Safety and Effectiveness of Trastuzumab Biosimilar SB3 in Korean Patients, a Post-Marketing Surveillance Study.

IF 2.5 3区医学 Q3 ONCOLOGY

Oncology Pub Date : 2024-01-01 Epub Date: 2023-10-27 DOI:10.1159/000534626

Changwan Jeon, Su Hwan Kang, Sung-Bae Kim, Nam-Sun Paik, Ilkyun Lee, Seung Ki Kim, Eun Young Kim, Gil Soo Son, Young Bum Yoo, Kyung-Hee Lee, JeongSoo Shin, Sungil Ju, Harah Jang, Min Ho Park

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引用次数: 0

Abstract

Introduction: SB3 is a trastuzumab biosimilar approved in Australia, Brazil, Canada, the European Union, the Republic of Korea, Switzerland, and the USA. This real-world study evaluated safety and effectiveness of SB3 as part of the Korean post approval safety management system.

Methods: This post-marketing surveillance in Korea included patients in line with approved indications, i.e., patients with early or metastatic breast cancer or metastatic gastric cancer. Safety outcomes were adverse events (AEs) and adverse drug reactions. Effectiveness outcomes were tumor response and event-free survival.

Results: 424 patients were evaluated: 366 patients (86%) with early breast cancer, 53 patients (13%) with metastatic breast cancer, and 5 patients (1%) with metastatic gastric cancer. Among patients with breast cancer, AEs (mostly mild) and adverse drug reactions were reported by 158 (37.7%) and 57 (13.6%) patients, respectively. Most patients with an AE (141, 89.2%) had no change in treatment schedule. Treatment was temporarily suspended in 14 (8.9%) patients with an AE and completely discontinued in 7 (4.4%). Among patients with early and metastatic breast cancer who were evaluated for efficacy, objective response rates were 82.7% and 38.3%, respectively. Pathological complete response was 64.6% in patients with early breast cancer.

Discussion/conclusion: Safety and efficacy of SB3 demonstrated in this real-world study were comparable with previous studies of reference trastuzumab.

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曲妥珠单抗生物类似物SB3在韩国患者中的安全性和有效性，一项上市后监测研究。

简介：SB3是一种曲妥珠单抗生物仿制药，已在澳大利亚、巴西、加拿大、欧盟、大韩民国、瑞士和美国获得批准。这项真实世界的研究评估了SB3作为韩国审批后安全管理系统一部分的安全性和有效性。方法：本次韩国上市后监测包括符合批准适应症的患者，即早期或转移性乳腺癌癌症或转移性癌症患者。安全性结果为不良事件和药物不良反应。有效性结果为肿瘤反应和无事件生存率。结果：424例患者被评估：366例（86%）早期乳腺癌癌症患者，53例（13%）转移性癌症患者，5例（1%）转移性癌症患者。在癌症患者中，分别有158名（37.7%）和57名（13.6%）患者报告了不良事件（大部分为轻度）和药物不良反应。大多数AE患者（141例，75.9%）的治疗方案没有改变。14例（8.2%）AE患者暂时停止治疗，7例（3.7%）完全停止治疗。在评估疗效的早期和转移性癌症患者中，客观缓解率分别为82.7%和38.3%。癌症早期患者的病理完全缓解率为64.6%。讨论/结论：这项真实世界研究中证明的SB3的安全性和有效性与之前参考曲妥珠单抗的研究相当。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Oncology 医学-肿瘤学

CiteScore

6.00

自引率

2.90%

发文量

审稿时长

6-12 weeks

期刊介绍： Although laboratory and clinical cancer research need to be closely linked, observations at the basic level often remain removed from medical applications. This journal works to accelerate the translation of experimental results into the clinic, and back again into the laboratory for further investigation. The fundamental purpose of this effort is to advance clinically-relevant knowledge of cancer, and improve the outcome of prevention, diagnosis and treatment of malignant disease. The journal publishes significant clinical studies from cancer programs around the world, along with important translational laboratory findings, mini-reviews (invited and submitted) and in-depth discussions of evolving and controversial topics in the oncology arena. A unique feature of the journal is a new section which focuses on rapid peer-review and subsequent publication of short reports of phase 1 and phase 2 clinical cancer trials, with a goal of insuring that high-quality clinical cancer research quickly enters the public domain, regardless of the trial’s ultimate conclusions regarding efficacy or toxicity.