Palbociclib for CDK4/6 Inhibition in Recurrent Ovarian Cancer: A Phase II Clinical Evaluation
Konecny GE, et al. International Journal of Gynecological Cancer, 2025, 35, 102028.
Palbociclib was clinically evaluated for its therapeutic potential in recurrent ovarian cancer through a prospective phase II trial. Eligible patients with RECIST- and/or CA-125-measurable disease received oral palbociclib at 125 mg daily for 21 consecutive days in a 28-day cycle, reflecting the established intermittent dosing strategy to mitigate hematologic toxicity. In hormone receptor-positive cases, concomitant aromatase inhibitor therapy was permitted to enhance endocrine responsiveness. The primary endpoint, biochemical response, was assessed via CA-125 reduction according to Gynecologic Cancer InterGroup criteria, while radiologic responses were evaluated by RECIST. Targeted next-generation sequencing was integrated to explore genomic correlates of therapeutic sensitivity and resistance. Although overall activity was modest, durable disease stabilization observed in low-grade serous ovarian cancer underscores the experimental relevance of CDK4/6 blockade and highlights the importance of biomarker-guided stratification in optimizing palbociclib-based therapeutic strategies.
