Safety evaluation of the trastuzumab biosimilar in Iranian women with HER2-positive breast cancer undergoing adjuvant chemotherapy: a post-marketing surveillance.

BACKGROUND

Trastuzumab is a humanized monoclonal antibody against the human epidermal growth factor receptor 2 (HER2). This post-marketing surveillance evaluates the safety of a trastuzumab biosimilar (AryoTrust), produced by AryoGen Co. Iran in Iranian women with HER2-positive non-metastatic breast cancer (BC).

RESEARCH DESIGN AND METHODS

The patients who had undergone adjuvant chemotherapy regimens received trastuzumab every three weeks for nine cycles. The study was started in February 2017 and finished in August 2022. Data regarding safety were collected using booklets and then analyzed.

RESULTS

A total of 597 women with a mean ±SD age of 48.13 ± 10.18 years underwent 5,313 injection cycles. They had received pre-study chemotherapies consisting of anthracyclines, taxanes, both, or other medications in 6.81, 7.33, 83.82, and 2.04% of cases, respectively. One hundred thirty-nine patients experienced at least one adverse event (AE). The most common AEs were decreased ejection fraction (EF, 5.7%), peripheral neuropathy (5.36%), and nausea (5.19%). Meningioma was the only life-threatening serious AE. Furthermore, bone pain and infusion-related reactions were the two most common grade three AEs. Nevertheless, the mean EF of patients did not change notably during the study.

CONCLUSIONS

The results demonstrate that this trastuzumab biosimilar is a generally well-tolerated and safe treatment for HER2-positive BC.

CLINICAL TRIAL REGISTRATION

www.clinicaltrials.gov identifier is NCT06021379.