Trastuzumab Biosimilar Has Comparative Safety and Efficacy After Long-Term Follow-Up

January 22, 2020 by Elisa Becze BA, ELS, Editor

After three years of follow-up, researchers demonstrated that trastuzumab-pkrb offered similar efficacy and cardiac toxicity results in patients with HER2-positive early-stage breast cancer. They presented their findings at the European Society for Medical Oncology Congress in September 2019 (

The researchers randomly assigned 549 women with newly diagnosed stage I–IIIa HER2-positive breast cancer to receive neoadjuvant trastuzumab or trastuzumab-pkrb for up to one year after treatment with docetaxel followed by chemotherapy with 5-fluorouracil, epirubicin, and cyclophosphamide. The safety and rate of pathologic complete response were similar.

At a median follow-up of 39 months, both arms had similar rates of disease-free and overall survival. Both had mean left-ventricular ejection fractions higher than 60% and no additional cases of heart failure during follow-up. The researchers concluded that their results support the similarity of the biosimilar and its reference product.

Learn more about biosimilars on the Oncology Nursing Podcast (

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