Quality of life in 269 poor-risk diffuse large B-cell lymphoma patients treated with rituximab versus observation after front-line auto transplantation: The GELA LNH98-3 randomized trial.

8082 Background: Little is known about the longitudinal course of health-related quality of life (QoL) in DLBCL patients during their post-treatment follow-up. We report on the QoL of patients treated in the randomised LNH98-3 trial of the Groupe d'Etudes des Lymphomes de l'Adulte (GELA). We aimed to assess QoL and fatigue following front-line autotransplantation (ASCT) and to analyse relations with rituximab maintenance. Methods: This study is registered with www.ClinicalTrials.gov number NCT00169169 (C Haioun, Annals of Oncology, 2009). High-dose CHOP induction therapy was received by 476 patients, and 330 responder-patients received ASCT. Following response to ASCT, 269 patients were randomized to rituximab treatment (4 cycles) or observation. They received the EORTC QLQ-C30 questionnaires at day 45 after ASCT and during follow-up (100 days, 1yr, 2yr, and 3 yr). Changes of mean QoL scores over time were analysed with mixed models. Analyses were done on an intention-to- treat basis. Results: From the 55...