Anti-PD-1/PD-L1 antibodies versus docetaxel in patients with previously treated non-small-cell lung cancer

// Qi Jiang 1, * , Mixue Xie 2, * , Mengye He 1 , Feifei Yan 1 , Xiaochen Zhang 1 and Sufen Yu 1 1 Department of Medical Oncology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, 310003, China 2 Senior Department of Haematology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, 310003, China * These authors contributed equally to this work and share the first authorship Correspondence to: Sufen Yu, email: zdyyysf@163.com Xiaochen Zhang, email: zhangxiaochen74@163.com Keywords: PD-1; PD-L1; immune checkpoint inhibitor; non-small cell lung cancer; meta-analysis Received: June 03, 2017      Accepted: December 13, 2017      Published: December 21, 2017 ABSTRACT Anti- PD-1/PD-L1 antibodies have been proved one of the most promising treatments against non-small-cell lung cancer (NSCLC); however, whether anti-PD-1/PD-L1 antibodies can provide added benefits for pretreated patients with advanced NSCLC and which patients are most likely to benefit from anti-PD-1/PD-L1 therapy remain controversial. This meta-analysis evaluated the efficacy and safety between anti-PD-1/PD-L1 antibodies and docetaxel in previously treated, advanced NSCLC. PubMed, EMBASE and Cochrane library databases were systematically searched for eligible studies. Five studies with a total of 3,025 patients were included. Our results showed that, for all patients, anti-PD-1/PD-L1 therapy prolonged overall survival (OS) (hazard ratio [HR] = 0.69; 95% CI, 0.63–0.75) and progression-free survival (PFS) (HR = 0.87; 95% CI, 0.80–0.94). For patients with PD-L1 expression ≥1%, anti-PD-1/PD-L1 therapy had higher objective response rates. In subgroup analysis according to the tumor PD-L1 expression level, anti-PD-1/PD-L1 therapy was associated with longer OS and PFS in patients with high PD-L1 expression (≥1%, ≥5%, ≥10% and ≥50%), but not in those with low expressions. In subgroup analysis of patients’ characteristics, anti-PD-1/PD-L1 antibodies showed OS benefits across most prespecified subgroups, except for patients with EGFR mutation-positive and never smokers. For patients with EGFR mutation, anti-PD-1/PD-L1 therapy was an unfavorable factor of PFS. The grade 3 or 4 adverse events rates of anti-PD-1/PD-L1 treatment were significantly lower than that of docetaxel. Our results suggest that anti-PD-1/PD-L1 therapy significantly improves survival compared with docetaxel in patients with previously treated, PD-L1-positive, advanced NSCLC, and has a distinct safety profile from chemotherapy.