In MONALEESA-2, 668 patients were randomly assigned 1:1 to receive either oral ribociclib at 600 mg daily for 3 weeks on and 1 week off plus letrozole at 2.5 mg daily or placebo for 3 weeks on and 1 week off plus letrozole at 2.5 mg daily. Data from the second-line population were not analyzed separately. Patients who had early relapse, defined as relapse within 12 months of the end of neoadjuvant or adjuvant endocrine therapy, were excluded from the first-line subgroup, as their disease behavior was more similar to that of second-line patients. Patients treated in the first-line setting were defined as those with de novo disease with no prior exposure to endocrine therapy, and those who had late relapse, defined as relapse more than 12 months after the end of neoadjuvant or adjuvant endocrine therapy. These same analyses were conducted separately in patients treated in the first-line setting. In this exploratory analysis, median PFS and median OS were evaluated in a pooled dataset of the 3 trials in all patients with visceral metastases, liver metastases, and visceral metastases with at least 3 metastatic sites of any type. MONALEESA-7 included premenopausal patients. MONALEESA-2 and MONALEESA-3 included postmenopausal patients. ![]() The MONALEESA-3 and MONALEESA-7 trials previously revealed a median PFS and median OS benefit of ribociclib plus endocrine therapy over endocrine therapy alone in patients with visceral metastases, including liver metastases. Those with liver metastases or multiple metastatic sites have particularly poor survival. Patients with HR-positive/HER2-negative advanced breast cancer with visceral metastases typically have a more aggressive cancer that responds less to treatment and progresses quickly. Yardley, MD, of the Sarah Cannon Research Institute at Tennessee Oncology, and colleagues, wrote. “Patients with visceral metastases experienced a clinically meaningful survival benefit with ribociclib plus endocrine therapy over endocrine therapy alone, with a 1-year improvement in median OS in patients receiving first-line therapy, making it an effective therapeutic option in this patient population,” lead study author, Denise A. Ribociclib also elicited a median OS of 49.0 months vs 46.5 months with placebo, resulting in a 19% relative reduction in the risk of death (HR, 0.81 95% CI, 0.69-0.94). ![]() Ribociclib (Kisqali) plus endocrine therapy elicited statistically significant progression-free survival (PFS) and overall survival (OS) benefits vs placebo plus endocrine therapy in patients with hormone receptor–positive/HER2-negative advanced breast cancer with visceral metastases, including those with liver metastases and multiple metastatic sites, according to findings from a pooled exploratory analysis of the phase 3 MONALEESA-2 (NCT01958021), MONALEESA-3 (NCT02422615), and MONALEESA-7 (NCT02278120) trials.įindings presented at the 2022 ESMO Congress showed that patients with visceral metastases treated with ribociclib in the first- or second-line setting (n = 640) achieved a median PFS of 22.1 months vs 12.7 months with placebo (n = 484), resulting in a 39% relative reduction in the risk of disease progression or death (HR, 0.61 95% CI, 0.53-0.70).
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