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

Autor:	Zahedi F; Faculty of Medicine, Qom University of Medical Sciences, Qom, Iran., Jafari A; Department of Radiation Oncology, Shahid Beheshti University of Medical Sciences, Tehran, Iran., Nasiri Motlagh B; Department of Radio-Oncology, Shahid Madani Hospital, Tabriz, Iran., Hamedi SH; Radiation Oncology Department, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran., Salek R; Cancer Research Center, Mashhad University of Medical Sciences, Mashhad, Iran., Khandoozi S; Cancer Research Center, Golestan University of Medical Sciences, Gorgan, Iran., Farshchian N; Imam Reza Hospital, Kermanshah University of Medicine Sciences, Kermanshah, Iran., Shahidsales S; Cancer Research Center, Mashhad University of Medical Sciences, Mashhad, Iran., Mafi AR; Department of Radiation Oncology, Shahid Beheshti University of Medical Sciences, Tehran, Iran., Hosseini S; Cancer Research Center, Mashhad University of Medical Sciences, Mashhad, Iran., Amouheidari A; Department of Radiation Oncology, Isfahan Milad Hospital, Isfahan, Iran., Varshoee Tabrizi F; Radiotherapy and Oncology Department, Reza Radiotherapy and Oncology Center, Mashhad, Iran., Khanjani N; Department of Radiation Oncology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran., Ahmadloo N; Department of Radiation Oncology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran., Dayyani M; Radiotherapy and Oncology Department, Reza Radiotherapy and Oncology Center, Mashhad, Iran., Khodabakhshi R; Radiation Oncology Department, Fayazbakhsh Hospital, Tehran, Iran., Mojahed MM; Valiasr Oncology Department, Qom University of Medical Sciences, Qom, Iran., Keshvari M; Department of Radiation Oncology, Shahid Beheshti University of Medical Sciences, Tehran, Iran., Fazl Ersi M; Radiotherapy and Oncology Department, Reza Radiotherapy and Oncology Center, Mashhad, Iran., Mirsadraee M; Radiotherapy and Oncology Department, Reza Radiotherapy and Oncology Center, Mashhad, Iran., Izadpanahi P; Radiotherapy and Oncology Department, Reza Radiotherapy and Oncology Center, Mashhad, Iran., Saadipoor A; Department of Radiation Oncology, Erfanniyayesh Hospital, Tehran, Iran., Nasrollahi H; Department of Radiation Oncology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran., Anbiaee R; Department of Radiation Oncology, Shahid Beheshti University of Medical Sciences, Tehran, Iran., Emadi Torghabeh A; Cancer Research Center, Mashhad University of Medical Sciences, Mashhad, Iran., Keramati A; Faculty of Medicine, Baqiyatallah University of Medical Sciences, Tehran, Iran., Amiran SA; Department of Internal Medicine, Faculty of Medicine, Kashan University of Medical Sciences, Kashan, Iran., Bayat Mokhtari N; Radiotherapy and Oncology Department, Reza Radiotherapy and Oncology Center, Mashhad, Iran., Taghizadeh Kermani A; Cancer Research Center, Mashhad University of Medical Sciences, Mashhad, Iran., Anvari K; Cancer Research Center, Mashhad University of Medical Sciences, Mashhad, Iran., Sadeghi Ivari M; Radiotherapy and Oncology Department, Reza Radiotherapy and Oncology Center, Mashhad, Iran., Dayani M; Department of Radiation Oncology, Imam Reza Hospital of Kermanshah, Kermanshah, Iran., Amirabadi A; Innovative Medical Research Center, Faculty of Medicine, Islamic Azad University Mashhad Branch, Mashhad, Iran., Saeidi Saedi H; Associated Professor of Radiation Oncology, Guilan University of Medical Sciences, Guilan, Iran., Sabzvari A; CinnaGen Medical Biotechnology Research Center, Alborz University of Medical Sciences, Karaj, Iran., Kafi H; Medical Department, Orchid Pharmed Company, Tehran, Iran., Homaei Shandiz F; Department of Radiation Oncology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.
Jazyk:	angličtina
Zdroj:	Expert opinion on drug safety [Expert Opin Drug Saf] 2024 Aug 01, pp. 1-6. Date of Electronic Publication: 2024 Aug 01.
DOI:	10.1080/14740338.2024.2385483
Abstrakt:	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.
Databáze:	MEDLINE
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