Outcome of patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL) remains poor, highlighting the need for novel treatment approaches. The multicentre randomised phase II LEGEND trial evaluated lenalidomide in combination with rituximab, methylprednisolone and gemcitabine (R-GEM-L) vs. standard R-GEM-P as second-line treatment of DLBCL. The study closed early to recruitment after the planned interim analysis failed to demonstrate a complete response (CR) rate of ≥ 40% in either arm. Among 34 evaluable patients, 7/18 (38.9%) achieved CR with R-GEM-L and 3/16 (18.8%) with R-GEM-P. Median event-free and overall survival was 3.5/3.8 months and 10.8/8.3 months for R-GEM-L and R-GEM-P, respectively. The incidence of grade ≥ 3 toxicities was 52% in R-GEM-L and 83% in R-GEM-P. Efficacy and tolerability of R-GEM-L seem comparable with R-GEM-P and other standard salvage therapies, but a stringent design led to early trial closure. Combination of lenalidomide with gemcitabine-based regimens should be further evaluated in r/r DLBCL.

中文翻译：

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R-GEM-来那度胺与 R-GEM-P 作为弥漫性大 B 细胞淋巴瘤二线治疗：英国 NRCI II 期随机 LEGEND 试验的结果。


复发/难治性 (r/r) 弥漫性大 B 细胞淋巴瘤 (DLBCL) 患者的预后仍然不佳，这凸显了对新治疗方法的需求。多中心随机 II 期 LEGEND 试验评估了来那度胺联合利妥昔单抗、甲泼尼龙和吉西他滨 (R-GEM-L) 与标准 R-GEM-P 作为 DLBCL 的二线治疗。由于计划的中期分析未能证明任一组的完全缓解 (CR) 率≥ 40%，该研究提前结束了招募。在 34 名可评估患者中，7/18 (38.9%) 的 R-GEM-L 患者达到 CR，3/16 (18.8%) 的 R-GEM-P 患者达到 CR。 R-GEM-L 和 R-GEM-P 的中位无事件生存期和总生存期分别为 3.5/3.8 个月和 10.8/8.3 个月。 R-GEM-L 中≥ 3 级毒性的发生率为 52%，R-GEM-P 中为 83%。 R-GEM-L 的功效和耐受性似乎与 R-GEM-P 和其他标准挽救疗法相当，但严格的设计导致试验提前结束。应在难治性 DLBCL 中进一步评估来那度胺与基于吉西他滨的治疗方案的组合。