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DOI: 10.1055/s-0045-1804535
Real-World Evidence for Comparative Outcomes between Innovator and Biosimilar Bevacizumab in Advanced Colorectal Cancers
Funding None.
Abstract
Purpose
Generic versions of bevacizumab are commonly used in India in patients with advanced/metastatic colorectal cancers (mCRCs), but there is limited real-world evidence (RWE) about their efficacy in comparison to the innovator bevacizumab.
Methods
Patients diagnosed with mCRC between January 2017 and January 2022 and receiving a combination of chemotherapy and bevacizumab were retrospectively analyzed for demographic variables and survivals. The primary endpoint of the study was the estimation and comparison of median progression-free survival (mPFS) between patients receiving innovator versus generic bevacizumab as first-line therapy (CT1) by the Kaplan–Meier method.
Results
A total of 944 patients were included in the analysis, of whom 652 patients (69%) received bevacizumab as CT1, 449 patients (48%) during second-line chemotherapy (CT2), and 74 patients (8%) during third-line therapy (CT3). The innovator was administered to 132 patients (14%), while the remaining 812 patients (86%) received a generic molecule. With a median follow-up of 18 months, there was no difference in mPFS between patients receiving the innovator or biosimilar (10 vs. 9.3 months, p = 0.62). Similarly, there was no difference in median overall survival (mOS) between patients receiving the innovator or biosimilar during CT1 (17.8 vs. 18 months, p = 0.85). Among the patients who received bevacizumab during CT2, there was no statistically significant difference in mPFS between the innovator and the biosimilar (5.5 vs. 5.8 months, p = 0.97), nor was there a difference in mOS between patients receiving the innovator or biosimilar during CT2 (8.15 vs. 8.58 months, p = 0.16).
Conclusion
The current study offers RWE to suggest similar outcomes with innovator and generic bevacizumab when combined with chemotherapy in mCRCs. This has significant implications in India and other low- and middle-income countries besides providing oncologists with greater confidence to use these molecules in their clinical practice.
Publikationsverlauf
Eingereicht: 30. Dezember 2024
Angenommen: 28. Januar 2025
Artikel online veröffentlicht:
06. März 2025
© 2025. MedIntel Services Pvt Ltd. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)
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