Wang Chao, Dong Yunzhuo, Men Peng, Zhang Ruixia, Xiao Ying, Bu Yishan, Qin Yinpeng, Zhang Xinran, Dou Qianqian, Yang Yiheng, Gao Huier, Zhang Yi
Department of Pharmacy, Tianjin First Central Hospital, Tianjin, China.
Department of Pharmacy, Peking University Third Hospital, Beijing, China.
Front Pharmacol. 2025 Jan 3;15:1426772. doi: 10.3389/fphar.2024.1426772. eCollection 2024.
Obinutuzumab was approved in China in June 2021 used in combination with chemotherapy (followed by obinutuzumab maintenance) for the treatment of adult patients with previously untreated stage II bulky, III, or IV follicular lymphoma (FL). The clinical application of obinutuzumab has recently begun in China, but there is a lack of evidence to determine under which circumstances it should be considered the treatment of choice. A comprehensive assessment is necessary to evaluate the efficacy, safety, and cost-effectiveness of obinutuzumab in adult patients with FL.
To summarize the evidence on the efficacy, safety, and cost-effectiveness of obinutuzumab in adult patients with FL, aiming to provide medical professionals with evidence for informed choices in clinical practice.
The approach to this evidence synthesis was a rapid review of systematic reviews/meta-analyses (SR/meta-analyses), health technology assessment (HTA) reports, and pharmacoeconomic studies that brings together and summarizes the efficacy, safety, and cost-effectiveness of obinutuzumab in adult patients with FL. A literature search was conducted across multiple databases, including PubMed, Embase, Wanfang, CNKI, Weipu database, the Cochrane Library, the Centre for Reviews and Dissemination (CRD) database, International Network of Agencies for Health Technology Assessment (INAHTA) and Canada's Drug Agency (CDA-AMC), International Society for Pharmacoeconomics and Outcomes Research (ISPOR), National Institute For Health and Care Excellence (NICE), Institute For Clinical And Economic Review (ICER), Grey Literature Database and Grey Net International. The studies on obinutuzumab for FL were searched in full text with as keywords, with a search time frame from the date of database creation to 29 November 2024. The literature was screened based on predefined inclusion and exclusion criteria, and data were meticulously extracted and synthesized by two authors. Simultaneously, the quality of the literature was thoroughly assessed.
Obinutuzumab based chemotherapy (the chemotherapy regimen-cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP); cyclophosphamide, vincristine, and prednisone (CVP); or bendamustine) significantly prolonged progression free survival (PFS) compared to other chemotherapy regimen at primary and updated analyses. The incidence of grade 3-5 AEs, infusion-related reactions (IRRs), and infection were higher in the obinutuzumab based chemotherapy group compared to other chemotherapies. The economic researches conducted in China, United States, Japan, Italy and Norway had demonstrated that obinutuzumab-based chemothrepy was cost-effective compared to other chemothrepies. Although obinutuzumab significantly prolonged PFS and was cost-effective, its safety profile was considered lower.
Compared with other chemothrapy regimen, obinutuzumab based chemotherapy significantly prolonged PFS and was cost-effective, while its safety profile was considered lower. Therefore, medical professionals should be caution when using or introducing obinutuzumab treatment for FL patients.
奥妥珠单抗于2021年6月在中国获批，与化疗联合使用（随后进行奥妥珠单抗维持治疗），用于治疗先前未接受过治疗的II期大包块、III期或IV期滤泡性淋巴瘤（FL）成年患者。奥妥珠单抗在中国的临床应用最近才开始，但缺乏证据来确定在何种情况下应将其视为首选治疗方法。有必要进行全面评估，以评价奥妥珠单抗在FL成年患者中的疗效、安全性和成本效益。
总结奥妥珠单抗在FL成年患者中的疗效、安全性和成本效益的证据，旨在为医学专业人员在临床实践中做出明智选择提供依据。
本证据综合方法是对系统评价/荟萃分析（SR/荟萃分析）、卫生技术评估（HTA）报告和药物经济学研究进行快速回顾，汇总并总结奥妥珠单抗在FL成年患者中的疗效、安全性和成本效益。在多个数据库中进行文献检索，包括PubMed、Embase、万方、知网、维普数据库、Cochrane图书馆、评价与传播中心（CRD）数据库、国际卫生技术评估机构网络（INAHTA）和加拿大药品管理局（CDA-AMC）、国际药物经济学和结果研究学会（ISPOR）、英国国家卫生与临床优化研究所（NICE）、临床与经济评论研究所（ICER）、灰色文献数据库和Grey Net International。以奥妥珠单抗治疗FL为关键词，在全文中检索相关研究，检索时间范围为数据库创建之日至2024年11月29日。根据预先定义的纳入和排除标准对文献进行筛选，由两位作者精心提取和综合数据。同时，对文献质量进行全面评估。
在初次分析和更新分析中，与其他化疗方案相比，基于奥妥珠单抗的化疗（化疗方案为环磷酰胺、多柔比星、长春新碱和泼尼松（CHOP）；环磷酰胺、长春新碱和泼尼松（CVP）；或苯达莫司汀）显著延长了无进展生存期（PFS）。与其他化疗相比，基于奥妥珠单抗的化疗组3-5级不良事件（AE）、输注相关反应（IRR）和感染的发生率更高。在中国、美国、日本、意大利和挪威进行的经济学研究表明，与其他化疗相比，基于奥妥珠单抗的化疗具有成本效益。尽管奥妥珠单抗显著延长了PFS且具有成本效益，但其安全性被认为较低。
与其他化疗方案相比，基于奥妥珠单抗的化疗显著延长了PFS且具有成本效益，但其安全性被认为较低。因此，医学专业人员在为FL患者使用或引入奥妥珠单抗治疗时应谨慎。
