Frontiers in oncology · 2026
Efficacy and safety analysis of immune checkpoint inhibitors combined with chemotherapy in the treatment of advanced triple-negative breast cancer: an umbrella meta-analysis.
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Cao Wendi, Rong Qingxi, Song Yingheng, Ma Zhijun, Dong Qiuxia
Аннотация
BACKGROUND: Triple-negative breast cancer (TNBC) is highly aggressive with poor prognosis and limited treatment options. Immune checkpoint inhibitors (ICIs) combined with chemotherapy have emerged as a promising strategy for advanced TNBC. This umbrella meta-analysis was conducted to comprehensively evaluate the efficacy and safety of this combination regimen.
METHODS: We systematically searched PubMed, Web of Science, and Embase for relevant articles up to August 2025. The methodological quality and evidence certainty of the included studies were assessed using AMSTAR-2, GRADE, and a prespecified classification scheme. Publication bias was examined through funnel plots and Egger's tests, and sensitivity analyses were performed to test result robustness. The appropriate effect model was selected based on heterogeneity.
RESULTS: A total of 11 meta analyses comprising 39,147 patients were included. ICIs combined with chemotherapy significantly improved overall survival (OS, HR = 0.89) and progression-free survival (PFS, HR = 0.81) compared with chemotherapy alone. The objective response rate showed no statistically significant improvement in either programmed cell death ligand-1 (PD-L1)-negative (RR = 1.01) or PD-L1-positive (RR = 1.17) populations. Regarding safety, combination therapy was associated with increased risks of all-grade and grade ≥3 adverse events(AEs), as well as a higher incidence of immune-related adverse events(irAEs). Findings concerning hepatitis require cautious interpretation due to the limited number of studies.
CONCLUSIONS: ICIs combined with chemotherapy confers survival benefits in advanced TNBC, though at the cost of increased immune-related toxicity. Given current evidence limitations, future research with more detailed stratification is needed to guide individualized treatment.
SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/prospero/, identifier CRD420251168274.
METHODS: We systematically searched PubMed, Web of Science, and Embase for relevant articles up to August 2025. The methodological quality and evidence certainty of the included studies were assessed using AMSTAR-2, GRADE, and a prespecified classification scheme. Publication bias was examined through funnel plots and Egger's tests, and sensitivity analyses were performed to test result robustness. The appropriate effect model was selected based on heterogeneity.
RESULTS: A total of 11 meta analyses comprising 39,147 patients were included. ICIs combined with chemotherapy significantly improved overall survival (OS, HR = 0.89) and progression-free survival (PFS, HR = 0.81) compared with chemotherapy alone. The objective response rate showed no statistically significant improvement in either programmed cell death ligand-1 (PD-L1)-negative (RR = 1.01) or PD-L1-positive (RR = 1.17) populations. Regarding safety, combination therapy was associated with increased risks of all-grade and grade ≥3 adverse events(AEs), as well as a higher incidence of immune-related adverse events(irAEs). Findings concerning hepatitis require cautious interpretation due to the limited number of studies.
CONCLUSIONS: ICIs combined with chemotherapy confers survival benefits in advanced TNBC, though at the cost of increased immune-related toxicity. Given current evidence limitations, future research with more detailed stratification is needed to guide individualized treatment.
SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/prospero/, identifier CRD420251168274.