Kimby Eva, Östenstad Björn, Brown Peter, Hagberg Hans, Erlanson Martin, Holte Harald, Linden Ola, Johansson Ann-Sofie, Ahlgren Tomas, Wader Karin, Wahlin Björn Engelbrekt, Delabie Jan, Sundström Christer
a Division of Hematology, Department of Medicine at Huddinge , Karolinska Institute and University Hospital , Stockholm , Sweden.
b Department of Oncology , Oslo University Hospital , Oslo , Norway.
Leuk Lymphoma. 2015;56(9):2598-607. doi: 10.3109/10428194.2015.1014363. Epub 2015 Mar 11.
Patients with advanced CD20 + indolent lymphoma, requiring therapy, were randomized to rituximab (four weekly infusions of 375 mg/m(2)) or to rituximab combined with 5 weeks of interferon-α2a (IFN-α2a) (3-4.5 MIU daily) as priming. Responding patients were eligible for a second cycle with the same allocated treatment. In total, 156 patients were randomized to rituximab and 157 to rituximab + IFN-α2a. In the intention-to treat (ITT) population, 244 patients (78%) responded to cycle 1. After a second cycle the complete remission/complete remission unconfirmed (CR/CRu) rate was 41% with the combination versus 24% with monotherapy (p = 0.005). The median time to treatment failure (primary endpoint) in ITT patients was 28 vs. 21.5 months, respectively (p = 0.302). After a long median follow-up (61 months), 33% (42% of patients responding to cycle 1) were still failure-free with an overall survival rate of 88% and with no difference between the treatment groups. The trial was registered at ClinicalTrials.gov Identifier: NCT01609010.
需要治疗的晚期CD20+惰性淋巴瘤患者被随机分为接受利妥昔单抗治疗组（每周静脉输注1次，共4次，每次375mg/m²）或利妥昔单抗联合α-2a干扰素（IFN-α2a）诱导治疗组（5周，每日3-4.5MIU）。缓解的患者有资格接受相同分配治疗的第二个周期。总共156例患者被随机分配接受利妥昔单抗治疗，157例患者被随机分配接受利妥昔单抗+IFN-α2a治疗。在意向性治疗（ITT）人群中，244例患者（78%）对第1周期治疗有反应。在第二个周期后，联合治疗组的完全缓解/未确认的完全缓解（CR/CRu）率为41%，而单药治疗组为24%（p=0.005）。ITT患者中至治疗失败（主要终点）的中位时间分别为28个月和21.5个月（p=0.302）。经过较长的中位随访期（61个月），33%（对第1周期治疗有反应的患者中的42%）仍无治疗失败，总生存率为88%，且治疗组之间无差异。该试验已在ClinicalTrials.gov注册，标识符为：NCT01609010。
