https://scholars.lib.ntu.edu.tw/handle/123456789/487287
標題: | A KRAS mutation status-stratified randomized phase II trial of gemcitabine and oxaliplatin alone or in combination with cetuximab in advanced biliary tract cancer | 作者: | Chen J.S. CHIH-HUNG HSU Chiang N.J. Tsai C.S. Tsou H.H. Huang S.F. Bai L.Y. Chang I.C. Shiah H.S. Ho C.L. Yen C.J. Lee K.D. Chiu C.F. Rau K.M. Yu M.S. Yang Y. Hsieh R.K. Chang J.Y. Shan Y.S. Chao Y. Chen L.-T. Chin Y.-H. Chung T.-R. Yu W.-L. Lee M.-H. Lin L.-F. Lin P.-C. Wu Y.-L. Wang H.-L. Lu L.-J. Chen S.-Y. Wu C.-C. Wei T.-C. on behalf of the Taiwan Cooperative Oncology Group |
關鍵字: | Biliary tract cancer; Cetuximab; Chemotherapy; KRAS mutation | 公開日期: | 2015 | 出版社: | Oxford University Press | 卷: | 26 | 期: | 5 | 起(迄)頁: | 943-949 | 來源出版物: | Annals of Oncology | 摘要: | Background: Previous clinical trials have not proved that adding epidermal growth factor receptor inhibitors to chemotherapy confers a survival benefit for patients with advanced biliary tract cancer (ABTC). Whether the KRAS mutation status of tumor cells confounded the results of past studies is unknown. Patients and methods: ABTC patients stratified by KRAS status, Eastern Cooperative Oncology Group performance status, and primary tumor location were randomized 1: 1 to receive GEMOX (800 mg/m2 gemcitabine and 85 mg/m2 oxaliplatin) or C-GEMOX (500 mg/m2 cetuximab plus GEMOX) every 2 weeks. The primary end point was objective response rate (ORR). Results: The study enrolled 122 patients between December 2010 and May 2012 (62 treated with C-GEMOX and 60 with GEMOX). Compared with GEMOX alone, C-GEMOX was associated with trend to better ORR (27% versus 15%; P=0.12) and progression-free survival (PFS, 6.7 versus 4.1 months; P = 0.05), but not overall survival (OS, 10.6 versus 9.8 months; P=0.91). KRAS mutations, which were detected in 36% of tumor samples, did not affect the trends of difference in ORR and PFS between C-GEMOX and GEMOX. The two treatment arms had similar adverse events, except that more patients had skin rashes, allergic reactions, and neutropenia in the C-GEMOX arm. Of patients with C-GEMOX, the presence of a grade 2 or 3 skin rash was associated with significantly better ORR, PFS, and OS. Conclusions: Addition of cetuximab did not significantly improve the ORR of GEMOX chemotherapy in ABTC, although a trend of PFS improvement was observed. The trend of improvement did not correlate with KRAS mutation status. ? The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-84929091392&doi=10.1093%2fannonc%2fmdv035&partnerID=40&md5=f0bb44f83285a369a70313438b0291d0 https://scholars.lib.ntu.edu.tw/handle/123456789/487287 |
ISSN: | 0923-7534 | DOI: | 10.1093/annonc/mdv035 | SDG/關鍵字: | cetuximab; gemcitabine; oxaliplatin; antineoplastic agent; cetuximab; deoxycytidine; KRAS protein, human; platinum complex; protein p21; adult; advanced cancer; aged; allergy; anorexia; Article; biliary tract cancer; cancer combination chemotherapy; cancer survival; controlled study; diarrhea; dose response; drug dose reduction; drug safety; drug withdrawal; fatigue; female; gene mutation; human; major clinical study; male; nausea; neuropathy; neutropenia; oncogene K ras; oral mucositis; overall survival; phase 2 clinical trial; priority journal; progression free survival; randomized controlled trial; rash; survival rate; survival time; thrombocytopenia; treatment outcome; tumor localization; vomiting; analogs and derivatives; Biliary Tract Neoplasms; clinical trial; comparative study; disease course; disease free survival; drug administration; genetic predisposition; genetics; Kaplan Meier method; middle aged; mortality; multicenter study; mutation; pathology; phenotype; proportional hazards model; Taiwan; time factor; very elderly; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Biliary Tract Neoplasms; Cetuximab; Deoxycytidine; Disease Progression; Disease-Free Survival; Drug Administration Schedule; Female; Genetic Predisposition to Disease; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Mutation; Organoplatinum Compounds; Phenotype; Proportional Hazards Models; Proto-Oncogene Proteins p21(ras); Taiwan; Time Factors; Treatment Outcome |
顯示於: | 腫瘤醫學研究所 |
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