PDF(Pubmed)
Abstract：
Background: Ontario publicly funds reference trastuzumab (Herceptin) and four biosimilar trastuzumab products for adjuvant treatment of HER2+ breast cancer. We assessed the real-world safety and effectiveness of biosimilar trastuzumab compared to Herceptin for adjuvant treatment of patients with HER2+ breast cancer. Methods: This was a population-based, retrospective study comparing the safety and effectiveness of biosimilar trastuzumab and Herceptin for neoadjuvant/adjuvant treatment of HER2+ breast cancer from 2016 to 2021. Treatment patients started biosimilar trastuzumab from November 2019 to June 2021; historical comparator patients started Herceptin from June 2016 to October 2019. Safety outcomes death within 30 days of last dose of trastuzumab, direct hospitalization, emergency department visit leading to hospitalization, early treatment discontinuation, and in-patient admission for congestive heart failure were measured using logistic/negative binomial regression. Overall survival (OS) was measured using Kaplan-Meier methods and Cox proportional hazards regression. Propensity score matching was applied. Results: From June 2016 to 2021, 5071 patients with breast cancer were treated with neoadjuvant/adjuvant trastuzumab. The rate of direct hospitalization (RR: 0.85, 95% CI: 0.74-0.98, p-value: 0.032) was significantly lower in biosimilar compared to Herceptin patients. OS (log-rank test p = 0.98) and risk of mortality (HR: 1.29, 95% CI: 0.72-2.30, p-value = 0.39) did not significantly differ between treatment groups. Conclusions: Biosimilar trastuzumab demonstrated similar safety and effectiveness to Herceptin. The findings can help improve confidence in and use of biosimilars and demonstrate the value of real-world evidence generation for supporting biosimilar implementations and reassessments.
摘要：
背景：安大略省公开资助参考曲妥珠单抗（赫赛汀）和四种生物类似药曲妥珠单抗产品用于HER2+乳腺癌的辅助治疗。我们评估了与赫赛汀相比，曲妥珠单抗用于HER2+乳腺癌患者辅助治疗的真实世界安全性和有效性。方法：这是一个以人群为基础的，回顾性研究比较2016-2021年生物类似药曲妥珠单抗和赫赛汀新辅助/辅助治疗HER2+乳腺癌的安全性和有效性.治疗患者从2019年11月至2021年6月开始使用生物类似药曲妥珠单抗；历史比较患者从2016年6月至2019年10月开始使用赫赛汀。安全性结果在最后一次曲妥珠单抗给药30天内死亡，直接住院,急诊就诊导致住院，早期停止治疗，采用logistic/负二项回归分析对充血性心力衰竭住院患者和住院患者进行了测量.使用Kaplan-Meier方法和Cox比例风险回归测量总生存期(OS)。采用倾向评分匹配。结果：2016年6月至2021年，5071例乳腺癌患者接受了新辅助/辅助曲妥珠单抗治疗。与赫赛汀患者相比，生物仿制药的直接住院率（RR：0.85，95％CI：0.74-0.98，p值：0.032）显着降低。OS（对数秩检验p=0.98）和死亡风险（HR：1.29，95％CI：0.72-2.30，p值=0.39）在治疗组之间没有显着差异。结论：生物类似药曲妥珠单抗与赫赛汀具有相似的安全性和有效性。这些发现可以帮助提高对生物仿制药的信心和使用，并证明现实世界证据生成对支持生物仿制药实施和重新评估的价值。
