C. Haioun

Efficacy of autologous stem cell transplantation in mantle cell lymphoma: a 3-year follow-up study.

This study was designed to evaluate the efficacy of therapeutic intensification with autologous stem cell transplantation (ASCT) for mantle cell lymphomas (MCL) in terms of response rate, duration of response, and event-free and overall survivals. Twenty-four patients with confirmed MCL responding to chemotherapy received a high-dose chemo-radiotherapy regimen followed by ASCT. Transplantation was performed during first-line therapy in nine cases, second-line in 13 cases and third-line in two cases. The source of hematopoietic stem cells was peripheral blood for 19 cases. At the time of ASCT, eight patients were in complete remission (33%). Seventeen of the 24 cases received an intensified regimen with TBI and seven received the BEAM or the BEAC regimen. After transplantation, 19 patients were in CR (79%). Nine of these were alive in continued CR at a median follow-up of 34 months, while seven relapsed at a median of 18 months. One patient died from Pneumocystis carinii interstitial pneumonitis and five patients developed secondary malignancies. With a median follow-up after transplantation of 34 months, the 3-year event-free survival was 55% and the 3-year overall survival was 68%. These results indicate that therapeutic intensification with ASCT might be an effective treatment for mantle cell lymphomas. Bone Marrow Transplantation (2000) 25, 251–256.

Rituximab plus gemcitabine and oxaliplatin in patients with refractory/relapsed diffuse large B-cell lymphoma who are not candidates for high-dose therapy. A phase II lymphoma study Association trial

A previous pilot study with rituximab, gemcitabine and oxaliplatin showed promising activity in patients with refractory/relapsed B-cell lymphoma. We, therefore, conducted a phase II study to determine whether these results could be reproduced in a multi-institutional setting. This phase II study included 49 patients with refractory (n=6) or relapsing (n=43) diffuse large B-cell lymphoma. The median age of the patients was 69 years. Prior treatment included rituximab in 31 (63%) and autologous transplantation in 17 (35%) patients. International Prognostic Index at enrollment was >2 in 34 patients (71%). The primary endpoint was overall response rate after four cycles of treatment. Patients were planned to receive eight cycles if they reached at least partial remission after four cycles. After four cycles 21 patients (44%) were in complete remission and 8 (17%) in partial remission, resulting in an overall response rate of 61%. Factors significantly affecting overall response rate were early (<1 year) progression/relapse (18% versus 54%; P=0.001) and prior exposure to rituximab (23% versus 65%; P=0.004). Five-year progression-free and overall survival rates were 12.8% and 13.9%, respectively. Rituximab, gemcitabine and oxaliplatin were well tolerated with grade 3–4 infectious episodes in 22% of the cycles. These results are the first confirmation from a multicenter study that rituximab, gemcitabine and oxaliplatin provide a consistent response rate in patients with refractory/relapsed diffuse large B-cell lymphoma. This therapy can now be considered as a platform for new combinations with targeted treatments. This trial was registered at clinicaltrial.gov under #NCT00169195.

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 dEtudes des Lymphomes de lAdulte (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...