responses, partial responses, and stable disease.
Results
A total of 101 patients received at least one dose of eribulin and were included in the safety set. The patients received a total of 543 treatment cycles, with a median of three cycles (range, 1 to 31 cycles). The most common adverse event was neutropenia (91.1% of patients, 48.3% of cycles). The frequent non-hematological adverse events included alopecia, decrease in appetite, fatigue/asthenia, and myalgia/arthralgia. The peripheral neuropathy of any grade occurred in 27 patients (26.7%), including grade 3 in two patients. Disease control rate was 52.7% and 51.3% of patients in the full analysis set and per-protocol set, respectively.
Conclusion
This study demonstrated the feasible safety profile and activity of eribulin in Korean patients with MBC.

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  • Effectiveness and healthcare costs of eribulin versus capecitabine among metastatic breast cancer patients in Taiwan
    Yu-Ju Lin, Chun-Nan Kuo, Yu Ko
    The Breast.2021; 57: 18.     CrossRef
  • Prognostic and predictive factors of eribulin in patients with heavily pre-treated metastatic breast cancer
    Pei-Hsin Chen, Dah-Cherng Yeh, Heng-Hsin Tung, Chin-Yao Lin
    Medicine.2021; 100(47): e27859.     CrossRef
  • Multifarious targets beyond microtubules—role of eribulin in cancer therapy
    Priya Seshadri, Barnali Deb, Prashant Kumar
    Frontiers in Bioscience-Scholar.2021;[Epub]     CrossRef
  • A nationwide, multicenter retrospective study on the effectiveness and safety of eribulin in Korean breast cancer patients (REMARK)
    Min Ho Park, Soo Jung Lee, Woo Chul Noh, Chang Wan Jeon, Seok Won Lee, Gil Soo Son, Byung-In Moon, Jin Sun Lee, Sung Soo Kang, Young Jin Suh, Geumhee Gwak, Tae Hyun Kim, Young Bum Yoo, Hyun-Ah Kim, Min Young Kim, Ju Yeon Kim, Joon Jeong
    The Breast.2020; 54: 121.     CrossRef
  • Effect of eribulin on patients with metastatic breast cancer: multicenter retrospective observational study in Taiwan
    Kun-Ming Rau, Fu Ou-Yang, Ta-Chung Chao, Yao-Lung Kuo, Tsui-Fen Cheng, Tsu-Yi Chao, Dar-Ren Chen, Yen-Dun Tzeng, Being-Whey Wang, Chun-Yu Liu, Ming-Hung Hu, Yin-Che Lu, Wei-Jen Ou, Chin-Ho Kuo, Chieh-Han Chuang, Jung-Yu Kan, Fang-Ming Chen, Ming-Feng Hou
    Breast Cancer Research and Treatment.2018; 170(3): 583.     CrossRef
  • Incidence and clinical parameters associated with eribulin mesylate-induced peripheral neuropathy
    Bin Zhao, Hong Zhao, Jiaxin Zhao
    Critical Reviews in Oncology/Hematology.2018; 128: 110.     CrossRef
  • Angiomodulators in cancer therapy: New perspectives
    Lenka Varinska, Peter Kubatka, Jan Mojzis, Anthony Zulli, Katarina Gazdikova, Pavol Zubor, Dietrich Büsselberg, Martin Caprnda, Radka Opatrilova, Iveta Gasparova, Martin Klabusay, Martin Pec, Eitan Fibach, Mariusz Adamek, Peter Kruzliak
    Biomedicine & Pharmacotherapy.2017; 89: 578.     CrossRef
  • Eribulin in Advanced Breast Cancer: Safety, Efficacy and New Perspectives
    Ornella Garrone, Emanuela Miraglio, Anna Maria Vandone, Paola Vanella, Daniele Lingua, Marco C Merlano
    Future Oncology.2017; 13(30): 2759.     CrossRef
  • Incidence and relative risk of peripheral neuropathy in cancer patients treated with eribulin: a meta-analysis
    Ling Peng, Yun Hong, Xianghua Ye, Peng Shi, Junyan Zhang, Yina Wang, Qiong Zhao
    Oncotarget.2017; 8(67): 112076.     CrossRef
  • 11,711 View
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Phase II Study of Irinotecan and Cisplatin Combination Chemotherapy in Metastatic, Unresectable Esophageal Cancer
Miso Kim, Bhumsuk Keam, Tae-Min Kim, Hoon-Gu Kim, Jin-Soo Kim, Sung Sook Lee, Seong Hoon Shin, Min Kyoung Kim, Keon Uk Park, Dong-Wan Kim, Hwan Jung Yun, Jong Seok Lee, Dae Seog Heo
Cancer Res Treat. 2017;49(2):416-422.   Published online July 28, 2016
DOI: https://doi.org/10.4143/crt.2016.121
AbstractAbstract PDFPubReaderePub
Purpose
The objective of this multicenter phase II study was to evaluate the efficacy and safety of irinotecan and cisplatin combination chemotherapy in metastatic, unresectable esophageal cancer.
Materials and Methods
Patients were treated with irinotecan 65 mg/m2 and cisplatin 30 mg/m2 on days 1 and 8 of each 21-day treatment cycle. The primary endpoint was response rate, and secondary endpoints were survival, duration of response, initial metabolic response rate, and toxicity.
Results
A total of 27 patients with squamous cell histology were enrolled in the study. The median age of the patients was 61 years. The objective response rate of the 20 patients in the perprotocol group was 30.0% (90% confidence interval [CI], 13.2 to 46.9). The median follow-up duration was 10.0 months, and the median progression-free survival and overall survival were 4.5 months (95% CI, 1.6 to 6.2) and 8.8 months (95% CI, 4.7 to 10.5), respectively. Four of 13 patients (30.8%) evaluated showed initial metabolic response. The median duration of response for partial responders was 5.0 months (range, 3.4 to 8.0 months). The following grade 3/4 treatment-related hematologic toxicities were reported: neutropenia (40.7%), anaemia (22.2%), and thrombocytopenia (7.4%). Two patients experienced febrile neutropenia. The most common grade 3/4 non-hematologic toxicities were asthenia (14.8%) and diarrhoea (11.1%).
Conclusion
Irinotecan and cisplatin combination chemotherapy showed modest anti-tumour activity and manageable toxicity for patients with metastatic, unresectable esophageal cancer.

Citations

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  • Potent molecular-targeted therapies for advanced esophageal squamous cell carcinoma
    Akira Ooki, Hiroki Osumi, Keisho Chin, Masayuki Watanabe, Kensei Yamaguchi
    Therapeutic Advances in Medical Oncology.2023;[Epub]     CrossRef
  • Efficacy and safety of irinotecan combined with raltitrexed or irinotecan monotherapy for salvage chemotherapy of esophageal squamous cell cancer: A prospective, open label, randomized phase II study
    Xichao Dai, Leilei Tao, Jinqiu Wang, Wenjuan Wu, Weigang Bian, Xichun Dai, Surong Chen
    Cancer Medicine.2023; 12(15): 16108.     CrossRef
  • Cisplatin-based combination therapy for cancer
    Minerva, Amrita Bhat, Sonali Verma, Gresh Chander, Rajeshwer Singh Jamwal, Bhawani Sharma, Audesh Bhat, Taruna Katyal, Rakesh Kumar, Ruchi Shah
    Journal of Cancer Research and Therapeutics.2023; 19(3): 530.     CrossRef
  • The development and progress of nanomedicine for esophageal cancer diagnosis and treatment
    Xiaokun Li, Lingmin Chen, Siyuan Luan, Jianfeng Zhou, Xin Xiao, Yushang Yang, Chengyi Mao, Pinhao Fang, Longqi Chen, Xiaoxi Zeng, Huile Gao, Yong Yuan
    Seminars in Cancer Biology.2022; 86: 873.     CrossRef
  • Rh-Endostatin Plus Irinotecan/Cisplatin as Second-Line Therapy for Advanced Esophageal Squamous Cell Carcinoma: An Open-Label, Phase II Study
    Zhihuang Hu, Si Sun, Xinmin Zhao, Hui Yu, Xianghua Wu, Jialei Wang, Jianhua Chang, Huijie Wang
    The Oncologist.2022; 27(4): 253.     CrossRef
  • Study of PD-1 Inhibitors in Combination with Chemoradiotherapy/Chemotherapy in Patients with Esophageal Squamous Carcinoma
    Tianhui Wei, Wenqi Ti, Qingxu Song, Yufeng Cheng
    Current Oncology.2022; 29(5): 2920.     CrossRef
  • Combined treatment with niclosamide and camptothecin enhances anticancer effect in U87 MG human glioblastoma cells
    Laura Valdez, Benxu Cheng, Daniela Gonzalez, Reanna Rodriguez, Paola Campano, Andrew Tsin, Xiaoqian Fang
    Oncotarget.2022; 13(1): 642.     CrossRef
  • Nivolumab for esophageal squamous cell carcinoma and the predictive role of PD-L1 or CD8 expression in its therapeutic effect
    Jiyun Lee, Binnari Kim, Hyun Ae Jung, Yoon La Choi, Jong-Mu Sun
    Cancer Immunology, Immunotherapy.2021; 70(5): 1203.     CrossRef
  • Advances in Our Understanding of the Molecular Mechanisms of Action of Cisplatin in Cancer Therapy
    Paul B Tchounwou, Shaloam Dasari, Felicite K Noubissi, Paresh Ray, Sanjay Kumar
    Journal of Experimental Pharmacology.2021; Volume 13: 303.     CrossRef
  • SHR‐1316, an anti‐PD‐L1 antibody, plus chemotherapy as the first‐line treatment for advanced esophageal squamous cell carcinoma: A multicentre, phase 2 study
    Lan Mu, Yan Song, Kuaile Zhao, Ying Liu, Qingxia Fan, Xi Wang, Qun Li, Xiaopeng Wang, Jing Huang
    Thoracic Cancer.2021; 12(9): 1373.     CrossRef
  • Self-targeted polymersomal co-formulation of doxorubicin, camptothecin and FOXM1 aptamer for efficient treatment of non-small cell lung cancer
    Mahsa Shahriari, Seyed Mohammad Taghdisi, Khalil Abnous, Mohammad Ramezani, Mona Alibolandi
    Journal of Controlled Release.2021; 335: 369.     CrossRef
  • Clinical efficacy of irinotecan plus raltitrexed chemotherapy in refractory esophageal squamous cell cancer
    Min Liu, Qingqing Jia, Xiaolin Wang, Changjiang Sun, Jianqi Yang, Yanliang Chen, Ying Li, Lingfeng Min, Xizhi Zhang, Caiyun Zhu, Johannes Artiaga Gubat, Yong Chen
    Anti-Cancer Drugs.2020; 31(4): 403.     CrossRef
  • Jiawei Xianglian Decoction (JWXLD), a Traditional Chinese Medicine (TCM), Alleviates CPT‐11‐Induced Diarrhea in Mice
    Jinhua Lu, Zechen Lin, Siyu Huang, Yiwei Shen, Jing Jiang, Shengyou Lin, Oliver Micke
    Evidence-Based Complementary and Alternative Medicine.2020;[Epub]     CrossRef
  • Treatment of esophageal cancer with multiple liver metastases: a case experience of sustained complete response
    Jiangfang Wang, Chaoyang Xu
    Journal of International Medical Research.2020;[Epub]     CrossRef
  • Development of chemotherapeutics for unresectable advanced esophageal cancer
    Hiroshi Imazeki, Ken Kato
    Expert Review of Anticancer Therapy.2020; 20(12): 1083.     CrossRef
  • Phase II clinical trial using camrelizumab combined with apatinib and chemotherapy as the first‐line treatment of advanced esophageal squamous cell carcinoma
    Bo Zhang, Ling Qi, Xi Wang, Jianping Xu, Yun Liu, Lan Mu, Xingyuan Wang, Lidan Bai, Jing Huang
    Cancer Communications.2020; 40(12): 711.     CrossRef
  • Systemic treatment of advanced esophageal squamous cell carcinoma: chemotherapy, molecular-targeting therapy and immunotherapy
    Hidekazu Hirano, Ken Kato
    Japanese Journal of Clinical Oncology.2019; 49(5): 412.     CrossRef
  • Carboxylesterase and UDP‐glucuronosyltransferases mediated metabolism of irinotecan: In vitro and in vivo insights from quantitative ultra‐performance liquid chromatography–mass spectrometry analysis
    Yifeng Qin, An Kang, Guisheng Zhou, Huan Wang, Wei Wei, Yujie Cao, Yanyan Chen, Jing Wang, Yajun Shi, Yuping Tang, Jianqin Jiang
    Biomedical Chromatography.2018;[Epub]     CrossRef
  • A combination of irinotecan/cisplatinum and irinotecan/temozolomide or tumor-targeting Salmonella typhimurium A1-R arrest doxorubicin- and temozolomide-resistant myxofibrosarcoma in a PDOX mouse model
    Tasuku Kiyuna, Yasunori Tome, Takashi Murakami, Kentaro Miyake, Kentaro Igarashi, Kei Kawaguchi, Hiromichi Oshiro, Takashi Higuchi, Masuyo Miyake, Norihiko Sugisawa, Zhiying Zhang, Sahar Razmjooei, Sintawat Wangsiricharoen, Bartosz Chmielowski, Scott D. N
    Biochemical and Biophysical Research Communications.2018; 505(3): 733.     CrossRef
  • Human non‑small cell lung cancer cells can be sensitized to camptothecin by modulating autophagy
    Yi-Han Chiu, Shih-Hsien Hsu, Hsiao-Wei Hsu, Kuo-Chin Huang, Wangta Liu, Chang-Yi Wu, Wei-Pang Huang, Jeff Chen, Bing-Hung Chen, Chien-Chih Chiu
    International Journal of Oncology.2018;[Epub]     CrossRef
  • ECRG2 enhances the anti-cancer effects of cisplatin in cisplatin-resistant esophageal cancer cells via upregulation of p53 and downregulation of PNCA
    Xin-Fang Hou, Lin-Ping Xu, Hai-Yan Song, Shuai Li, Chen Wu, Ju-Feng Wang
    World Journal of Gastroenterology.2017; 23(10): 1796.     CrossRef
  • Combination of histoculture drug response assay and qPCR as an effective method to screen biomarkers for personalized chemotherapy in esophageal cancer
    Bin Wei, Jiru Wang, Xiaohui Zhang, Zhaoye Qian, Jingjing Wu, Yuan Sun, Qin Han, Li Wan, Jing Zhu, Yong Gao, Xiaofei Chen
    Oncology Letters.2017;[Epub]     CrossRef
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Induction of Apoptosis in Intestinal Toxicity to a Histone Deacetylase Inhibitor in a Phase I Study with Pelvic Radiotherapy
Erta Kalanxhi, Karianne Risberg, Imon S. Barua, Svein Dueland, Stein Waagene, Solveig Norheim Andersen, Solveig J. Pettersen, Jessica M. Lindvall, Kathrine Røe Redalen, Kjersti Flatmark, Anne Hansen Ree
Cancer Res Treat. 2017;49(2):374-386.   Published online July 28, 2016
DOI: https://doi.org/10.4143/crt.2016.080
AbstractAbstract PDFPubReaderePub
Purpose
When integrating molecularly targeted compounds in radiotherapy, synergistic effects of the systemic agent and radiation may extend the limits of patient tolerance, increasing the demand for understanding the pathophysiological mechanisms of treatment toxicity. In this Pelvic Radiation and Vorinostat (PRAVO) study, we investigated mechanisms of adverse effects in response to the histone deacetylase (HDAC) inhibitor vorinostat (suberoylanilide hydroxamic acid, SAHA) when administered as a potential radiosensitiser.
Materials and Methods
This phase I study for advanced gastrointestinal carcinoma was conducted in sequential patient cohorts exposed to escalating doses of vorinostat combined with standard-fractionated palliative radiotherapy to pelvic target volumes. Gene expression microarray analysis of the study patient peripheral blood mononuclear cells (PBMC) was followed by functional validation in cultured cell lines and mice treated with SAHA.
Results
PBMC transcriptional responses to vorinostat, including induction of apoptosis, were confined to the patient cohort reporting dose-limiting intestinal toxicities. At relevant SAHA concentrations, apoptotic features (annexin V staining and caspase 3/7 activation, but not poly-(ADP-ribose)-polymerase cleavage) were observed in cultured intestinal epithelial cells. Moreover, SAHA-treated mice displayed significant weight loss.
Conclusion
The PRAVO study design implemented a strategy to explore treatment toxicity caused by an HDAC inhibitor when combined with radiotherapy and enabled the identification of apoptosis as a potential mechanism responsible for the dose-limiting effects of vorinostat. To the best of our knowledge, this is the first report deciphering mechanisms of normal tissue adverse effects in response to an HDAC inhibitor within a combined-modality treatment regimen.

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  • Effect of MicroRNA-210 on the Growth of Ovarian Cancer Cells and the Efficacy of Radiotherapy
    Yinlong Zhao, Shirui Liu, Yu Wen, Lili Zhong
    Gynecologic and Obstetric Investigation.2021; 86(1-2): 71.     CrossRef
  • Valproic Acid Downregulates Cytokine Expression in Human Macrophages Infected with Dengue Virus
    Félix G. Delgado, Paola Cárdenas, Jaime E. Castellanos
    Diseases.2018; 6(3): 59.     CrossRef
  • Synthesis, cytotoxic activity, and mode of action of new Santacruzamate A analogs
    Silmara N. Andrade, Fernanda C. G. Evangelista, Diego Seckler, Deisielly R. Marques, Túlio R. Freitas, Renata R. Nunes, Júlia T. Oliveira, Rosy I. M. A. Ribeiro, Hélio B. Santos, Ralph G. Thomé, Alex G. Taranto, Fabio V. Santos, Gustavo H. R. Viana, Rossi
    Medicinal Chemistry Research.2018; 27(11-12): 2397.     CrossRef
  • Radiosensitization In Vivo by Histone Deacetylase Inhibition with No Increase in Early Normal Tissue Radiation Toxicity
    Blaz Groselj, Jia-Ling Ruan, Helen Scott, Jessica Gorrill, Judith Nicholson, Jacqueline Kelly, Selvakumar Anbalagan, James Thompson, Michael R.L. Stratford, Sarah J. Jevons, Ester M. Hammond, Cheryl L. Scudamore, Martin Kerr, Anne E. Kiltie
    Molecular Cancer Therapeutics.2018; 17(2): 381.     CrossRef
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Is there a "Trial Effect" on Outcome of Patients with Metastatic Renal Cell Carcinoma Treated with Sunitinib?
Daniel Keizman, Keren Rouvinov, Avishay Sella, Maya Gottfried, Natalie Maimon, Jenny J. Kim, Mario A. Eisenberger, Victoria Sinibaldi, Avivit Peer, Michael A. Carducci, Wilmosh Mermershtain, Raya Leibowitz-amit, Rony Weitzen, Raanan Berger
Cancer Res Treat. 2016;48(1):281-287.   Published online March 5, 2015
DOI: https://doi.org/10.4143/crt.2014.289
AbstractAbstract PDFPubReaderePub
Purpose
Studies suggested the existence of a ‘trial effect', in which for a given treatment, participation in a clinical trial is associated with a better outcome. Sunitinib is a standard treatment for metastatic renal cell carcinoma (mRCC). We aimed to study the effect of clinical trial participation on the outcome of mRCC patients treated with sunitinib, which at present, is poorly defined.
Materials and Methods
The records of mRCC patients treated with sunitinib between 2004-2013 in 7 centers across 2 countries were reviewed. We compared the response rate (RR), progression free survival (PFS), and overall survival (OS), between clinical trial participants (n=49) and a matched cohort of non-participants (n=49) who received standard therapy. Each clinical trial participant was individually matched with a non participant by clinicopathologic factors. PFS and OS were determined by Cox regression.
Results
The groups were matched by age (median 64), gender (male 67%), Heng risk (favorable 25%, intermediate 59%, poor 16%), prior nephrectomy (92%), RCC histology (clear cell 86%), pre-treatment NLR (>3 in 55%, n=27), sunitinib induced hypertension (45%), and sunitinib dose reduction/treatment interruption (41%). In clinical trial participants versus non-participants, RR was partial response/stable disease 80% (n=39) versus 74% (n=36), and progressive disease 20% (n=10) versus 26% (n=13) (p=0.63, OR 1.2). The median PFS was 10 versus 11 months (HR=0.96, p=0.84), and the median OS 23 versus 24 months (HR=0.97, p=0.89).
Conclusions
In mRCC patients treated with sunitinib, the outcome of clinical trial participants was similar to that of non-participants who received standard therapy.

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  • Clinical characteristics and outcomes of patients enrolled in clinical trials compared with those of patients outside clinical trials in advanced gastric cancer
    Jae Joon Han, Jin Won Kim, Koung Jin Suh, Ji‐won Kim, Se Hyun Kim, Yu Jung Kim, Jee Hyun Kim, Jong Seok Lee, Keun‐Wook Lee
    Asia-Pacific Journal of Clinical Oncology.2019; 15(3): 158.     CrossRef
  • Participants in a randomized controlled trial had longer overall survival than non-participants: a prospective cohort study
    Shinji Ohno, Hirofumi Mukai, Kazutaka Narui, Yasuo Hozumi, Yasuo Miyoshi, Hiroshi Yoshino, Hiroyoshi Doihara, Akihiko Suto, Motoshi Tamura, Takashi Morimoto, Hisamitsu Zaha, Takashi Chishima, Reiki Nishimura, Takashi Ishikawa, Yukari Uemura, Yasuo Ohashi
    Breast Cancer Research and Treatment.2019; 176(3): 631.     CrossRef
  • Long-term response to sunitinib: everolimus treatment in metastatic clear cell renal cell carcinoma
    Anna M Czarnecka, Paweł Sobczuk, Jan Korniluk, Marta Spychalska, Krzysztof Bogusz, Anna Owczarek, Anna Brodziak, Dominika Labochka, Barbara Moszczuk, Cezary Szczylik
    Future Oncology.2017; 13(1): 31.     CrossRef
  • Assessment of ethnic differences in sunitinib outcome between Caucasian and Asian patients with metastatic renal cell carcinoma: a meta-analysis
    Xiaoyan Liu, Marta Fiocco, Jesse J. Swen, Henk-Jan Guchelaar
    Acta Oncologica.2017; 56(4): 582.     CrossRef
  • Eligibility for phase 3 clinical trials of systemic therapy in real-world patients with metastatic renal cell cancer managed in a rural region
    Carsten Nieder, Mohsan A. Syed, Astrid Dalhaug, Adam Pawinski, Jan Norum
    Medical Oncology.2017;[Epub]     CrossRef
  • Overexpression of the YAP1 oncogene in clear cell renal cell carcinoma is associated with poor outcome
    Agnieszka Rybarczyk, Jakub Klacz, Agata Wronska, Marcin Matuszewski, Zbigniew Kmiec, Piotr M. Wierzbicki
    Oncology Reports.2017; 38(1): 427.     CrossRef
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  • 8 Web of Science
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Current Status and Challenges of Cancer Clinical Trials in Korea
Byoung Yong Shim, Se Hoon Park, Soonil Lee, Jin-Soo Kim, Kyoung Eun Lee, Yoon-Koo Kang, Myung-Ju Ahn
Cancer Res Treat. 2016;48(1):20-27.   Published online March 2, 2015
DOI: https://doi.org/10.4143/crt.2014.317
AbstractAbstract PDFPubReaderePub
Purpose
Cancer clinical trials in Korea have rapidly progressed in terms of quantity and quality during the last decade. This study evaluates the current status of cancer clinical trials in Korea and their associated problems. Materials and Methods We analyzed the clinical trials approved by the Korea Food and Drug Administration (KFDA) between 2007 and 2013. A nationwide on-line survey containing 22 questions was also performed with several cooperative study groups and individual researchers in 56 academic hospitals.
Results
The number of cancer clinical trials approved by the KFDA increased almost twofold from 2007 to 2013. The number of sponsor-initiated clinical trials (SITs) increased by 50% and investigator-initiated clinical trials (IITs) increased by almost 640%. Three hundred and fortyfour clinical trials were approved by the KFDA between 2012 and 2013. At the time of the on-line survey (August 2013), 646 SITs and 519 IITs were ongoing in all hospitals. Six high volume hospitals were each conducting more than 50 clinical trials, including both SITs and IITs. Fifty-six investigators (31%) complained of the difficulties in raising funds to conduct clinical trials. Conclusion The number of cancer clinical trials in Korea rapidly increased from 2007 to 2013, as has the number of multicenter clinical trials and IITs run by cooperative study groups. Limited funding for IIT is a serious problem, and more financial support is needed both from government agencies and public donations from non-profit organizations.

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  • Trends of clinical trials from 2017 to 2019 in Korea: an integrated analysis based on the Ministry of Food and Drug Safety (MFDS) and the Clinical Research Information Service (CRIS) registries
    Ki Young Huh, Kyung-Sang Yu, Hyeong-Seok Lim, Hyungsub Kim
    Translational and Clinical Pharmacology.2021; 29(4): 186.     CrossRef
  • Regional Differences in Access to Clinical Trials for Cancer in Korea
    Woorim Kim, Seongkyeong Jang, Yoon Jung Chang
    Quality Improvement in Health Care.2021; 27(1): 20.     CrossRef
  • Effects of pharmacist interventions on reducing prescribing errors of investigational drugs in oncology clinical trials
    Jin Young Moon, Yeonhong Lee, Ji Min Han, Mi Hyung Lee, Jeong Yee, Mi Kyung Song, Young Ju Kim, Hye Sun Gwak
    Journal of Oncology Pharmacy Practice.2020; 26(1): 29.     CrossRef
  • Anticancer Agents Based on Vulnerable Components in a Signalling Pathway
    Ankur Vaidya, Shweta Jain, Sanjeev Sahu, Pankaj Kumar Jain, Kamla Pathak, Devender Pathak, Raj Kumar, Sanjay Kumar Jain
    Mini-Reviews in Medicinal Chemistry.2020; 20(10): 886.     CrossRef
  • Linguistic Validation of the US National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in Korean
    Juhee Cho, Junghee Yoon, Youngha Kim, Dongryul Oh, Seok Jin Kim, Jinseok Ahn, Gee Young Suh, Seok Jin Nam, Sandra A. Mitchell
    Journal of Global Oncology.2019; (5): 1.     CrossRef
  • Survey of Medical Oncology Status in Korea (SOMOS-K): A National Survey of Medical Oncologists in the Korean Association for Clinical Oncology (KACO)
    Do Yeun Kim, Yun Gyoo Lee, Bong-Seog Kim
    Cancer Research and Treatment.2017; 49(3): 588.     CrossRef
  • Korean Cancer Patients’ Awareness of Clinical Trials, Perceptions on the Benefit and Willingness to Participate
    Yoojoo Lim, Jee Min Lim, Won Jae Jeong, Kyung-Hun Lee, Bhumsuk Keam, Tae-Yong Kim, Tae Min Kim, Sae-Won Han, Do Youn Oh, Dong-Wan Kim, Tae-You Kim, Dae Seog Heo, Yung-Jue Bang, Seock-Ah Im
    Cancer Research and Treatment.2017; 49(4): 1033.     CrossRef
  • 11,226 View
  • 129 Download
  • 7 Web of Science
  • 7 Crossref
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Phase I Study of CKD-516, a Novel Vascular Disrupting Agent, in Patients with Advanced Solid Tumors
Do-Youn Oh, Tae-Min Kim, Sae-Won Han, Dong-Yeop Shin, Yun Gyoo Lee, Keun-Wook Lee, Jee Hyun Kim, Tae-You Kim, In-Jin Jang, Jong-Seok Lee, Yung-Jue Bang
Cancer Res Treat. 2016;48(1):28-36.   Published online February 23, 2015
DOI: https://doi.org/10.4143/crt.2014.258
AbstractAbstract PDFPubReaderePub
Purpose
CKD-516 is a newly developed vascular disrupting agent. This phase I dose-escalation study of CKD-516 was conducted to determine maximum-tolerated dose (MTD), safety, pharmacokinetics, and preliminary antitumor efficacy in patients with advanced solid tumors. Materials and Methods Patients received CKD-516 intravenously on D1 and D8 every 3 weeks, in a standard 3+3 design. Safety was evaluated by National Cancer Institute Common Terminology Criteria for Adverse Events ver. 4.02 and response was assessed by Response Evaluation Criteria in Solid Tumor ver. 1.1.
Results
Twenty-three patients were treated with CKD-516 at seven dosing levels: 1 mg/m2/day (n=3), 2 mg/m2/day (n=3), 3.3 mg/m2/day (n=3), 5 mg/m2/day (n=3), 7 mg/m2/day (n=3), 9 mg/m2/day (n=6), and 12 mg/m2/day (n=2). Mean age was 54 and 56.5% of patients were male. Two dose-limiting toxicities, which were both grade 3 hypertension, were observed in two patients at 12 mg/m2/day. The MTD was determined as 12 mg/m2/day. Most common adverse events were gastrointestinal adverse events (diarrhea, 34.8% [30.4% grade 1/2, 13.0% grade 3]; nausea, 21.7% [all grade 1/2]; vomiting, 21.7% [all grade 1/2]), myalgia (17.4%, all grade 1/2), and abdominal pain (21.7% [21.7% grade 1/2, 4.3% grade 3]). The pharmacokinetic study showed the dose-linearity of all dosing levels. Among 23 patients, six patients (26.1%) showed stable disease. Median progression-free survival was 39 days (95% confidence interval, 37 to 41 days). Conclusion This study demonstrates feasibility of CKD-516, novel vascular disrupting agent, in patients with advanced solid tumor. MTD of CKD-516 was defined as 12 mg/m2/day on D1 and D8 every 3 weeks.

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    Vajja Krishna Rao, Anvesh Ashtam, Dulal Panda, Sankar K. Guchhait
    ChemMedChem.2024;[Epub]     CrossRef
  • Thiazole, Isatin and Phthalimide Derivatives Tested in vivo against Cancer Models: A Literature Review of the Last Six Years
    Aline Ferreira Pinto, Janine Siqueira Nunes, José Eduardo Severino Martins, Amanda Calazans Leal, Carla Cauanny Vieira Costa Silva, Anderson José Firmino Santos da Silva, Daiane Santiago da Cruz Olímpio, Elineide Tayse Noberto da Silva, Thiers Araújo Camp
    Current Medicinal Chemistry.2024; 31(20): 2991.     CrossRef
  • CKD-516 potentiates the anti-cancer activity of docetaxel against epidermal growth factor receptor tyrosine kinase inhibitor-resistant lung cancer
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    Pharmacology Research & Perspectives.2020;[Epub]     CrossRef
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  • Discovery of tertiary amide derivatives incorporating benzothiazole moiety as anti-gastric cancer agents in vitro via inhibiting tubulin polymerization and activating the Hippo signaling pathway
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    European Journal of Medicinal Chemistry.2020; 203: 112618.     CrossRef
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    BMC Cancer.2020;[Epub]     CrossRef
  • Discovery and optimization of 3,4,5-trimethoxyphenyl substituted triazolylthioacetamides as potent tubulin polymerization inhibitors
    Fang Yang, Cai-Ping He, Peng-Cheng Diao, Kwon Ho Hong, Jin-Jun Rao, Pei-Liang Zhao
    Bioorganic & Medicinal Chemistry Letters.2019; 29(1): 22.     CrossRef
  • Vascular Disrupting Agents in cancer treatment: Cardiovascular toxicity and implications for co-administration with other cancer chemotherapeutics
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    Pharmacology & Therapeutics.2019; 202: 18.     CrossRef
  • Combretastatin A4 Nanoparticles Combined with Hypoxia-Sensitive Imiquimod: A New Paradigm for the Modulation of Host Immunological Responses during Cancer Treatment
    Na Shen, Jing Wu, Chenguang Yang, Haiyang Yu, Shengcai Yang, Tete Li, Jingtao Chen, Zhaohui Tang, Xuesi Chen
    Nano Letters.2019; 19(11): 8021.     CrossRef
  • Recent advances in trimethoxyphenyl (TMP) based tubulin inhibitors targeting the colchicine binding site
    Ling Li, Sibo Jiang, Xiaoxun Li, Yao Liu, Jing Su, Jianjun Chen
    European Journal of Medicinal Chemistry.2018; 151: 482.     CrossRef
  • Combination of anti-vascular agent - DMXAA and HIF-1α inhibitor - digoxin inhibits the growth of melanoma tumors
    Ryszard Smolarczyk, Tomasz Cichoń, Ewelina Pilny, Magdalena Jarosz-Biej, Aleksandra Poczkaj, Natalia Kułach, Stanisław Szala
    Scientific Reports.2018;[Epub]     CrossRef
  • Chemoembolization with Vascular Disrupting Agent CKD-516 Dissolved in Ethiodized Oil in Combination with Doxorubicin: A VX2 Tumor Model Study
    In Joon Lee, Myungsu Lee, Soo Jin Kim, You Kyung Kim, Jong Yun Won, Jin Wook Chung
    Journal of Vascular and Interventional Radiology.2018; 29(8): 1078.     CrossRef
  • Enhanced efficacy of radiofrequency ablation for hepatocellular carcinoma using a novel vascular disrupting agent, CKD-516
    Su Jung Ham, YoonSeok Choi, Seul-I Lee, Jinil Kim, Young Il Kim, Jin Wook Chung, Kyung Won Kim
    Hepatology International.2017; 11(5): 446.     CrossRef
  • Early investigational tubulin inhibitors as novel cancer therapeutics
    Kunal Nepali, Ritu Ojha, Hsueh-Yun Lee, Jing-Ping Liou
    Expert Opinion on Investigational Drugs.2016; 25(8): 917.     CrossRef
  • Blocking Blood Flow to Solid Tumors by Destabilizing Tubulin: An Approach to Targeting Tumor Growth
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    Journal of Medicinal Chemistry.2016; 59(19): 8685.     CrossRef
  • Current Advances of Tubulin Inhibitors in Nanoparticle Drug Delivery and Vascular Disruption/Angiogenesis
    Souvik Banerjee, Dong-Jin Hwang, Wei Li, Duane Miller
    Molecules.2016; 21(11): 1468.     CrossRef
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Phase I Study of Axitinib in Combination with Cisplatin and Capecitabine in Patients with Previously Untreated Advanced Gastric Cancer
Do-Youn Oh, Toshihiko Doi, Kuniaki Shirao, Keun-Wook Lee, Sook Ryun Park, Ying Chen, Liqiang Yang, Olga Valota, Yung-Jue Bang
Cancer Res Treat. 2015;47(4):687-696.   Published online February 12, 2015
DOI: https://doi.org/10.4143/crt.2014.225
AbstractAbstract PDFPubReaderePub
Purpose
This phase I trial evaluated the question of whether the standard starting dose of axitinib could be administered in combination with therapeutic doses of cisplatin/capecitabine in patients with previously untreated advanced gastric cancer, and assessed overall safety, pharmacokinetics, and preliminary antitumor activity of this combination.
Materials and Methods
Patients in dose level (DL) 1 received axitinib 5 mg twice a day (days 1 to 21) with cisplatin 80 mg/m2 (day 1) and capecitabine 1,000 mg/m2 twice a day (days 1 to 14) in 21-day cycles. Maximum tolerated dose (MTD) was the highest dose at which ≤ 30% of the first 12 patients experienced a dose-limiting toxicity (DLT) during cycle 1. Ten additional patients were enrolled and treated at the MTD in order to obtain additional safety and pharmacokinetic data.
Results
Three DLTs occurred during cycle 1 in three (25%) of the first 12 patients: ruptured abdominal aortic aneurysm, acute renal failure, and > 5 consecutive days of missed axitinib due to thrombocytopenia. DL1 was established as the MTD, since higher DL cohorts were not planned. Common grade 3/4 non-hematologic adverse events in 22 patients treated at DL1 included hypertension (36.4%) and decreased appetite and stomatitis (18.2% each). Cisplatin/capecitabine slightly increased axitinib exposure; axitinib decreased capecitabine and 5-fluorouracil exposure. Eight patients (36.4%) each had partial response or stable disease. Median response duration was 9.1 months; median progression-free survival was 3.8 months.
Conclusion
In patients with advanced gastric cancer, standard doses of axitinib plus therapeutic doses of cisplatin and capecitabine could be administered in combination. Adverse events were manageable.

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  • Construction of a hypoxia-immune-related prognostic panel based on integrated single-cell and bulk RNA sequencing analyses in gastric cancer
    Cuncan Deng, Guofei Deng, Hongwu Chu, Songyao Chen, Xiancong Chen, Xing Li, Yulong He, Chunhui Sun, Changhua Zhang
    Frontiers in Immunology.2023;[Epub]     CrossRef
  • Early TP53 Alterations Shape Gastric and Esophageal Cancer Development
    Pranshu Sahgal, Brandon M. Huffman, Deepa T. Patil, Walid K. Chatila, Rona Yaeger, James M. Cleary, Nilay S. Sethi
    Cancers.2021; 13(23): 5915.     CrossRef
  • High ELK3 Expression is Associated with the VEGF-C/VEGFR-3 Axis and Gastric Tumorigenesis and Enhances Infiltration of M2 Macrophages
    Wang Dazhi, Jiao Zheng, Ren Chunling
    Future Medicinal Chemistry.2020; 12(24): 2209.     CrossRef
  • RETRACTED: Long non-coding RNA LINC00978 promotes cell proliferation and tumorigenesis via regulating microRNA-497/NTRK3 axis in gastric cancer
    Ju-Yuan Bu, Wei-Ze Lv, Yi-Feng Liao, Xiao-Yu Xiao, Bao-Jun Lv
    International Journal of Biological Macromolecules.2019; 123: 1106.     CrossRef
  • RETRACTED ARTICLE: Anti-gastric cancer effect of Salidroside through elevating miR-99a expression
    Lin Yang, Yanan Yu, Qi Zhang, Xiaoyu Li, Cuiping Zhang, Tao Mao, Siliang Liu, Zibin Tian
    Artificial Cells, Nanomedicine, and Biotechnology.2019; 47(1): 3500.     CrossRef
  • Stomatitis and VEGFR-Tyrosine Kinase Inhibitors (VR-TKIs): A Review of Current Literature in 4369 Patients
    Claudia Arena, Giuseppe Troiano, Alfredo De Lillo, Nunzio F. Testa, Lorenzo Lo Muzio
    BioMed Research International.2018; 2018: 1.     CrossRef
  • Anti-angiogenic Therapy in Patients with Advanced Gastric and Gastroesophageal Junction Cancer: A Systematic Review
    Li-Tzong Chen, Do-Youn Oh, Min-Hee Ryu, Kun-Huei Yeh, Winnie Yeo, Roberto Carlesi, Rebecca Cheng, Jongseok Kim, Mauro Orlando, Yoon-Koo Kang
    Cancer Research and Treatment.2017; 49(4): 851.     CrossRef
  • Angiogenesis inhibitors in early development for gastric cancer
    Mauricio P. Pinto, Gareth I. Owen, Ignacio Retamal, Marcelo Garrido
    Expert Opinion on Investigational Drugs.2017; 26(9): 1007.     CrossRef
  • HER2-induced metastasis is mediated by AKT/JNK/EMT signaling pathway in gastric cancer
    Yiseul Choi, Young San Ko, Jin Ju Park, Youngsun Choi, Younghoon Kim, Jung-Soo Pyo, Bo Gun Jang, Douk Ho Hwang, Woo Ho Kim, Byung Lan Lee
    World Journal of Gastroenterology.2016; 22(41): 9141.     CrossRef
  • 15,089 View
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Review Article
The Role of Stereotactic Ablative Radiotherapy for Early-Stage and Oligometastatic Non-small Cell Lung Cancer: Evidence for Changing Paradigms
Max Dahele, Suresh Senan
Cancer Res Treat. 2011;43(2):75-82.   Published online June 30, 2011
DOI: https://doi.org/10.4143/crt.2011.43.2.75
AbstractAbstract PDFPubReaderePub
A compelling body of non-randomized evidence has established stereotactic ablative lung radiotherapy (SABR) as a standard of care for medically inoperable patients with peripheral early-stage non-small cell lung cancer (NSCLC). This convenient outpatient therapy, which is typically delivered in 3-8 fractions, is also well tolerated by elderly and frail patients, makes efficient use of resources and is feasible using standard commercial equipment. The introduction of lung SABR into large populations has led to an increased utilization of radiotherapy, a reduction in the proportion of untreated patients and an increase in overall survival. In selected patients, the same ablative technology can now achieve durable local control of NSCLC metastases in a variety of common locations including the adrenal glands, bone, brain, and liver. At the same time as this, advances in prognostic molecular markers and targeted systemic therapies mean that there is now a subgroup of patients with stage IV NSCLC and a median survival of around 2 years. This creates opportunities for new trials that incorporate SABR and patient-specific systemic strategies. This selective mini-review focuses on the emerging role of SABR in patients with early-stage and oligometastatic NSCLC.

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  • Navigating patient journey in early diagnosis of lung cancer in India
    Bivas Biswas, Deepak Talwar, Priti Meshram, Pramod K. Julka, Anurag Mehta, SP Somashekhar, Srinivas Chilukuri, Abhishek Bansal
    Lung India.2023; 40(1): 48.     CrossRef
  • Design, Synthesis and Anticancer Evaluation of Nitroimidazole Radiosensitisers
    Lydia P. Liew, Avik Shome, Way W. Wong, Cho R. Hong, Kevin O. Hicks, Stephen M. F. Jamieson, Michael P. Hay
    Molecules.2023; 28(11): 4457.     CrossRef
  • Breast Metastasis of Lung Cancer After Computed Tomography-Guided Core Needle Biopsy: A Case Report
    Rong Zhao, Jun Xing, Jinnan Gao
    Frontiers in Surgery.2022;[Epub]     CrossRef
  • Radiosurgery and fractionated stereotactic radiotherapy in oligometastatic/oligoprogressive non-small cell lung cancer patients: Results of a multi-institutional series of 198 patients treated with “curative” intent
    Michela Buglione, Barbara Alicja Jereczek-Fossa, Marco Lorenzo Bonù, Davide Franceschini, Andrei Fodor, Isa Bossi Zanetti, Marianna Alessandra Gerardi, Paolo Borghetti, Davide Tomasini, Nadia Gisella Di Muzio, Olga Oneta, Marta Scorsetti, Ciro Franzese, P
    Lung Cancer.2020; 141: 1.     CrossRef
  • Staging Lung Cancer
    Girish S. Shroff, Chitra Viswanathan, Brett W. Carter, Marcelo F. Benveniste, Mylene T. Truong, Bradley S. Sabloff
    Radiologic Clinics of North America.2018; 56(3): 411.     CrossRef
  • Stereotactic Body Radiation Therapy for Early-Stage Non–Small Cell Lung Cancer: A Primer for Radiologists
    Jennifer A. Febbo, Ramya S. Gaddikeri, Palmi N. Shah
    RadioGraphics.2018; 38(5): 1312.     CrossRef
  • Preliminary comparison of the registration effect of 4D-CBCT and 3D-CBCT in image-guided radiotherapy of Stage IA non–small-cell lung cancer
    Zhibo Tan, Chuanyao Liu, Ying Zhou, Weixi Shen
    Journal of Radiation Research.2017; 58(6): 854.     CrossRef
  • Narcissus, the Beam, and lung cancer
    Gaetano Rocco
    The Journal of Thoracic and Cardiovascular Surgery.2016; 152(2): 338.     CrossRef
  • Efficacy of stereotactic radiotherapy for brain metastases using dynamic jaws technology in the helical tomotherapy system
    Taro Murai, Akihiro Hayashi, Yoshihiko Manabe, Chikao Sugie, Taiki Takaoka, Takeshi Yanagi, Tetsuya Oguri, Masayuki Matsuo, Yoshimasa Mori, Yuta Shibamoto
    The British Journal of Radiology.2016; 89(1066): 20160374.     CrossRef
  • Targeting tumour hypoxia to prevent cancer metastasis. From biology, biosensing and technology to drug development: the METOXIA consortium
    Erik O. Pettersen, Peter Ebbesen, Roben G. Gieling, Kaye J. Williams, Ludwig Dubois, Philippe Lambin, Carol Ward, James Meehan, Ian H. Kunkler, Simon P. Langdon, Anne H. Ree, Kjersti Flatmark, Heidi Lyng, Maria J. Calzada, Luis del Peso, Manuel O. Landazu
    Journal of Enzyme Inhibition and Medicinal Chemistry.2015; 30(5): 689.     CrossRef
  • Monte Carlo validation of the TrueBeam 10XFFF phase–space files for applications in lung SABR
    Tony Teke, Cheryl Duzenli, Alanah Bergman, Francis Viel, Parmveer Atwal, Ermias Gete
    Medical Physics.2015; 42(12): 6863.     CrossRef
  • Stratégies d’évaluation de la réponse après irradiation stéréotaxique des cancers bronchiques primitifs et des métastases pulmonaires
    I. Barillot, O. Munier, M. Hatime, F. Mornex
    Cancer/Radiothérapie.2014; 18(4): 308.     CrossRef
  • Short-Course Treatment With Gefitinib Enhances Curative Potential of Radiation Therapy in a Mouse Model of Human Non-Small Cell Lung Cancer
    Sivan M. Bokobza, Yanyan Jiang, Anika M. Weber, Aoife M. Devery, Anderson J. Ryan
    International Journal of Radiation Oncology*Biology*Physics.2014; 88(4): 947.     CrossRef
  • Can an alternative backround-corrected [18F] fluorodeoxyglucose (FDG) standard uptake value (SUV) be used for monitoring tumor local control following lung cancer stereotactic body radiosurgery?
    Charles Shang, Michael Kasper, Vindu Kathriarachchi, Rashmi Benda, Joseph Kleinman, Jeremy Cole, Timothy Williams
    International Journal of Cancer Therapy and Oncology.2014; 2(3): 020317.     CrossRef
  • Stereotactic ablative body radiotherapy combined with immunotherapy: Present status and future perspectives
    N.H. Rekers, E.G.C. Troost, C.M.L. Zegers, W.T.V. Germeraad, L.J. Dubois, P. Lambin
    Cancer/Radiothérapie.2014; 18(5-6): 391.     CrossRef
  • Cáncer de pulmón
    P. Resano Barrio, Y. Anta Mejía
    Medicine - Programa de Formación Médica Continuada Acreditado.2014; 11(67): 3983.     CrossRef
  • Increasing Use of Advanced Radiation Therapy Technologies in the Last 30 Days of Life Among Patients Dying As a Result of Cancer in the United States
    B. Ashleigh Guadagnolo, Kai-Ping Liao, Sharon H. Giordano, Linda S. Elting, Thomas A. Buchholz, Ya-Chen Tina Shih
    Journal of Oncology Practice.2014; 10(4): e269.     CrossRef
  • Extra-thoracic tumor burden but not thoracic tumor burden on 18F-FDG PET/CT is an independent prognostic biomarker for extensive-disease small cell lung cancer
    Jong-Ryool Oh, Ji-Hyoung Seo, Chae Moon Hong, Shin Young Jeong, Sang-Woo Lee, Jaetae Lee, Jung-Joon Min, Ho-Chun Song, Hee-Seung Bom, Young-Chul Kim, Byeong-Cheol Ahn
    Lung Cancer.2013; 81(2): 218.     CrossRef
  • Changing trends in radiation therapy technologies in the last year of life for patients diagnosed with metastatic cancer in the United States
    B. Ashleigh Guadagnolo, Jinhai Huo, Kai‐Ping Liao, Thomas A. Buchholz, Prajnan Das
    Cancer.2013; 119(5): 1089.     CrossRef
  • Escaping death to quiescence: Avoiding mitotic catastrophe after DNA damage
    Zhiyuan Shen, Steven C. Huhn, Bruce G. Haffty
    Cell Cycle.2013; 12(11): 1664.     CrossRef
  • CyberKnife robotic image-guided stereotactic radiotherapy for oligometastic cancer
    B.A. Jereczek-Fossa, I. Bossi-Zanetti, R. Mauro, G. Beltramo, L. Fariselli, L.C. Bianchi, C. Fodor, P. Fossati, G. Baroni, R. Orecchia
    Strahlentherapie und Onkologie.2013; 189(6): 448.     CrossRef
  • The development of stereotactic body radiotherapy (SBRT) for medically inoperable early stage non-small cell lung cancer: an international phenomenon
    Gregory M. M. Videtic
    Journal of Radiation Oncology.2012; 1(1): 3.     CrossRef
  • Improving lung cancer survival; time to move on
    Marlies E Heuvers, Joost P Hegmans, Bruno H Stricker, Joachim G Aerts
    BMC Pulmonary Medicine.2012;[Epub]     CrossRef
  • Radiographic changes after lung stereotactic ablative radiotherapy (SABR) – Can we distinguish recurrence from fibrosis? A systematic review of the literature
    Kitty Huang, Max Dahele, Suresh Senan, Matthias Guckenberger, George B. Rodrigues, Aaron Ward, R. Gabriel Boldt, David A. Palma
    Radiotherapy and Oncology.2012; 102(3): 335.     CrossRef
  • 12,981 View
  • 103 Download
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Original Article
Analysis of Clinical Trials in the Journal of Korean Cancer Association for the Last Ten Years
Y S Park
J Korean Cancer Assoc. 2000;32(2):431-438.
AbstractAbstract PDF
PURPOSE
In Korea, many clinical trials have been published in medical journals. However, there has yet to be a study focusing on the scientific competence of the planning, execution and result interpretation of these reports. Therefore, this paper analyzed the clinical trials in the Journal of Korean Cancer Association for the last 10 years.
MATERIALS AND METHODS
All the clinical trials were analyzed according to the characteristics of clinical trial, disease, types and goals of treatment, The prospective studies were analyzed according to the competence of objectives, methods, results, and conclusion section. Clinical trials of surgical treatment were excluded from this study.
RESULTS
A total 223 (20.6%) out of 1,0S2 papers were reports of clinical trials. Of all the elinical trials, phase II, prospective, and single center studies were most common. Among 157 studies (70.4%) that were prospective, 29 studies (18.5%) did not clearly define eligibility criteria. The most common defect in the results was the lack of patients for the analysis (68 trials, 43.3%), and the median size of the trial was 30 patients. Statistical errors were found in 38 trials (24.3%).
CONCLUSION
A lot of clinical trials reported in the Journal of Korean Cancer Association need to be improved in tenns of quality. Also, the editors should review the submitted reports more thoroughly.
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Clinical Trial
Efficacy of Gemcitabine Chemotherpy in Advanced Non-small cell Lung Cancer ( NSCLC ): A Phase 2 Study
Hyuk Jae Chang, Joong Bae Ahn, Jun Gu Lee, Kwang Yong Shim, Sun Young Rha, Sae Kyu Kim, Jun Chang, Sung Kyu Kim, Won Young Lee, Nae Chun Yoo, Hyun Cheol Chung, Jae Kyung Roh, Byung Soo Kim, Sung Jun Choi, Tae Won Kim, Chul Won Suh, Joo Hang Kim
J Korean Cancer Assoc. 1999;31(3):523-532.
AbstractAbstract PDF
PURPOSE
To evaluate the efficacy and safety of gemcitabine, a pyrimidine antimetabolite against advanced non-small cell lung cancer (NSCLC).
MATERIALS AND METHODS
Forty patients with unresectable stage IIIb to IV, pathologacally documented NSCLC were evaluated. Patients received gemcitabine 1000 mg/m, as a 30 to 60-min, intravenous infusion on days 1, 8 and 15, which was repeated every 28 days. Responses were assessed every two courses. Twenty-five to fifty percent dose reduction was permitted, ptovided that overall toxicity was severe according to World Health Organization (WHO) toxicity criteria.
RESULTS
Of all 40 patients (32 men, 8 women; age range 37 to 73 years; median 63 years), 3S patients were assessable for response. 15 patients had stage IIIb disease and 25 had stage IV. Nineteen patients were histologically classified as adenocarcinoma (47.5%), 17 as squamous cell carcinoma (42.5%), 1 as large cell carcinoma (2.5%), 1 as mixed carcinoma (2.5%) and 2 as undifferentiated carcinoma (5.0%). The overall response rate was 20%. None of the patients showed complete response while 7 showed partial response (20%), 5 had stable diseases (23%) and 23 had progressive diseases (57%). During a total of 119 courses, hematologic toxicity was negligible. Granulo- cytopenia worse than WHO grade 3 occured in 11.8%, anemia in O.S% and thrombocytopenia in 0.8%, respectively. Non-hematologic toxicity was minor and easily controlled. There was no case of febrile neutropenia or treatment-related death.
CONCLUSION
The single agent efficacy of gemcitabine is comparable to other agents commonly used to treat NSCLC. Gemcitabine has unusually mild side effect profile for such an active agent. This significant activity in conjunction with a very favorable toxicity profile supports further investigation in combination with other agents in patients with inoperable NSCLC.
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Original Article
A Phase 1 Clinical Trial and Pharmacokinetic Evaluation of DA-125 ( A Novel Anthracycline Derivative ) in Advanced Carcer Patients
Jae Kyung Roh, Sun Young Rha, Jong In Lee, Kyung Hee Lee, Joon Oh Park, Jae Yong Cho, Nae Chun Yoo, Hyun Cheol chung, Joo Hang Kim, Jin Sik Min, Byung Soo Kim, Myung Geol Lee, Won Bae Kim, Joong Ik Y
J Korean Cancer Assoc. 1996;28(6):961-973.
AbstractAbstract PDF
Background
DA-125 {(7-0-12.6-dioxy-2-fluoro-2-L-talopyranosyl)- adriamycinone-14-b-alaninate HC1}, is a novel water soluble derivative of fluorinated doxorubicin. Our previous studies showed that DA-125 is more stable and effective than doxorubicin, especially to doxorubicin resistant tumor cell lines in vitro and in vivo. We initiated phase I clinical trial to evaluate the toxicities and the pharmacokinetics of DA-l25 in advanced cancer patients. Method: Advanced cancer patients who were refractory to the standard treatment with normal hepatic and renal functions were eligible after informed consent. Drug was administered intravenously for 5 minutes with initial starting dose of 20 mg/§³(10% of murine LD10). For each dose level, 3 patients were enrolled and the next increased dose was administered if there were no toxicities greater than WHO grade III. Blood, urine and bile (if possible) were collected for the pharmacokinetic evaluation. Result: Twenty three patients were enrolled with 22 evaluable patients (3 at 20 mg/§³, 3 at 40 mg/§³, 3 at 60 mg/§³, 6 at 80 mg/§³ and 7 at 100 mg/§³ of DA-125). All treated patients did not suffer from life-threatening side effects. Hematologic alterations especially neutropenia were major toxicities. Up to 60 mg/§³ dose, toxicities greater than WHO grade II were not observed. At 80 mg/§³ dose, one heavily pretreated patient developed grade III neutropenia. At 100 mg/§³ dose, one patient developed grade IV thrombocytopenia without evidence of clinical bleeding and 2 patients showed grade III neutropenia Grade I and II nausea and vomiting were observed at 80 mg/§³ and 100 mg/§³ dose level. Cardiac toxicities did not occur in any patient. DA-125 was rapidly hydralized to Ml(active metabolite), after IV administration. The plasma half life of M1 was 1.1~2.6 hours and that of M2 was 7.8~9.4 hours. The AUC of both metabolites were dose dependent(Ml: 0.154~0.638ug.hr/ml, M2: 0.684~3.07 ug.hr;ml). Urinary excretion of Ml wss less than 1% of administered dose until 96 hours and that of M2 was 10~22%. In one patient with periampullary cancer, 52.3% of the metabolites were excreted through bile. Conclusion: The results of the present study demonstrated that DA-125 was well tolerable to the advanced cancer patients and 100 mg/§³ was considered as maximally tolerated dose. We are planning the phase II trial on the basis of these results.
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Cancer Res Treat : Cancer Research and Treatment
© Korean Cancer Association.
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