作为胆道癌的第一线治疗方法,本特拉弗苏普阿尔法和化疗:一个随机的2/3阶段试验
Do-Youn Oh1,2, Masafumi Ikeda3, Choong-Kun Lee4
1Division of Medical Oncology, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.
Hepatology (Baltimore, Md.)
|June 14, 2024
概括
宾特拉弗苏普阿尔法与吉姆西塔宾和西斯普拉丁结合并没有改善胆道癌症患者的整体存活率. 组合疗法显示效果与单独使用吉姆西塔和西斯普拉丁相美,不良事件增加.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 胃肠病学 胃肠病学
背景情况:
- 胆道癌 (BTC) 是一种具有有限治疗选择的侵袭性恶性瘤.
- 宾特拉夫苏普阿尔法 (BA) 是一种免疫疗法剂,旨在抑制PD-L1和TGF-β.
- 评估高级BTC的新组合至关重要.
研究的目的:
- 为了比较bintrafusp alfa (BA) 加上gemcitabine和cisplatin (GemCis) 与单独使用GemCis的疗效和安全性,在先进/转移性胆道癌症的未经治疗的患者中.
- 作为主要终点,评估整体存活率 (OS).
主要方法:
- 进行了一项随机,双盲,安慰剂控制,适应性2/3期试验 (NCT04066491).
- 297名本地发病/转移性BTC的未经治疗的患者被随机分配给接受BA + GemCis或安慰剂 + GemCis.
- 主要终点是整体存活时间 (OS).
主要成果:
- 在BA组 (11.5个月) 和安慰剂组 (11.5个月) (危险比1.23;p = 0.7394) 之间,中位 OS 是可比的.
- 最常见的不良事件是≥3级贫血 (BA:26.0%;安慰剂:22.8%).
- 与安慰剂组 (7.4%) 相比,BA组的出血事件更频繁 (28.8%).
结论:
- 宾特拉弗苏普阿尔法与吉姆西塔和西斯普拉丁结合,在胆道癌症的第一线治疗中,没有显示出比单独的吉姆西塔和西斯普拉丁具有临床意义的益处.
- 该研究因缺乏疗效而提前中止.
- 组合疗法与更高的出血不良事件发生率有关.
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