PMID- 36378154 OWN - NLM STAT- MEDLINE DCOM- 20230203 LR - 20230216 IS - 1537-4513 (Electronic) IS - 1524-9557 (Linking) VI - 46 IP - 2 DP - 2023 Feb-Mar 01 TI - Efficacy and Safety of Immune Checkpoint Inhibitors in Triple-negative Breast Cancer: A Study Based on 41 Cohorts Incorporating 6558 Participants. PG - 29-42 LID - 10.1097/CJI.0000000000000447 [doi] AB - The project was designed to investigate the efficacy and safety of immune checkpoint inhibitors (ICIs) in triple-negative breast cancer (TNBC). Electronic databases were screened to identify relevant trials. The primary endpoints were prognostic parameters and adverse events (AEs) through pooled rate, odds ratio, and hazard ratio (HR) with 95% CI. Totally, 6558 TNBC patients from 41 cohorts were included. The pooled pathologic complete response rate (odds ratio=2.03, 95% CI: 1.35-3.06, P =0.0007) and event-free survival (HR=0.84, 95% CI: 0.73-0.96, P =0.0100) of ICIs plus chemotherapy was higher than that of chemotherapy-alone in early-stage TNBC. For metastatic TNBC, compared with chemotherapy-alone, the addition of ICIs prolonged the progression-free survival (PFS) (HR=0.92, 95% CI: 0.88-0.96, P <0.0001); the improvement also existed in the following 3 subgroups: programmed cell death-ligand 1 positive, race of White and Asian, and patients without previous neoadjuvant or adjuvant chemotherapy; however, the benefit of the combined regimen was not observed in overall survival (OS) (HR=0.95; 95% CI: 0.89-1.03, P =0.2127). In addition, the pooled rates of OS, PFS, and objective response rate of ICIs plus chemotherapy were better than those of ICIs plus targeted therapy or ICIs-alone. In the safety analysis, compared with chemotherapy-alone, ICIs plus chemotherapy increased immune-related AEs and several serious AE. The regimen of ICIs plus chemotherapy is promising in both early-stage and metastatic TNBC, while the increased serious AE should not be neglected. Furthermore, the pooled rates of OS, PFS, and objective response rate of ICIs plus chemotherapy were better than those of ICIs plus targeted therapy or ICIs-alone. CI - Copyright (c) 2022 Wolters Kluwer Health, Inc. All rights reserved. FAU - Wu, Qing AU - Wu Q AD - Department of Oncology, Molecular Oncology Research Institute. AD - Department of Oncology, National Regional Medical Center, Binhai Campus of the First Affiliated Hospital, Fujian Medical University, Fuzhou, China. FAU - Wu, Chunlan AU - Wu C AD - Department of Oncology, Molecular Oncology Research Institute. AD - Department of Oncology, National Regional Medical Center, Binhai Campus of the First Affiliated Hospital, Fujian Medical University, Fuzhou, China. FAU - Xie, Xianhe AU - Xie X AD - Department of Oncology, Molecular Oncology Research Institute. AD - Department of Oncology, National Regional Medical Center, Binhai Campus of the First Affiliated Hospital, Fujian Medical University, Fuzhou, China. AD - Fujian Key Laboratory of Precision Medicine for Cancer, The First Affiliated Hospital, Fujian Medical University, Fuzhou, Fujian Province, China. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20221116 PL - United States TA - J Immunother JT - Journal of immunotherapy (Hagerstown, Md. : 1997) JID - 9706083 RN - 0 (Immune Checkpoint Inhibitors) SB - IM MH - Humans MH - *Immune Checkpoint Inhibitors/adverse effects MH - *Triple Negative Breast Neoplasms/drug therapy MH - Prognosis MH - Progression-Free Survival MH - Proportional Hazards Models EDAT- 2022/11/16 06:00 MHDA- 2023/02/04 06:00 CRDT- 2022/11/15 10:43 PHST- 2022/06/30 00:00 [received] PHST- 2022/08/17 00:00 [accepted] PHST- 2022/11/16 06:00 [pubmed] PHST- 2023/02/04 06:00 [medline] PHST- 2022/11/15 10:43 [entrez] AID - 00002371-202302000-00001 [pii] AID - 10.1097/CJI.0000000000000447 [doi] PST - ppublish SO - J Immunother. 2023 Feb-Mar 01;46(2):29-42. doi: 10.1097/CJI.0000000000000447. Epub 2022 Nov 16.