肿瘤细胞治疗研究
英文原题：Circulating Tumor DNA Assessment of Disease Response in Large B-Cell Lymphoma: Lisocabtagene Maraleucel Versus Autologous Stem Cell Transplantation Standard Therapy.
我们报告了TRANSFORM研究（ClinicalTrials.gov标识符：NCT03575351）的相关循环肿瘤DNA（ctDNA）分析，该研究评估了lisocabtagene maraleucel（liso-cel）与标准治疗（挽救性免疫化疗、大剂量化疗、自体干细胞移植[ASCT]）在二线大B细胞淋巴瘤（LBCL）中的疗效。
我们报告了TRANSFORM研究（ClinicalTrials.gov标识符：NCT03575351）的相关循环肿瘤DNA（ctDNA）分析，该研究评估了lisocabtagene maraleucel（liso-cel）与标准治疗（挽救性免疫化疗、大剂量化疗、自体干细胞移植[ASCT]）在二线大B细胞淋巴瘤（LBCL）中的疗效。在预设时间点（随机分组、第43天、第64天和第126天[ liso-cel后3个月，ASCT后约2个月]），使用超灵敏PhasED-Seq对136例患者的ctDNA与疗效的关联进行了研究。ctDNA清除（可测量残留病[MRD]阴性）在所有时间点均预测两组的无事件生存期（EFS）更长，且liso-cel治疗组达到MRD阴性的患者显著更多。在完全缓解（CR）且MRD阴性的患者中，liso-cel相较于ASCT表现出更优的结局，包括更长的EFS、无进展生存期（PFS）和缓解持续时间。ASCT后CR患者中ctDNA重新出现，证实了其预测复发的潜力。在调整正电子发射断层扫描（PET）反应后，MRD阴性仍与EFS显著相关，而交互作用检验显示PET状态与治疗组之间对EFS存在显著交互作用。liso-cel通过ctDNA实现了更深、更持久的分子清除，与二线LBCL治疗中相较于ASCT更优的EFS和PFS一致。ctDNA-MRD提供了超越PET的预后价值，支持其作为治疗反应和复发预测的补充生物标志物的作用。
We report correlative circulating tumor DNA (ctDNA) analyses from TRANSFORM (ClinicalTrials.gov identifier: NCT03575351) evaluating lisocabtagene maraleucel (liso-cel) versus standard of care (salvage immunochemotherapy, high-dose chemotherapy, autologous stem cell transplantation [ASCT]) in second-line large B-cell lymphoma (LBCL). ctDNA association with efficacy was investigated at predefined time points (random assignment, day 43, day 64, and day 126 [3 months after liso-cel, approximately 2 months after ASCT]) for 136 patients using ultrasensitive PhasED-Seq. ctDNA clearance (measurable residual disease [MRD] neg ) predicted longer event-free survival (EFS) at all time points in both arms, with significantly more liso-cel-treated patients achieving MRD neg . Liso-cel demonstrated superior outcomes versus ASCT, including longer EFS, progression-free survival (PFS), and duration of response among patients in complete response (CR) and MRD neg . ctDNA re-emergence in patients with CR after ASCT confirmed its potential in predicting relapse. MRD neg remained significantly associated with EFS after adjusting for positron emission tomography (PET) response, while interaction testing revealed a significant interaction between PET status and treatment arm for EFS. Liso-cel achieved deeper, more durable molecular clearance by ctDNA, consistent with superior EFS and PFS versus ASCT for second-line LBCL treatment. ctDNA-MRD provided prognostic value beyond PET, supporting its role as a complementary biomarker for treatment response and relapse prediction.
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