Randomized intergroup trial of first line treatment for patients <=60 years with diffuse large B-cell non-Hodgkin's lymphoma (DLBCL) with a CHOP-like regimen with or without the anti-CD20 antibody rituximab -early stopping after the first interim analysis

Abstract

6500 Background: While rituximab improved outcome in elderly patients with DLBCL (Coiffier et al., 2002), there is no data for young low-risk patients. Methods: In a randomized study conducted in 18 countries, untreated patients (18–60 years) with low-risk DLBCL (IPI 0 or 1, stages II-IV and stage I with bulk) were randomized to 6 cycles of a CHOP-like regimen (CHEMO) or the same chemotherapy plus rituximab 375 mg/m2 given on days 1, 22, 43, 64, 85, and 106 (R-CHEMO). Radiotherapy was planned to initial bulk and/or extranodal involvement. The primary endpoint was time to treatment failure (TTF) with events defined as failure to achieve complete remission, progressive disease, relapse, or death. The trial was powered to show a 10% difference in TTF rate after 3 years. Results: Between 05/2000 and 10/2003, 824 patients were recruited. The first planned interim analysis was performed on 326 evaluable patients with confirmed CD20 positive DLBCL (median age 48 years; IPI=1: 56%, 24% stage III/IV disease, 32% e...