We present a long‐term follow‐up of the UK chlorambucil, mitoxantrone and dexamethasone (CMD) versus fludarabine, mitoxantrone and dexamethasone (FMD) for untreated advanced, symptomatic follicular lymphoma (FL). This trial was the first to prospectively assess molecular response and the impact on outcomes for 400 patients. The median progression‐free survival (PFS) and overall survival (OS) for CMD were 3·6 and 14·6 years vs. 3·0 and 15·7 years for FMD, respectively. Estimates for Restricted Mean Survival Time (RMST) suggested no difference in PFS or OS. For the whole cohort there was a highly significant difference in survival by POD24, with a median OS from a risk‐defining event of 3·9 years compared to 13·7 years for all others (RMST P < 0·001). Molecular remission was achieved in 25/46 patients (54·3%) in the CMD arm and 20/41 (48·8%) in the FMD arm (P = 0·6). Molecular negativity resulted in median PFS of 5·6 years vs. 2·3 years for molecularly positive (log‐rank P < 0·001) and median OS not reached versus 12·5 years (log‐rank P < 0·01). No cases of progression occurred in minimal residual disease (MRD) negative patients after six years of follow‐up. Although there was no difference in outcomes between arms, this is the first prospective study to report MRD negativity resulting in significantly improved OS.

中文翻译：

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英国NCRI对苯丁酸氮芥，米托蒽醌和地塞米松（CMD）与氟达拉滨，米托蒽醌和地塞米松（FMD）治疗未经治疗的晚期滤泡性淋巴瘤的研究：分子反应强烈预测总体生存期延长

对于未经治疗的晚期，有症状的滤泡性淋巴瘤（FL），我们对英国苯丁酸氮芥，米托蒽醌和地塞米松（CMD）与氟达拉滨，米托蒽醌和地塞米松（FMD）进行了长期随访。该试验是第一个前瞻性评估分子反应及其对400例患者结局影响的试验。CMD的中位无进展生存期（PFS）和总体生存期（OS）分别为3·6和14·6年，而FMD的中位无进展生存期（PFS）为3·0和15·7年。限制平均生存时间（RMST）的估计值表明PFS或OS没有差异。在整个队列中，POD24的生存率存在显着差异，风险定义事件的OS中位数为3·9年，而其他所有人群的OS为13·7年（RMST P <0·001）。在CMD组中有25/46位患者（54·3％）在FMD组中有20/41（48·8％）患者获得了分子缓解（P  = 0·6）。分子阴性导致中位无进展生存期为5·6年，而分子阳性的中位无进展生存期为2·3年（对数秩P  <0·001），未达到中位OS的为12·5年（对数秩P  <0·01） 。随访六年后，最小残留疾病（MRD）阴性患者无进展病例。尽管两组之间的结局没有差异，但这是第一个报告MRD阴性的前瞻性研究，可显着改善OS。