Kerri Fitzgerald

DocwireNews

The phase II MAINTAIN trial evaluated the efficacy of adding ribociclib to endocrine therapy in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer and observed a significant survival benefit. The results were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.The combination of cyclin-dependent kinase (CDK) and endocrine therapy is standard of care in HR-positive, HER2-negative metastatic breast cancer. Prior observational data demonstrated a potential benefit of continuing CDK 4/6 inhibitor therapy and switching endocrine therapy once the disease has progressed.The current investigator-initiated, multicenter, double-blind, placebo-controlled trial evaluated 120 patients (1 was male) with measurable or non-measurable HR-positive, HER2-negative metastatic breast cancer who progressed during CDK 4/6 inhibitor and endocrine therapy. Patients who previously received fulvestrant received exemestane as endocrine therapy and vice versa. Patients who had received neither therapy were randomized based on the investigator&rsquo;s decision, although fulvestrant was encouraged.Median patient age was 57 years, and most patients (n=88; 74%) were white. Patients were randomized 1:1 to receive fulvestrant (n=99; 83%) or exemestane (n=20; 17%) with or without ribociclib.Prior CDK 4/6 therapies included palbociclib (n=100; 84%), ribociclib (n=13; 11%), abemaciclib (n=2; 2%), and palbociclib plus another CDK 4/6 inhibitor (n=4; 3%).Patients receiving ribociclib in addition to endocrine therapy had a median progression-free survival (PFS; primary outcome) of 5.33 months (95% CI, 3.25-8.12), while those who received endocrine therapy alone had a median PFS of 2.76 months (95% CI, 2.66-3.25; hazard ratio [HR], 0.56; P=.004).At 6 months, 42% of patients in the ribociclib group remained progression-free compared with 24% of those who received endocrine therapy alone. At 12 months, 25% and 7% of patients, respectively, were progression-free.The most common hematologic adverse events occurring in patients treated with and without ribociclib were neutropenia (72% vs 15%), anemia (23% vs 22%), and thrombocytopenia (25% vs 5%). The percentage of patients in the ribociclib cohort who experienced infection was 10 (n=6) compared with 5% (n=3) in those who did not receive ribociclib. A total of 2 patients (3%) receiving ribociclib experienced pneumonitis.&ldquo;This is the first randomized trial to show the benefit of ribociclib and switching endocrine therapy after progression on a CDK 4/6 inhibitor. Ribociclib plus endocrine therapy led to a statistically significant improvement in PFS compared with placebo plus endocrine therapy in participants with tumor progression following a CDK 4/6 inhibitor,&rdquo; Kevin Kalinsky, MD, MS, of the Winship Cancer Institute of Emory University, concluded during his presentation at ASCO.ReferenceKalinsky K, Accordino MK, Chiuzan C, et al. A randomized, phase II trial of fulvestrant or exemestane with or without ribociclib after progression on anti-estrogen therapy plus cyclin-dependent kinase 4/6 inhibition (CDK 4/6i) in patients (pts) with unresectable or hormone receptor&ndash;positive (HR+), HER2-negative metastatic breast cancer (MBC): MAINTAIN trial. <a href="https://meetings.asco.org/abstracts-presentations/208019">Abstract #LBA1004</a>. Presented at the 2022 American Society of Clinical Oncology Annual Meeting; June 3-7, 2022; Chicago, IL.

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The phase II MAINTAIN trial evaluated the efficacy of adding ribociclib to endocrine therapy in patients with hormone receptor (HR)-positive, human epidermal growth factor ...

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