Real-World Outcomes of Ribociclib and Aromatase Inhibitor Use in First Line Hormone Receptor Positive,HER2-Negative Metastatic Breast Cancer |
| |
| Affiliation: | 1. Personalised Oncology Division, Walter and Eliza Hall Institute of Medical Research, Parkville, VIC, Australia;2. Department of Medical Oncology, Peter MacCallum Cancer Centre, Parkville, VIC, Australia;3. St Vincent''s Private Hospital, Fitzroy, VIC, Australia;4. Northern Cancer Institute, St Leonards, NSW, Australia;5. Department of Medical Oncology, Bendigo Health, Bendigo, VIC, Australia;6. The Mater Hospital, North Sydney, NSW, Australia;7. Department of Medical Oncology, Eastern Health, Box Hill, VIC, Australia;8. Albury Wodonga Regional Cancer Centre, Albury Wodonga Health, East Albury, NSW, Australia;9. Department of Medical Oncology, Princess Alexandra Hospital, Woolloongabba, QLD, Australia;10. Epworth Freemasons, East Melbourne, VIC, Australia;11. St Vincent''s Clinical School, University of New South Wales, NSW, Australia;12. Department of Medical Oncology, Liverpool Hospital, Liverpool, NSW, Australia;13. Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS, Australia;14. Department of Medical Oncology, Royal Brisbane and Women''s Hospital, Herston, QLD, Australia;15. Wollongong Private Hospital, Wollongong, NSW, Australia;16. St John of God Subiaco Hospital, Subiaco, WA, Australia;17. Department of Medical Oncology, Olivia Newton-John Cancer and Wellness Centre, Austin Health, Heidelberg, VIC, Australia;18. Department of Medical Oncology, Western Health, Footscray, VIC, Australia |
| |
| Abstract: | BackgroundInternational 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 MethodsKARMA 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.ResultsData 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.ConclusionThe 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: | |
| 本文献已被 ScienceDirect 等数据库收录！ |
|
