We investigated rituximab maintenance therapy in patients with diffuse large B-cell lymphoma (n=662) or follicular lymphoma grade 3b (n=21) in first complete remission. Patients were randomized to rituximab maintenance (n=338) or observation (n=345). At a median follow-up of 45 months, the event-free survival rate (the primary endpoint) at 3 years was 80.1% for rituximab maintenance versus 76.5% for observation. This difference was not statistically significant for the intent-to-treat population (likelihood ratio P=0.0670). The hazard ratio by treatment arm was 0.79 (95% confidence interval 0.57-1.08; P=0.1433). The secondary endpoint, progression-free survival was also not met for the whole statistical model (likelihood ratio P=0.3646). Of note, rituximab maintenance was superior to observation when treatment arms only were compared (hazard ratio: 0.62; 95% confidence interval 0.43-0.90; P=0.0120). Overall survival remained unchanged (92.0 versus 90.3%). In subgroup analysis male patients benefited from rituximab maintenance with regards to both event-free survival (84.1% versus 74.4%) (hazard ratio: 0.58; 95% confidence interval 0.36-0.94; P=0.0267) and progression-free survival (89.0% versus 77.6%) (hazard ratio: 0.45; 95% confidence interval 0.25-0.79; P=0.0058). Women had more grade 3/4 adverse events (P=0.0297) and infections (P=0.0341). Men with a low International Prognostic Index treated with rituximab had the best outcome. In summary, rituximab maintenance in first remission after R-CHOP-like treatment did not prolong event-free, progression-free or overall survival of patients with aggressive B-non-Hodgkin lymphoma. The significantly better outcome of men warrants further studies prior to the routine use of rituximab maintenance in men with low International Prognostic Index. This trial is registered under EUDRACT #2005-005187-90 and www.clinicaltrials.gov as #NCT00400478.

1st Medical Dept Landesklinikum Wiener Neustadt Austria Arbeitsgemeinschaft Medikamentöse Tumortherapie AGMT Salzburg Austria

3rd Dept of Medicine AKH Linz Austria Arbeitsgemeinschaft Medikamentöse Tumortherapie AGMT Salzburg Austria

3rd Medical Dept Hanusch Hospital Vienna Austria Arbeitsgemeinschaft Medikamentöse Tumortherapie AGMT Salzburg Austria

Ankara University School of Medicine Dept of Hematology Ankara Turkey

Assign Data Management and Biostatistics GmbH Assign Group Innsbruck Austria Arbeitsgemeinschaft Medikamentöse Tumortherapie AGMT Salzburg Austria

Australasian Leukaemia and Lymphoma Group East Melbourne Australia

Clinic for Hematology Clinical Center Serbia Belgrade Serbia

Dept of Hematology Hadassah Hebrew University Medical Center Jerusalem Israel

Dept of Internal Medicine 3 Private Medical University of Salzburg Austria Arbeitsgemeinschaft Medikamentöse Tumortherapie AGMT Salzburg Austria

Dept of Internal Medicine 4 Wels Grieskirchen Hospital Wels Austria Arbeitsgemeinschaft Medikamentöse Tumortherapie AGMT Salzburg Austria

Dept of Internal Medicine Faculty of Medicine Chiang Mai University Thailand

Dept of Internal Medicine Sundsvall Hospital Sweden

Division of Hematology and Oncology Dept of Medicine Taipei Veterans General Hospital and National Yang Ming University Taipei Taiwan

Institute of Hematology and Blood Transfusion 1st Dept of Medicine 1st Faculty of Medicine Charles University General Hospital Czech Lymphoma Study Group Praha Czech Republic

Institute of Pathology and Microbiology Wilhelminenspital Vienna Austria

LBI ACR and ACR ITR Vienna Kaiser Franz Josef Spital Vienna Austria Arbeitsgemeinschaft Medikamentöse Tumortherapie AGMT Salzburg Austria

Medical University of Vienna Dept of Medicine 1 Division of Hematology and Hemostaseology Comprehensive Cancer Center Vienna Austria Arbeitsgemeinschaft Medikamentöse Tumortherapie AGMT Salzburg Austria

NOU Klenova Bratislava Slovakia

University Medical Unit Queen Mary Hospital Hong Kong China

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Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma

Rituximab maintenance overcomes the negative prognostic factor of obesity in CLL: Subgroup analysis of the international randomized AGMT CLL-8a mabtenance trial

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EudraCT
2005-005187-90

ClinicalTrials.gov
NCT00400478