Trials that treat what should be observed: SWOG 2308, a study of mosunetuzumab-axgb in asymptomatic low tumor burden follicular lymphoma

IF 2 Q3 HEALTH POLICY & SERVICES Journal of Cancer Policy Pub Date : 2025-03-01 Epub Date: 2025-01-31 DOI:10.1016/j.jcpo.2025.100560
Myung Sun Kim , Vinay Prasad
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Abstract

S2308 is a study comparing rituximab, which is not the standard of care, to.mosunetuzumab-axgb, a first-in-class CD20-directed CD3 T-cell engager with.unknown long term side effects, in a heterogeneous patient population in which a fifth.of patients do not need treatment for at least 10 years. The treatment of asymptomatic.low tumor burden follicular lymphoma is watchful waiting and no treatment has.demonstrated improvement in OS after long term follow up. Beyond the limitations of.the study design, this study would be the basis of regulatory approval and cooperative.groups receiving federal funding should not be running this trial. Study sites are US based and mostly include community oncology practices, risking inclusion of very low.risk patients that are most likely to be harmed by any treatment
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治疗应该观察的试验:SWOG 2308,一项mosunetuzumab-axgb治疗无症状低肿瘤负荷滤泡性淋巴瘤的研究。
S2308是一项比较利妥昔单抗的研究,利妥昔单抗不是治疗标准。mosunetuzumab-axgb,一类首个靶向cd20的CD3 t细胞接合剂。未知的长期副作用,在异质患者人群中有五分之一。大多数患者至少在10年内不需要治疗。无症状治疗。低肿瘤负荷滤泡性淋巴瘤需要观察等待,在长期随访后,没有治疗显示OS改善。超越…的限制。研究设计,本研究将得到监管部门批准和合作的基础。接受联邦资助的团体不应该进行这项试验。研究地点位于美国。并且主要包括社区肿瘤学实践,纳入的风险非常低。风险患者最有可能受到任何治疗的伤害。
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来源期刊
Journal of Cancer Policy
Journal of Cancer Policy Medicine-Health Policy
CiteScore
2.40
自引率
7.70%
发文量
47
审稿时长
65 days
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