Abstract Introduction Breast cancer is one of the most common cancers worldwide and a leading cause of cancer-related death in women. For HER2-positive breast cancer, monoclonal antibodies like trastuzumab have become a cornerstone of treatment, significantly improving outcomes. Clinical trials have demonstrated that CT-P6, a biosimilar, offers comparable efficacy to trastuzumab, but its safety profile—particularly concerning cardiotoxicity—has not been extensively studied. This study aims to evaluate the impact of CT-P6 on cardiotoxicity compared to trastuzumab in patients with HER2-positive breast cancer. Methods A thorough literature search was conducted across Medline, PubMed, Cochrane Library, and ClinicalTrials.gov, for studies published up to September 2024 using the following search terms: CT-P6, HER2-positive breast cancer, and cardiotoxicity. Five studies which comprised two randomized controlled trials (RCTs) and three retrospective cohort study design. Risk assessment using Cochrane risk of bias 2 (RoB 2) and ROBINS-I tool were used. Outcome measurement for effectiveness used the Pathological complete response (PCR), defined as absence of invasive tumor cells in the breast and axillary lymph nodes. Safety assessment used mean change of ejection fraction of 10%. The results from these trials were pooled and analysed using a fixed-effects model. All statistical analyses were performed using Review Manager Software version 5.4. Results A total of 1,456 patients were included across the studies, with 729 patients receiving CT-P6 biosimilars and 727 receiving trastuzumab. Non inferiority margin set for pathological complete response was at 1.5. Therefore, CT-P6 biosimilar was non-inferior compared to trastuzumab therapy with upper margin on 1.33 (OR 1.08 95% CI 0.87-1.33 I² = 0%, p 0.001). For the safety profile, there was no significant difference in ejection fraction decline in the CT-P6 biosimilars compared to trastuzumab (OR 1.31 95% CI 0.90-1.90 I² = 0%, p = 0.16). Conclusions The results from this meta-analysis and the reviewed literature consistently indicate that CT-P6 biosimilars have a comparable efficacy and safety profile to trastuzumab in terms of cardiotoxicity. This meta-analysis suggests that CT-P6 biosimilars may be a preferable treatment strategy in patients with breast cancer.
Santoceldes et al. (2025) studied this question.
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