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.
- 1Department of Internal Medicine, Ruian Hospital of Traditional Chinese Medicine, Ruian, China.
- 2Department of Geriatrics, Ruian Hospital of Traditional Chinese Medicine, Ruian, China.
- 3Department of Oncology, Ruian Hospital of Traditional Chinese Medicine, Ruian, China.
Abstract
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. 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. 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). 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.
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BibTeX
@article{qian2026therapeutic,
title = {{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.}},
author = {Wanli Qian and Guozhong Chen and Xiaohe Cai and Shuting Yao},
journal = {Translational cancer research},
year = {2026},
month = sep,
doi = {10.21037/tcr-2026-1633},
url = {https://europepmc.org/article/MED/42997918},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - 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.
AU - Wanli Qian
AU - Guozhong Chen
AU - Xiaohe Cai
AU - Shuting Yao
PY - 2026
DA - 2026/09/28
JO - Translational cancer research
DO - 10.21037/tcr-2026-1633
UR - https://europepmc.org/article/MED/42997918
AB - 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. 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. 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). 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.
SN - 2218-676X
SN - 2219-6803
ER -