Real-World Evidence on Clinical Outcomes and Safety of Trastuzumab Biosimilar in Colombian Breast Cancer Patients
Author(s)
Ricardo Ballesteros-Ramírez, MD1, Juan Manuel Reyes Sanchez, MSc2, Jorge Reyes-Lara, MD1, Andrés Muñoz, MD2, Mónica García, MSc2, Andrea C. Rubio, MSc2, Jair A. Arciniegas, MSc2, Andreina J. Alamo, BSc2, Paola Pinilla, MD1;
1Grupo de Oncología, Pontificia Universidad Javeriana – Hospital Universitario San Ignacio, Bogotá, Colombia, 2Pfizer, Bogotá, Colombia
1Grupo de Oncología, Pontificia Universidad Javeriana – Hospital Universitario San Ignacio, Bogotá, Colombia, 2Pfizer, Bogotá, Colombia
Presentation Documents
OBJECTIVES: To assess the effectiveness and safety profile, including adverse events (AEs), of trastuzumab biosimilar treatment in Colombian breast cancer patients between 2019 and 2022, based on real-world evidence.
METHODS: This retrospective cohort study analyzed patients treated with trastuzumab-qyyp for HER2-positive metastatic breast cancer (mBC) or early breast cancer (eBC) at a Colombian clinic between October 2015 and December 2022 (EUPAS49290). The index date was defined as first trastuzumab infusion. Data extracted from electronic health records included demographics, clinical characteristics, progression, death, and AE. Outcomes were assessed using Kaplan-Meier analysis for progression-free survival and Cox regression.
RESULTS: Fifty patients were included in the study (16 patients in mBC and 34 eBC). Median follow-up was 13.5 months (SD 11.1) with mean age of 58.8 years (SD 11.7). Most patients (80%) maintained ECOG ≤1. Treatment discontinuation occurred in 28 patients (56%), primarily due to treatment completion (n=11, 39.6%) and AE (n=6, 21.1%). Clinical benefit (complete response, partial response, or stable disease) was achieved in 50% of mBC and 79.4% of eBC patients. The mPFS reached 33 months (95% CI 20 - NA) in eBC, while not reached in mBC. Patients experienced a mean of 10 adverse events (SD 7.5), predominantly diarrhea (14.3%), nausea (8.4%), and fatigue (5.2%). Ten AEs were documented in 8 patients, including grade 4 (n=5), and grade 3 (n=5) events, with no significant correlation between adverse event occurrence and trastuzumab.
CONCLUSIONS: Trastuzumab-qyyp demonstrated effectiveness in both mBC and eBC with manageable adverse events primarily being gastrointestinal symptoms and fatigue. Treatment discontinuation due to adverse events was infrequent.
METHODS: This retrospective cohort study analyzed patients treated with trastuzumab-qyyp for HER2-positive metastatic breast cancer (mBC) or early breast cancer (eBC) at a Colombian clinic between October 2015 and December 2022 (EUPAS49290). The index date was defined as first trastuzumab infusion. Data extracted from electronic health records included demographics, clinical characteristics, progression, death, and AE. Outcomes were assessed using Kaplan-Meier analysis for progression-free survival and Cox regression.
RESULTS: Fifty patients were included in the study (16 patients in mBC and 34 eBC). Median follow-up was 13.5 months (SD 11.1) with mean age of 58.8 years (SD 11.7). Most patients (80%) maintained ECOG ≤1. Treatment discontinuation occurred in 28 patients (56%), primarily due to treatment completion (n=11, 39.6%) and AE (n=6, 21.1%). Clinical benefit (complete response, partial response, or stable disease) was achieved in 50% of mBC and 79.4% of eBC patients. The mPFS reached 33 months (95% CI 20 - NA) in eBC, while not reached in mBC. Patients experienced a mean of 10 adverse events (SD 7.5), predominantly diarrhea (14.3%), nausea (8.4%), and fatigue (5.2%). Ten AEs were documented in 8 patients, including grade 4 (n=5), and grade 3 (n=5) events, with no significant correlation between adverse event occurrence and trastuzumab.
CONCLUSIONS: Trastuzumab-qyyp demonstrated effectiveness in both mBC and eBC with manageable adverse events primarily being gastrointestinal symptoms and fatigue. Treatment discontinuation due to adverse events was infrequent.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
CO21
Topic
Clinical Outcomes
Topic Subcategory
Clinical Outcomes Assessment
Disease
SDC: Oncology