Abstract
BackgroundThe trastuzumab biosimilar CT-P6 has demonstrated equivalent efficacy and comparable safety to reference trastuzumab (RTZ) in clinical trials of human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC). Here, we present the first real-world comparison of CT-P6 versus RTZ with dual HER2-targeted therapy for the neoadjuvant and palliative first-line treatment with HER2-positive EBC and metastatic breast cancer (MBC) patients in two tertiary hospitals in Korea.MethodsWe retrospectively investigated medical records in the Severance Breast Cancer Registry in Korea. We identified patients with HER2-positive EBC (n=254) who had received neoadjuvant chemotherapy with RTZ or CT-P6, plus pertuzumab, carboplatin and docetaxel (TCHP) and untreated stage IV MBC (n=103) who had received palliative first-line treatment with RTZ or CT-P6, plus pertuzumab and docetaxel (THP) between May 2014 and December 2019. The primary endpoints were pathologic complete response (pCR) in the EBC and progression-free survival (PFS) in the MBC cohort. Overall survival (OS), overall response rate (ORR), disease control rate (DCR), and cardiac safety were secondary endpoints.ResultsA similar percentage of EBC patients achieved a pCR with CT-P6 versus RTZ (74.4% [93/125]) vs 69.8% [90/129], p=0.411). For patients with MBC, median follow-up duration was 23.0 and 41.0 months for CT-P6 and RTZ groups, respectively; median PFS did not differ significantly between two groups (13.0 vs 18.0 months, 95% confidence intervals (CIs) 0.0-26.6 vs 11.3-24.7, p=0.976). The ORR, DCR, and cardiac safety profiles did not also show significant difference efficacy outcomes between two groups.ConclusionsThese real-world data suggest that biosimilar trastuzumab CT-P6 has similar effectiveness and cardiac safety to RTZ in HER2-positive EBC and MBC patients, when administered as part of dual HER2-targeted therapy with pertuzumab plus chemotherapy in the neoadjuvant or palliative setting.
Highlights
Breast cancer is a heterogeneous disease that has multiple subtypes
A similar percentage of early breast cancer (EBC) patients achieved a pathologic complete response (pCR) with CT-P6 versus reference trastuzumab (RTZ) (74.4% [93/125]) vs 69.8% [90/129], p=0.411)
The overall response rate (ORR), disease control rate (DCR), and cardiac safety profiles did not show significant difference efficacy outcomes between two groups. These real-world data suggest that biosimilar trastuzumab CT-P6 has similar effectiveness and cardiac safety to RTZ in human epidermal growth factor receptor 2 (HER2)-positive EBC and metastatic breast cancer (MBC) patients, Real-World Data for CT-P6 when administered as part of dual HER2-targeted therapy with pertuzumab plus chemotherapy in the neoadjuvant or palliative setting
Summary
Breast cancer is a heterogeneous disease that has multiple subtypes. Approximately 25% of breast cancers amplify the human epidermal growth factor receptor 2 (HER2) oncogene, resulting in a more aggressive phenotype with poorer prognosis [1]. The development of trastuzumab, a humanized monoclonal antibody that binds to the HER2 extracellular domain, has transformed the treatment of HER2-positive breast cancers [2] and improved clinical responses [2,3,4] and disease free survival [5]. The development of novel biologic agents is expensive, which can translate into high drug costs [8] Despite their efficacy, the costs associated with these drugs can pose a burden on healthcare systems and create barriers to access. The trastuzumab biosimilar CT-P6 has demonstrated equivalent efficacy and comparable safety to reference trastuzumab (RTZ) in clinical trials of human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC). We present the first real-world comparison of CT-P6 versus RTZ with dual HER2-targeted therapy for the neoadjuvant and palliative first-line treatment with HER2-positive EBC and metastatic breast cancer (MBC) patients in two tertiary hospitals in Korea
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