Rituximab‐containing induction followed by autologous stem cell transplantation (ASCT) is the standard first‐line treatment for young mantle cell lymphoma patients. However, most patients relapse after ASCT. We investigated in a randomised phase II study the outcome of a chemo‐immuno regimen and ASCT with or without maintenance therapy with bortezomib. Induction consisted of three cycles R‐CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone), two cycles high‐dose cytarabine, BEAM (carmustine, etoposide, cytarabine, melphalan) and ASCT. Patients responding were randomised between bortezomib maintenance (1·3 mg/m² intravenously once every 2 weeks, for 2 years) and observation. Of 135 eligible patients, 115 (85%) proceeded to ASCT, 60 (44%) were randomised. With a median follow‐up of 77·5 months for patients still alive, 5‐year event‐free survival (EFS) was 51% (95% CI 42–59%); 5‐year overall survival (OS) was 73% (95% CI 65–80%). The median follow‐up of randomised patients still alive was 71·5 months. Patients with bortezomib maintenance had a 5‐year EFS of 63% (95% CI 44–78%) and 5‐year OS of 90% (95% CI 72–97%). The patients randomised to observation had 5‐year PFS of 60% (95% CI, 40–75%) and OS of 90% (95% CI 72–97%). In conclusion, in this phase II study we found no indication of a positive effect of bortezomib maintenance after ASCT.

中文翻译：

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新诊断的套细胞淋巴瘤患者接受 R-CHOP、阿糖胞苷和自体干细胞移植后硼替佐米维持治疗，随机 II 期 HOVON 试验的结果。


含利妥昔单抗诱导随后自体干细胞移植（ASCT）是年轻套细胞淋巴瘤患者的标准一线治疗。然而，大多数患者在 ASCT 后复发。我们在一项随机 II 期研究中调查了化学免疫疗法和 ASCT 联合或不联合硼替佐米维持治疗的结果。诱导包括三个周期的 R-CHOP（利妥昔单抗、环磷酰胺、阿霉素、长春新碱、泼尼松）、两个周期的高剂量阿糖胞苷、BEAM（卡莫司汀、依托泊苷、阿糖胞苷、美法仑）和 ASCT。有反应的患者被随机分为硼替佐米维持治疗（1·3 mg/m ²静脉注射，每两周一次，持续 2 年）和观察组。在 135 名符合条件的患者中，115 名 (85%) 进行了 ASCT，60 名 (44%) 被随机分组​​。对于仍然存活的患者，中位随访时间为 77·5 个月，5 年无事件生存率 (EFS) 为 51% (95% CI 42-59%)； 5 年总生存率 (OS) 为 73% (95% CI 65–80%)。随机分组仍存活的患者的中位随访时间为 71·5 个月。硼替佐米维持治疗患者的 5 年 EFS 为 63%（95% CI 44-78%），5 年 OS 为 90%（95% CI 72-97%）。随机接受观察的患者的 5 年 PFS 为 60%（95% CI，40-75%），OS 为 90%（95% CI 72-97%）。总之，在这项 II 期研究中，我们没有发现 ASCT 后硼替佐米维持治疗有积极作用的迹象。