THE PRELIMINARY REPORT ON COMPARATIVE EFFICACY AND CARDIAC SAFETY OF TRASTUZUMAB BIOSIMILARS TO THE ORIGINATOR IN EARLY BREAST CANCER: A RETROSPECTIVE STUDY
DOI:
https://doi.org/10.69598/tbps.19.1.83-94Keywords:
trastuzumab, originator, biosimilar, early breast cancer, left ventricular ejection fractionAbstract
Due to limited research in Thailand, this study was conducted to compare the efficacy and safety of trastuzumab biosimilars to the prototype in the treatment of early breast cancer. Data was collected from electronic medical records of patients with HER2-positive early breast cancer who were first treated with trastuzumab biosimilars or the prototype between 1 August 2019 and 1 October 2021 at Maharaj Nakorn Chiang Mai Hospital. The primary outcomes of a one-year follow up were cardiotoxicity and response rate. Of the 54 patients included in the study, 30 were in the prototype group (55.6%) and 24 in the biosimilar group (44.4%). All patients were women with an average age 57.5 years in the prototype group and 51.8 years in the biosimilar group. Most patients received trastuzumab with paclitaxel every 3 weeks following the regimen of adriamycin and cyclophosphamide. The response rate for both groups was similar with 93.3% in the prototype and 90.9% in the biosimilar. During the trastuzumab treatment, two patients in the prototype group were diagnosed with heart failure, while none in the biosimilar group received this diagnosis. The mean change of the left ventricular ejection fraction (LVEF) from baseline was greater, but was not anymore significant in the prototype group than that of the biosimilar group; -6.2% vs -0.4% This pilot study showed that the trastuzumab biosimilars revealed a similar efficacy and cardiotoxicity compared with that of the prototype group in treating HER2-positive early breast cancer.
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