Real-World Safety and Effectiveness of a Bevacizumab Biosimilar (ABP 215) in Metastatic Colorectal Cancer Patients in Canada.

Autor: Cheung WY; Tom Baker Cancer Centre, Calgary, AB, Canada., Samimi S; CIUSSS-du Nord-de-l'Île-de-Montréal, Montréal, QC, Canada., Ma K; CISSS de Laval, Laval, QC, Canada., Knight GJ; Grand River Regional Cancer Centre, Kitchener, ON, Canada., Kassam S; Southlake Regional Health Centre, Newmarket, ON, Canada., Colwell B; Nova Scotia Health Authority Queen Elizabeth II Health Sciences Centre, Halifax, NS, Canada., Beaudoin A; CIUSSS de I'Estrie - Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada., Vincent MD; London Health Sciences Centre, Victoria Hospital, London, ON, Canada., Trinkaus M; Markham Stouffville Hospital, Markham, ON, Canada., Filion A; CISSS de Chaudière-Appalaches, Lévis, QC, Canada., Marquis K; CISSS du Bas-Saint-Laurent - Hôpital régional de Rimouski, Rimouski, QC, Canada., Karachiwala H; Cross Cancer Institute, Edmonton, AB, Canada., Asmis T; The Ottawa Hospital Cancer Center, Ottawa, ON, Canada., Sideris L; CIUSSS de l'Est-de-l'Île-de-Montréal - Hôpital Maisonneuve-Rosemont, Montréal, QC, Canada., Wani RJ; Amgen Canada Inc., Mississauga, ON, Canada., Ngan E; Amgen Canada Inc., Mississauga, ON, Canada., Inam N; Amgen Canada Inc., Mississauga, ON, Canada., Du Y; Amgen, Shanghai, China., Nunez L; IQVIA, Global Database Studies, Mölndal, Sweden., Eberg M; IQVIA Solutions Canada Inc., Kirkland, QC, Canada., Alemayehu M; IQVIA Solutions Canada Inc., Mississauga, ON, Canada., Meyer PF; IQVIA Solutions Canada Inc., Kirkland, QC, Canada., Mancini J; IQVIA Solutions Canada Inc., Kirkland, QC, Canada., Cirone Morris C; Amgen Canada Inc., Mississauga, ON, Canada. Electronic address: ccirone@amgen.com.
Jazyk: angličtina
Zdroj: Clinical colorectal cancer [Clin Colorectal Cancer] 2024 Mar; Vol. 23 (1), pp. 46-57.e4. Date of Electronic Publication: 2023 Oct 28.
DOI: 10.1016/j.clcc.2023.10.007
Abstrakt: Background: ABP 215 is a biosimilar to the reference product, bevacizumab, and was one of the first biosimilars approved by Health Canada for the first-line treatment of metastatic colorectal cancer (mCRC). This study aimed to address gaps in real-world evidence (RWE) including patient characteristics, treatment safety (primary objective), and effectiveness (secondary objective) for first-line ABP 215 therapy in Canadian patients with mCRC.
Materials and Methods: Retrospective data were collected in 2 waves, at least 1 year (Wave 1) or 2 years (Wave 2) after commercial availability of ABP 215 at each participating site.
Results: A total of 75 patients from Wave 1 and 164 patients from Wave 2 treated with a minimum of 1 cycle of ABP 215 were included. At least one safety event of interest (EOI) was recorded for 34.7% of Wave 1 and 42.7% of Wave 2 patients. The median progression free survival (PFS) for Wave 1 and 2 patients were 9.47 (95% confidence interval [CI]: 6.71, 11.90) and 21.38 (95% CI: 15.82, not estimable) months, respectively. Median overall survival was not estimable for Wave 1 and was 26.45 months for Wave 2.
Conclusion: The safety and effectiveness of ABP 215 observed in this real-world study were comparable to clinical trial findings and to other RWE with longer PFS in the current study.
(Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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