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Outcomes With Immunotherapy in Hormone Receptor-Positive Breast Cancer: A Systematic Review and Meta-Analysis.
Moazzam Shahzad1, Muhammad K Amin2, Amir Kasaeian3
1H. Lee Moffitt Cancer Center, Tampa, FL.
American Journal of Clinical Oncology
|May 15, 2026
Summary
Immunotherapy offers a modest increase in complete response for hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer but shows higher toxicity and no significant survival benefits. Further research is needed.
Area of Science:
- Oncology
- Immunotherapy
- Breast Cancer Research
Background:
- Hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer historically exhibits limited efficacy with immunotherapy.
- Understanding immunotherapy's role in this specific breast cancer subtype is crucial for treatment advancement.
Purpose of the Study:
- To systematically review and conduct a meta-analysis evaluating the efficacy and safety of immunotherapy in HR+/HER2- breast cancer patients.
- To determine the impact of immunotherapy on response rates, survival, and adverse events in this population.
Main Methods:
- A comprehensive systematic search of major databases (PubMed, Embase, MEDLINE, ClinicalTrials.gov, Cochrane Library) was performed through May 2025, adhering to PRISMA guidelines.
- Meta-analyses utilized random-effects models to pool risk ratios and event rates from 11 randomized controlled trials involving 7480 patients.
- Heterogeneity was assessed using I² statistics to ensure robust analysis.
Main Results:
- Immunotherapy did not significantly improve overall response rate (RR: 1.20) or partial response rate (RR: 1.03) but showed improved complete response (RR: 1.63) in HR+/HER2- breast cancer.
- Increased therapy-related adverse events were observed with immunotherapy (RR: 1.29).
- Pooled median overall survival was 23.6 months and progression-free survival was 6.6 months, with 4% overall mortality in the immunotherapy group.
Conclusions:
- Immunotherapy may offer a modest benefit in complete response rates for HR+/HER2- breast cancer.
- The observed increase in toxicity and lack of consistent improvement in overall or progression-free survival suggest caution.
- Future biomarker-driven clinical trials are essential to optimize immunotherapy use in this patient group.
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