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Title: Real-World Outcomes of Ribociclib and Aromatase Inhibitor Use in First Line Hormone Receptor Positive, HER2-Negative Metastatic Breast Cancer.
Austin Authors: Wong, Vanessa ;de Boer, Richard;Baron-Hay, Sally;Blum, Robert;Boyle, Frances;Chua, Susan;Clarke, Kerrie;Cuff, Katharine;Green, Michael;Lim, Elgene;Mok, Kelly;Nott, Louise;Nottage, Michelle;Tafreshi, Ali;Tsoi, Daphne;Uccellini, Anthony;Hong, Wei;Gibbs, Peter;Lok, Sheau Wen
Affiliation: The Mater Hospital, North Sydney, NSW,Australia
Wollongong Private Hospital, Wollongong, NSW,Australia
St John of God Subiaco Hospital, Subiaco, WA,Australia
Personalised Oncology Division, Walter and Eliza Hall Institute of Medical Research, Parkville, VIC,Australia
Northern Cancer Institute, St Leonards, NSW,Australia
Department of Medical Oncology, Peter MacCallum Cancer Centre, Parkville, VIC,Australia
St Vincent's Private Hospital, Fitzroy, VIC,Australia
Olivia Newton-John Cancer Wellness and Research Centre
Department of Medical Oncology, Western Health, Footscray, VIC,Australia
Department of Medical Oncology, Bendigo Health, Bendigo, VIC,Australia
Department of Medical Oncology, Eastern Health, Box Hill, VIC,Australia
Albury Wodonga Regional Cancer Centre, Albury Wodonga Health, East Albury, NSW,Australia
Department of Medical Oncology, Princess Alexandra Hospital, Woolloongabba, QLD,Australia
Epworth Freemasons, East Melbourne, VIC,Australia
St Vincent's Clinical School, University of New South Wales, NSW,Australia
Department of Medical Oncology, Liverpool Hospital, Liverpool, NSW,Australia
Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS,Australia
Department of Medical Oncology, Royal Brisbane and Women's Hospital, Herston, QLD,Australia
Issue Date: 30-Aug-2022
Date: 2022
Publication information: Clinical Breast Cancer 2022; 22(8)
Abstract: 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. 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. 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. 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.
DOI: 10.1016/j.clbc.2022.08.011
Journal: Clinical breast cancer
PubMed URL: 36151018
Type: Journal Article
Subjects: Breast cancer
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