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贝瓦西祖马布埃洛提尼布切换维护化学反应性晚期胆囊和胆管癌 (BEER BTC):一个多中心,开放标签,随机,第二阶段试验

Anant Ramaswamy¹, Prabhat Bhargava¹, Sujay Srinivas¹

¹Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

|August 5, 2024

概括

与主动监测相比,在晚期胆道癌 (BTCs) 中,切换维护贝瓦齐祖马布和埃洛提尼布显著改善了无进展生存率. 这种组合在第二阶段研究中显示出可接受的安全性.

科学领域:

在瘤学瘤学.
胃肠病学胃肠病学
临床试验临床试验

背景情况:

晚期胆道癌症 (BTCs) 通常需要化疗,通常是基于gemcitabine的.
有限的前性数据存在于BTCs的化学治疗后有效的维护策略.
积极监测是响应性高级BTCs的初始化疗后的标准方法.

研究的目的:

评估贝瓦齐祖马布加埃洛提尼布作为切换维护疗法的疗效和安全性,与晚期BTC患者的积极监测对比.
确定这种维持策略对无进展生存期 (PFS) 的影响.

主要方法:

进行了一项由研究者发起的,随机的,开放的,综合的II-III期研究.
纳入了成年患者,在经过6个月的基于凝胺的化疗后,BTC和疾病稳定性已晚.
患者被随机分配1:1接受主动监测或切换维护 (贝瓦齐祖马布加埃洛提尼布) 直到疾病进展或不可接受的毒性.

主要成果:

98名患者被随机分配;80%患有胆囊癌.
随访时间中位数为13.4个月.
在贝瓦西祖马布-埃洛提尼布组中,PFS的中位数为5.3个月,而在主动监测组中为3.1个月 (HR,0.51;P = .0013).
3级不良事件很少发生,包括状皮疹,口腔口腔炎和出血.

结论:

作为交换维护的贝瓦西祖马布和埃洛提尼布组合显著改善了高级BTC患者的PFS.
与主动监测相比,治疗表明了可接受的安全性.
该研究将进入第三阶段,以评估整体生存效益.

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