PMID- 34794831 OWN - NLM STAT- MEDLINE DCOM- 20220128 LR - 20220531 IS - 1879-114X (Electronic) IS - 0149-2918 (Linking) VI - 43 IP - 11 DP - 2021 Nov TI - Efficacy and Safety of Programmed Cell Death 1 Inhibitor Monotherapy Versus Chemotherapy as Second-Line Treatment for Advanced Esophageal Cancer: A Meta-analysis and Systematic Review. PG - 1997-2012 LID - S0149-2918(21)00391-X [pii] LID - 10.1016/j.clinthera.2021.09.018 [doi] AB - PURPOSE: With programmed cell death 1 (PD-1) inhibitors approved for second-line treatment of advanced esophageal cancer, immunotherapy and chemotherapy have gradually become the main treatments for second-line treatment of patients with advanced esophageal cancer (AEC). This meta-analysis and systematic review were conducted to evaluate the efficacy and safety of PD-1 inhibitors monotherapy versus chemotherapy in second-line treatment of AEC. METHODS: Eligible randomized controlled trials were searched in PubMed, Embase, and the Cochrane Library and abstracts presented at the American Society of Clinical Oncology or European Society of Medical Oncology were reviewed to assess the efficacy and tolerability of PD-1/programmed cell death ligand 1 (PD-L1) inhibitors relative to chemotherapy for AEC from January 2016 to October 2020. Patients diagnosed with AEC and progressing after first-line therapy were included in this study. Hazard ratios (HRs) of progression-free survival (PFS) and overall survival (OS), risk ratios (RRs) of objective response rate (ORR), and the odds ratios (ORs) of adverse effects (AEs) were calculated. FINDINGS: The study included 4 randomized controlled trials with 1683 patients. The results indicated that PD-1 inhibitors prolonged the OS (HR = 0.79; 95% CI, 0.71-0.88; P < 0.01) and improved the ORR (RR = 3.00; 95% CI, 2.36-3.82; P = 0.01) but did not improve the PFS (HR = 0.96; 95% CI, 0.76-1.20; P = 0.692) compared with chemotherapy in the second-line treatment of AEC. PD-1 inhibitors alone were associated with a lower incidence of all treatment-related AEs (OR = 0.29; 95% CI, 0.09-0.89; P = 0.03) and grade 3 to 5 treatment-related AEs (OR = 0.26; 95% CI, 0.16-0.44; P < 0.01) versus chemotherapy. PD-1 inhibitors prolonged OS mainly in the following patient groups: male, age <65 years, Eastern Cooperative Oncology Group performance status of 1, or PD-L1 tumor proportion score >/=10%. Asian patients had a longer OS than non-Asian patients (P = 0.01). IMPLICATIONS: The available evidence indicates that the efficacy and tolerability of PD-1 inhibitors were better than chemotherapy in the second-line treatment of AEC, and the benefiting population of these patients was limited to males, those <65 years of age, those with a Eastern Cooperative Oncology Group performance status of 1, or those with a PD-L1 tumor proportion score >/=10%. Notably, Asian patients receiving immune monotherapy had longer OS than non-Asian patients. CI - Copyright (c) 2021 Elsevier Inc. All rights reserved. FAU - Yang, Yong-Liang AU - Yang YL AD - The Second People's Hospital of Lianyungang, The Affiliated Hospital of Bengbu Medical College, Lianyungang, Jiangsu, China. FAU - Li, Zhi-Qiang AU - Li ZQ AD - The Second People's Hospital of Lianyungang, The Affiliated Hospital of Bengbu Medical College, Lianyungang, Jiangsu, China. FAU - Wang, Qiu-Lu AU - Wang QL AD - The Second People's Hospital of Lianyungang, The Affiliated Hospital of Bengbu Medical College, Lianyungang, Jiangsu, China. FAU - Gu, Jing-Jing AU - Gu JJ AD - The Second People's Hospital of Lianyungang, The Affiliated Hospital of Bengbu Medical College, Lianyungang, Jiangsu, China. FAU - Fang, Xin-Jian AU - Fang XJ AD - The Second People's Hospital of Lianyungang, The Affiliated Hospital of Bengbu Medical College, Lianyungang, Jiangsu, China. FAU - Huang, Guan-Hong AU - Huang GH AD - The Second People's Hospital of Lianyungang, The Affiliated Hospital of Bengbu Medical College, Lianyungang, Jiangsu, China. Electronic address: hghlyg0002@sina.com. LA - eng PT - Journal Article PT - Meta-Analysis PT - Systematic Review DEP - 20211115 PL - United States TA - Clin Ther JT - Clinical therapeutics JID - 7706726 RN - 0 (B7-H1 Antigen) SB - IM MH - Aged MH - Apoptosis MH - B7-H1 Antigen MH - *Carcinoma, Non-Small-Cell Lung MH - *Esophageal Neoplasms/drug therapy MH - Humans MH - *Lung Neoplasms MH - Male MH - Progression-Free Survival OTO - NOTNLM OT - PD-1 OT - PD-L1 OT - advanced esophageal cancer OT - chemotherapy OT - efficacy OT - safety EDAT- 2021/11/20 06:00 MHDA- 2022/01/29 06:00 CRDT- 2021/11/19 05:45 PHST- 2021/03/11 00:00 [received] PHST- 2021/08/25 00:00 [revised] PHST- 2021/09/24 00:00 [accepted] PHST- 2021/11/20 06:00 [pubmed] PHST- 2022/01/29 06:00 [medline] PHST- 2021/11/19 05:45 [entrez] AID - S0149-2918(21)00391-X [pii] AID - 10.1016/j.clinthera.2021.09.018 [doi] PST - ppublish SO - Clin Ther. 2021 Nov;43(11):1997-2012. doi: 10.1016/j.clinthera.2021.09.018. Epub 2021 Nov 15.