CompLEEment-1: Phase 3b study of ribociclib + letrozole for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (ABC) in patients with no prior endocrine therapy (ET) for ABC

Laurentiis, Michelino De; Jiménez, M. Martín; Ring, Alistair; Cottu, Paul; Zhou, Katie; Wu, Jiwen; Zarate, Juan Pablo; Zamagni, Claudio

doi:10.1093/annonc/mdx365.082

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“…CompLEEment-1 (C-1) was a large, international phase IIIb study that included patients with previously untreated HR-positive, HER2-negative de novo MBC or relapsed disease with at least 12 months duration after neoadjuvant/adjuvant AI exposure. All patients were treated with ribociclib and letrozole and if premenopausal, ovarian function suppression or ablation [ 21 ]. Results from the Canadian cohort of 251 women were presented at the European Society of Medical Oncology meeting in 2020.…”

Section: Discussionmentioning

confidence: 99%

First-Line Treatment with a Cyclin-Dependent Kinase 4/6 Inhibitor Plus an Aromatase Inhibitor for Metastatic Breast Cancer in Alberta

2021

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In this analysis, we describe population-based outcomes for first-line treatment with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) combined with an aromatase inhibitor (AI). All patients who were prescribed CDK4/6i + AI from January 2016 through June 2019 were included. Patient demographics, tumour and treatment characteristics were collected and described. Survival distributions were estimated using the Kaplan–Meier method. Multivariate analysis (MVA) was constructed to examine associations between potentially prognostic clinical variables and progression-free survival (PFS). In total, 316 patients were included. The median age was 61 years. After a median follow-up of 28.1 months, the median PFS was 37.9 months (95% CI, 26.7–NR). In the MVA, PR-negative tumour (HR, 2.37; 95% CI, 1.45–3.88; p = 0.001) and CDK4/6i dose reduction (HR, 1.51; 95% CI, 1.06–2.16; p = 0.022) predicted worse PFS. Median overall survival (OS) was not reached. The 30-month and 36-month OS rates were 74% and 68%, respectively. Of patients who progressed, 89% received second-line treatment. Median time to progression on second-line chemotherapy was 9.0 (5.8–17.6) months, and median time to progression on second-line hormonal therapy +/− targeted agent was 4.0 (3.4–8.6) months (p = 0.012). CDK4/6i + AI as first-line treatment for HR-positive, HER2-negative MBC in Alberta is justified based on favourable PFS and early OS outcomes.

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Section: Discussionmentioning

confidence: 99%