Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH.
Dana Farber Cancer Institute, Boston, MA.
Blood. 2024 Sep 5;144(10):1083-1092. doi: 10.1182/blood.2024023962.
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 www.clinicaltrials.gov as #NCT01415752.
尽管套细胞淋巴瘤（MCL）的初始治疗尚未标准化，但在老年患者中，苯达莫司汀联合利妥昔单抗（BR）通常被应用。在诱导治疗后，通常会使用利妥昔单抗（R）维持治疗。因此，ECOG-ACRIN 癌症研究组 E1411 进行了一项开放性、随机的 2 期临床试验，旨在检验以下 2 个问题：（1）硼替佐米联合 BR 诱导（BVR）和/或（2）利妥昔单抗联合来那度胺（LR）维持治疗是否能改善初治 MCL 患者的无进展生存期（PFS）？2012 年至 2016 年，共纳入 373 例未经治疗的患者，其中 87%年龄≥60 岁。中位随访 7.5 年后，BR 与 BVR 的中位 PFS 无差异（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 治疗无意外的额外毒性，对接受的治疗总剂量/持续时间无影响。与诱导治疗无关，来那度胺的加入并不能显著改善 PFS，R 与 LR （5.9 年 vs 7.2 年；HR，0.84；90%CI，0.62-1.15）的中位 PFS 无差异。大多数患者按计划剂量完成了 24 个周期的 LR。总之，在初治 MCL 中，BR 诱导时加入硼替佐米并不能延长 PFS，BR 后 LR 维持治疗与单独使用 R 相比，PFS 无延长。尽管如此，在这项前瞻性合作组试验中，超过 5 年的中位 PFS 结果表明，BR 继以 R 维持治疗是老年 MCL 患者非常有效的初始治疗。该试验在 www.clinicaltrials.gov 注册，编号为 NCT01415752。
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