SynthesisBreast cancer research and treatment2026
The impact of menopausal status on the efficacy of adjuvant CDK4/6 inhibitors in hormone receptor-positive early breast cancer: a systematic review and meta-analysis of phase III clinical trials.
Synthesis in Breast cancer research and treatment, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
purposeAdjuvant cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) improve outcomes in hormone receptor-positive (HR+), HER2-negative early breast cancer, though trial results have been heterogeneous. Menopausal status and endocrine therapy backbone may contribute to variability in treatment effect. We performed a meta-analysis evaluating whether menopausal status influences the efficacy of adjuvant CDK 4/6 inhibition.
methodsA systematic review of phase III randomized trials evaluating adjuvant CDK4/6i in HR+/HER2- early-stage breast cancer was conducted. Trial-level hazard ratios (HRs) and 95% confidence intervals (CIs) for iDFS and OS were extracted separately for pre-/peri-menopausal and postmenopausal subgroups. HRs were pooled using random-effects modelling (DerSimonian-Laird method) with inverse-variance modeling. Heterogeneity was assessed using I² statistics. A sensitivity analysis limited to approved CDK4/6i (ribociclib and abemaciclib) was performed.
resultsFour trials comprising 17,748 participants were included, of whom 45% were pre-/peri-menopausal and 55% were postmenopausal. Pooled iDFS HRs were 0.80 (95% CI 0.67-0.97, I²=64%) in pre-/peri-menopausal patients and 0.79 (95% CI 0.72-0.86, I²=0%) in postmenopausal patients. Pooled OS HRs were 1.02 (95% CI 0.67-1.54, I²=80%) in pre-/peri-menopausal and 0.89 (95% CI 0.78-1.03, I²=0%) in postmenopausal patients. No significant subgroup differences were observed for iDFS or OS. Compared to post-menopausal participants, those who were premenopausal had 3.0% fewer absolute iDFS events at 5-6 years. Sensitivity analyses yielded consistent findings.
conclusionsEfficacy of adjuvant CDK4/6 inhibition in HR+/HER2-negative early breast cancer does not appear to be influenced by menopausal status as defined in individual trials. Greater heterogeneity among pre-/peri-menopausal patients may reflect differences in endocrine therapy backbone, tumor characteristics and patient risk. CLINICAL TRIAL NUMBER: Not applicable.
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