TY - JOUR AB - Anti‑programmed cell death protein‑1 (PD‑1)/programmed cell death 1 ligand 1 (PD‑L1) antibodies have been widely used in cancers. The present study aimed to evaluate the efficacy and safety of PD‑1/PD‑L1 inhibitors in human cancers. Studies were searched from Cochrane Library, PubMed and Embase databases. Randomized controlled trials (RCTs) that investigated adjuvant therapy with anti‑PD‑1/PD‑L1 agents in solid cancers were eligible for inclusion. As the primary focus of the meta‑analysis, clinical outcome measures including overall survival (OS), disease‑free survival (DFS), and adverse events (AEs) were analyzed by Stata 15.0 software. A total of six RCTs (n=4,436) met the inclusion criteria. The DFS [hazard ratio (HR)=0.71; 95% confidence interval (CI): 0.63‑0.78; P<0.001] and OS (HR=0.66, 95% CI: 0.46‑0.86, P<0.001) of patients were significantly prolonged by adjuvant immunotherapy. Subgroup analysis indicated that significantly improved DFS was observed in patients treated with different anti‑PD‑1/PD‑L1 drugs (nivolumab, pembrolizumab, or atezolizumab), as well as in those with different tumors (melanoma, urothelial carcinoma, esophageal or gastroesophageal junction cancer, or renal cell carcinoma), and PD‑L1 status [negative (<1%) or positive (≥1%)]. However, PD‑1/PD‑L1 inhibitors was associated with increased ≥ grade 3 treatment‑related AEs (odds ratio=1.63; 95% CI: 1.20‑2.21; P=0.002). The available evidence suggests that adjuvant therapy with PD‑1/PD‑L1 inhibitors provided more survival benefit than placebo for patients with cancer, with increased grade 3 or higher AEs. Prospero registration no. CRD42021290654. AD - Radiotherapy Department, The Third Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi 530000, P.R. China Department of Gastroenterology, The Third Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi 530000, P.R. China Ear, Nose and Throat and Head and Neck Surgery Department, The Third Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi 530000, P.R. China AU - Mo,Dun-Chang AU - Liang,Zi-Yu AU - Chen,Long AU - Huang,Jian-Feng AU - Luo,Peng-Hui AU - Wang,Han-Lei DA - 2022/12/01 DO - 10.3892/etm.2022.11685 IS - 6 JO - Exp Ther Med KW - adjuvant immunotherapy programmed cell death protein‑1/programmed cell death 1 ligand 1 immune checkpoint inhibitor meta‑analysis PY - 2022 SN - 1792-0981 1792-1015 SP - 749 ST - Efficacy and safety of adjuvant therapy with PD‑1/PD‑L1 inhibitors in cancer T2 - Experimental and Therapeutic Medicine TI - Efficacy and safety of adjuvant therapy with PD‑1/PD‑L1 inhibitors in cancer UR - https://doi.org/10.3892/etm.2022.11685 VL - 24 ER -