Real-World Outcomes of Ribociclib and Aromatase Inhibitor Use in First Line Hormone Receptor Positive, HER2-Negative Metastatic Breast Cancer

Wong, V; De Boer, R; Baron-Hay, S; Blum, R; Boyle, F; Chua, S; Clarke, K; Cuff, K; Green, M; Lim, E; Mok, K; Nott, L; Nottage, M; Tafreshi, A; Tsoi, D; Uccellini, A; Hong, W; Gibbs, P; Lok, SW

Author(s): Wong, V; De Boer, R; Baron-Hay, S; Blum, R; Boyle, F; Chua, S; Clarke, K; Cuff, K; Green, M; Lim, E; Mok, K; Nott, L; Nottage, M; Tafreshi, A; Tsoi, D; Uccellini, A; Hong, W; Gibbs, P; Lok, SW;
Details: Publication Year 2022-12,Volume 22,Issue #8,Page 792-800
Journal Title: Clinical Breast Cancer
Publication Type: Research article
Abstract: BACKGROUND: International guidelines recommend combining a CDK4/6 inhibitor and endocrine therapy (ET) as first line treatment for hormone receptor (HR) positive, HER2 negative metastatic breast cancer (MBC). Results from MONALEESA-2 demonstrate superior progression free survival (PFS) and overall survival (OS) with ribociclib (CDK4/6 inhibitor) and ET compared to ET alone. Real world outcomes have yet to be reported. MATERIALS AND METHODS: KARMA is a non-interventional registry of Australian patients receiving first-line treatment with ribociclib and aromatase inhibitor (AI), obtained via a Medicine Access Program (MAP) for HR+, HER2- MBC. Outcomes were compared with the ribociclib/letrozole cohort in MONALEESA-2. RESULTS: Data from 160 patients at 17 sites was analysed. Median follow-up is 36.5 months. Compared to MONALEESA-2, patients were numerically younger (54.3 vs. 62 years), with higher rates of bone-only metastases (31% vs. 21%). A total of 63 of 160 (39%) patients remain on treatment. A total of 56% of patients had at least 1 dose reduction, with neutropenia (68%) and abnormal liver enzymes (17%) the most common reasons. A total of 17 of 160 (11%) discontinued treatment due to toxicity, with no treatment related deaths. Median PFS was not reached (95% CI 29.9- NR), with PFS at 12 months and 18 months being 76% and 67% respectively versus 25.3 months, 73% and 63% in MONALEESA-2. CONCLUSION: The ribociclib and AI combination was well tolerated in this real-world setting. The KARMA registry cohort achieved a superior PFS (>36.5 months) to MONALEESA-2, potentially due to more favourable baseline disease characteristics. Less frequent assessment scheduling in this non trial setting may also contribute.
Keywords: Humans; Female; *Aromatase Inhibitors/therapeutic use; *Breast Neoplasms/pathology; Letrozole; Receptors, Estrogen; Antineoplastic Combined Chemotherapy Protocols/adverse effects; Australia; Receptor, ErbB-2; Breast cancer; Medicine access programs; Registries
Department(s): Medical Oncology; Familial Cancer Centre
PubMed ID: 36151018
Publisher's Version: https://doi.org/10.1016/j.clbc.2022.08.011
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2025-05-16 01:15:01

Last Modified: 2025-05-16 01:16:07