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Precision Oncology Clinical Trials: A Systematic Review of Phase II Clinical Trials with Biomarker-Driven, Adaptive Design
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Hyerim Ha, Hee Yeon Lee, Jee Hyun Kim, Do Yeun Kim, Ho Jung An, SeungJin Bae, Hye-sung Park, Jin Hyoung Kang
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Cancer Res Treat. 2024;56(4):991-1013. Published online May 7, 2024
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DOI: https://doi.org/10.4143/crt.2024.128
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Abstract
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- Novel clinical trial designs are conducted in the precision medicine era. This study aimed to evaluate biomarker-driven, adaptive phase II trials in precision oncology, focusing on infrastructure, efficacy, and safety. We systematically reviewed and analyzed the target studies. EMBASE and PubMed searches from 2015 to 2023 generated 29 eligible trials. Data extraction included infrastructure, biomarker screening methodologies, efficacy, and safety profiles. Government agencies, cancer hospitals, and academic societies with accumulated experiences led investigator-initiated precision oncology clinical trials (IIPOCTs), which later guided sponsor-initiated precision oncology clinical trials (SIPOCTs). Most SIPOCTs were international studies with basket design. IIPOCTs primarily used the central laboratory for biomarker screening, but SIPOCTs used both central and local laboratories. Most of the studies adapted next-generation sequencing and/or immunohistochemistry for biomarker screening. Fifteen studies included an independent central review committee for outcome investigation. Efficacy assessments predominantly featured objective response rate as the primary endpoint, with varying results. Nine eligible studies contributed to the United States Food and Drug Administration’s marketing authorization. Safety monitoring was rigorous, but reporting formats lacked uniformity. Health-related quality of life and patient-reported outcomes were described in some protocols but rarely reported. Our results reveal that precision oncology trials with adaptive design rapidly and efficiently evaluate anticancer drugs’ efficacy and safety, particularly in specified biomarker-driven cohorts. The evolution from IIPOCT to SIPOCT has facilitated fast regulatory approval, providing valuable insights into the precision oncology landscape.
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- Co-Encapsulation of Multiple Antineoplastic Agents in Liposomes by Exploring Microfluidics
Sajid Asghar, Radu Iliescu, Rares-Ionut Stiufiuc, Brindusa Dragoi International Journal of Molecular Sciences.2025; 26(8): 3820. CrossRef
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- Head and Neck cancer
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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
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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
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Cancer Res Treat. 2024;56(1):37-47. Published online July 20, 2023
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DOI: https://doi.org/10.4143/crt.2023.433
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Abstract
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- Purpose
Precision oncology approach for recurrent and metastatic head and neck squamous cell carcinoma (HNSCC) is necessary due to its dismal prognosis. We performed a genomic profile-based umbrella trial of patients with platinum-refractory HNSCC (KCSG-TRIUMPH). Here, we present an in-depth report of the the nintedanib arm (arm 3) of the current trial.
Materials and Methods The TRIUMPH study was a multicenter, open-label, single-arm phase 2 trial, in which patients were assigned to treatment arms based on next-generation sequencing (NGS)–based, matching genomic profiles. Patients whose tumors harbor fibroblast growth factor receptor (FGFR) alteration were enrolled in the nintedanib arm (arm 3) as part of the TRIUMPH study. The primary endpoint was the overall response rate (ORR), and secondary endpoints included overall survival (OS), progression-free survival (PFS), safety, and biomarker analysis.
Results Between October 2017 and August 2020, 207 were enrolled in the TRIUMPH study, and eight were enrolled in the nintedanib arm. ORR and disease control rate were 42.9% and 57.1%, respectively. The median PFS was 5.6 months and the median duration of response was 9.1 months. Median OS was 11.1 months. One patient maintained the partial response for 36 months. Overall, the toxicity profiles were manageable.
Conclusion Single-agent nintedanib has demonstrated significant efficacy in FGFR-mutated, recurrent or metastatic HNSCC patients, with tolerable toxicity profiles. The results from the study have provided the basis for routine NGS screening and FGFR-targeted therapy. Because of the small number of patients due to slow accrual in this study, further studies with a larger cohort are warranted for statistical power.
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- Targeting fibroblast growth factor receptor (FGFR) with inhibitors in head and neck cancers: Their roles, mechanisms and challenges
Daowen Luo, Sirinart Kumfu, Nipon Chattipakorn, Siriporn C. Chattipakorn Biochemical Pharmacology.2025; 235: 116845. CrossRef - One-pot synthesis and pharmacological evaluation of new quinoline/pyrimido-diazepines as pulmonary antifibrotic agents
Michael Atef Fawzy, Karim Hagag Ibrahim, Ashraf A Aly, Asmaa H Mohamed, Sara Mohamed Naguib Abdel Hafez, Walaa Yehia Abdelzaher, Eslam B Elkaeed, Aisha A Alsfouk, El-Shimaa MN Abdelhafez Future Medicinal Chemistry.2024; 16(21): 2211. CrossRef - Critical review of the current and future prospects of VEGF-TKIs in the management of squamous cell carcinoma of head and neck
Prashant Puttagunta, Saagar V. Pamulapati, James E. Bates, Jennifer H. Gross, William A. Stokes, Nicole C. Schmitt, Conor Steuer, Yong Teng, Nabil F. Saba Frontiers in Oncology.2023;[Epub] CrossRef
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- Head and Neck Cancer
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Outcomes and Biomarkers of Immune Checkpoint Inhibitor Therapy in Patients with Refractory Head and Neck Squamous Cell Carcinoma: KCSG HN18-12
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Yun-Gyoo Lee, Hyun Chang, Bhumsuk Keam, Sang Hoon Chun, Jihyun Park, Keon Uk Park, Seong Hoon Shin, Ho Jung An, Kyoung Eun Lee, Keun-Wook Lee, Hye Ryun Kim, Sung-Bae Kim, Myung-Ju Ahn, In Gyu Hwang
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Cancer Res Treat. 2021;53(3):671-677. Published online December 7, 2020
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DOI: https://doi.org/10.4143/crt.2020.824
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Abstract
PDF Supplementary Material PubReader ePub
- Purpose
This study was conducted to determine the effectiveness of immune checkpoint inhibitors (ICIs) in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) after platinum-containing chemotherapy. We also identified clinical biomarkers which may be predictive of patient prognosis.
Materials and Methods We analyzed 125 patients with R/M HNSCC who received ICIs, retrospectively. Overall response rate (ORR) was the primary study outcome. Overall survival (OS) and progression-free survival (PFS) were the secondary study outcomes.
Results The patients received anti–programmed cell death protein-1 (PD-1) (n=73, 58%), anti–programmed death-ligand 1 (PD-L1) (n=24, 19%), or a combination of anti–PD-1/PD-L1 and anti–cytotoxic T-lymphocyte antigen 4 (n=28, 22%). The median age was 57 years (range, 37 to 87). The location of the primary tumor was in the oral cavity in 28% of the cases, followed by oropharynx (27%), hypopharynx (20%), and larynx (12%). The ORR was 15% (19/125). With 12.3 months of median follow-up, median PFS was 2.7 months. Median OS was 10.8 months. A neutrophil-to-lymphocyte ratio (NLR) > 4 was significantly associated with poor response to ICIs (odds ratio, 0.30; p=0.022). A sum of the target lesions > 40 mm (hazard ratio [HR], 1.53; p=0.046] and a NLR > 4 (HR, 1.75; p=0.009) were considered to be predictive markers of short PFS. A poor performance status (HR, 4.79; p < 0.001), a sum of target lesions > 40 mm (HR, 1.93; p=0.025), and an NLR > 4 (HR, 3.36; p < 0.001) were the significant predictors for poor survival.
Conclusion ICIs exhibited favorable antitumor activity in R/M HNSCC. Clinically, our findings can be used to recognize patients benefit from receiving ICI.
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Citations
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- Neutrophil‐to‐Lymphocyte Ratio and Pembrolizumab Outcomes in Oral Cavity Squamous Cell Carcinoma
Angeline A. Truong, Rex H. Lee, Xin Wu, Alain P. Algazi, Hyunseok Kang, Ivan H. El‐Sayed, Jonathan R. George, Chase M. Heaton, William R. Ryan, Yena Jeon, Mi‐Ok Kim, Patrick K. Ha, Katherine C. Wai Otolaryngology–Head and Neck Surgery.2025; 172(2): 548. CrossRef - Risk Factors for Progressive Disease After Immune Checkpoint Inhibitor Therapy in Head and Neck Squamous Cell Carcinoma
Seo Yoon Jang, Yun‐Gyoo Lee, Sang Hoon Chun, Ji Hyun Park, Keon Uk Park, Hyun Chang, Keun‐Wook Lee, Hye Ryun Kim, Seong Hoon Shin, Ho Jung An, Kyoung Eun Lee, In Gyu Hwang, Myung‐Ju Ahn, Sung‐Bae Kim, Bhumsuk Keam Head & Neck.2025;[Epub] CrossRef - Pretreatment neutrophil-to-lymphocyte ratio is associated with immunotherapy efficacy in patients with advanced cancer: a systematic review and meta-analysis
Jialin Su, Yuning Li, Shuhua Tan, Tianli Cheng, Yongzhong Luo, Lemeng Zhang Scientific Reports.2025;[Epub] CrossRef - Neutrophil‐to‐Lymphocyte Ratio as a Predictor for PD‐L1 Inhibitor Treatment in Recurrent or Metastatic Nasopharyngeal Carcinoma
Kun Gao, Zhigong Wei, Zheran Liu, Yiyan Pei, Huilin Li, Ge Song, Jin Xiang, Junyou Ge, Yan Qing, Youneng Wei, Ping Ai, Ye Chen, Xingchen Peng Head & Neck.2025;[Epub] CrossRef - Exploring Surgical Oncology-Based Comparative and Systematic Analysis of the Diagnostic Potential of Various Novel Biomarkers in Head and Neck Squamous Cell Carcinoma
Mostafa Ahmed Abdellah Ahmed, Amna Batool, Aws Khaled Mohammad Rababah, Madeeha Minhas, Abdul Mannan Jehangir, Maryum Sana, Muhammad Haseeb, Ehsan Ul Haq Mzahri Cureus.2025;[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 - Inflammatory markers as prognostic markers in patients with head and neck squamous cell carcinoma treated with immune checkpoint inhibitors: a systematic review and meta-analysis
Quan Wang, Xiangzhi Yin, Shengxia Wang, Haijun Lu Frontiers in Oncology.2024;[Epub] CrossRef - Predictive value of early dynamic changes of NLR and PLR for the efficacy of immune checkpoint inhibitor in head and neck squamous cell carcinoma
Dong Hyun Kim, Seo Yoon Jang, Bhumsuk Keam Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology.2024; 138(6): 763. CrossRef - Diagnostic Predictors of Immunotherapy Response in Head and Neck Squamous Cell Carcinoma
Piero Giuseppe Meliante, Federica Zoccali, Marco de Vincentiis, Massimo Ralli, Carla Petrella, Marco Fiore, Antonio Minni, Christian Barbato Diagnostics.2023; 13(5): 862. CrossRef - Patterns of recurrence in head and neck squamous cell carcinoma to inform personalized surveillance protocols
Catherine T. Haring, Lulia A. Kana, Sarah M. Dermody, Collin Brummel, Jonathan B. McHugh, Keith A. Casper, Steven B. Chinn, Kelly M. Malloy, Michelle Mierzwa, Mark E. P. Prince, Andrew J. Rosko, Jennifer Shah, Chaz L. Stucken, Andrew G. Shuman, J. Chad Br Cancer.2023; 129(18): 2817. CrossRef - Immunotherapy with PD-1 Inhibitor Nivolumab in Recurrent/Metastatic Platinum Refractory Head and Neck Cancers—Early Experiences from Romania and Literature Review
Camil Ciprian Mireștean, Mihai Cosmin Stan, Michael Schenker, Constantin Volovăț, Simona Ruxandra Volovăț, Dragoș Teodor Petru Iancu, Roxana Irina Iancu, Florinel Bădulescu Diagnostics.2023; 13(16): 2620. CrossRef -
Integrating Cutting-Edge Methods to Oral Cancer Screening, Analysis, and Prognosis
Sagar Dholariya, Ragini D. Singh, Amit Sonagra, Dharamveer Yadav, Bhairavi N. Vajaria, Deepak Parchwani Critical Reviews™ in Oncogenesis.2023; 28(2): 11. CrossRef - Neutrophil–lymphocyte ratio and platelet–lymphocyte ratio as potential predictive markers of treatment response in cancer patients treated with immune checkpoint inhibitors: a systematic review and meta-analysis
Tibera K. Rugambwa, Omar Abdihamid, Xiangyang Zhang, Yinghui Peng, Changjing Cai, Hong Shen, Shan Zeng, Wei Qiu Frontiers in Oncology.2023;[Epub] CrossRef - Characterization of Age-Associated, Neutrophil-to-Lymphocyte Ratio (NLR) and Systemic Immune-Inflammatory Index (SII) as Biomarkers of Inflammation in Geriatric Patients with Cancer Treated with Immune Checkpoint Inhibitors: Impact on Efficacy and Surviva
Khalil Choucair, Caroline Nebhan, Alessio Cortellini, Stijn Hentzen, Yinghong Wang, Cynthia Liu, Raffaele Giusti, Marco Filetti, Paolo Antonio Ascierto, Vito Vanella, Domenico Galetta, Annamaria Catino, Nour Al-Bzour, Azhar Saeed, Ludimila Cavalcante, Pam Cancers.2023; 15(20): 5052. CrossRef - A systematic review and meta-analysis of prognostic indicators in patients with head and neck malignancy treated with immune checkpoint inhibitors
Dengxiong Kang, Siping Liu, Xin Yuan, Shenxiang Liu, Zhengrong Zhang, Zhilian He, Xudong Yin, Haiyan Mao Journal of Cancer Research and Clinical Oncology.2023; 149(20): 18215. CrossRef - Prognostic value of neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio during immune checkpoint inhibitor treatment in recurrent or metastatic head and neck squamous cell carcinoma patients
Jun-Liang Li, Tsai-Ling Hsieh, Ming-Che Ou, Frank Cheau-Feng Lin, Stella Chin-Shaw Tsai Oral Oncology.2022; 126: 105729. CrossRef - Neutrophil‐to‐lymphocyte ratio as a prognostic marker for head and neck squamous cell carcinoma treated with immune checkpoint inhibitors: Meta‐analysis
Yukinori Takenaka, Ryohei Oya, Norihiko Takemoto, Hidenori Inohara Head & Neck.2022; 44(5): 1237. CrossRef - Safety and Efficacy of Influenza Vaccination in Patients Receiving Immune Checkpoint Inhibitors. Systematic Review with Meta-Analysis
Maria A. Lopez-Olivo, Valeria Valerio, Aliza R. Karpes Matusevich, Marianela Brizio, Michelle Kwok, Yimin Geng, Maria E. Suarez-Almazor, Ines Colmegna Vaccines.2022; 10(8): 1195. CrossRef - Identification of Immune-Related LncRNA Pairs for Predicting Prognosis and Immunotherapeutic Response in Head and Neck Squamous Cell Carcinoma
Xueying Wang, Kui Cao, Erliang Guo, Xionghui Mao, Lunhua Guo, Cong Zhang, Junnan Guo, Gang Wang, Xianguang Yang, Ji Sun, Susheng Miao Frontiers in Immunology.2021;[Epub] CrossRef - Roles of Major RNA Adenosine Modifications in Head and Neck Squamous Cell Carcinoma
Xing-xing Huo, Shu-jie Wang, Hang Song, Ming-de Li, Hua Yu, Meng Wang, Hong-xiao Gong, Xiao-ting Qiu, Yong-fu Zhu, Jian-ye Zhang Frontiers in Pharmacology.2021;[Epub] CrossRef
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- Lung cancer
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Real-World Experience of Nivolumab in Non-small Cell Lung Cancer in Korea
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Sun Min Lim, Sang-We Kim, Byoung Chul Cho, Jin Hyung Kang, Myung-Ju Ahn, Dong-Wan Kim, Young-Chul Kim, Jin Soo Lee, Jong-Seok Lee, Sung Yong Lee, Keon Uk Park, Ho Jung An, Eun Kyung Cho, Tae Won Jang, Bong-Seog Kim, Joo-Hang Kim, Sung Sook Lee, Im-II Na, Seung Soo Yoo, Ki Hyeong Lee
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Cancer Res Treat. 2020;52(4):1112-1119. Published online May 15, 2020
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DOI: https://doi.org/10.4143/crt.2020.245
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Abstract
PDF Supplementary Material PubReader ePub
- Purpose
The introduction of immune checkpoint inhibitors represents a major advance in the treatment of lung cancer, allowing sustained recovery in a significant proportion of patients. Nivolumab is a monoclonal anti–programmed death cell protein 1 antibody licensed for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy. In this study, we describe the demographic and clinical outcomes of patients with advanced NSCLC treated with nivolumab in the Korean expanded access program.
Materials and Methods
Previously treated patients with advanced non-squamous and squamous NSCLC patients received nivolumab at 3 mg/kg every 2 weeks up to 36 months. Efficacy data including investigator-assessed tumor response, progression data, survival, and safety data were collected.
Results
Two hundred ninety-nine patients were treated across 36 Korean centers. The objective response rate and disease control rate were 18% and 49%, respectively; the median progression-free survival was 2.1 months (95% confidence interval [CI], 1.87 to 3.45), and the overall survival (OS) was 13.2 months (95% CI, 10.6 to 18.9). Patients with smoking history and patients who experienced immune-related adverse events showed a prolonged OS. Cox regression analysis identified smoking history, presence of immune-related adverse events as positive factors associated with OS, while liver metastasis was a negative factor associated with OS. The safety profile was generally comparable to previously reported data.
Conclusion
This real-world analysis supports the use of nivolumab for pretreated NSCLC patients, including those with an older age.
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- Advances in reprogramming of energy metabolism in tumor T cells
Liu Xuekai, Song Yan, Chu Jian, Song Yifei, Wu Xinyue, Zhang Wenyuan, Han Shuwen, Yang Xi Frontiers in Immunology.2024;[Epub] CrossRef - Effectiveness and Safety of PD-1 Inhibitors’ Treatment for Patients with Non-Small-Cell Lung Cancer in China: A Real-World Study
Ning Wan, Yongbang Chen, Liqing Lu, Bing Wang, Liuliu He, Hongyi Liang, Fei Xie, Xiaoshun Jian, Bo Ji, Jianping Zhang, Hammoda Abu-Odah European Journal of Cancer Care.2024; 2024: 1. CrossRef - Optimization of treatment strategies for elderly patients with advanced non-small cell lung cancer
Qiang Chen, Shuo Ying, Jianwen Qin, Li Zhang Frontiers in Oncology.2024;[Epub] CrossRef - Real-World Data on Pembrolizumab for Pretreated Non-Small-Cell Lung Cancer: Clinical Outcome and Relevance of the Lung Immune Prognostic Index
Ana Ortega-Franco, Clare Hodgson, Haseem Raja, Mathew Carter, Colin Lindsay, Sarah Hughes, Laura Cove-Smith, Paul Taylor, Yvonne Summers, Fiona Blackhall, Raffaele Califano Targeted Oncology.2022; 17(4): 453. CrossRef - Liver metastases and the efficacy of immune checkpoint inhibitors in advanced lung cancer: A systematic review and meta-analysis
Handai Xia, Wengang Zhang, Yuqing Zhang, Xiaoling Shang, Yanguo Liu, Xiuwen Wang Frontiers in Oncology.2022;[Epub] CrossRef - Immune-Related Adverse Events Predict the Efficacy of Immune Checkpoint Inhibitors in Lung Cancer Patients: A Meta-Analysis
Donghui Wang, Cen Chen, Yanli Gu, Wanjun Lu, Ping Zhan, Hongbing Liu, Tangfeng Lv, Yong Song, Fang Zhang Frontiers in Oncology.2021;[Epub] CrossRef - Broad-Spectrum Antibiotic Regimen Affects Survival in Patients Receiving Nivolumab for Non-Small Cell Lung Cancer
Min Jung Geum, Chungsoo Kim, Ji Eun Kang, Jae Hee Choi, Jae Song Kim, Eun Sun Son, Sun Min Lim, Sandy Jeong Rhie Pharmaceuticals.2021; 14(5): 445. CrossRef - Nivolumab
Reactions Weekly.2021; 1855(1): 269. CrossRef - Immune-Related Adverse Events Associated With Outcomes in Patients With NSCLC Treated With Anti-PD-1 Inhibitors: A Systematic Review and Meta-Analysis
Zhe Zhao, Xinfeng Wang, Jinghan Qu, Wei Zuo, Yan Tang, Huijuan Zhu, Xiaoguang Chen Frontiers in Oncology.2021;[Epub] CrossRef
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Ramosetron versus Palonosetron in Combination with Aprepitant and Dexamethasone for the Control of Highly-Emetogenic Chemotherapy-Induced Nausea and Vomiting
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Jin Hyoung Kang, Jung Hye Kwon, Yun-Gyoo Lee, Keon Uk Park, Ho Jung An, Joohyuk Sohn, Young Mi Seol, Hyunwoo Lee, Hwan-Jung Yun, Jin Seok Ahn, Ji Hyun Yang, Hunho Song, Dong-Hoe Koo, Jin Young Kim, Gun Min Kim, Hwa Jung Kim
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Cancer Res Treat. 2020;52(3):907-916. Published online March 18, 2020
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DOI: https://doi.org/10.4143/crt.2019.713
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Abstract
PDF Supplementary Material PubReader ePub
- Purpose
The purpose of this study was to compare ramosetron (RAM), aprepitant (APR), and dexamethasone (DEX) [RAD] with palonosetron (PAL), APR, and DEX [PAD] in controlling highly-emetogenic chemotherapy (HEC)–induced nausea and vomiting.
Materials and Methods
Patients were randomly assigned (1:1) to receive RAD or PAD:RAM (0.3 mg intravenously) or PAL (0.25 mg intravenously) D1, combined with APR (125 mg orally, D1 and 80 mg orally, D2-3) and DEX (12 mg orally or intravenously, D1 and 8 mg orally, D2-4). Patients were stratified by gender, cisplatin-based chemotherapy, and administration schedule. The primary endpoint was overall complete response (CR), defined as no emesis and no rescue regimen during 5 days of HEC. Secondary endpoints were overall complete protection (CP; CR+nausea score < 25 mm) and total control (TC; CR+nausea score < 5 mm). Quality of life was assessed by Functional Living Index Emesis (FLIE) questionnaire on D0 and D6.
Results
A total of 279 patients receiving RAD (n=137) or PAD (n=142) were evaluated. Overall CR rates in RAD and PAD recipients were 81.8% and 79.6% (risk difference [RD], 2.2%; 95% confidence interval [CI], −7.1 to 11.4), respectively. Overall CP and TC rates for RAD and PAD were 56.2% and 58.5% (RD, −2.3%; 95% CI, −13.9 to 9.4) and 47.5% vs. 43.7% (RD, 3.8%; 95% CI, −7.9 to 15.5), respectively. FLIE total score ≥ 108 (no impact on daily life) was comparable between RAD and PAD (73.9% vs. 73.4%, respectively). Adverse events were similar between the two groups.
Conclusion
In all aspects of efficacy, safety and QOL, RAD is non-inferior to PAD for the control of CINV in cancer patients receiving HEC.
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Büşra Burcu, Nadir Adnan Hacım, Ozan Caliskan, Serdar Demirgan, Talar Vartanoglu Aktokmakyan, Serhat Meric, Tomris Duymaz, Onder Karabay, Ali Solmaz Acta Chirurgica Belgica.2024; 124(1): 41. CrossRef - 2023 updated MASCC/ESMO consensus recommendations: prevention of nausea and vomiting following high-emetic-risk antineoplastic agents
Jørn Herrstedt, L Celio, PJ Hesketh, L Zhang, R Navari, A Chan, M Saito, R Chow, M Aapro Supportive Care in Cancer.2024;[Epub] CrossRef - 2023 MASCC and ESMO guideline update for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting
J. Herrstedt, R. Clark-Snow, C.H. Ruhlmann, A. Molassiotis, I. Olver, B.L. Rapoport, M. Aapro, K. Dennis, P.J. Hesketh, R.M. Navari, L. Schwartzberg, M.L. Affronti, M.A. Garcia-Del-Barrio, A. Chan, L. Celio, R. Chow, M. Fleury, R.J. Gralla, R. Giusti, F. ESMO Open.2024; 9(2): 102195. CrossRef - Ramosetron 3.0 μg/mL Combining with Dexamethasone (0.05, 0.1, 0.2 mg/mL) in Infusion Solutions: A Physicochemical Stability Study
Baoxia Fang, Lijun Zhao, Shirong Yu, Fuchao Chen Dose-Response.2024;[Epub] CrossRef - Efficacy and safety of Antiemetic Regimens for Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: A Systematic Review and Network Meta-Analysis
Marco Filetti, Pasquale Lombardi, Raffaele Giusti, Rosa Falcone, Florian Scotte, Diana Giannarelli, Antonella Carcagnì, Valeria Altamura, Giovanni Scambia, Gennaro Daniele Cancer Treatment Reviews.2023; : 102512. CrossRef - Effect of Acupuncture on Delayed Emesis for the Patients Who Received High-Emetogenic Chemotherapy with Standard Antiemetic Prophylaxis (KHMC-HO-01): An Open-Label, Randomized Study
Chi Hoon Maeng, Seunghoon Lee, Jae Joon Han, Hong Jun Kim, Dongwoo Nam, Junhee Lee, Sun Kyung Baek, Maria Grazia Ferraro Evidence-Based Complementary and Alternative Medicine.2022; 2022: 1. CrossRef - Cardioprotective action of aprepitant in a rat model of ischemia-reperfusioninduced myocardial injury: role of PI3K-AkT-GSK-3β-HIF-1α signaling pathway
Mei Qian, Yang Liu Acta Cirúrgica Brasileira.2022;[Epub] CrossRef - Comparison of the Effectiveness of Palonosetron and Ramosetron in Preventing Postoperative Nausea and Vomiting: Updated Systematic Review and Meta-Analysis with Trial Sequential Analysis
Hyo Jin Kim, EunJin Ahn, Geun Joo Choi, Hyun Kang Journal of Personalized Medicine.2022; 13(1): 82. CrossRef - Oliceridine is Associated with Reduced Risk of Vomiting and Need for Rescue Antiemetics Compared to Morphine: Exploratory Analysis from Two Phase 3 Randomized Placebo and Active Controlled Trials
Timothy L. Beard, Cathy Michalsky, Keith A. Candiotti, Paul Rider, Linda Wase, Ashraf S. Habib, Mark A. Demitrack, Michael J. Fossler, Eugene R. Viscusi Pain and Therapy.2021; 10(1): 401. CrossRef - Forsythiae Fructus aqueous extract attenuates cisplatin-induced kaolin consumption (pica) by inhibiting NLRP3 inflammasome activation in rats
Qi Meng, Pingping Bi, Guanglong Zhang, Yaqi Li, Siqi Chen, Ke Nie Bioscience, Biotechnology, and Biochemistry.2021; 85(9): 2054. CrossRef - Antiemetics for adults for prevention of nausea and vomiting caused by moderately or highly emetogenic chemotherapy: a network meta-analysis
Vanessa Piechotta, Anne Adams, Madhuri Haque, Benjamin Scheckel, Nina Kreuzberger, Ina Monsef, Karin Jordan, Kathrin Kuhr, Nicole Skoetz Cochrane Database of Systematic Reviews.2021;[Epub] CrossRef - Duration of dexamethasone administration for the prevention of chemotherapy-induced nausea and vomiting – A systematic review and meta-analysis
Ajay Raghunath, Sahan D. Chandrasekara, Shane N. Anthony, Ben Markman Critical Reviews in Oncology/Hematology.2020; 152: 103012. CrossRef
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Clinical Characteristics of Clear Cell Ovarian Cancer: A Retrospective Multicenter Experience of 308 Patients in South Korea
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Hee Yeon Lee, Ji Hyung Hong, Jae Ho Byun, Hee-Jun Kim, Sun Kyung Baek, Jin Young Kim, Ki Hyang Kim, Jina Yun, Jung A Kim, Kwonoh Park, Hyo Jin Lee, Jung Lim Lee, Young-Woong Won, Il Hwan Kim, Woo Kyun Bae, Kyong Hwa Park, Der-Sheng Sun, Suee Lee, Min-Young Lee, Guk Jin Lee, Sook Hee Hong, Yun Hwa Jung, Ho Jung An
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Cancer Res Treat. 2020;52(1):277-283. Published online July 12, 2019
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DOI: https://doi.org/10.4143/crt.2019.292
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Abstract
PDF PubReader ePub
- Purpose
The purpose of this study was to evaluate clinical characteristics and treatment pattern of ovarian clear cell carcinoma (OCCC) in Korea and the role of adjuvant chemotherapy in early
stage.
Materials and Methods
Medical records of 308 cases of from 21 institutions were reviewed and data including age, performance status, endometriosis, thromboembolism, stage, cancer antigen 125, treatment, recurrence, and death were collected.
Results
Regarding stage of OCCC, it was stage I in 194 (63.6%), stage II in 34 (11.1%), stage III in 66 (21.6%), and stage IV in 11 (3.6%) patients. All patients underwent surgery. Optimal surgery (residual disease ≤ 1 cm) was achieved in 89.3%. Majority of patients (80.5%) received postoperative chemotherapy. The most common regimen was taxane-platinum combination (96%). Median relapse-free survival (RFS) was 138.5 months for stage I, 33.4 for stage II, 19.3 for stage III, and 9.7 for stage IV. Median overall survival (OS) were not reached, 112.4, 48.7, and 18.3 months for stage I, II, III, and IV, respectively. Early-stage (stage I), endometriosis, and optimal debulking were identified as favorable prognostic factors for RFS. Early-stage and optimal debulking were also favorable prognostic factors for OS. Majority of patients with early-stage received adjuvant chemotherapy. However, additional survival benefit was not found in terms of recurrence.
Conclusion
Majority of patients had early-stage and received postoperative chemotherapy regardless of stage. Early-stage and optimal debulking were identified as favorable prognostic factors. In stage IA or IB, adding adjuvant chemotherapy did not show difference in survival. Further study focusing on OCCC is required.
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Roberta Rosso, Margherita Turinetto, Fulvio Borella, Nicolas Chopin, Pierre Meeus, Alexandra Lainè, Isabelle Ray-Coquard, Olivia Le Saux, Domenico Ferraioli The Oncologist.2025;[Epub] CrossRef - From clinical management to personalized medicine: novel therapeutic approaches for ovarian clear cell cancer
Zesi Liu, Chunli Jing, Fandou Kong Journal of Ovarian Research.2024;[Epub] CrossRef - SOX17 expression in ovarian clear cell carcinoma
Daichi Kodama, Motoki Takenaka, Chiemi Saigo, Masako Azuma, Yuki Hanamatsu, Masanori Isobe, Tamotsu Takeuchi Journal of Ovarian Research.2024;[Epub] CrossRef - Construction of a Prediction Model of Cancer-Specific Survival after Ovarian Clear Cell Carcinoma Surgery
Mengqi Huang, Li Ling, Yanbo Liu, Yujuan Li Clinical and Experimental Obstetrics & Gynecology.2024;[Epub] CrossRef - Patients with stage IA ovarian clear cell carcinoma do not require chemotherapy following surgery
Li Shuqing, Zhu Zhiling Cancer Medicine.2023; 12(6): 6668. CrossRef - Clear cell carcinoma of the ovary and venous thromboembolism: a systematic review and meta-analysis
Hamidreza Didar, Farah Farzaneh, Hanieh Najafiarab, Kosar Namakin, Kimiya Gohari, Ali Sheidaei, Sepehr Ramezani Current Medical Research and Opinion.2023; 39(6): 901. CrossRef - The Significance of Radiotherapy in Ovarian Clear Cell Carcinoma: A Systematic Review and Meta-Analysis
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Feasibility Study of Physician Orders for Life-Sustaining Treatment for Patients with Terminal Cancer
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Ho Jung An, Hyun Jeong Jeon, Sang Hoon Chun, Hyun Ae Jung, Hee Kyung Ahn, Kyung Hee Lee, Min-ho Kim, Ju Hee Kim, Jaekyung Cheon, JinShil Kim, Su-Jin Koh
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Cancer Res Treat. 2019;51(4):1632-1638. Published online April 18, 2019
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DOI: https://doi.org/10.4143/crt.2019.009
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Abstract
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- Purpose
Physician Orders for Life-Sustaining Treatment (POLST) form is a legal document for terminally ill patients to make medical decisions with physicians near the end-of-life. A multicenter prospective study was conducted to evaluate the feasibility of POLST administration in actual oncological practice.
Materials and Methods
Patients with terminal cancer, age ≥ 20 years, and capable of communicating were eligible. The primary endpoint was the completion rate of POLST. Data about physicians’ or patients’ barriers were also collected.
Results
From June to December 2017, 336 patients from seven hospitals were eligible. Median patient age was 66 years (range, 20 to 94 years); 52.7% were male; and 60.4% had poor performance status. Primary cancer sites were hepato-pancreato-biliary (26.2%), lung (23.2%), and gastrointestinal (19.9%). Expected survival duration was 10.6±7.3 weeks, with 41.2% receiving hospice care, 37.9% showing progression after cancer treatment, and the remaining patients were under active treatment (15.8%) or initially diagnosed with terminal cancer (5.1%). POLST forms were introduced to 60.1% of patients, and 31.3% signed the form. Physicians’ barriers were reluctance of family (49.7%), lack of rapport (44.8%), patients’ denial of prognosis (34.3%), lack of time (22.7%), guilty feelings (21.5%), and uncertainty about either prognosis (21.0%) or the right time to discuss POLST (16.6%). The patients’ barriers were the lack of knowledge/understanding of POLST (65.1%), emotional discomfort (63.5%), difficulty in decision-making (66.7%), or denial of prognosis (14.3%).
Conclusion
One-third of patients completed POLST forms, and various barriers were identified. To overcome such barriers, social engagement, education, and systematic support might be necessary.
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Jiyeon Choi, Heejung Jeon, Ilhak Lee Asian Bioethics Review.2024; 16(1): 33. CrossRef - An Integrative Review of the State of POLST Science: What Do We Know and Where Do We Go?
Elizabeth E. Umberfield, Matthew C. Fields, Rachel Lenko, Teryn P. Morgan, Elissa Schuler Adair, Erik K. Fromme, Hillary D. Lum, Alvin H. Moss, Neil S. Wenger, Rebecca L. Sudore, Susan E. Hickman Journal of the American Medical Directors Association.2024; 25(4): 557. CrossRef - Experience and perspectives of end-of-life care discussion and physician orders for life-sustaining treatment of Korea (POLST-K): a cross-sectional study
Hyeon-Su Im, Insook Lee, Shinmi Kim, Jong Soo Lee, Ju-Hee Kim, Jae Young Moon, Byung Kyu Park, Kyung Hee Lee, Myung Ah Lee, Sanghoon Han, Yoonki Hong, Hyeyeoung Kim, Jaekyung Cheon, Su-Jin Koh BMC Medical Ethics.2023;[Epub] CrossRef - Problems Related to the Act on Decisions on Life-Sustaining Treatment and Directions for Improvement
Dae Seog Heo, Shin Hye Yoo, Bhumsuk Keam, Sang Ho Yoo, Younsuck Koh The Korean Journal of Hospice and Palliative Care.2022; 25(1): 1. CrossRef - Discussing POLST-facilitated hospice care enrollment in patients with terminal cancer
Ho Jung An, Hyun Jeong Jeon, Sang Hoon Chun, Hyun Ae Jung, Hee Kyung Ahn, Kyung Hee Lee, Min-ho Kim, Ju Hee Kim, Jaekyung Cheon, Su-Jin Koh Supportive Care in Cancer.2022; 30(9): 7431. CrossRef - The Medical Orders for Scope of Treatment (MOST) form completion: a retrospective study
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Gavin D Perkins, Claire A Hawkes, Karin Eli, James Griffin, Claire Jacques, Caroline J Huxley, Keith Couper, Cynthia Ochieng, Jonathan Fuld, Zoe Fritz, Rob George, Doug Gould, Richard Lilford, Martin Underwood, Catherine Baldock, Chris Bassford, Peter-Mar Health and Social Care Delivery Research.2022; 10(40): 1. CrossRef - Emergency Healthcare Providers’ Knowledge about and Attitudes toward Advance Directives: A Cross-Sectional Study between Nurses and Emergency Medical Technicians at an Emergency Department
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Mirinae Kim, Minju Kim International Journal of Environmental Research and Public Health.2021; 18(9): 4415. CrossRef - Changes in decision-making process for life-sustaining treatment in patients with advanced cancer after the life-sustaining treatment decisions-making act
Hyeyeong Kim, Hyeon-Su Im, Kyong Og Lee, Young Joo Min, Jae-Cheol Jo, Yunsuk Choi, Yoo Jin Lee, Daseul Kang, Changyoung Kim, Su-Jin Koh, Jaekyung Cheon BMC Palliative Care.2021;[Epub] CrossRef - Asian patients’ perspectives on advance care planning: A mixed-method systematic review and conceptual framework
Diah Martina, Olaf P Geerse, Cheng-Pei Lin, Martina S Kristanti, Wichor M Bramer, Masanori Mori, Ida J Korfage, Agnes van der Heide, Judith AC Rietjens, Carin CD van der Rijt Palliative Medicine.2021; 35(10): 1776. CrossRef - Life-Sustaining Treatment States in Korean Cancer Patients after Enforcement of Act on Decisions on Life-Sustaining Treatment for Patients at the End of Life
Young-Woong Won, Hwa Jung Kim, Jung Hye Kwon, Ha Yeon Lee, Sun Kyung Baek, Yu Jung Kim, Do Yeun Kim, Hyewon Ryu Cancer Research and Treatment.2021; 53(4): 908. CrossRef - Advance care planning in Asian culture
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Clinical Features of Male Breast Cancer: Experiences from Seven Institutions Over 20 Years
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Ji Hyung Hong, Kyung Sun Ha, Yun Hwa Jung, Hye Sung Won, Ho Jung An, Guk Jin Lee, Donghoon Kang, Ji Chan Park, Sarah Park, Jae Ho Byun, Young Jin Suh, Jeong Soo Kim, Woo Chan Park, Sang Seol Jung, Il Young Park, Su-Mi Chung, In Sook Woo
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Cancer Res Treat. 2016;48(4):1389-1398. Published online April 11, 2016
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DOI: https://doi.org/10.4143/crt.2015.410
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Abstract
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- Purpose
Breast cancer treatment has progressed significantly over the past 20 years. However, knowledge regarding male breast cancer (MBC) is sparse because of its rarity. This study is an investigation of the clinicopathologic features, treatments, and clinical outcomes of MBC.
Materials and Methods
Clinical records of 59 MBC patients diagnosed during 1995-2014 from seven institutions in Korea were reviewed retrospectively.
Results
Over a 20-year period, MBC patients accounted for 0.98% among total breast cancer patients, and increased every 5 years. The median age of MBC patientswas 66 years (range, 24 to 87 years). Forty-three patients (73%) complained of a palpable breast mass initially. The median symptom duration was 5 months (range, 1 to 36 months). Mastectomy was performed in 96% of the patients. The most frequent histology was infiltrating ductal carcinoma (75%). Ninety-one percent of tumors (38/43) were estrogen receptor–positive, and 28% (11/40) showed epidermal growth factor receptor 2 (HER-2) overexpression. After curative surgery, 42% of patients (19/45) received adjuvant chemotherapy; 77% (27/35) received hormone therapy. Five out of ten patients with HER-2 overexpressing tumors did not receive adjuvant anti–HER-2 therapy, while two out of four patients with HER-2 overexpressing tumors received palliative trastuzumab for recurrent and metastatic disease. Letrozole was used for one patient in the palliative setting. The median overall survival durations were 7.2 years (range, 0.6 to 17.0 years) in patients with localized disease and 2.9 years (range, 0.6 to 4.3 years) in those with recurrent or metastatic disease.
Conclusion
Anti–HER-2 and hormonal therapy, except tamoxifen, have been underutilized in Korean MBC patients compared to female breast cancer patients. With the development of precision medicine, active treatment with targeted agents should be applied. Further investigation of the unique pathobiology of MBC is clinically warranted.
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The Efficacy of External Beam Radiotherapy for Airway Obstruction in Lung Cancer Patients
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Jeong Won Lee, Jong Hoon Lee, Hoon-Kyo Kim, Byoung Yong Shim, Ho Jung An, Sung Hwan Kim
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Cancer Res Treat. 2015;47(2):189-196. Published online September 12, 2014
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DOI: https://doi.org/10.4143/crt.2013.261
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Abstract
PDF PubReader ePub
- Purpose
The objective of this study was to evaluate external beam radiotherapy (EBRT) in lung cancer patients who suffer from airway obstruction. Materials and Methods Medical data of 95 patients with a lung mass that obstructed the airway and received EBRT for it were analyzed. Fifty-nine patients (62.1%) had non-small cell lung cancer and 36 patients (37.9%) had small cell lung cancer. Radiotherapy was given at 8 to 45 Gy (median, 30 Gy) in 1 to 15 fractions (median, 10 fractions). The response to EBRT was assessed through changes in radiographic findings and/or subjective symptoms between before and after EBRT. The median follow-up duration was 124 days. The primary end point was the airway-obstruction resolving rate after EBRT. The secondary end points were patient survival and toxic effects of EBRT. Results Improvement of airway obstruction after EBRT on chest X-ray was achieved in 75 of 95 patients (78.9%). The median time for resolving the radiologic findings and/or symptoms of airway obstruction after EBRT was 7 days (range, 1 to 76 days). The 1-year survival rate was significantly higher in responders than non-responders (12.5% vs. 0.0%, p < 0.001). The biologically effective dose of ≥ 39 Gyα/β=10 (p < 0.01) and the longest obstructive lesion of < 6 cm (p=0.04) were significantly associated with a good response to EBRT in resolving the airway obstruction. No one had grade 3 or higher acute and chronic toxicities. Conclusion EBRT is an effective treatment in relieving airway obstruction without severe toxicities in lung cancer patients.
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Pseudocirrhosis of Breast Cancer Metastases to the Liver Treated by Chemotherapy
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Su Lim Lee, Eun Deok Chang, Sae Jung Na, Jeong Soo Kim, Ho Jung An, Yoon Ho Ko, Hye Sung Won
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Cancer Res Treat. 2014;46(1):98-103. Published online January 15, 2014
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DOI: https://doi.org/10.4143/crt.2014.46.1.98
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Abstract
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- Pseudocirrhosis refers to a condition that shows changes in hepatic contour that mimic cirrhosis radiographically in the absence of the typical histopathological findings of cirrhosis. This condition has been observed in patients with cancer metastatic to the liver, both in those who have undergone prior systemic chemotherapy and those who have not. Pseudocirrhosis may cause difficulty in interpretation of the response to chemotherapy and hepatic decompression and complication of portal hypertension have a negative effect on the prognosis. We report on a case of breast cancer with liver metastases that showed cirrhotic changes during disease progression. Progression of liver metastases was confirmed by F18 fluorodeoxyglucose positron emission tomography/computed tomography (PET-CT). We also performed ultrasound-guided liver biopsy and confirmed tumor infiltration with severe desmoplastic fibrosis. This case suggests the pathogenesis of pseudocirrhosis through histopathological findings and the role of PET-CT in evaluation of the response to chemotherapy in patients with pseudocirrhosis.
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Citations
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Laura A. Huppert, Zak Walker, Moming Li, Mi-Ok Kim, Jennifer Callan, Danielle Brandman, Melanie Majure, Michelle E. Melisko, Hope S. Rugo, Spencer Behr, A. Jo Chien Breast Cancer Research and Treatment.2023; 197(1): 137. CrossRef - Imaging in metastatic breast cancer, CT, PET/CT, MRI, WB-DWI, CCA: review and new perspectives
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Phase II Trial of Neoadjuvant Docetaxel/Cisplatin/5-Fluorouracil Combined with Pegteograstim for Unresectable, Locally Advanced Sinonasal Squamous Cell Carcinoma: KCSG HN18-07
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Bhumsuk Keam, Ho Jung An, Seong Hoon Shin, Min Kyoung Kim, Jung Hae Cho, Seyoung Seo, Sung-Bae Kim
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Received October 24, 2024 Accepted December 13, 2024 Published online December 16, 2024
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DOI: https://doi.org/10.4143/crt.2024.1025
[Epub ahead of print]
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Abstract
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- Purpose
The role of neoadjuvant chemotherapy in locally advanced sinonasal squamous cell carcinoma (SNSCC) has not been established prospectively. We conducted a phase II trial of neoadjuvant chemotherapy (NAC) with docetaxel/cisplatin/5-fluorouracil (TPF) in this population.
Materials and Methods Eligible patients had unresectable, locally advanced SNSCC, defined as T3/4 category or potential compromise of critical organ function on surgery. Three TPF (docetaxel 75 mg/m2 and cisplatin 75 mg/m2 on day 1, 5-fluorouracil 1,000 mg/m2 on days 1-4 every 3 weeks) cycles were administered with prophylactic pegteograstim. The primary outcome was the objective response rate (ORR); the secondary outcomes included 2-year progression-free survival (PFS), eyeball preservation rate, and safety.
Results Among 28 patients screened, 25 were evaluable for efficacy (one screen-failure; two evaluable for safety only). The confirmed ORR was 72.0%. The definitive post-NAC treatment comprised chemoradiotherapy (n=15) and surgery (n=10). With a median follow-up of 25.5 months, median PFS was not reached and the 2-year PFS rate was 60.4%. Response to NAC was related to prolonged PFS (p=0.038). No patient underwent eyeball exenteration at the data cutoff point. Treatment-related adverse events of grade ≥ 3 were neutropenia (48.1%) including febrile neutropenia (14.8%), followed by acute kidney injury (22.2%), nausea/vomiting (11.1%), anemia (7.4%), thrombocytopenia (7.4%), and enterocolitis (3.7%).
Conclusion TPF NAC showed a promising efficacy and might help preserve critical structures in this population, which needs to be validated in a large prospective trial (KCT0003377).
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