J Clin Oncol:PD-1和CTLA-4双重阻断二线治疗晚期宫颈癌疗效显著

2021-12-27 yd2015 MedSci原创

这项迄今为止规模最大的临床试验评估了PD-1和CTLA-4双重阻断在复发和/或转移性宫颈癌患者中的应用,发现了有希望和持久的临床活性,具有良好的耐受性。

宫颈癌仍然是世界范围内最常见的妇科恶性肿瘤,也是女性癌症死亡的第四大原因。复发和/或转移性宫颈癌的预后较差,仍需要寻找更有效的治疗方案,特别是对于一线化疗+贝伐单抗治疗后进展的患者。近期,Journal of Clinical Oncology杂志上发表了一项研究成果,主要是评估PD-1抑制剂Balstilimab+ CTLA-4抑制剂zalifrelimab治疗一线铂类化疗进展的复发和或转移性宫颈癌患者的疗效和安全性。

该研究是开放标签的II期临床研究(NCT03495882),纳入的患者静脉给balstilimab 3mg /kg,每2周一次+zalifrelimab1mg/ kgonce每6周一次,共治疗24个月。主要终点为客观缓解率(ORR,由独立中心评审评估)。次要研究终点包括应答持续时间(DOR)、安全性、耐受性和总生存期。

2018年8月27日至2020年5月7日,155例患者被纳入研究。中位年龄为50岁(范围为24-76岁),超过一半的患者的ECOG为0(57.4%)。86例(55.5%)患者为PD-L1阳性(CPS≥1%),38例(24.5%)为PD-L1阴性;20%患者无法评估或无法获得组织。病理类型为鳞状细胞癌(70.3%)、腺癌(27.1%)和非鳞癌(2.6%)。

中位随访时间为21.0个月(最小为11.8个月;最大,32.11+个月)。125例可评估患者中,ORR为25.6%(95%CI, 18.8 to 33.9),包括10例CRs (8.0%) 和22例PRs (17.6%)。DCR为52.0% (95% CI, 43.3 to 60.6)。中位DOR未达到(95%CI,9.7 to NR)。治疗至应答的中位时间为2.7个月(1.3-15.8)。

           疗效评估

ORR亚组分析发现,PD-L1阳性患者(n=67)的ORR为32.8%,PD-L1阴性患者(n=33)的ORR为9.1%,PD-L1未明状态患者(n=25)的ORR为28%。鳞状细胞癌患者(n=89)的ORR为32.6%,腺癌患者(n=34)的ORR为8.8%,而腺鳞癌患者(n=2)的ORR为0。

数据截止时,中位无进展生存期(PFS)为2.7个月(95% CI, 1.5 - 3.7), 12个月的PFS为21.3% (95% CI, 14.1-29.4)。中位OS为12.8个月(95% CI, 8.8-17.6),6个月和12个月OS率分别为69.2% (95% CI, 60.1-76.7)和53.3% (95% CI, 43.8-61.9)。

              PFS和OS

所有级别中最常见的治疗相关不良事件(TRAE)是甲状腺功能减退(16.8%)、腹泻(14.2%)、疲劳(11.6%)和恶心(9.0%),大多数事件的严重程度为1级或2级。3级TRAE的总发生率为20.0%,ALT升高(2.6%)和腹泻(1.9%)最为常见。TRAE导致剂量中断或停药的病例分别为19例(12.3%)和12例(7.7%)。AST升高(4例患者)或ALT水平升高(3例患者)是剂量中断的主要原因,腹泻是停止治疗的主要原因(3例患者)。共有16名患者(10.3%)经历了严重的TRAE,其中免疫介导的小肠结肠炎(3名患者)是最常见的事件。研究者评估的3例死亡(1.3%)与研究中发生的治疗有关。这些病例涉及到肺炎、免疫介导肾炎和糖尿病。

          不良反应

 

69例(44.5%)患者出现imAE,最常见的是甲状腺功能减退(22例,14.2%)、甲状腺功能亢进和腹泻(11例,7.1%)。

综上,这项迄今为止规模最大的临床试验评估了PD-1和CTLA-4双重阻断在复发和/或转移性宫颈癌患者中的应用,发现了有希望和持久的临床活性,具有良好的耐受性。

 

原始出处:

O'Malley DM, Neffa M, Monk BJ, Melkadze T, Huang M, Kryzhanivska A, Bulat I, Meniawy TM, Bagameri A, Wang EW, Doger de Speville Uribe B, Hegg R, Ortuzar Feliu W, Ancukiewicz M, Lugowska I. Dual PD-1 and CTLA-4 Checkpoint Blockade Using Balstilimab and Zalifrelimab Combination as Second-Line Treatment for Advanced Cervical Cancer: An Open-Label Phase II Study. J Clin Oncol. 2021 Dec 21:JCO2102067. doi: 10.1200/JCO.21.02067. Epub ahead of print. PMID: 34932394.

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    2022-07-16 minlingfeng
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    2021-12-28 ms8000000116883957

    学到了

    0

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    2021-12-27 ms8000001879015771

    宫颈癌仍然是世界范围内最常见的妇科恶性肿瘤,也是女性癌症死亡的第四大原因。复发和/或转移性宫颈癌的预后较差,仍需要寻找更有效的治疗方案,特别是对于一线化疗+贝伐单抗治疗后进展的患者。

    0

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    2021-12-27 ms2000000184355752

    学习了

    0

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    2021-12-24 一闲
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    2021-12-24 hywen7328
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