Lessons learned: Evidence has suggested that capecitabine-cisplatin is similar or possibly superior to S-1-cisplatin in terms of safety and efficacy for Japanese patients with advanced gastric cancer (AGC).As far as we are aware, our study is the first randomized trial of two regimens consisting of an oral fluoropyrimidine plus cisplatin in human epidermal growth receptor 2-negative AGC patients with measurable lesions.
Background: We performed a phase II study to evaluate the safety and efficacy of capecitabine plus cisplatin in comparison with S-1 plus cisplatin for first-line treatment of human epidermal growth receptor 2 (HER2)-negative advanced gastric cancer in Japan.
Methods: Eligible patients were randomly assigned to receive either capecitabine at 1,000 mg/m2 twice daily for 14 days plus cisplatin at 80 mg/m2 on day 1 every 3 weeks (n = 43) or S-1 at 40-60 mg twice daily for 21 days plus cisplatin at 60 mg/m2 on day 8 every 5 weeks (n = 41). The primary endpoint of the study was response rate.
Results: Response rate did not differ significantly between the capecitabine-cisplatin and S-1-cisplatin groups (53.5% vs. 51.2%, respectively, p > .999). S-1-cisplatin tended to confer a better progression-free survival (PFS; median of 5.9 vs. 4.1 months, p = .284), overall survival (OS; median of 13.5 vs. 10.0 months, p = .290), and time to treatment failure (TTF; median of 4.5 vs. 3.1 months, p = .052) compared with capecitabine-cisplatin. Common hematologic toxicities of grade 3 or 4 included anemia and neutropenia in both groups. However, anorexia, fatigue, and hyponatremia of grade 3 or 4 occurred more frequently in the capecitabine-cisplatin group.
Conclusion: Capecitabine-cisplatin failed to demonstrate superior efficacy compared with S-1-cisplatin. The higher incidence of severe adverse events with capecitabine-cisplatin suggests that S-1-cisplatin should remain the standard first-line chemotherapy for HER2-negative advanced gastric cancer in Japan.
摘要
背景。我们进行了一项 II 期研究,以评估卡培他滨和顺铂在日本人表皮生长受体 2 (HER2) 阴性晚期胃癌患者的一线治疗方面与 S‐1 和顺铂相比的安全性和有效性。
方法。将符合条件的患者随机分配接受卡培他滨1 000 mg/m2,每天给药 2 次,持续给药 14 天和顺铂80 mg/m2,在每 3 周的第 1 天给药 (n =43)治疗或者 S‐1 40–60 mg,每天给药 2 次,持续给药 21 天和顺铂 60 mg/m2, 在每 5 周的第 8 天给药 (n = 41)治疗。本研究的主要终点是缓解率。
结果。缓解率在卡培他滨‐顺铂组和 S‐1‐顺铂组之间没有显著差异(分别为 53.5% 与 51.2%,p > 0.999)。与卡培他滨‐顺铂相比,S‐1‐顺铂在无进展生存期(PFS;中位数为 5.9 个月与 4.1 个月,p = 0.284)、总生存期(OS,中位数为13.5 个月与 10.0 个月,p = 0.290)以及至治疗失败时间(TTF;中位数为 4.5 个月与 3.1 个月,p = 0.052)等方面倾向于更好的结果。两组中常见的 3 级或 4 级血液学毒性包括贫血和中性粒细胞减少。但是,在卡培他滨‐顺铂组中,3 级或 4 级厌食、疲劳和低钠血症发生的频率更高。
结论。卡培他滨‐顺铂没有显示出比 S‐1‐顺铂更高的有效性。卡培他滨‐顺铂所引起的严重不良反应具有较高的发生率表明,仍然应将 S‐1‐顺铂作为日本 HER2 阴性晚期胃癌患者的标准一线化疗方案
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