Avilés A, Cleto S, Huerta-Guzmán J, Neri N
Department of Hematology, Oncology Hospital, National Medical Center, IMSS, México, DF, Mexico.
Eur J Haematol. 2001 Feb;66(2):94-9. doi: 10.1034/j.1600-0609.2001.00272.x.
We conducted a randomized clinical trial to evaluate the role of interferon alfa 2b (IFN) as maintenance therapy in patients with diffuse large B-cell lymphoma with high or high-intermediate clinical risk on complete remission (CR) after CHOP-BLEO regimens.
Patients were initially treated with CHOP-BLEO regimens (which include increased doses of cyclophosphamide and epirubicine, instead of doxorubicin). If the patients achieved CR they were randomly assigned to receive either maintenance therapy with IFN 5.0 MU, three times at week by 1 yr, or no treatment (control group).
Two hundred and twenty-three patients were considered as candidates for the study. They were of high (80%) or high-intermediate (20%) clinical risk; additionaly most patients had poor prognostic factors such as high levels of beta 2 microglobulin, lactic dehydrogenase levels, bulky disease (defined as a tumor mass >10 cm) or multiple extranodal involvement. In an intent-to-treat analysis all patients were evaluable to efficacy and toxicity. Median follow-up was 45 months, the estimated 5-yr overall survival and event-free survival (EFS) for patients who received IFN were 71% (95% confidence interval (CI): 61-83%) and 57% (95% CI: 39-69%), respectively, values which were not statistically different from the control group: 69% (95% CI: 63-79%) and 54% (95% CI: 37-63%), respectively (p=0.2). Toxicity was mild.
These results suggest that IFN used as maintenance therapy at these doses and schedules is not useful in aggressive malignant lymphoma when more intensive chemotherapy has been employed during induction treatment. Nevertheless, follow-up is too short, and long-term follow-up would be necessary in order to draw definitive conclusions. Probably, an multicenter study is necessary to define the role of IFN as maintenance therapy in this patient setting.
我们开展了一项随机临床试验，以评估α-2b干扰素（IFN）作为维持治疗在接受CHOP - BLEO方案后完全缓解（CR）的高或高中度临床风险弥漫性大B细胞淋巴瘤患者中的作用。
患者最初接受CHOP - BLEO方案治疗（该方案包括增加剂量的环磷酰胺和表柔比星，而非多柔比星）。若患者达到CR，则随机分配接受IFN 5.0 MU维持治疗，每周3次，共1年，或不接受治疗（对照组）。
223例患者被视为该研究的候选对象。他们具有高（80%）或高中度（20%）临床风险；此外，大多数患者具有不良预后因素，如β2微球蛋白水平高、乳酸脱氢酶水平高、肿块大（定义为肿瘤肿块>10 cm）或多处结外受累。在意向性治疗分析中，所有患者均可评估疗效和毒性。中位随访时间为45个月，接受IFN治疗患者的估计5年总生存率和无事件生存率（EFS）分别为71%（95%置信区间（CI）：61 - 83%）和57%（95% CI：39 - 69%），这些值与对照组相比无统计学差异：分别为69%（95% CI：63 - 79%）和54%（95% CI：37 - 63%）（p = 0.2）。毒性较轻。
这些结果表明，在诱导治疗期间采用了更强化疗的侵袭性恶性淋巴瘤中，按这些剂量和疗程使用IFN作为维持治疗并无益处。然而，随访时间过短，需要进行长期随访才能得出明确结论。可能需要开展一项多中心研究来确定IFN在该患者群体中作为维持治疗的作用。
