Muñoz Caroline, Beca Jaclyn M, Dvorani Erind, Mercer Rebecca E, Arias Jessica, Adamic Andrea, Gavura Scott, Chan Kelvin K W
Ontario Health (Cancer Care Ontario), Toronto, Ontario, Canada.
Canadian Centre for Applied Research in Cancer Control, Toronto, Ontario, Canada.
J Natl Compr Canc Netw. 2024 Dec;22(10):677-684. doi: 10.6004/jnccn.2024.7053.
Ontario has publicly funded biosimilar bevacizumab for first-line metastatic colorectal cancer (mCRC) since 2019. Clinical trials demonstrate comparable efficacy and safety of bevacizumab biosimilars to originator bevacizumab. The objective of this study was to assess real-world safety and effectiveness of the implementation of bevacizumab biosimilars compared with originator bevacizumab in patients with mCRC.
This was a population-based, retrospective study comparing Ontario patients starting treatment with bevacizumab biosimilars between August 12, 2019, and March 31, 2021, and starting treatment with originator bevacizumab between July 2, 2008, and August 11, 2019. Safety outcomes included death within 30 days of the last dose received, any hospitalization, direct hospitalization, and hospitalization resulting from bevacizumab-related toxicity, chemotherapy-related toxicity, and febrile neutropenia. Event rates were assessed using negative binomial and logistic regression. The effectiveness outcome was overall survival, calculated using Kaplan-Meier and Cox proportional hazards regression. A subgroup analysis compared safety and effectiveness outcomes between patients on bevacizumab biosimilar products and matched comparators.
We identified 8,996 patients who initiated first-line treatment of bevacizumab for mCRC. Accounting for duration of follow-up, no significant differences were observed in the rate of hospitalization between treatment groups. No differences in overall survival (log-rank P>.05) or hazard ratios (propensity score-matched hazard ratio, 1.03; 95% CI, 0.92-1.16) were observed in the crude and propensity score-matched cohorts. Subgroup analysis demonstrated similar safety and effectiveness patterns.
The demonstrated similarity in safety and effectiveness between bevacizumab biosimilars and originator bevacizumab provides further support for the use of and confidence in biosimilar products.
自2019年以来，安大略省已为一线转移性结直肠癌（mCRC）患者提供了贝伐单抗生物类似药的公共资金支持。临床试验表明，贝伐单抗生物类似药与原研贝伐单抗具有相当的疗效和安全性。本研究的目的是评估与原研贝伐单抗相比，贝伐单抗生物类似药在mCRC患者中的真实世界安全性和有效性。
这是一项基于人群的回顾性研究，比较了2019年8月12日至2021年3月31日开始使用贝伐单抗生物类似药治疗的安大略省患者，以及2008年7月2日至2019年8月11日开始使用原研贝伐单抗治疗的患者。安全结局包括最后一剂用药后30天内的死亡、任何住院情况、直接住院以及因贝伐单抗相关毒性、化疗相关毒性和发热性中性粒细胞减少导致的住院。使用负二项式和逻辑回归评估事件发生率。有效性结局是总生存期，使用Kaplan-Meier法和Cox比例风险回归计算。亚组分析比较了使用贝伐单抗生物类似药产品的患者与匹配的对照者之间的安全性和有效性结局。
我们确定了8996例开始一线使用贝伐单抗治疗mCRC的患者。考虑到随访时间，各治疗组之间的住院率没有显著差异。在粗队列和倾向评分匹配队列中，总生存期（对数秩检验P>0.05）或风险比（倾向评分匹配风险比为1.03；95%CI，0.92-1.16）均未观察到差异。亚组分析显示了相似的安全性和有效性模式。
贝伐单抗生物类似药与原研贝伐单抗在安全性和有效性方面表现出的相似性，为生物类似药产品的使用和信心提供了进一步支持。
