尼沃卢马布和苏尼蒂尼布在晚期骨肉瘤患者:一个多中心,单臂,第二阶段试验
Emanuela Palmerini1, Antonio Lopez Pousa2, Giovanni Grignani3
1Osteoncology, Bone and Soft Tissue Tumors and Innovative Therapies, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.
Cancer
|November 14, 2024
概括
在IMMUNOSARC第二阶段试验中,sunitinib加nivolumab在晚期骨肉瘤中在6个月内实现了42%的无进展生存率. 然而,该疗法呈现出相关的毒性概况,并观察到显著的不良事件.
科学领域:
- 在瘤学瘤学.
- 医学研究 医学研究
- 临床试验 临床试验
背景情况:
- 先进的骨肉瘤 (BS) 是一组具有挑战性的癌症,治疗选择有限.
- 在IMMUNOSARC第二阶段研究 (NCT03277924) 评估了组合治疗的有效性和安全性,用于成人患者的高级BS.
研究的目的:
- 在晚期骨肉瘤患者中评估sunitinib加nivolumab在6个月后无进展生存率 (PFSR) 的初级终点.
- 评估二级终点,包括整体存活率 (OS),客观反应率 (ORR) 和治疗方案的安全性概况.
主要方法:
- 该研究招募了诊断为晚期骨肉瘤的进展性成人患者.
- 治疗包括苏尼蒂尼布 (37.5毫克/天1-14天,然后25毫克/天) 与尼沃卢马布 (3毫克/公斤每2周一次) 结合.
- 通过中央放射学审查确定了6个月的无进展生存率;整体生存率,ORR (RECIST v1.1) 和安全性也被评估.
主要成果:
- 在40名注册患者中,38名患者可根据主要终点进行评估. 在6个月后的PFSR为42% (95% CI,27-58).
- 平均无进展生存时间为3.8个月,平均整体生存时间为11.9个月,客观应答率为5%.
- 3级以上的不良事件包括中性质减退 (15%),高血压 (15%) 和ALT/AST升高 (12.5%). 17%的患者因毒性而停止治疗,其中包括1例5级肺炎.
结论:
- 苏尼替尼和尼沃卢马布的组合达到其主要终点,在先进的骨肉瘤患者中,在6个月后,无进展生存率超过15%.
- 尽管满足了主要终点,但该治疗方案表现出显著的毒性概况,需要仔细考虑其临床适用性.
关键词:
尤文肉瘤 (Ewing Sarcoma) 是一种癌症.这是一种PD-L1抑制剂.抗血管新生素的抗血管新生素.骨头 骨头 骨头 骨头没有区分的软骨肉瘤 (chondrosarcoma).免疫疗法 免疫疗法这就是尼沃卢马布 (nivolumab).骨质肉瘤是骨质肉瘤的一种疾病.肉瘤 肉瘤是一种肉瘤.苏尼提尼布 (sunitinib) 的使用方法更多相关视频
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