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Comparative Effectiveness and Safety of Trastuzumab Biosimilars to Herceptin for Adjuvant Treatment of HER2+ Breast Cancer.
Muñoz, Caroline; Tai, Xiaochen; Arias, Jessica; Eisen, Andrea; Chaudhry, Munaza; Gavura, Scott; Chan, Kelvin K W.
Afiliación
  • Muñoz C; Ontario Health (Cancer Care Ontario), 525 University Ave, Toronto, ON M5G 2L3, Canada.
  • Tai X; Canadian Centre for Applied Research in Cancer Control, Toronto, ON M5G 2L3, Canada.
  • Arias J; Ontario Health (Cancer Care Ontario), 525 University Ave, Toronto, ON M5G 2L3, Canada.
  • Eisen A; Ontario Health (Cancer Care Ontario), 525 University Ave, Toronto, ON M5G 2L3, Canada.
  • Chaudhry M; Ontario Health (Cancer Care Ontario), 525 University Ave, Toronto, ON M5G 2L3, Canada.
  • Gavura S; Sunnybrook Health Sciences Centre, Toronto, ON M4N 3M3, Canada.
  • Chan KKW; Ontario Health (Cancer Care Ontario), 525 University Ave, Toronto, ON M5G 2L3, Canada.
Curr Oncol ; 31(3): 1633-1644, 2024 03 21.
Article en En | MEDLINE | ID: mdl-38534957
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de la Mama / Biosimilares Farmacéuticos Límite: Female / Humans Idioma: En Revista: Curr Oncol Año: 2024 Tipo del documento: Article País de afiliación: Canadá Pais de publicación: Suiza
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de la Mama / Biosimilares Farmacéuticos Límite: Female / Humans Idioma: En Revista: Curr Oncol Año: 2024 Tipo del documento: Article País de afiliación: Canadá Pais de publicación: Suiza