Efficacy and safety analysis of immune checkpoint inhibitors combined with chemotherapy in the treatment of advanced triple-negative breast cancer: an umbrella meta-analysis - Report - MDSpire

Assessment of the Safety and Effectiveness of Combining Immune Checkpoint Inhibitors with Chemotherapy for Advanced Triple-Negative Breast Cancer: A Comprehensive Meta-Analysis

  • By

  • Wendi Cao

  • Qingxi Rong

  • Yingheng Song

  • Zhijun Ma

  • Qiuxia Dong

  • July 21, 2026

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Clinical Report: Safety and Effectiveness of ICIs with Chemotherapy in TNBC

Overview

This meta-analysis evaluates the efficacy and safety of immune checkpoint inhibitors (ICIs) combined with chemotherapy for advanced triple-negative breast cancer (TNBC).

Background

Triple-negative breast cancer (TNBC) is a highly aggressive subtype with limited treatment options and poor prognosis. The combination of immune checkpoint inhibitors (ICIs) with chemotherapy has emerged as a potential strategy to improve outcomes in advanced TNBC. Understanding the efficacy and safety of this combination is crucial for optimizing treatment approaches in this challenging patient population.

Data Highlights

OutcomeHazard Ratio (HR) / Risk Ratio (RR)
Overall Survival (OS)HR = 0.89
Progression-Free Survival (PFS)HR = 0.81
Objective Response Rate (PD-L1-negative)RR = 1.01
Objective Response Rate (PD-L1-positive)RR = 1.17

Key Findings

  • ICIs combined with chemotherapy improved overall survival (OS) (HR = 0.89) and progression-free survival (PFS) (HR = 0.81) in advanced TNBC.
  • The objective response rate showed no significant improvement in PD-L1-negative populations (RR = 1.01).
  • In PD-L1-positive populations, the objective response rate was slightly improved (RR = 1.17).
  • Combination therapy was associated with increased risks of all-grade and grade ≥3 adverse events.
  • A higher incidence of immune-related adverse events (irAEs) was observed with the combination therapy.
  • Findings regarding hepatitis require cautious interpretation due to limited studies.

Clinical Implications

Clinicians should be vigilant regarding the increased risk of immune-related toxicities associated with the combination of ICIs and chemotherapy.

Conclusion

The findings support the use of ICIs in conjunction with chemotherapy for advanced TNBC, highlighting the need for careful monitoring of adverse effects. Further studies are warranted to enhance treatment personalization.

Related Resources & Content

  1. Frontiers in Immunology, 2026 -- Efficacy and Safety of Immune Checkpoint Inhibitors Combined with Antiangiogenic Agents in Advanced Cervical Cancer: A Systematic Review and Meta-Analysis
  2. The ASCO Post, 2024 -- Addition of Immune Checkpoint Inhibitors to Neoadjuvant Chemotherapy for Early Breast Cancer
  3. Frontiers in Oncology, 2026 -- Efficacy and safety of combined immune therapy for advanced cervical cancer: a systematic review and meta-analysis
  4. Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, staging and treatment of patients with metastatic breast cancer, PMC
  5. New England Journal of Medicine, 2022 -- Pembrolizumab plus Chemotherapy in Advanced Triple-Negative Breast Cancer
  6. Frontiers in Oncology — Correction: The efficacy of angiogenesis inhibitors combined with chemotherapy in advanced breast cancer: a systematic review and meta-analysis
  7. Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, staging and treatment of patients with metastatic breast cancer - PMC
  8. Pembrolizumab plus Chemotherapy in Advanced Triple-Negative Breast Cancer | New England Journal of Medicine
  9. Oncology (Cancer)/Hematologic Malignancies Approval Notifications | FDA

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