Observational studyThe Pan African medical journal2026
Clinical outcomes and toxicity in metastatic breast cancer patients treated with first or second-line cyclin-dependent kinase (CDK) 4/6 inhibitors and endocrine therapy in Egypt.
Observational study in The Pan African medical journal, 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
Introduction: cyclin-dependent kinase 4/6 inhibitors (CDK4/6is) are widely used to treat hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (MBC). This study aimed to assess the real-world efficacy and tolerability of CDK 4/6i in the Egyptian population. Methods: prospective observational study for HR+/HER2- MBC treated in the clinical oncology department of Ain Shams University Hospitals, Egypt, between July 2022 and September 2024. Results: sixty-two patients were included (mean age, 53.8 years; range, 29-85). Thirty-one (50%) received CDK4/6is as first-line therapy and 31 as second-line therapy. Median follow-up time was 14.2 months (range 12-24 months). Thirty patients (48.3%) started on Ribociclib, 9 (14.5%) on Abemaciclib, and 23 (37.1%) on Palbociclib, with 15 patients switched from Ribociclib and Abemaciclib to Palbociclib due to logistical causes. Median progression-free survival (PFS) was 14 months (6-27 months) and 11 months for first- and second-line therapy, respectively. Patients and treatment characteristics did not significantly impact PFS. Ribociclib and Palbociclib most frequently caused neutropenia (70.0% and 68.4%, respectively), while Abemaciclib caused diarrhea (55.6%). The rate of dose reductions was 24.6%. Age was significantly correlated with a higher incidence of hematological (p=0.03) and nephrological toxicity (p=0.02). Furthermore, medical comorbidities were associated with a significantly higher frequency of grade 3-4 hematological events (p=0.02). Conclusion: our findings demonstrate that CDK4/6is are both effective and well-tolerated for HR+//HER2- MBC patients within a diverse patient population. Additionally, this prospective evaluation supports the efficacy of lower-dose levels of CDK4/6is, without negatively impacting PFS.
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