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Meta-analysis finds immunotherapy plus chemotherapy improves outcomes in triple-negative breast cancer

Meta-analysis finds immunotherapy plus chemotherapy improves outcomes in triple-negative breast canc…
Photo by National Institute of Allergy and Infectious Diseases / Unsplash
Key Takeaway
Consider immunotherapy plus chemotherapy for TNBC, noting improved pCR and survival with increased AE risk.

This meta-analysis examined outcomes for triple-negative breast cancer patients receiving immunotherapy combined with chemotherapy versus chemotherapy alone in neoadjuvant and adjuvant settings. The analysis included multiple studies, though the total sample size and follow-up duration were not reported. The primary outcome was pathological complete response, with secondary outcomes including progression-free survival, overall survival, event-free survival, and adverse events.

In the neoadjuvant setting, immunotherapy plus chemotherapy significantly improved pathological complete response compared to chemotherapy alone, with an odds ratio of 1.90. Event-free survival was also improved, with a hazard ratio of 0.65. The benefit for pathological complete response was observed in both PD-L1-positive patients and PD-L1-negative patients, with odds ratios of 1.65 and 1.56, respectively.

In the adjuvant setting, progression-free survival was prolonged in the intention-to-treat population, with a hazard ratio of 0.82. The benefit was more pronounced in PD-L1-positive subgroups, with a hazard ratio of 0.71. Safety data indicated an increased incidence of any-grade adverse events in the neoadjuvant setting, though specific rates were not reported.

Key limitations include the lack of reported absolute numbers, sample size, and follow-up duration. The analysis combined different immunotherapy agents and chemotherapy regimens. For clinical practice, these findings reinforce the potential benefit of immunotherapy combinations in triple-negative breast cancer, particularly in neoadjuvant settings, while highlighting the need to balance efficacy with the increased risk of adverse events.

Study Details

Study typeMeta analysis
EvidenceLevel 1
PublishedApr 2026
View Original Abstract ↓
This meta-analysis evaluated the efficacy and safety of combining immune checkpoint inhibitors (ICIs) with chemotherapy in triple-negative breast cancer (TNBC). We systematically searched PubMed, Embase, and the Cochrane Library for randomized controlled trials (RCTs) comparing immunotherapy plus chemotherapy with chemotherapy alone in TNBC patients, published from inception through 30 June 2022. Outcomes included pathological complete response (pCR), progression-free survival (PFS), overall survival (OS), adverse events (AEs), and immune-related AEs (irAEs), analyzed using hazard ratios (HRs) or odds ratios (ORs). The addition of ICIs to chemotherapy improved pCR (OR 1.90, 95 % CI: 1.28-2.83, *P* = 0.002) and event-free survival (EFS) (HR 0.65, 95 % CI: 0.51-0.82, *P* = 0.0004) in the neoadjuvant setting. Notably, pCR benefits persisted regardless of PD-L1 status (OR 1.65, 95 % CI: 1.26-2.16, *P* = 0.0002 in PD-L1-positive patients; OR 1.56, 95 % CI: 1.04-2.33, *P* = 0.03 in PD-L1-negative patients). In the adjuvant setting, ICIs significantly prolonged PFS in both the intention-to-treat population (HR 0.82, 95 % CI: 0.74-0.90, *P* < 0.0001, *I*² = 0 %) and PD-L1-positive subgroups (HR 0.71, 95 % CI: 0.62-0.82, *P* < 0.00001, *I*² = 12 %). However, combination therapy increased the incidence of any-grade AEs, serious AEs, and grade ≥3 AEs in neoadjuvant treatment. The experimental group also exhibited higher toxicity for irAEs, including hypothyroidism and hyperthyroidism. These findings support the use of ICIs with chemotherapy for TNBC, though careful monitoring of adverse effects is warranted. PROSPERO registration number:CRD42022367366.
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