与切除胆道癌症的观察结果相比,辅助剂S-1 (JCOG1202,ASCOT):一个多中心的,开放的,随机的,受控的,第三期试验
Kohei Nakachi1, Masafumi Ikeda2, Masaru Konishi3
1Department of Medical Oncology, Tochigi Cancer Center, Utsunomiya, Japan; Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Lancet (London, England)
|January 21, 2023
概括
在切除的胆道癌症患者中,辅助S-1化疗显著改善了整体存活率. 这一发现表明S-1可能成为治疗这种癌症的新标准.
科学领域:
- 癌症学
- 胃肠病学
- 临床试验
背景情况:
- 在晚期胆道癌症中,S-1 显示有效性和轻度毒性.
- 切除的胆道癌症 (BTC) 缺乏已知的辅助治疗方案.
- 对切除的BTC进行辅助S-1的评估至关重要.
研究的目的:
- 评估辅助剂S-1能否改善整体存活率 (OS),而不是切除BTC的观察结果.
- 为了比较辅助剂S-1与观察之间的无复发生存期 (RFS).
- 在这种情况下评估辅助剂S-1的安全性.
主要方法:
- 在38个日本医院进行了开放式多中心随机试验.
- 440名BTC切除患者随机分配 (1:1) 进行观察或S-1.
- 主要终点:整体存活率;次要:没有复发的存活率和安全性.
主要成果:
- 随访时间中位数为45. 4个月.
- 三年后的生存率为S-1的77. 1%,而观察后为67. 6% (HR为0. 69, p=0. 0080).
- 三至四级不良事件包括中性质减退 (14%),胆道感染 (7%) 和S-1.
结论:
- 在切除的胆道癌症中,辅助剂S-1显著改善了整体存活率.
- 虽然需要进一步的长期数据,但S-1显示出作为标准护理的潜力.
- 在亚洲切除BTC的患者中,S-1为辅助治疗提供了一个有前途的选择.
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