Real-World Comparison of CT-P6 and Reference Trastuzumab for the Treatment of HER2-Positive Early-Stage and Metastatic Breast Cancer
Abstract Background: Here, we present the first real-world comparison of CT-P6 versus reference trastuzumab (RTZ) for the neoadjuvant treatment of patients with HER2-positive EBC, and for the palliative first-line treatment of patients with HER2-positive metastatic breast cancer (MBC).Methods: We retrospectively identified patients with HER2-positive EBC who had received neoadjuvant treatment with RTZ or CT-P6, plus pertuzumab, carboplatin, and docetaxel, followed by surgery, alongside patients with newly diagnosed HER2-positive MBC who had received palliative treatment with RTZ or CT-P6, plus pertuzumab and docetaxel. The primary endpoints were pathologic complete response (pCR) in the EBC cohort, and progression-free survival (PFS) in the MBC cohort. Results: A similar percentage of patients with EBC achieved a pCR with CT-P6 (74.4% [93/125]) and RTZ (69.8% [90/129]) (p=0.411). For patients with MBC, median PFS did not differ significantly between the two groups (CT-P6: 13.9 months [95% confidence intervals (CIs) not available]; RTZ: 18.4 months [95% CIs 12.5–24.3]; p=0.653). The cardiac safety profiles of CT-P6 and RTZ were similar. Conclusions: These real-world data suggest that CT-P6 has similar effectiveness and cardiac safety to RTZ in patients with HER2-positive EBC and MBC, when administered as part of dual HER2-targeted therapy with pertuzumab plus chemotherapy in the neoadjuvant or palliative setting.