Summary

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• Kisqali (ribociclib) is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy and for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women or in men.
• This summary is based on the review of 10 systematic review(s)/meta-analysis(es). ^[1-10]
• CDK4/6 inhibitors (ribociclib, palbociclib, and abemaciclib) combined with endocrine therapy significantly improved progression-free survival (PFS) and overall survival (OS) in patients with HR+/HER2- advanced breast cancer compared to endocrine therapy alone. Specific combinations showed varied outcomes: abemaciclib + letrozole had the most favorable PFS, while ribociclib + fulvestrant yielded the best OS.
• All treatment combinations involving CDK4/6 inhibitors significantly reduced PFS hazard risks compared to monotherapy with aromatase inhibitors or fulvestrant. There were no statistically significant differences in OS among the three CDK4/6 inhibitors.
• Subgroup analyses were conducted in some studies, particularly focusing on postmenopausal women with HR+/HER2- advanced breast cancer. However, specific findings for different subgroups were generally not detailed in the provided studies.
• Across the studies, CDK4/6 inhibitors, when combined with fulvestrant, consistently showed significant improvements in both PFS and OS compared to fulvestrant alone, with no significant heterogeneity observed among the trials.
• Ribociclib and abemaciclib were associated with higher gastrointestinal toxicity (grade 1-2 vomiting) and grade 3-4 diarrhea, respectively, compared to palbociclib, which showed higher rates of neutropenia and lower GI toxicity.
• Severe adverse events (AEs) were most commonly observed with combinations involving palbociclib + AI, abemaciclib + AI or fulvestrant, and ribociclib + AI; hematological toxicity was notably high with palbociclib and ribociclib, while abemaciclib had a higher incidence of gastrointestinal toxicity.
• The combination of CDK4/6 inhibitors with fulvestrant did not significantly increase serious AEs compared to fulvestrant alone, although specific CDK4/6 inhibitors demonstrated variable safety profiles regarding diarrhea, fatigue, neutropenia, and hepatotoxicity.
• There is no population or subgroup information available in the reviewed studies.