J Immunother Cancer:复肿吴小华教授团队研究表明卡瑞利珠单抗联合法米替尼(famitinib)可作为铂类耐药复发卵巢癌治疗有效方案

2022-01-14 yd2015 MedSci原创

研究表明,卡瑞利珠单抗与法米替尼联合在经治的铂耐药患者中显示出抗肿瘤活性,且安全性可接受,值得进一步探索。

近期,J Immunother Cancer杂志上发表了一项来自复旦大学附属肿瘤医院吴小华教授团队的研究成果,主要是评估PD-1抑制剂卡瑞利珠单抗联合法米替尼(famitinib)治疗铂类耐药复发卵巢癌的疗效。

该研究是一项开放标签、多中心的II期临床研究。纳入符合条件的铂耐药卵巢癌患者,其接受卡瑞利珠单抗(200 mg,每3周静脉滴注)和口服法米替尼(20 mg,每日1次)。所有患者在最近一次铂基化疗期间或<6个月出现疾病进展。主要终点为确定的客观缓解率(ORR)。次要终点包括疾病控制率(DCR)、应答持续时间(DoR)、治疗至出现应答时间(TTR)、无进展生存期(PFS)、总生存期(OS)、12个月OS率和安全性。

2019年4月19日至2020年4月9日,共37例铂耐药患者接受卡瑞利珠单抗+法米替尼治疗。患者的中位年龄为52岁(范围35 ~ 69岁)。最常见的转移部位为淋巴结(29例,78.4%)、腹膜(21例,56.8%)和肝脏(13例,35.1%)。最常见的肿瘤组织学类型是高级别浆液性癌(22例,59.5%)。11例(29.7%)患者为原发性铂耐药,15例(40.5%)患者为继发性铂耐药,11例(29.7%)患者为原发性铂难治。

截止日期为2021年4月9日,9例(24.3%)患者获得了确认的客观缓解,ORR为24.3% (95% CI, 11.8 - 41.2), DCR为54.1% (95% CI, 36.9 - 70.5)。没有患者达到CR, 9例(24.3%)患者达到PR, 11例(29.7%)患者达到SD。采用该联合方案的患者中位TTR为2.1个月(范围为1.8-4.1),中位DoR为4.1个月(95% CI为1.9 - 6.3)。

         疗效评估

中位随访时间为22.0个月(范围,12.0 - 23.7),中位无进展生存期(PFS)为4.1个月(95% CI, 2.1 - 5.7),中位OS为18.9个月(95% CI, 10.8 -未达到)。6个月、9个月和12个月的OS率分别为89.2% (95% CI, 73.7-95.8)、78.4% (95% CI, 61.4-88.5)和67.2% (95% CI, 49.4-79.9)。

             PFS和OS

原发性铂耐药,继发性铂耐药和原发性铂难治性患者的ORR分别为36.4% (95% CI, 10.9-69.2),13.3% (95% CI, 1.7-40.5)和27.3% (95% CI, 6.0-61.0) 。而DCR分别为72.2% (95% CI, 39.0- 94.0), 40.0% (95% CI, 16.3-67.7) 和2.7% (95%CI, 39.0-94.0)。

PD- L1 CPS ≥1和<1患者的ORR分别为50.0% (95% CI, 15.7-84.3)和18.2% (95% CI, 2.3-51.8);而DCR分别为62.5% (95% CI, 24.5-91.5)和54.5% (95% CI, 23.4-83.3)。

最常见的3级治疗相关不良事件为高血压(32.4%)、中性粒细胞计数下降(29.7%)和血小板计数下降(13.5%)。1例(2.7%)患者死于5级出血。

                 不良反应

综上,研究表明,卡瑞利珠单抗与法米替尼联合在经治的铂耐药患者中显示出抗肿瘤活性,且安全性可接受,值得进一步探索。

原始出处:

Xia L, Peng J, Lou G, Pan M, Zhou Q, Hu W, Shi H, Wang L, Gao Y, Zhu J, Zhang Y, Sun R, Zhou X, Wang Q, Wu X. Antitumor activity and safety of camrelizumab plus famitinib in patients with platinum-resistant recurrent ovarian cancer: results from an open-label, multicenter phase 2 basket study. J Immunother Cancer. 2022 Jan;10(1):e003831. doi: 10.1136/jitc-2021-003831. PMID: 35017154.

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    2022-03-28 柳叶一刀
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    2022-07-12 gracezdd
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    2022-01-16 fengxx

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