Although initial therapy of mantle cell lymphoma (MCL) is not standardized, bendamustine plus rituximab (BR) is commonly used in older patients. Rituximab (R) maintenance after induction is often used. Thus, the open-label, randomized phase 2 ECOG-ACRIN Cancer Research Group E1411 trial was designed to test 2 questions: (1) does addition of bortezomib to BR induction (BVR) and/or (2) addition of lenalidomide to rituximab (LR) maintenance improve progression-free survival (PFS) in patients with treatment-naïve MCL? From 2012 to 2016, 373 previously untreated patients, 87% aged ≥60 years, were enrolled in this trial. At a median follow-up of 7.5 years, there is no difference in the median PFS of BR compared with BVR (5.5 vs 6.4 years; hazard ratio [HR], 0.90; 90% confidence interval [CI], 0.70-1.16). There were no unexpected additional toxicities with BVR treatment compared with BR, with no impact on total dose/duration of treatment received. Independent of the induction treatment, addition of lenalidomide did not significantly improve PFS, with median PFS in R vs LR (5.9 vs 7.2 years; HR, 0.84; 90% CI, 0.62-1.15). Most patients completed the planned 24 cycles of LR at the scheduled dose. In summary, adding bortezomib to BR induction does not prolong PFS in treatment-naïve MCL, and LR maintenance was not associated with longer PFS compared with R alone after BR. Nonetheless, the >5-year median PFS outcomes in this prospective cooperative group trial indicate the efficacy of BR followed by R maintenance as highly effective initial therapy for older patients with MCL. This trial was registered at as #NCT01415752.

中文翻译：

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苯达莫司汀-利妥昔单抗 ± 硼替佐米诱导和利妥昔单抗 ± 来那度胺维持治疗 MCL 的随机研究


尽管套细胞淋巴瘤（MCL）的初始治疗尚未标准化，但苯达莫司汀加利妥昔单抗（BR）通常用于老年患者。诱导后经常使用利妥昔单抗 (Rituximab) 维持治疗。因此，开放标签、随机 2 期 ECOG-ACRIN 癌症研究组 E1411 试验旨在测试 2 个问题：(1) 在 BR 诱导 (BVR) 中添加硼替佐米和/或 (2) 在利妥昔单抗中添加来那度胺（ LR）维持治疗可改善初治 MCL 患者的无进展生存期 (PFS)？从2012年到2016年，373名既往未接受治疗的患者参加了这项试验，其中87%年龄≥60岁。在中位随访 7.5 年时，BR 与 BVR 的中位 PFS 没有差异（5.5 年 vs 6.4 年；风险比 [HR]，0.90；90% 置信区间 [CI]，0.70-1.16）。与 BR 相比，BVR 治疗没有出现意外的额外毒性，对总剂量/治疗持续时间没有影响。独立于诱导治疗，添加来那度胺并未显着改善 PFS，R 与 LR 的中位 PFS（5.9 年 vs 7.2 年；HR，0.84；90% CI，0.62-1.15）。大多数患者按预定剂量完成了计划的 24 个 LR 周期。总之，在 BR 诱导中添加硼替佐米不会延长初治 MCL 的 PFS，并且与 BR 后单独使用 R 相比，LR 维持与更长的 PFS 无关。尽管如此，这项前瞻性合作小组试验中 >5 年的中位 PFS 结果表明，BR 继之以 R 维持作为老年 MCL 患者的高效初始治疗的疗效。该试验注册号为#NCT01415752。