PD-(L)1 抑制剂与化疗药物及其联合方案一线治疗 NSCLC 的间接比较
PD-(L)1 inhibitors vs. chemotherapy vs. their combination in front-line treatment for NSCLC: An indirect comparison.
机构信息
Department of Thoracic Surgery and Oncology, The First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, China.
Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.
出版信息
Int J Cancer. 2019 Dec 1;145(11):3011-3021. doi: 10.1002/ijc.32366. Epub 2019 May 10.
We comprehensively compared the therapeutic effects and safety of PD-1/L1 antibodies (I), chemotherapy (C) or their combination (I + C) as first-line treatments for advanced NSCLC. Online databases were searched to identify RCTs. Survival outcomes and safety events were pooled by indirect treatment comparison. Main subgroup analyses were conducted according to PD-L1 expression. A total of 11 RCTs involving 6,731 patients were included. Overall, PD-1/L1 inhibitors showed no difference to chemotherapy in PFS (HR 0.90, 0.65-1.24) and OS (HR 0.84, 0.64-1.09), while I + C was superior to chemotherapy both in PFS (HR 0.64, 0.58-0.71) and OS (HR 0.74, 0.62-0.89). I + C also showed advantages over PD-1/L1 in PFS (HR 0.71, 0.51-0.99) but not OS (HR 0.88, 0.64-1.22). In the PD-L1 < 1% subgroup, I + C was beneficial both in OS (HR 0.78, 0.67-0.90) and PFS (HR 0.72, 0.65-0.80) than chemotherapy. In PD-L1 ≥ 50% population, PD-1/L1 had longer OS than chemotherapy (HR 0.71, 0.60-0.84); I + C also had longer OS (HR 0.61, 0.49-0.77) and PFS (HR 0.41,0.34-0.49) than chemotherapy. In indirect analysis (PD-L1 ≥ 50%), I + C was superior to PD-1/L1 in terms of PFS (HR 0.54, 0.35-0.82), but not OS (HR 0.86, 0.65-1.14). Both treatment-related and immune-mediated adverse events occurred most frequently in the combination therapy group. We suggest that a combination regimen is preferable as first-line treatment for NSCLC patients with different PD-L1 expression, in the meanwhile, in cautious of side effects.
我们全面比较了 PD-1/L1 抗体（I）、化疗（C）或两者联合（I+C）作为晚期 NSCLC 一线治疗的疗效和安全性。通过在线数据库检索到 RCTs。通过间接治疗比较来合并生存结局和安全性事件。根据 PD-L1 表达情况进行主要亚组分析。共纳入 11 项 RCTs，涉及 6731 例患者。总体而言，与化疗相比，PD-1/L1 抑制剂在 PFS（HR 0.90，0.65-1.24）和 OS（HR 0.84，0.64-1.09）方面无差异，而 I+C 在 PFS（HR 0.64，0.58-0.71）和 OS（HR 0.74，0.62-0.89）方面均优于化疗。与 PD-1/L1 相比，I+C 在 PFS（HR 0.71，0.51-0.99）方面具有优势，但在 OS（HR 0.88，0.64-1.22）方面无优势。在 PD-L1<1%亚组中，I+C 在 OS（HR 0.78，0.67-0.90）和 PFS（HR 0.72，0.65-0.80）方面均优于化疗。在 PD-L1≥50%人群中，PD-1/L1 较化疗具有更长的 OS（HR 0.71，0.60-0.84）；I+C 也具有更长的 OS（HR 0.61，0.49-0.77）和 PFS（HR 0.41，0.34-0.49）优于化疗。在间接分析（PD-L1≥50%）中，I+C 在 PFS（HR 0.54，0.35-0.82）方面优于 PD-1/L1，但在 OS（HR 0.86，0.65-1.14）方面无优势。治疗相关和免疫介导的不良事件最常发生在联合治疗组。我们建议，对于不同 PD-L1 表达的 NSCLC 患者，联合治疗方案作为一线治疗更优，但需谨慎处理副作用。
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