PMID- 34267656 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20210717 IS - 1663-9812 (Print) IS - 1663-9812 (Electronic) IS - 1663-9812 (Linking) VI - 12 DP - 2021 TI - Efficacy and Safety of Anti-PD-1/ PD-L1 Monotherapy for Metastatic Breast Cancer: Clinical Evidence. PG - 653521 LID - 10.3389/fphar.2021.653521 [doi] LID - 653521 AB - Background: Success has been reported in PD-1/PD-L1 blockade via pembrolizumab, atezolizumab, or avelumab monotherapy in manifold malignancies including metastatic breast cancer. Due to lack of large-scale study, here we present interim analyses to evaluate the safety and efficacy of these promising strategies in patients with advanced breast cancer. Methods: Six studies including 586 advanced breast cancer patients treated with anti-PD-1/PD-L1 monotherapy agents before July 1, 2020, were included. The anti-PD-1/PD-L1 agents include pembrolizumab, atezolizumab, land avelumab. Statistics was analyzed by R software and IBM SPSS Statistics 22. Results: Global analysis showed that for this monotherapy, the complete response was 1.26%, partial response was 7.65%, objective response rate (ORR) was 9.85%, and disease control rate (DCR) was 18.33%. 1-year overall survival rate and 6-month progression-free survival rate were 43.34 and 17.24%. Overall incidence of adverse events (AEs) was 64.18% in any grade and 12.94% in severe grade, while the incidence of immune-related AEs (irAEs) was approximately 14.75%: the most common treatment-related AEs of any grade that occurred in at least 5% of patients were arthralgia and asthenia; the most common severe treatment-related AEs occurred in at least 1% of patients were anemia and autoimmune hepatitis; the most common irAEs were hypothyroidism. Besides, the incidence of discontinue and death due to treatment-related AEs was about 3.06 and 0.31%, respectively. Additionally, by comparing efficacy indicators between PD-L1-positive and PD-L1-negative groups, an implicated correspondence between efficacy and the expression of PD-L1 biomarker was found: the PR was 9.93 vs 2.69%; the ORR was 10.62 vs. 3.07%; the DCR was 17.95 vs. 4.71%. Conclusion: Anti-PD-1/PD-L1 monotherapy showed a manageable safety profile and had a promising and durable anti-tumor efficacy in metastatic breast cancer patients. Higher PD-L1 expression may be closely correlated to a better clinical efficacy. CI - Copyright (c) 2021 Qi, Zhang, Wang, Kong, Zhai, Fang and Wang. FAU - Qi, Yihang AU - Qi Y AD - Department of Breast Surgical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Zhang, Lin AU - Zhang L AD - School of Population Medicine and Public Health, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. AD - Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, VIC, Australia. AD - Centre of Cancer Research, Victorian Comprehensive Cancer Centre, Melbourne, VIC, Australia. FAU - Wang, Zhongzhao AU - Wang Z AD - Department of Breast Surgical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Kong, Xiangyi AU - Kong X AD - Department of Breast Surgical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Zhai, Jie AU - Zhai J AD - Department of Breast Surgical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Fang, Yi AU - Fang Y AD - Department of Breast Surgical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Wang, Jing AU - Wang J AD - Department of Breast Surgical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. LA - eng PT - Journal Article DEP - 20210629 PL - Switzerland TA - Front Pharmacol JT - Frontiers in pharmacology JID - 101548923 PMC - PMC8276035 OTO - NOTNLM OT - PD-1 OT - PD-L1 OT - breast cancer OT - efficacy OT - immunotherapy OT - safety COIS- The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2021/07/17 06:00 MHDA- 2021/07/17 06:01 PMCR- 2021/06/29 CRDT- 2021/07/16 06:36 PHST- 2021/01/14 00:00 [received] PHST- 2021/05/28 00:00 [accepted] PHST- 2021/07/16 06:36 [entrez] PHST- 2021/07/17 06:00 [pubmed] PHST- 2021/07/17 06:01 [medline] PHST- 2021/06/29 00:00 [pmc-release] AID - 653521 [pii] AID - 10.3389/fphar.2021.653521 [doi] PST - epublish SO - Front Pharmacol. 2021 Jun 29;12:653521. doi: 10.3389/fphar.2021.653521. eCollection 2021.