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Pemetrexed Maintenance versus Observation in Patients with Advanced Urothelial Carcinoma Who Completed First-line Platinum-based Chemotherapy without Disease Progression (PREMIER, KCSG GU16-05)
Inkeun Park, Shinkyo Yoon, Ilhwan Kim, Kwonoh Park, Suee Lee, Bhumsuk Keam, Joo-Hwan Park, Jin Young Kim, Yoon Ji Choi, Byeong Seok Sohn, Jae Lyun Lee
Received October 16, 2024  Accepted December 26, 2024  Published online December 27, 2024  
DOI: https://doi.org/10.4143/crt.2024.1003    [Accepted]
AbstractAbstract PDF
Purpose
Platinum-based chemotherapy is the standard treatment for advanced urothelial carcinoma (aUC). Switch maintenance therapy after first-line (1L) treatment may delay disease progression. This study evaluated pemetrexed as switch maintenance therapy versus observation in aUC patients without disease progression after initial chemotherapy.
Materials and Methods
Eligible aUC patients who did not progress after 4–6 cycles of cisplatin or carboplatin-based chemotherapy were randomized 1:1 to receive maintenance pemetrexed (500 mg/m2 IV every 3 weeks, up to 16 cycles) or observation. The primary endpoint was progression-free survival (PFS); secondary endpoints included overall survival (OS), response rate, and safety.
Results
The trial was closed early due to slow accrual after avelumab approval. From October 2016 to December 2022, 97 patients were randomized to pemetrexed (n=49) or observation (n=48). The median age was 69 years (range: 43–90) and 66 (range33–82), respectively, with 63% and 73% of patients being male, respectively. The median PFS was 6.0 months (95% CI, 3.4–8.5) with pemetrexed versus 2.3 months (1.8–2.7) with observation (p=0.044, HR 0.64; 95% CI, 0.41–0.99). The median OS was 18.1 months (95% CI, 6.9–29.4) for pemetrexed and 17.9 months (16.1–19.7) for observation (p=0.913, HR 1.03; 95% CI, 0.61–1.73). Common adverse events in the pemetrexed group included anemia (30%), fatigue (18%), and neutropenia (12%), primarily grade 1 or 2.
Conclusion
The PREMIER trial showed that switch maintenance pemetrexed significantly prolonged PFS in aUC patients post-1L platinum-based chemotherapy, with a favorable safety profile. Further studies on combination maintenance therapies are warranted.
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Clinical Characteristics of Clear Cell Ovarian Cancer: A Retrospective Multicenter Experience of 308 Patients in South Korea
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
Cancer Res Treat. 2020;52(1):277-283.   Published online July 12, 2019
DOI: https://doi.org/10.4143/crt.2019.292
AbstractAbstract PDFPubReaderePub
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.

Citations

Citations to this article as recorded by  
  • Ovarian clear cell carcinoma: open questions on the management and treatment algorithm
    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
    Yuan Zhuang, Hua Yang
    Cancer Control.2023;[Epub]     CrossRef
  • Clinical perspectives of rare ovarian tumors: clear cell ovarian cancer
    Satoe Fujiwara
    Japanese Journal of Clinical Oncology.2023; 53(8): 664.     CrossRef
  • Application of precision medicine based on next-generation sequencing and immunohistochemistry in ovarian cancer: a real-world experience
    Yoo-Na Kim, Yun Soo Chung, Ji Hyun Lee, Eunhyang Park, Seung-Tae Lee, Sunghoon Kim, Jung-Yun Lee
    Journal of Gynecologic Oncology.2023;[Epub]     CrossRef
  • Characteristics and Prognosis of Ovarian Pure Clear Cell Carcinoma: A Retrospective Experience of 136 Patients
    Yang Gao, Wei Ding, Pengpeng Qu
    Clinical and Experimental Obstetrics & Gynecology.2023;[Epub]     CrossRef
  • A clearer view on ovarian clear cell carcinoma
    Aglaja De Pauw, Eline Naert, Koen Van de Vijver, Tummers Philippe, Katrien Vandecasteele, Hannelore Denys
    Acta Clinica Belgica.2022; 77(4): 792.     CrossRef
  • Friend or foe? The prognostic role of endometriosis in women with clear cell ovarian carcinoma. A UK population-based cohort study
    Anastasios Tranoulis, Felicia Helena Buruiana, Bindiya Gupta, Audrey Kwong, Aarti Lakhiani, Jason Yap, Janos Balega, Kavita Singh
    Archives of Gynecology and Obstetrics.2022; 305(5): 1279.     CrossRef
  • Association Between Endometriosis and Prognosis of Ovarian Cancer: An Updated Meta-Analysis
    Peng Chen, Chi-Yuan Zhang
    Frontiers in Oncology.2022;[Epub]     CrossRef
  • Clinical analysis and literature review of a case of ovarian clear cell carcinoma with PIK3CA gene mutation: A case report
    Abdulkarim Mohamed Farah, Shiyu Gu, Yan Jia
    Medicine.2022; 101(37): e30666.     CrossRef
  • Clear cell carcinoma of the ovary: a clinical and molecular perspective
    Yasushi Iida, Aikou Okamoto, Robert L Hollis, Charlie Gourley, C Simon Herrington
    International Journal of Gynecological Cancer.2021; 31(4): 605.     CrossRef
  • Clinical characteristics and prognosis of ovarian clear cell carcinoma: a 10-year retrospective study
    Chenchen Zhu, Jing Zhu, Lili Qian, Hanyuan Liu, Zhen Shen, Dabao Wu, Weidong Zhao, Weihua Xiao, Ying Zhou
    BMC Cancer.2021;[Epub]     CrossRef
  • The oncological outcome of the patients with ovarian clear cell cancer: Platinum-based adjuvant chemotherapy is not suitable
    Caner ÇAKIR, Fatih KILIÇ, Çiğdem KILIÇ, Dilek YÜKSEL, Vakkas KORKMAZ, Günsu KİMYON CÖMERT, Osman TÜRKMEN, Taner TURAN
    Journal of Surgery and Medicine.2021; 5(8): 1.     CrossRef
  • Development and validation of Nomograms for predicting overall survival and Cancer-specific survival in patients with ovarian clear cell carcinoma
    Qian Chen, Shu Wang, Jing-He Lang
    Journal of Ovarian Research.2020;[Epub]     CrossRef
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BioPATH: A Biomarker Study in Asian Patients with HER2+ Advanced Breast Cancer Treated with Lapatinib and Other Anti-HER2 Therapy
Sung-Bae Kim, In-Gu Do, Janice Tsang, Tae-You Kim, Yoon-Sim Yap, Gerardo Cornelio, Gyungyub Gong, Soonmyung Paik, Suee Lee, Ting-Ying Ng, Sarah Park, Ho-Suk Oh, Joanne Chiu, Joohyuk Sohn, Moonhee Lee, Young-Jin Choi, Eun Mi Lee, Kyong-Hwa Park, Christos Nathaniel, Jungsil Ro
Cancer Res Treat. 2019;51(4):1527-1539.   Published online June 4, 2019
DOI: https://doi.org/10.4143/crt.2018.598
AbstractAbstract PDFPubReaderePub
Purpose
BioPATH is a non-interventional study evaluating the relationship of molecular biomarkers (PTEN deletion/downregulation, PIK3CA mutation, truncated HER2 receptor [p95HER2], and tumor HER2 mRNA levels) to treatment responses in Asian patients with HER2+ advanced breast cancer treated with lapatinib and other HER2-targeted agents. Materials and Methods Female Asian HER2+ breast cancer patients (n=154) who were candidates for lapatinib-based treatment following metastasis and having an available primary tumor biopsy specimen were included. The primary endpoint was progression-free survival (PFS). Secondary endpoints were response rate, overall survival on lapatinib, correlation between biomarker status and PFS for any previous trastuzumab-based treatment, and conversion/conservation rates of the biomarker status between tissue samples collected at primary diagnosis and at recurrence/metastasis. Potential relationships between tumor mRNA levels of HER2 and response to lapatinib-based therapy were also explored.
Results
p95HER2, PTEN deletion/downregulation, and PIK3CA mutation did not demonstrate any significant co-occurrence pattern and were not predictive of clinical outcomes on either lapatinib-based treatment or any previous trastuzumab-based therapy in the metastatic setting. Proportions of tumors positive for p95HER2 expression, PIK3CA mutation, and PTEN deletion/down-regulation at primary diagnosis were 32%, 31.2%, and 56.2%, respectively. Despite limited availability of paired samples, biomarker status patterns were conserved in most samples. HER2 mRNA levels were not predictive of PFS on lapatinib.
Conclusion
The prevalence of p95HER2 expression, PIK3CA mutation, and PTEN deletion/downregulation at primary diagnosis were similar to previous reports. Importantly, no difference was observed in clinical outcome based on the status of these biomarkers, consistent with reports from other studies.

Citations

Citations to this article as recorded by  
  • PIK3CA Mutation is Associated with Poor Response to HER2-Targeted Therapy in Breast Cancer Patients
    Ju Won Kim, Ah Reum Lim, Ji Young You, Jung Hyun Lee, Sung Eun Song, Nam Kwon Lee, Seung Pil Jung, Kyu Ran Cho, Cheol Yong Kim, Kyong Hwa Park
    Cancer Research and Treatment.2023; 55(2): 531.     CrossRef
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    Justus Rosin, Ella Svegrup, Antonios Valachis, Ioannis Zerdes
    Breast Cancer Research and Treatment.2023; 201(2): 161.     CrossRef
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    Haizhu Chen, Xingbin Hu, Daquan Wang, Ying Wang, Yunfang Yu, Herui Yao
    Translational Oncology.2023; 37: 101738.     CrossRef
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    Jessica W. Chen, Karthikeyan Murugesan, Justin Y. Newberg, Ethan S. Sokol, Heidi M. Savage, Thomas J. Stout, Sophia L. Maund, Katherine E. Hutchinson
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    Ugo Testa, Germana Castelli, Elvira Pelosi
    Medical Sciences.2020; 8(1): 18.     CrossRef
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  • 194 Download
  • 4 Web of Science
  • 5 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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    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
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    npj Breast Cancer.2022;[Epub]     CrossRef
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    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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Pazopanib for the Treatment of Non-clear Cell Renal Cell Carcinoma: A Single-Arm, Open-Label, Multicenter, Phase II Study
Ki Sun Jung, Su Jin Lee, Se Hoon Park, Jae-Lyun Lee, Se-Hoon Lee, Jae Yun Lim, Jung Hun Kang, Suee Lee, Sun Young Rha, Kyung Hee Lee, Ho Young Kim, Ho Yeong Lim
Cancer Res Treat. 2018;50(2):488-494.   Published online May 22, 2017
DOI: https://doi.org/10.4143/crt.2016.584
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
The optimal treatment strategy for patients with metastatic non-clear cell type renal cell carcinoma (nccRCC) remains unclear. Although several inhibitors of vascular endothelial growth factor have recently shown efficacy against nccRCC, the clinical benefit of pazopanib in nccRCC has not been analyzed. We therefore designed a single-arm, open-label, phase II study to determine the efficacy and safety of pazopanib in patients with nccRCC.
Materials and Methods
Patientswith locally advanced or metastatic nccRCC, exceptfor collecting duct or sarcomatoid type, received 800 mg/day of pazopanib daily until progression of disease or intolerable toxicity. One cyclewas defined as 4weeks and tumorresponsewas evaluated every two cycles. The primary objective was overall response rate (ORR).
Results
A total of 29 eligible patients were enrolled at nine centers in Korea from December 2012 and September 2014. The median age of the patients was 58 years (range, 27 to 76 years) and 21 patients (72%) were male. Regarding histology type, 19 patients had papillary, three had chromophobe, two had unclassified and five had unknown non-clear cell type. Of 28 evaluable patients, eight achieved a confirmed partial response with ORR of 28%. The median progression-free survival was 16.5 months (95% confidence interval, 10.9 to 22.1) and median overall survival was not reached. Sixteen patients (55%) experienced treatment-related toxicity of grade 3 or more, but most adverse events were overcome through dose reduction and delay.
Conclusion
In this prospective phase II study, pazopanib demonstrated promising activity and tolerable safety profile in patients with metastatic nccRCC.

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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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    Yu-Ju Lin, Chun-Nan Kuo, Yu Ko
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    Priya Seshadri, Barnali Deb, Prashant Kumar
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    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
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    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
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Clinical Significance of Peroxisome Proliferator-Activated Receptor γ and TRAP220 in Patients with Operable Colorectal Cancer
Kyung A Kwon, Jeanho Yun, Sung Yong Oh, Bong-Gun Seo, Suee Lee, Ji-Hyun Lee, Sung-Hyun Kim, Hong Jo Choi, Mee Sook Roh, Hyo-Jin Kim
Cancer Res Treat. 2016;48(1):198-207.   Published online June 23, 2015
DOI: https://doi.org/10.4143/crt.2015.024
AbstractAbstract PDFPubReaderePub
Purpose
The peroxisome proliferator-activated receptor γ (PPARγ) is a nuclear receptor that regulates expression of mediators of lipid metabolism and the inflammatory response. Thyroid hormone receptor-associated proteins 220 (TRAP220) is an essential component of the TRAP/Mediator complex. The objective of this study was to clarify whether PPARγ or TRAP220 are significant prognostic markers in resectable colorectal cancer (CRC).
Materials and Methods
A total of 399 patients who underwent curative resection for CRC were enrolled. We investigated the presence of PPARγ and TARP220 in CRC tissues and adjacent normal tissues by immunohistochemistry. Correlation between the expression of these factors and clinicopathologic features and survival was investigated.
Results
Median age of the patients was 63 years (range, 22 to 87 years), and median follow-up duration 61.1 months (range, 2 to 114 months). PPARγ and TRAP220 expression showed significant correlation with depth of invasion (p=0.013 and p=0.001, respectively). Expression of TRAP220 also showed association with lymph node metastasis and TNM stage (p=0.001). Compared with patients with TRAP220 negative tumors, patients with TRAP220 positive tumors had longer 5-year disease-free survival (DFS) tendency (p=0.051). Patients who were PPARγ positive combined with TRAP220 positive had a better 5-year DFS (64.8% vs. 79.3%, p=0.013). In multivariate analysis expression of both PPARγ and TRAP220 significantly affected DFS (hazard ratio, 0.620; 95% confidence interval, 0.379 to 0.997; p=0.048).
Conclusion
TRAP220 may be a valuable marker for nodal metastasis and TNM stage. Tumor co-expression of PPARγ and TRAP220 represents a biomarker for good prognosis in CRC patients.

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    Jing Zhou, Zhanzhao Liu, Lingjing Zhang, Xiao Hu, Zhihua Wang, Hong Ni, Yue Wang, Junfang Qin
    Cancer Research and Treatment.2020; 52(3): 830.     CrossRef
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    Hyun-Ju Kim, Jeanho Yun
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A Phase II Study of Modified FOLFOX4 for Colorectal Cancer Patients with Peritoneal Carcinomatosis
Dong Hyun Lee, Sung Yong Oh, Yu Rim Lee, Seok Jae Huh, Hyun Hwa Yoon, Sung Hyun Kim, Suee Lee, Ji Hyun Lee, Young Kim, Hyo-Jin Kim, Hyuk-Chan Kwon
Cancer Res Treat. 2011;43(4):225-230.   Published online December 27, 2011
DOI: https://doi.org/10.4143/crt.2011.43.4.225
AbstractAbstract PDFPubReaderePub
PURPOSE
Peritoneal carcinomatosis (PC) of colorectal cancer (CRC) is common and is the second most common cause of death. Clinical studies regarding chemotherapy for CRC with PC have been classically rather limited in scope. We evaluated the efficacy of modified oxaliplatin, leucovorin, and fluorouracil (m-FOLFOX4) regimen for PC of CRC origin.
MATERIALS AND METHODS
CRC patients with PC were treated with cycles of oxaliplatin at 85 mg/m2 on day 1, leucovorin 20 mg/m2 followed by 5-fluorouracil (5-FU) via a 400 mg/m2 bolus and a 22 hours continuous infusion of 600 mg/m2 5-FU on days 1-2 at 2-week intervals.
RESULTS
Forty patients participated in this study. Median age was 55 years. Thirty-two patients (80.0%) received previous operation, and 60.0% of PC occurred synchronously. Thirty-five patients (87.5%) were assessable and exhibited measurable lesions. Two patients (5.7%) demonstrated complete response and five patients (14.3%) showed partial response. The median time to progression was 4.4 months (95% confidence interval, 2.5 to 6.3 months), the median overall survival time was 21.5 months (95% confidence interval, 17.2 to 25.7 months). There was no treatment related death. Presence of liver metastasis (p=0.022), performance status (p=0.039), and carcinoembryonic antigen level (p=0.016) were related to the time to progression. Patients with low carcinoembryonic antigen level (37.2 months vs. 15.6 months, p=0.001) or good performance status (22.5 months vs. 6.8 months, p=0.040) showed better overall survival.
CONCLUSION
The m-FOLFOX4 regimen was determined to be effective for CRC patients with PC.

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Predictive Value of In Vitro Adenosine Triphosphate-Based Chemotherapy Response Assay in Advanced Gastric Cancer Patients Who Received Oral 5-Fluorouracil after Curative Resection
Ji Hyun Lee, Min-Chan Kim, Sung Yong Oh, Hyuk-Chan Kwon, Sung-Hyun Kim, Kyung A Kwon, Suee Lee, Jin Sook Jeong, Seok-Reyol Choi, Hyo-Jin Kim
Cancer Res Treat. 2011;43(2):117-123.   Published online June 30, 2011
DOI: https://doi.org/10.4143/crt.2011.43.2.117
AbstractAbstract PDFPubReaderePub
PURPOSE
To assess the usefulness of adenosine triphosphate-based chemotherapy response assay (ATP-CRA) results in advanced gastric cancer patients receiving adjuvant chemotherapy.
MATERIALS AND METHODS
Sixty-two patients underwent curative surgical resection between January, 2006 and December, 2008. Their highly purified surgical specimens were evaluated by ATP-CRAs. Of the 62, 49 had successful assay results and they received either oral 5-fluorouracil or other chemotherapies. We retrospectively analyzed data for 24 patients who were treated with oral 5-fluorouracil and whose assays were successful.
RESULTS
The median observation time was 24.6 months (range, 10.1 to 40.9 months). The median treatment time was 11.2 months (range, 1.2 to 17.7 months). The median age was 66 years (range, 30 to 81 years). Patients were grouped into sensitive- and resistant-groups according to adenosine triphosphate-based chemotherapy response results for fluorouracil. The sensitive-group showed a significantly longer time to relapse (not reached in the sensitive-group vs. 24.8 months in the resistant-group, p=0.043) and longer overall survival compared to the resistant-group (not reached in the sensitive-group vs. 35.7 months in the resistant-group, p=0.16, statistically insignificant).
CONCLUSION
Patients who receive curative surgical resection significantly benefit from sensitive adjuvant chemotherapy according to ATP-CRA results for time to relapse.

Citations

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Case Report
A Case of 5-Fluorouracil Induced Encephalopathy
Kyung A Kwon, Hyuk-Chan Kwon, Min Chan Kim, Sung-Hyun Kim, Sung Yong Oh, Suee Lee, Hyo-Jin Kim
Cancer Res Treat. 2010;42(2):118-120.   Published online June 30, 2010
DOI: https://doi.org/10.4143/crt.2010.42.2.118
AbstractAbstract PDFPubReaderePub

Patients with reduced dihydropyrimidine dehydrogenase (DPD) activity are at risk for experiencing serious adverse effects following 5-fluorouracil (5-FU) based chemotherapy. Neurotoxicity is considered an extremely rare side effect of 5-FU. We report here on an unusual case of 5-FU induced encephalopathy. A 38-year-old woman with advanced gastric carcinoma was treated with adjuvant chemotherapy that consisted of infused 5-FU (1,000 mg/m2) for 5 days and cisplatin (60 mg/m2) on day 1 following total gastrectomy. Nineteen days after starting chemotherapy, the patient displayed a sudden onset of slurred speech, confusion, cognitive disturbances and paranoia. A magnetic resonance image (MRI) of the brain showed no structural abnormalities, and the other laboratory tests provided no explanations for her symptoms, other than a slightly elevated ammonia level. The patient was treated with a lactulose retention enema and thiamine infusion, the 5-FU was halted and her symptoms then recovered after 7 days.

Citations

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    Ana Dias-Carvalho, Mariana Ferreira, Rita Ferreira, Maria de Lourdes Bastos, Susana Isabel Sá, João Paulo Capela, Félix Carvalho, Vera Marisa Costa
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Original Articles
Phase II Study of Gemcitabine plus Cisplatin in Patients with Anthracycline- and Taxane- Pretreated Metastatic Breast Cancer
Jung Hwan Kim, Sung Yong Oh, Hyuk-Chan Kwon, Suee Lee, Sung-Hyun Kim, Dae-Cheol Kim, Jin-Hwa Lee, Hyung-Sik Lee, Se-Heun Cho, Hyo-Jin Kim
Cancer Res Treat. 2008;40(3):101-105.   Published online September 30, 2008
DOI: https://doi.org/10.4143/crt.2008.40.3.101
AbstractAbstract PDFPubReaderePub
Purpose

Metastatic breast cancer patients are usually exposed to taxane and anthracycline as neoadjuvant, adjuvant and palliative chemotherapeutic agents. This study was designed to determine the efficacy and safety of the use of a gemcitabine and cisplatin (GP) combination treatment in patients with metastatic breast cancer that were pretreated with anthracycline and taxane.

Materials and Methods

We evaluated the use of a GP regimen (1,000 mg/m2 gemcitabine administered on days 1 and 8 plus 60 mg/m2 cisplatin administered on day 1 every 3 weeks) in 38 breast cancer patients who had received prior chemotherapy with anthracycline and taxane as an adjuvant or neoadjuvant therapy, or as a palliative therapy.

Results

The median patient age was 49 years (age range, 35~69 years). The overall response rate was 28.9% in 11 patients (95% confidence interval [CI], 14~44%). The median time to progression was 5.2 months (95% CI, 3.6~6.8 months). Median survival was 19.5 months (95% CI, 11.2~27.8 months). Major grade 3/4 hematological toxicity was due to leukopenia (36 of 157 cycles, 23.1%). Non-hematological toxicity was rarely severe; grade1/2 nausea and vomiting were observed in 37.8% of the patients. There were no treatment related deaths.

Conclusions

Our results suggest that the use of gemcitabine plus cisplatin appears to be effective and has an acceptable toxicity profile in patients with advanced breast cancer that have been pretreated with anthracycline and taxane.

Citations

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  • Maintenance chemotherapy after 6 cycles of platinum-doublet regimen in anthracycline-and taxane-pretreated metastatic breast cancer
    Eun Kyo Joung, Ji Hyun Yang, Sooeun Oh, Se Jun Park, Jieun Lee
    The Korean Journal of Internal Medicine.2021; 36(1): 182.     CrossRef
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    Jung Sun Kim, In Hae Park, Keun Seok Lee, Jungsil Ro
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    Pramod K. Julka, Raju T. Chacko, Shona Nag, Rajinder Parshad, Aravindan Nair, Chaitanyanand B. Koppiker, Fen Chao Richard Xue, Helen Barraclough, Navreet Dhindsa, Anil Seth, Anurita Majumdar, Tarun Puri
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    Tao Wang, Shaohua Zhang, Min Zeng, Xinyou Lu, Ge Shen, Shikai Wu, Santai Song, Zefei Jiang
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    Ali I. Shamseddine, Fadi S. Farhat
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Gemcitabine versus Gemcitabine Combined with Cisplatin Treatment Locally Advanced or Metastatic Pancreatic Cancer: A Retrospective Analysis
Jae-Hyuk Choi, Sung Yong Oh, Hyuk-Chan Kwon, Jung Hwan Kim, Jae Hoon Lee, Suee Lee, Dong Mee Lee, Sung-Hyun Kim, Myung Hwan Rho, Young-Hoon Kim, Mee-Sook Rho, Hyo-Jin Kim
Cancer Res Treat. 2008;40(1):22-26.   Published online March 31, 2008
DOI: https://doi.org/10.4143/crt.2008.40.1.22
AbstractAbstract PDFPubReaderePub
Purpose

Gemcitabine is the most active agent to treat unresectable pancreatic cancer. The superiority of combining other drugs with cisplatin is still controversial; therefore, we performed a retrospective analysis of gemcitabine versus gemcitabine combined with cisplatin to determine the treatment outcomes for patients with locally advanced or metastatic pancreatic cancer.

Materials and Methods

From 2001 to 2007, we enrolled 60 patients who were treated with gemcitabine or gemcitabine combined with cisplatin for locally advanced or metastatic pancreatic cancer. Gemcitabine 1, 000 mg/m2 (G) was administrated at day 1 and day 8 every 3 weeks. Cisplatin 60 mg/m2 was added at day 1 every 3 weeks to the gemcitabine schedule (GP).

Results

Number of G: GP was 34: 26, locally advanced to metastatic ratio was 35% to 65% in group G and 46% to 54% in group GP. Median follow up duration was 29 months. The median number of chemotherapy cycles was 4 (range: 2~11) for the G group, and 4 (range: 1~11) for the GP group. The response rate of the G and GP groups was 17% and 11%, respectively. The progression free survival (PFS) was 4.5 months and 2.8 months, respectively, for the G and GP groups. The overall survival (OS) was 10.7 and 8.7 months respectively, for the G and GP groups, but there is no statistically significant difference of the PFS (p=0.2396) and OS (p=0.4643) between the 2 groups. The hematological toxicity profile was similar (the grade III neutropenia and thrombocytopenia was 4.4% and 3.1%, respectively, in G group, and 7.5% and 2.8%, respectively, in the GP group). But non-hematological toxicities such as skin rash, abnormal liver function and nausea/vomiting were observed in 3 patients of the GP group. On the prognostic factor analysis, no factors predicted a longer PFS and OS for both the G and GP groups.

Conclusions

Gemcitabine single treatment might be more tolerable and it had the same efficacy compared to cisplatin combination treatment in this retrospective study.

Citations

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    David J. Kuter
    Haematologica.2022; 107(6): 1243.     CrossRef
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    Irene Marini, Gunalp Uzun, Kinan Jamal, Tamam Bakchoul
    Haematologica.2022; 107(6): 1264.     CrossRef
  • Concurrent chemotherapy alone versus irreversible electroporation followed by chemotherapy on survival in patients with locally advanced pancreatic cancer
    Giuseppe Belfiore, Maria Paola Belfiore, Alfonso Reginelli, Raffaella Capasso, Francesco Romano, Giovanni Pietro Ianniello, Salvatore Cappabianca, Luca Brunese
    Medical Oncology.2017;[Epub]     CrossRef
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    Eric S. Winer, Howard Safran, Boguslawa Karaszewska, Sebastian Bauer, Dilawar Khan, Steffen Doerfel, Paul Burgess, Stacey Kalambakas, Yasser Mostafa Kamel, Frederic Forget
    International Journal of Hematology.2017; 106(6): 765.     CrossRef
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    Eric S. Winer, Howard Safran, Boguslawa Karaszewska, Donald A. Richards, Lee Hartner, Frederic Forget, Rodryg Ramlau, Kirushna Kumar, Bhabita Mayer, Brendan M. Johnson, Conrad A. Messam, Yasser Mostafa Kamel
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    Qin Li, Zhenyan Yuan, Han Yan, Zhaoyang Wen, Ruixue Zhang, Bangwei Cao
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    Qin Li, Han Yan, Wenting Liu, Hongchao Zhen, Yifan Yang, Bangwei Cao, Jonathan R. Brody
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    Samantha B. Kasloff, Matteo S. Pizzuto, Micol Silic-Benussi, Silvia Pavone, Vincenzo Ciminale, Ilaria Capua, K. L. Beemon
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Case Reports
Unusual Presentation of Large B Cell Lymphoma- Bone and Stomach- Treated with Autologous Transplantation
Bokyung Kim, Sung Yong Oh, Suee Lee, Hyuk-Chan Kwon, Sung-Hyun Kim, Sook Hee Hong, Sung-Soo Kim, Hyo-Jin Kim
Cancer Res Treat. 2007;39(4):181-184.   Published online December 31, 2007
DOI: https://doi.org/10.4143/crt.2007.39.4.181
AbstractAbstract PDFPubReaderePub

Extranodal presentation of diffuse large B cell lymphoma (DLBL) is frequently observed in the gastrointestinal tract, CNS, bone, testes and liver. However, the simultaneous detection of multiple extranodal involvement at presentation is quite an uncommon occurrence. In this study, we report on a patient with an uncommon presentation of DLBL, and he had symptoms of left knee joint pain and hematemesis, characterized by bone and stomach involvement. Computed tomography and fluorodeoxyglucose-positron emission tomography (FDG-PET) scanning revealed a rapid, extensive spread to the bones and soft tissues. Subsequent histopathological examination verified the bony and gastric CD20-positive DLBL localization. We diagnosed this case as DLBL of stage IV with an international prognostic index of 3, and classified him into the high intermediate risk group. This patient was treated via chemotherapy with an R-CHOP regimen. After achieving a partial response, the patient received autologous peripheral blood stem cell transplantation. The patient attained partial remission, as shown on the FDG-PET scan, and he displayed improvement of his left femur pain.

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Extraskeletal Mesenchymal Chondrosarcoma of the Heart Responded to Systemic Chemotherapy: A Case Report
Chien Ter Hsing, Sung Yong Oh, Suee Lee, Hyuk-Chan Kwon, Sung-Hyun Kim, Tae-Ho Park, Jong Soo Woo, Seo Hee Na, Hyo-Jin Kim
Cancer Res Treat. 2007;39(3):131-133.   Published online September 30, 2007
DOI: https://doi.org/10.4143/crt.2007.39.3.131
AbstractAbstract PDFPubReaderePub

Mesenchymal chondrosarcoma is a rare cartilaginous ne - oplasm of an extraskeletal origin, and this predominately occurs in the head and neck, and also in the lower extremities. Fewer than twenty cases of cardiac mesenchymal chondrosarcoma have so far been reported on. For the most part, the results of treatment for patients with this condition have been dismal. In this study, we describe a case of cardiac mesenchymal chondrosarcoma that responded to chemotherapy following surgical biopsy. A 46-year-old man was referred for evaluation of his pleural effusions in both lungs. Chest computed tomography revealed an ovoid-shaped mass in the posterior wall of the patient's left atrium. The echocardiogram revealed a large ovoid-shaped immobile mass (11×6 cm2) in the pericardiac space, which was attached to the posterior wall of the left atrium. Emergency pericardiostomy with closure thoracostomy was performed. Seven days later, a thoracotomy was performed for reduction and diagnosis of the cardiac mass. The pathological diagnosis was extraskeletal mesenchymal chondrosarcoma of the heart.. Postoperative chemotherapy was performed for the huge remaining mass with a combined regimen of etoposide, ifosfamide and cisplatin. After 6 cycles, the patient showed a partial response without symptoms. Although cardiac mesenchymal chondrosarcoma has been reported to be chemotherapy-resistant with a short survival duration, chemotherapy may prove to be an effective treatment modality.

Citations

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Original Article
A Phase II Study of Paclitaxel and Cisplatin as Salvage Therapy for Patients with Advanced or Metastatic Gastric Cancer
Bong-Gun Seo, Sung Yong Oh, Dong Mee Lee, Hyun Seung Yoo, Suee Lee, Seong-Geun Kim, Sung-Hyun Kim, Hyuk-Chan Kwon, Hyo-Jin Kim
Cancer Res Treat. 2007;39(1):6-9.   Published online March 31, 2007
DOI: https://doi.org/10.4143/crt.2007.39.1.6
AbstractAbstract PDFPubReaderePub
Purpose

To evaluate the therapeutic activity and safety of paclitaxel and cisplatin combination chemotherapy in patients with advanced or metastatic gastric cancers that are unresponsive to primary chemotherapy.

Materials and Methods

Advanced or metastatic gastric cancer patients unresponsive to first line chemotherapy were entered into this trial. The treatment regimen consisted of paclitaxel, 175 mg/m2 by 3-hour infusion on day 1, and cisplatin, 60 mg/m2 by 1 hour infusion on day 1, with the treatment repeated every 3 weeks.

Results

37 patients were entered in this study, with 32 fully evaluable for response. 4 (13%), 13 (40%) and 15 (47%) patients achieved a partial response, stable disease and progressed, respectively. The median time to progression was 4.0 months (95% CI: 2.0~6.0 months), and the median overall survival was 12.6 months (95% CI: 5.5~19.7 months), with a 1-year survival rate of 54%. Of a total of 135 cycles of chemotherapy, grades 3 and 4 hematological toxicities were neutropenia (14%) and anemia (3%). Grade ≥2 neuropathy was observed in 6 patients (17%).

Conclusion

The combination of paclitaxel and cisplatin is an effective and tolerable salvage treatment modality for advanced gastric cancer.

Citations

Citations to this article as recorded by  
  • Treatment Outcome and Safety of the TCX Regimen for Advanced Gastric Cancer: A Prospective Cohort Study
    Hieu Trong Nguyen, Kien Hung Do, Nguyen Ba Le, Thang Tran
    Cancer Management and Research.2022; Volume 14: 2825.     CrossRef
  • Multi-center Phase II Trial of Weekly Paclitaxel Plus Cisplatin Combination Chemotherapy in Patients with Advanced Gastric and Gastro-esophageal Cancer
    Q. Sun, C. Liu, H. Zhong, B. Zhong, H. Xu, W. Shen, D. Wang
    Japanese Journal of Clinical Oncology.2009; 39(4): 237.     CrossRef
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Cancer Res Treat : Cancer Research and Treatment
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