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Jaeger: Roche: Honoraria, Membership on an entity’s Board of Directors or advisory committees, Research Funding. Off Label Use: Rituximab as maintenance treatment for DLBCL. Trneny:Roche: Honoraria, Research Funding. Fridrik:Roche: Honoraria. Hedenus:Vifor Pharma: Consultancy, Honoraria. Thaler:Roche: Honoraria, Research Funding. Keil:Roche: Honoraria. Dittrich:Roche: Honoraria, Research Funding. Greil:Roche: Honoraria, Membership on an entity’s Board of Directors or advisory committees, Research Funding. Goldstein:Roche: Membership on an entity’s Board of Directors or advisory committees.

Rationale.Improved outcome of female patients treated with rituximab (R) has been reported for first-line diffuse large B-cell lymphoma (DLBCL) (Müller C, et al. Blood 2012; 119: 3276-84), maintenance treatment of relapsed DLBCL (Gisselbrecht C, et al. J Clin Oncol 2012; 30: 4462-9), and induction as well as maintenance treatment of follicular lymphoma (Jäger U, et al. Haematologica 2012; 97: 1431-8; Salles G, et al. Lancet 2011; 377: 42-51.). This sex-specific response has been attributed to lower body weight or a smaller volume of distribution of the drug in women. Rituximab maintenance in DLBCL and FL grade 3 in complete remission (CR) or CR unconfirmed (CRu) after R-CHOP-like therapy did not significantly prolong EFS or PFS in the NHL13 trial conducted by the Austrian Study Group (AGMT) (http://www.clinicaltrials.gov/ct2/show/NCT00400478?term=ML+18223&rank=1). However, a trend for improved EFS (p value = 0.067), a 44% reduction of relapses, as well as a particularly good outcome in patients with an International Prognostic Index (IPI) of 0 or 1 was noted (Jaeger U, et al. Hematol Oncol 2013; 31 (Suppl. 1): 96-150 (abstract 119)). In the second interim analysis imbalances in toxicity between male and female patients treated with R were observed. This prompted us to analyse sex specific outcome in the final analysis.