Article
Author: 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  ; Izadpanahi, Payam  ; Bayat Mokhtari, Narges  ; Dayyani, Mahdieh  ; Amiran, Seyed Ahmadreza  ; Keshvari, Masoumeh  ; Keramati, Alireza  ; Salek, Roham  ; Homaei Shandiz, Fatemeh  ; Anbiaee, Robab  ; Varshoee Tabrizi, Fatemeh  ; Mirsadraee, Marjaneh  ; Saeidi Saedi, Hamid  ; Ahmadloo, Niloofar  ; Sadeghi Ivari, Mahboobeh  ; Farshchian, Negin  ; Khodabakhshi, Reza  ; Anvari, Kazem  ; Zahedi, Fatemeh  ; Mojahed, Mohammad Mahdi  ; Kafi, Hamidreza  ; Khanjani, Nezhat  ; 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.