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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

Cited 260 time in Web of Science Cited 270 time in Scopus
Authors
Hecht, J. Randolph; Bang, Yung-Jue; Qin, Shukui K.; Chung, Hyun C.; Xu, Jianming M.; Park, Joon O.; Jeziorski, Krzysztof; Shparyk, Yaroslav; Hoff, Paulo M.; Sobrero, Alberto; Salman, Pamela; Li, Jin; Protsenko, Svetlana A.; Wainberg, Zev A.; Buyse, Marc; Afenjar, Karen; Houe, Vincent; Garcia, Agathe; Kaneko, Tomomi; Huang, Yingjie; Khan-Wasti, Saba; Santillana, Sergio; Press, Michael F.; Slamon, Dennis
Issue Date
2016-02
Citation
Journal of Clinical Oncology, Vol.34 No.5, pp.443-451
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 1,250mg 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. (C) 2015 by American Society of Clinical Oncology
ISSN
0732-183X
URI
https://hdl.handle.net/10371/173089
DOI
https://doi.org/10.1200/JCO.2015.62.6598
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College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
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