Article
作者: Fazl Ersi, Mitra ; Taghizadeh Kermani, Ali ; Saadipoor, Afshin ; Emadi Torghabeh, Ali ; Dayani, Malihe ; Jafari, Anya ; Hamedi, Seyed Hassan ; Hosseini, Sare ; Nasiri Motlagh, Behnam ; Nasrollahi, Hamid ; Bayat Mokhtari, Narges ; Izadpanahi, Payam ; Dayyani, Mahdieh ; Amiran, Seyed Ahmadreza ; Keshvari, Masoumeh ; Salek, Roham ; Keramati, Alireza ; Homaei Shandiz, Fatemeh ; Anbiaee, Robab ; Varshoee Tabrizi, Fatemeh ; Mirsadraee, Marjaneh ; Ahmadloo, Niloofar ; Saeidi Saedi, Hamid ; Sadeghi Ivari, Mahboobeh ; Farshchian, Negin ; Anvari, Kazem ; Khodabakhshi, Reza ; Mojahed, Mohammad Mahdi ; Zahedi, Fatemeh ; Khanjani, Nezhat ; Kafi, Hamidreza ; Khandoozi, Seyedreza ; Sabzvari, Araz ; Shahidsales, Soodabeh ; Amouheidari, Alireza ; Mafi, Ahmad R ; Amirabadi, Amir
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 3 weeks for nine cycles. The study 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 received pre-study chemotherapies consisting of anthracyclines, taxanes, both, or other medications in 6.70, 7.20, 82.41, and 2.01% of the cases, respectively. One hundred and 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.