Is First Line Single Agent Rituximab the Best Treatment for Indolent Non-Hodgkin's Lymphoma? Update of a Multicentric Study Comparing Rituximab vs CNOP vs Rituximab Plus CNOP.

PURPOSE:To evaluate efficacy, safety, Disease-Free Survival (DFS) and Overall Survival (OS) in patients with indolent non-Hodgkin's lymphoma (NHL) treated with chemotherapy vs. immunotherapy vs immunochemotherapy as first-line therapy, an up-date report.METHODS:Patients with indolent NHL were randomized to receive: (A) Rituximab x 6/w, (B) CNOP (cyclophosphamide, mitoxantrone, vincristine and prednisone) x 6 or (C) R-CNOP x 6, at standard doses.RESULTS:195 patients were included, 183 are evaluable for OS and toxicity (A62, B55 and C66), 144 are evaluable for overall response rate (ORR) and DFS (A53, B41 and C50). Clinical characteristics: 89 male (45.6%), mean age 59{+/-}14 ({+/-}SD), 148 (75.9%) in stage (III/IV), without significant differences between groups. Overall Response Rate (CR+PR) was: A 84.9%, B83.4% and C90% (P=0.545). Neutropenia grade 3/4 was more frequent in the chemotherapy groups: A 4.8%, B 23.6% and C18.2% (P=0.001) as it was the infectious toxicity (grade 2/4) A:4.8%, B:5.5% and C15.2% (P=0.07). DFS at 24 months was: A 68%, B65% and C70%, (P=0.93) and the OS was A87%, B84% and C78%. P=0.89.CONCLUSIONS:We did not find any important differences, between groups, regarding the Overall Response Rate, Disease Free Survival and Overall Survival at 24 months. However, single agent rituximab was better tolerated, with less toxicity in comparison with the chemotherapy containing groups. Based on these findings, it maybe reasonable to use immunotherapy only, as first-line therapy for patients with indolent NHL.