Randomised phase III trial of second-line irinotecan plus cisplatin versus irinotecan alone in patients with advanced gastric cancer refractory to S-1 monotherapy: TRICS trial
Randomised phase III trial of second-line irinotecan plus cisplatin versus irinotecan alone in patients with advanced gastric cancer refractory to S-1 monotherapy: TRICS trial
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DOI：
10.1016/j.ejca.2015.02.009
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发表时间：
2015-05-01
影响因子：
8.4
通讯作者：
Tsujinaka, Toshimasa
中科院分区：
文献类型：
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作者：
Nishikawa, Kazuhiro;Fujitani, Kazumasa;Tsujinaka, Toshimasa
目的：治疗晚期胃癌（AGC）的最佳二线方案仍不清楚。虽然伊立替康（CPT-11）+顺铂（CDDP）联合治疗和CPT-11单药治疗已在二线环境中进行了探索，但尚未评估初始接受S-1单药治疗的AGC患者的二线铂类治疗的优效性;因此，我们旨在检查CPT-11/CDDP联合治疗相对于CPT-11单药治疗的生存获益。在S-1单药治疗晚期癌症后出现进展或在完成S-1辅助治疗后6个月内复发的AGC患者被随机分配至CPT-11/CDDP组CPT-1160mg/m2，CDDP 30mg/m2，q2w，CPT-11150mg/m2，q2w。CPT-11/CDDP和CPT-11的中位总生存期分别为13.9（95%置信区间[CI]：10.8-17.6）和12.7（95% CI：10.3-17.2）个月（风险比：0.834; 95% CI：0.596-1.167，P = 0.288）。次要终点无显著差异，包括无进展生存期（4.6 [95% CI：3.4-5.9] vs 4.1 [95% CI：3.3-4.9]个月）和缓解率（16.9% [95% CI：8.8-28.3] vs 15.4% [95% CI：7.6-26.5]）。CPT-11/CDDP组3-4级贫血（16% vs 4%）和血清乳酸脱氢酶水平升高（5% vs 0%）的发生率高于CPT-11组。探索性亚组分析显示，CPT-11/CDDP对卵巢型AGC的疗效显著高于CPT-11（总生存期：15.8 vs 14.0个月; P = 0.019）。结论：S-1单药治疗失败后，在CPT-11中加入CDDP未观察到生存获益。(C)2015年，作者。由Elsevier Ltd.发布。这是CCBY-NC-ND许可证下的开放获取文章（http：//creativecommons.org/licenses/by-nc-nd/4.0/）。
Aim: The optimal second-line regimen for treating advanced gastric cancer (AGC) remains unclear. While irinotecan (CPT-11) plus cisplatin (CDDP) combination therapy and CPT-11 monotherapy have been explored in the second-line setting, the superiority of second-line platinum-based therapies for AGC patients initially treated with S-1 monotherapy has not yet been evaluated; therefore, we aimed to examine the survival benefit of CPT-11/CDDP combination over CPT-11 monotherapy.Methods: AGC patients showing progression after S-1 monotherapy for advanced cancer or recurrence within 6 months after completion of S-1 adjuvant therapy were randomly allocated to CPT-11/CDDP (CPT-11, 60 mg/m(2); CDDP, 30 mg/m(2) , q2w) or CPT-11 (150 mg/m(2), q2w).Results: Sixty-eight advanced and 95 recurrent cases were evaluated. The median overall survivals were 13.9 (95% confidence interval [CI]: 10.8-17.6) and 12.7 (95% CI: 10.3-17.2) months for CPT-11/CDDP and CPT-11, respectively (hazard ratio: 0.834; 95% CI: 0.596-1.167, P = 0.288). No significant differences were observed in the secondary end-points, including progression-free survival (4.6 [95% CI: 3.4-5.9] versus 4.1 [95% CI: 3.3-4.9] months) and response rate (16.9% [95% CI: 8.8-28.3] versus 15.4% [95% CI: 7.6-26.5]). The incidences of grade 3-4 anaemia (16% versus 4%) and elevated serum lactate dehydrogenase levels (5% versus 0%) were higher for CPT-11/CDDP than for CPT-11. Exploratory subgroup analysis revealed that CPT-11/CDDP was significantly more effective for intestinal-type AGC, compared with CPT-11 (overall survival: 15.8 versus 14.0 months; P = 0.019).Conclusion: No survival benefit was observed upon adding CDDP to CPT-11 after S-1 monotherapy failure. (C) 2015 The Authors. Published by Elsevier Ltd. This is an open access article under the CCBY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).