Adjuvant capecitabine plus oxaliplatin after D2 gastrectomy in Japanese patients with gastric cancer: a phase II studyReport as inadecuate




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Gastric Cancer

, Volume 20, Issue 2, pp 332–340

First Online: 08 March 2016Received: 04 December 2015Accepted: 22 February 2016DOI: 10.1007-s10120-016-0606-4

Cite this article as: Fuse, N., Bando, H., Chin, K. et al. Gastric Cancer 2017 20: 332. doi:10.1007-s10120-016-0606-4

Abstract

BackgroundAdjuvant chemotherapy with XELOX capecitabine plus oxaliplatin has been shown to be beneficial following resection of gastric cancer in South Korean, Chinese, and Taiwanese patients. This phase II study J-CLASSIC-PII was undertaken to evaluate the feasibility of XELOX in Japanese patients with resected gastric cancer.

MethodsPatients with stage II or III gastric cancer who underwent curative D2 gastrectomy received adjuvant XELOX eight 3-week cycles of oral capecitabine, 1000 mg-m twice daily on days 1–14, plus intravenous oxaliplatin 130 mg-m on day 1. The primary endpoint was dose intensity. Secondary endpoints were safety, proportion of patients completing treatment, and 1-year disease-free survival DFS rate.

ResultsOne hundred patients were enrolled, 76 of whom completed the study as planned. The mean dose intensity was 67.2 % 95 % CI, 61.9–72.5 % for capecitabine and 73.4 % 95 % CI, 68.4–78.4 % for oxaliplatin, which were higher than the predefined age-adjusted threshold values of 63.4 % and 69.4 %, respectively, and the study therefore met its primary endpoint. The 1-year DFS rate was 86 % 95 % CI, 77–91 %. No new safety signals were identified.

ConclusionsThe feasibility of adjuvant XELOX in Japanese patients with resected gastric cancer is similar to that observed in South Korean, Chinese, and Taiwanese patients in the Capecitabine and Oxaliplatin Adjuvant Study in Stomach Cancer CLASSIC study. Based on findings from this study and the CLASSIC study, the XELOX regimen can be considered an adjuvant treatment option for Japanese gastric cancer patients who have undergone curative resection.

KeywordsAdjuvant treatment Feasibility study Gastric cancer Japanese study XELOX Electronic supplementary materialThe online version of this article doi:10.1007-s10120-016-0606-4 contains supplementary material, which is available to authorized users.

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Author: Nozomu Fuse - Hideaki Bando - Keisho Chin - Seiji Ito - Takaki Yoshikawa - Akira Tsuburaya - Masanori Terashima - Yoshiyuki

Source: https://link.springer.com/







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