Kim Myung Sun, Prasad Vinay
Medical Oncology/Hematology, Compass Oncology, Portland, OR, USA.
Department of Epidemiology and Biostatistics, University of California San Francisco, USA.
J Cancer Policy. 2025 Mar;43:100560. doi: 10.1016/j.jcpo.2025.100560. Epub 2025 Jan 31.
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.
S2308是一项研究，在一个异质性患者群体中，将非标准治疗药物利妥昔单抗与莫苏奈妥珠单抗-axgb（一种一流的靶向CD20的CD3 T细胞衔接器，长期副作用未知）进行比较，该群体中有五分之一的患者至少10年不需要治疗。无症状低肿瘤负荷滤泡性淋巴瘤的治疗是观察等待，长期随访后没有治疗显示出总生存期有改善。除了研究设计的局限性外，这项研究将成为监管批准的基础，接受联邦资金的合作组不应进行这项试验。研究地点在美国，主要包括社区肿瘤医疗实践，有可能纳入风险极低的患者，而这些患者很可能因任何治疗而受到伤害。
