Efficacy and safety of PD-1/PD-L1 inhibitors plus nab-paclitaxel for patients with non-small cell lung cancer who have progressed after platinum-based chemotherapy
Efficacy and safety of PD-1/PD-L1 inhibitors plus nab-paclitaxel for patients with non-small cell lung cancer who have progressed after platinum-based chemotherapy
复制标题
PD-1/PD-L1抑制剂联合白蛋白结合型紫杉醇对铂类化疗后进展的非小细胞肺癌患者的疗效和安全性
DOI：
10.1177/1758835920936882
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发表时间：
2020-07-01
影响因子：
4.9
通讯作者：
Hu, Yi
中科院分区：
文献类型：
--
作者：
Zhang, Fan;Huang, Di;Hu, Yi
背景资料：免疫治疗联合铂类化疗目前是非小细胞肺癌（NSCLC）患者的标准一线治疗。方法：选取解放军总医院2015年至2018年既往接受铂类化疗后，接受过抗PD-1/PD-L1单药治疗或联合nab-紫杉醇治疗的未接受过免疫治疗的转移性非小细胞肺癌患者。结果：57例患者中，40例接受抗PD-1/PD-L1单药治疗，17例接受抗PD-1/PD-L1联合nab-紫杉醇治疗。中位OS随访时间为16.3个月，与免疫单药治疗组相比，白蛋白结合型紫杉醇组的OS显著更长（中位数为28.6个月vs 15.9个月，log-rankp = 0.020）。当在考克斯比例回归模型中通过协变量校正时，治疗组[p = 0.009，风险比（HR）0.361; 95%置信区间（CI）0.168-0.773]和体能状态（p = 0.003，HR 0.372; 95% CI 0.192-0.721）均与联合治疗的OS延长独立相关。此外，免疫检查点抑制剂（ICI）联合nab-紫杉醇组的ORR为23.5%（4/17），免疫单药治疗组为13.5%（5/37）（p = 0.439），DCR分别为88.2%（15/17）和59.5%（22/37）（p = 0.034）。结论：PD-1/PD-L1抑制剂联合白蛋白结合型紫杉醇治疗以铂类为基础的化疗后进展的转移性NSCLC患者，比ICI单药治疗有更长的OS和更高的应答率。这些发现需要通过前瞻性研究进一步探讨。
Background: Immunotherapy combined with platinum-based chemotherapy is now the standard first-line treatment for non-small cell lung cancer (NSCLC) patients. However, limited evidence exists to show the efficacy of immunotherapy plus taxanes for patients who have progressed after platinum-based chemotherapy.Methods: The immunotherapy naive patients with metastatic NSCLC who received anti-PD-1/PD-L1 monotherapy or combined with nab-paclitaxel after prior platinum-based chemotherapy from 2015 to 2018 in PLA General Hospital were identified. The progression-free survival, overall survival (OS), objective response rate (ORR), disease control rate (DCR) and safety were assessed.Results: Of 57 patients, 40 were treated with anti-PD-1/PD-L1 monotherapy and 17 were treated with anti-PD-1/PD-L1 plus nab-paclitaxel. With a median OS follow-up of 16.3 months, the nab-paclitaxel group showed significantly longer OS compared with the immune monotherapy group (median, 28.6 monthsversus15.9 months, log-rankp = 0.020). When adjusted by covariates in COX proportional regression model, both the treatment group [p = 0.009, hazard ratio (HR) 0.361; 95% confidence interval (CI) 0.168-0.773] and performance status (p = 0.003, HR 0.372; 95% CI 0.192-0.721) demonstrated independent association with the longer OS from combination therapy. In addition, ORR was 23.5% (4/17) in the immune checkpoints inhibitors (ICIs) plus nab-paclitaxel groupversus13.5% (5/37) in immune monotherapy group (p = 0.439), with a DCR of 88.2% (15/17) and 59.5% (22/37) (p = 0.034), respectively. The incidence of grade 3/4 adverse events was 23.5% (4/17) in the combination group and 2.5% (1/40) in the immune monotherapy group.Conclusion: PD-1/PD-L1 inhibitor plus nab-paclitaxel resulted in significantly longer OS and higher responseversusICI single agent in metastatic NSCLC patients who have progressed after platinum-based chemotherapy. These findings need to be further explored by prospective studies.