PMID- 26986169 OWN - NLM STAT- MEDLINE DCOM- 20160802 LR - 20220419 IS - 1536-5964 (Electronic) IS - 0025-7974 (Print) IS - 0025-7974 (Linking) VI - 95 IP - 11 DP - 2016 Mar TI - The Efficacy and Safety of Programmed Cell Death 1 and Programmed Cell Death 1 Ligand Inhibitors for Advanced Melanoma: A Meta-Analysis of Clinical Trials Following the PRISMA Guidelines. PG - e3134 LID - 10.1097/MD.0000000000003134 [doi] LID - e3134 AB - The purpose of this study was to investigate the efficacy and safety of programmed cell death 1 (PD-1) and programmed cell death 1 ligand (PD-L1) inhibitors using a meta-analysis of present trials for advanced melanoma. A fully recursive literature search of the primary electronic databases for available trials was performed. The objective response rate (ORR) and the median progression-free survival (PFS) of clinical responses were considered the main endpoints to evaluate the efficacy, whereas Grade 3-4 adverse effects (AEs) were analyzed to evaluate safety. The ORR of PD-1 and PD-L1 inhibitors was 30% (95% CI: 25-35%). No significant difference in the ORR was observed after the comparisons of low-dose, median-dose, and high-dose cohorts. In addition, the rate of Grade 3-4 AEs was 9% (95% CI: 6-12%). According to the 3 randomized controlled trials that compared PD-1 inhibitors with chemotherapy, the difference between these 2 groups was found to be statistically significant with respect to the ORR, PFS and the incidence of Grade 3-4 AEs; that is, the relative risk (RR) of the ORR was 3.42 (95% CI: 2.49-4.69, P < 0.001), the hazard ratio (HR) of the PFS was 0.50 (95% CI: 0.44-0.58, P < 0.001), and the RR of Grade 3-4 AEs was 0.45 (95% CI: 0.31-0.65, P < 0.001). According to a meta-analysis of limited concurrent studies, PD-1 and PD-L1 inhibitors appear to be associated with improved response rates, superior response durability and tolerable toxicity in patients with advanced melanoma. FAU - Guan, Xiuwen AU - Guan X AD - From the Department of Medical Oncology (XG, FM, ZY, BX), and State Key Laboratory of Molecular Oncology (HW, HQ), Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Wang, Haijuan AU - Wang H FAU - Ma, Fei AU - Ma F FAU - Qian, Haili AU - Qian H FAU - Yi, Zongbi AU - Yi Z FAU - Xu, Binghe AU - Xu B LA - eng PT - Journal Article PT - Meta-Analysis PT - Research Support, Non-U.S. Gov't PT - Review PL - United States TA - Medicine (Baltimore) JT - Medicine JID - 2985248R RN - 0 (Antibodies, Monoclonal) RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Antineoplastic Agents) RN - 0 (B7-H1 Antigen) RN - 0 (CD274 protein, human) RN - 0 (PDCD1 protein, human) RN - 0 (Programmed Cell Death 1 Receptor) RN - 31YO63LBSN (Nivolumab) RN - B932PAQ1BQ (pidilizumab) RN - DPT0O3T46P (pembrolizumab) SB - IM MH - Antibodies, Monoclonal/therapeutic use MH - Antibodies, Monoclonal, Humanized/therapeutic use MH - Antineoplastic Agents/adverse effects/*therapeutic use MH - B7-H1 Antigen/*antagonists & inhibitors MH - Clinical Trials as Topic MH - Disease-Free Survival MH - Humans MH - Melanoma/*drug therapy MH - Nivolumab MH - Programmed Cell Death 1 Receptor/*antagonists & inhibitors MH - Treatment Outcome PMC - PMC4839950 COIS- The authors have no conflicts of interest to disclose. EDAT- 2016/03/18 06:00 MHDA- 2016/08/03 06:00 PMCR- 2016/03/18 CRDT- 2016/03/18 06:00 PHST- 2016/03/18 06:00 [entrez] PHST- 2016/03/18 06:00 [pubmed] PHST- 2016/08/03 06:00 [medline] PHST- 2016/03/18 00:00 [pmc-release] AID - 00005792-201603150-00076 [pii] AID - 10.1097/MD.0000000000003134 [doi] PST - ppublish SO - Medicine (Baltimore). 2016 Mar;95(11):e3134. doi: 10.1097/MD.0000000000003134.