复发性卵巢癌:帕博利珠单抗联合贝伐珠单抗和环磷酰胺治疗安全有效

2021-01-22 太后殿下 张师前公众号

美国Roswell Park综合癌症中心Zsiros等报告,在该项Ⅱ期非随机临床试验中,帕博利珠单抗联合贝伐珠单抗和口服环磷酰胺的耐受性良好,在复发性卵巢癌患者中有95.0%的临床获益率和25.0%的

美国Roswell Park综合癌症中心Zsiros等报告,在该项期非随机临床试验中,帕博利珠单抗联合贝伐珠单抗和口服环磷酰胺的耐受性良好,在复发性卵巢癌患者中有95.0%的临床获益率和25.0%的持续缓解(>12个月)率。这种联合方案或成为复发性卵巢癌未来的治疗策略。(JAMA Oncol. doi: 10.1001/jamaoncol.2020.5945)

复发性卵巢癌治疗选择的临床获益有限,且患者的生活质量不良,这表明可耐受的有效疗法的需求尚未被满足。在铂类敏感复发的、铂类耐药或难治的上皮性卵巢癌、输卵管癌或原发性腹膜癌中,该研究旨在评估帕博利珠单抗联合贝伐珠单抗和规律性口服环磷酰胺的疗效和安全性。

2016年9月6日至2018年6月27日, 该项开放性单臂期队列研究在美国的一家机构招募患者,分析了2016年9月6日至2020年2月20日的数据。符合条件的患者为复发性卵巢癌,根据免疫相关的实体瘤反应评估标准(irRECIST)存在可测量的疾病,并且ECOG PS评分为 0~1。

在治疗周期中,患者每天接受200 mg的帕博利珠单抗和15 mg/kg的贝伐珠单抗(每3周),以及口服50 mg的环磷酰胺,直到疾病进展、出现不可接受的毒性或撤回同意。主要结果是客观缓解率(ORR)和无进展生存期(PFS)。在40例患者中,30 例(75.0%)为铂类耐药卵巢癌,10 例(25.0%)为铂类敏感性卵巢癌,平均年龄为 62.2 岁 ±9.4 岁。根据irRECIST标准,对治疗有反应3例(7.5%)完全缓解,16例(40.0%)部分缓解,19例(47.5%)病情稳定,ORR 为47.5%,38例(95.0%)有临床获益,10例(25.0%)获得持续缓解。

中位PFS为10.0个月(90%CI6.5~17.4 个月)。与治疗相关的最常见的 3~4 级不良事件为高血压(6例,15.0%)和淋巴细胞减少(3例,7.5%)。最常报告的不良事件包括疲劳(18例,45.0%),腹泻(13例,32.5%)和高血压(11例,27.5%)。

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    2021-01-22 wxl882001

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