Lancet:切除的IB–IIIA期NSCLC患者辅助化疗后应用阿特珠单抗可额外获益

2021-09-21 Nebula MedSci原创

手术切除的 II-IIIA 期 NSCLC 患者在辅助化疗后接受阿特珠单抗治疗的无病生存益处优于最佳支持治疗

约 50% 的新确诊的非小细胞肺癌(NSCLC)患者为局限性(I 期或 II 期)或局部晚期(III 期)。I 期和 II 期以及部分 III 期 NSCLC 患者可进行治愈性手术。但是,采用手术治疗的 IIIA 期患者的 5 年存活率只有 36%。我们需要开发新的辅助策略来优化早期 NSCLC 患者完全手术切除后的结局。

本研究旨在评估以铂类为基础的化疗后予以阿特珠单抗辅助治疗 vs 最佳支持性治疗对这类患者预后的影响

IMpower010 试验是一项在 22 个国家的 227 处地点开展的随机、多中心、开放标签的 3 期研究,招募了年满 18 岁的晚期切除的 IB(肿瘤≥4 cm)-IIIA 期 NSCLC 患者,辅助化疗后(1-4个疗程),1:1 随机分至两组,接受阿特珠单抗辅助治疗或最佳支持性治疗。主要终点是调查员评估的无病生存期。

2015 年 10 月 7 日至 2018 年 9 月 19 日期间,共招募了1280位完全切除术后的患者。1269 位接受了辅助化疗,其中 1005 位被随机分至阿特珠单抗组(n=507)或最佳支持治疗组(n=498);每组都有 495 位患者接受了研究治疗。

PD-L1 表达 ≥1%的 II-IIIA 期患者的无病生存率

II-IIIA 期患者中位随访了 32.2 个月后,与最佳支持治疗相比,阿特珠单抗治疗提高了 PD-L1 表达 ≥1%的 II-IIIA 期患者的无病生存率(中位无病生存期:未达到 vs 35.3 个月;HR 0.66; 95% CI 0.50-0.88; p=0.0039)和 II-IIIA 期患者总队列的无病生存率(中位无病生存期:42.3 vs 35.3 个月;HR 0.79; 0.64-0.96; p=0.020)。

II-IIIA 期患者总队列的无病生存率

在意向治疗人群中,阿特珠单抗组相比最佳支持治疗的无病生存率的风险比为 0.81(中位无病生存期:未达到 vs 37.2 个月;95% CI 0.64-0.96; p=0.040)。阿特珠单抗相关的 3 级和 4 级不良事件的发生率为 11%(53/495),5 级不良事件的发生率是 1%(4/495)。

意向治疗人群的无病生存率

IMpower010 试验的结果表明,手术切除的 II-IIIA 期 NSCLC 患者在辅助化疗后接受阿特珠单抗治疗的无病生存益处优于最佳支持治疗,而且在 PD-L1 表达 ≥1% 的亚组中优势更明显。总之,辅助化疗后予以阿特珠单抗可为已切除的早期 NSCLC 患者提供有希望的治疗选择。

原始出处:

Enriqueta Felip, et al. Adjuvant atezolizumab after adjuvant chemotherapy in resected stage IB–IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase 3 trial. The Lancet. September 20, 2021. https://doi.org/10.1016/S0140-6736(21)02098-5

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    2021-09-25 jklm09
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    2021-10-27 juliusluan78
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    2022-04-16 howi
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    2021-09-21 ms6000000500146229

    学习了

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