Lapatinib in Combination With Capecitabine Plus Oxaliplatin in Human Epidermal Growth Factor Receptor 2–Positive Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Adenocarcinoma: TRIO-013/LOGiC—A Randomized Phase III Trial
-
Published:2016-02-10
Issue:5
Volume:34
Page:443-451
-
ISSN:0732-183X
-
Container-title:Journal of Clinical Oncology
-
language:en
-
Short-container-title:JCO
Author:
Hecht J. Randolph1, Bang Yung-Jue1, Qin Shukui K.1, Chung Hyun C.1, Xu Jianming M.1, Park Joon O.1, Jeziorski Krzysztof1, Shparyk Yaroslav1, Hoff Paulo M.1, Sobrero Alberto1, Salman Pamela1, Li Jin1, Protsenko Svetlana A.1, Wainberg Zev A.1, Buyse Marc1, Afenjar Karen1, Houé Vincent1, Garcia Agathe1, Kaneko Tomomi1, Huang Yingjie1, Khan-Wasti Saba1, Santillana Sergio1, Press Michael F.1, Slamon Dennis1
Affiliation:
1. J. Randolph Hecht, Zev A. Wainberg, and Dennis Slamon, David Geffen School of Medicine, University of California Los Angeles, Santa Monica; Michael F. Press, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Yung-Jue Bang, Seoul National University College of Medicine; Hyun C. Chung, Yonsei Cancer Center, Yonsei Cancer Research Institute, Yonsei University College of Medicine; Joon O. Park, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul,...
Abstract
Purpose To evaluate the efficacy of adding lapatinib to capecitabine and oxaliplatin (CapeOx) in patients with previously untreated human epidermal growth factor receptor 2 (HER2) –amplified advanced gastroesophageal adenocarcinoma. Patients and Methods Patients with HER2-positive advanced gastroesophageal adenocarcinoma were randomly assigned at a one-to-one ratio to CapeOx plus lapatinib 1,250 mg or placebo daily. Primary end point was overall survival (OS) in patients with centrally confirmed HER2 amplification in the primary efficacy population. Results A total of 545 patients were randomly assigned, and 487 patients comprised the primary efficacy population. Median OS in the lapatinib and placebo arms was 12.2 (95% CI, 10.6 to 14.2) and 10.5 months (95% CI, 9.0 to 11.3), respectively, which was not significantly different (hazard ratio, 0.91; 95% CI, 0.73 to 1.12). Median progression-free survival in the lapatinib and placebo arms was 6.0 (95% CI, 5.6 to 7.0) and 5.4 months (95% CI, 4.4 to 5.7), respectively (hazard ratio, 0.82; 95% CI, 0.68 to 1.00; P = .0381). Response rate was significantly higher in the lapatinib arm: 53% (95% CI, 46.4 to 58.8) compared with 39% (95% CI, 32.9 to 45.3) in the placebo arm (P = .0031). Preplanned exploratory subgroup analyses showed OS in the lapatinib arm was prolonged in Asian and younger patients. No correlation was observed between HER2 immunohistochemistry status and survival. There were increased toxicities in the lapatinib arm, particularly diarrhea. Conclusion Addition of lapatinib to CapeOx did not increase OS in patients with HER2-amplified gastroesophageal adenocarcinoma. There were clear differences in the effect of lapatinib depending on region and age. Future studies could examine this correlation.
Publisher
American Society of Clinical Oncology (ASCO)
Subject
Cancer Research,Oncology
Cited by
452 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献
|
|