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Real-world outcomes among patients with metastatic colorectal cancer treated first line with a bevacizumab biosimilar (bevacizumab-awwb)
BACKGROUND: Bevacizumab-awwb (MVASI(®)) was the first U.S. Food and Drug Administration-approved biosimilar to Avastin(®) (reference product [RP]) for the treatment of several different types of cancers, including metastatic colorectal cancer (mCRC), an indication approved based on extrapolation. OB...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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SAGE Publications
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10288425/ https://www.ncbi.nlm.nih.gov/pubmed/37360769 http://dx.doi.org/10.1177/17588359231182386 |
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author | Jin, Ran Ogbomo, Adesuwa S. Accortt, Neil A. Lal, Lincy S. Bishi, Geetanjali Sandschafer, Darcie Goldschmidt, Jerome H. |
author_facet | Jin, Ran Ogbomo, Adesuwa S. Accortt, Neil A. Lal, Lincy S. Bishi, Geetanjali Sandschafer, Darcie Goldschmidt, Jerome H. |
author_sort | Jin, Ran |
collection | PubMed |
description | BACKGROUND: Bevacizumab-awwb (MVASI(®)) was the first U.S. Food and Drug Administration-approved biosimilar to Avastin(®) (reference product [RP]) for the treatment of several different types of cancers, including metastatic colorectal cancer (mCRC), an indication approved based on extrapolation. OBJECTIVES: Evaluate treatment outcomes in mCRC patients who received first-line (1L) bevacizumab-awwb at treatment initiation or as continuing bevacizumab therapy (switched from RP). DESIGN: A retrospective chart review study. METHODS: Adult patients who had a confirmed diagnosis of mCRC (initial presentation of CRC on or after 01 January 2018) and initiated 1L bevacizumab-awwb between 19 July 2019 and 30 April 2020 were identified from the ConcertAI Oncology Dataset. A chart review was conducted to evaluate patient baseline clinical characteristics and effectiveness and tolerability outcomes during the follow-up. Study measures were reported stratified by prior use of RP: (1) naïve patients and (2) switchers (patients who switched to bevacizumab-awwb from RP without advancing the line of therapy). RESULTS: At the end of study period, naïve patients (n = 129) had a median 1L progression-free survival (PFS) of 8.6 months [95% confidence interval (CI), 7.6–9.9] and a 12-month overall survival (OS) probability of 71.4% (95% CI, 61.0–79.5%). Switchers (n = 105) had a median 1L PFS of 14.1 months (95% CI, 12.1–15.8) and a 12-month OS probability of 87.6% (95% CI, 79.1–92.8%). During treatment with bevacizumab-awwb, 20 events of interest (EOIs) were reported in 18 naïve patients (14.0%) and 4 EOIs reported in 4 switchers (3.8%), of which the most commonly reported events were thromboembolic and hemorrhagic events. Most EOIs resulted in emergency department visit and/or treatment hold/discontinuation/switch. None of the EOIs resulted in death. CONCLUSION: In this real-world cohort of mCRC patients who were treated 1L with a bevacizumab biosimilar (bevacizumab-awwb), the clinical effectiveness and tolerability data were as expected and consistent with previously published findings from real-world studies of bevacizumab RP in mCRC patients. |
format | Online Article Text |
id | pubmed-10288425 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | SAGE Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-102884252023-06-24 Real-world outcomes among patients with metastatic colorectal cancer treated first line with a bevacizumab biosimilar (bevacizumab-awwb) Jin, Ran Ogbomo, Adesuwa S. Accortt, Neil A. Lal, Lincy S. Bishi, Geetanjali Sandschafer, Darcie Goldschmidt, Jerome H. Ther Adv Med Oncol Original Research BACKGROUND: Bevacizumab-awwb (MVASI(®)) was the first U.S. Food and Drug Administration-approved biosimilar to Avastin(®) (reference product [RP]) for the treatment of several different types of cancers, including metastatic colorectal cancer (mCRC), an indication approved based on extrapolation. OBJECTIVES: Evaluate treatment outcomes in mCRC patients who received first-line (1L) bevacizumab-awwb at treatment initiation or as continuing bevacizumab therapy (switched from RP). DESIGN: A retrospective chart review study. METHODS: Adult patients who had a confirmed diagnosis of mCRC (initial presentation of CRC on or after 01 January 2018) and initiated 1L bevacizumab-awwb between 19 July 2019 and 30 April 2020 were identified from the ConcertAI Oncology Dataset. A chart review was conducted to evaluate patient baseline clinical characteristics and effectiveness and tolerability outcomes during the follow-up. Study measures were reported stratified by prior use of RP: (1) naïve patients and (2) switchers (patients who switched to bevacizumab-awwb from RP without advancing the line of therapy). RESULTS: At the end of study period, naïve patients (n = 129) had a median 1L progression-free survival (PFS) of 8.6 months [95% confidence interval (CI), 7.6–9.9] and a 12-month overall survival (OS) probability of 71.4% (95% CI, 61.0–79.5%). Switchers (n = 105) had a median 1L PFS of 14.1 months (95% CI, 12.1–15.8) and a 12-month OS probability of 87.6% (95% CI, 79.1–92.8%). During treatment with bevacizumab-awwb, 20 events of interest (EOIs) were reported in 18 naïve patients (14.0%) and 4 EOIs reported in 4 switchers (3.8%), of which the most commonly reported events were thromboembolic and hemorrhagic events. Most EOIs resulted in emergency department visit and/or treatment hold/discontinuation/switch. None of the EOIs resulted in death. CONCLUSION: In this real-world cohort of mCRC patients who were treated 1L with a bevacizumab biosimilar (bevacizumab-awwb), the clinical effectiveness and tolerability data were as expected and consistent with previously published findings from real-world studies of bevacizumab RP in mCRC patients. SAGE Publications 2023-06-21 /pmc/articles/PMC10288425/ /pubmed/37360769 http://dx.doi.org/10.1177/17588359231182386 Text en © The Author(s), 2023 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage). |
spellingShingle | Original Research Jin, Ran Ogbomo, Adesuwa S. Accortt, Neil A. Lal, Lincy S. Bishi, Geetanjali Sandschafer, Darcie Goldschmidt, Jerome H. Real-world outcomes among patients with metastatic colorectal cancer treated first line with a bevacizumab biosimilar (bevacizumab-awwb) |
title | Real-world outcomes among patients with metastatic colorectal cancer treated first line with a bevacizumab biosimilar (bevacizumab-awwb) |
title_full | Real-world outcomes among patients with metastatic colorectal cancer treated first line with a bevacizumab biosimilar (bevacizumab-awwb) |
title_fullStr | Real-world outcomes among patients with metastatic colorectal cancer treated first line with a bevacizumab biosimilar (bevacizumab-awwb) |
title_full_unstemmed | Real-world outcomes among patients with metastatic colorectal cancer treated first line with a bevacizumab biosimilar (bevacizumab-awwb) |
title_short | Real-world outcomes among patients with metastatic colorectal cancer treated first line with a bevacizumab biosimilar (bevacizumab-awwb) |
title_sort | real-world outcomes among patients with metastatic colorectal cancer treated first line with a bevacizumab biosimilar (bevacizumab-awwb) |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10288425/ https://www.ncbi.nlm.nih.gov/pubmed/37360769 http://dx.doi.org/10.1177/17588359231182386 |
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