Adjuvant capecitabine plus oxaliplatin after D2 gastrectomy in Japanese patients with gastric cancer: a phase II study.
Adjuvant capecitabine plus oxaliplatin after D2 gastrectomy in Japanese patients with gastric cancer: a phase II study.
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DOI：
10.1007/s10120-016-0606-4
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发表时间：
2017-03
期刊：
影响因子：
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通讯作者：
Sasako M
中科院分区：
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作者：
Fuse N;Bando H;Chin K;Ito S;Yoshikawa T;Tsuburaya A;Terashima M;Kawashima Y;Fukunaga T;Gotoh M;Emi Y;Yoshida K;Oki E;Takahashi S;Kuriki H;Sato K;Sasako M
在韩国、中国和中国台湾患者中，XALIX（卡培他滨+奥沙利铂）辅助化疗已被证明对胃癌切除术有益。本II期研究（J-CLASSIC-PII）旨在评价XAPEX在日本胃癌切除患者中的可行性。接受根治性D2胃切除术的II期或III期胃癌患者接受辅助XALIX治疗（8个3周周期的口服卡培他滨，1000 mg/m2，每日2次，第1-14天，加上第1天静脉注射奥沙利铂130 mg/m2）。主要终点为剂量强度。次要终点是安全性、完成治疗的患者比例和1年无病生存率（DFS）。入组了100例患者，其中76例按计划完成了研究。卡培他滨和奥沙利铂的平均剂量强度分别为67.2%（95%CI，61.9- 72.5%）和73.4%（95%CI，68.4- 78.4%），分别高于预先设定的年龄校正阈值63.4%和69.4%，因此研究符合其主要终点。1年DFS率为86%（95%CI，77- 91%）。未发现新的安全性信号。日本胃癌切除患者中XALIX辅助治疗的可行性与卡培他滨和奥沙利铂胃癌辅助治疗研究（CLASSIC）中在韩国、中国和中国台湾患者中观察到的结果相似。根据本研究和CLASSIC研究的结果，XALIX方案可被视为接受根治性切除术的日本胃癌患者的辅助治疗选择。本文的在线版本（doi：10.1007/s10120-016-0606-4）包含补充材料，可供授权用户使用。
Adjuvant 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. Patients with stage II or III gastric cancer who underwent curative D2 gastrectomy received adjuvant XELOX (eight 3-week cycles of oral capecitabine, 1000 mg/m2 twice daily on days 1–14, plus intravenous oxaliplatin 130 mg/m2 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. One 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. The 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. The online version of this article (doi:10.1007/s10120-016-0606-4) contains supplementary material, which is available to authorized users.