Therapeutic value of PD-1/PD-L1 blockade plus chemotherapy in advanced or metastatic triple-negative breast cancer: a systematic review and meta-analysis of randomized controlled trials
Year: 2026
Type: review
Study designs: Systematic Review, Meta-Analysis
Abstract: Background: Advanced or metastatic triple-negative breast cancer (TNBC) has a poor prognosis, and chemotherapy alone offers limited efficacy. This study aimed to systematically evaluate the efficacy and safety of programmed death-1/programmed death-ligand 1 (PD-1/PD-L1) inhibitors combined with chemotherapy versus chemotherapy alone or placebo plus chemotherapy in patients with advanced or metastatic TNBC. Methods: PubMed, Embase, Web of Science, Cochrane Library and Scopus were searched from database inception to February 1, 2026. Randomized controlled trials (RCTs) comparing PD-1/PD-L1 inhibitors plus chemotherapy with chemotherapy alone or placebo plus chemotherapy were included. The main efficacy outcomes were progression-free survival (PFS), overall survival (OS), objective response rate (ORR), disease control rate (DCR) or clinical benefit rate (CBR); safety outcomes included grade ≥3 adverse events (AEs), serious adverse events (SAEs), and treatment discontinuation due to AEs. Results: A total of 8 RCTs involving 3,534 patients were included, with 2,111 patients in the experimental group and 1,423 in the control group. Meta-analysis showed that PD-1/PD-L1 inhibitors combined with chemotherapy improved PFS [hazard ratio (HR) =0.78, 95% confidence interval (CI): 0.71-0.85, P<0.001] and OS (HR =0.86, 95% CI: 0.78-0.94, P=0.002). Compared with the control group, the combination group had a higher ORR [odds ratio (OR) =1.51, 95% CI: 1.28-1.79, P<0.01], and DCR or CBR was also improved (OR =1.82, 95% CI: 1.05-3.18, P=0.03). In terms of safety, the risk of grade ≥3 AEs was increased in the combination group (OR =1.18, 95% CI: 1.02-1.35, P=0.02), and the risk of treatment discontinuation due to AEs was also higher (OR =1.85, 95% CI: 1.47-2.32, P<0.001). Conclusions: PD-1/PD-L1 inhibitors combined with chemotherapy can improve survival and tumor response outcomes in patients with advanced or metastatic TNBC, but they also increase the risk of grade ≥3 AEs and treatment discontinuation.
Source: Translational Cancer Research
Authors: Wanli Qian, Guozhong Chen, Xiaohe Cai, Shuting Yao
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W7224079212