@article{Ulrich Jaeger_Marek Trneny_Helen Melzer_Michael Praxmarer_Weerasak Nawarawong_Dina Ben Yehuda_David Goldstein_Bilijana Mihaljevic_Osman Ilhan_Veronika Ballova_Michael Hedenus_Liang-Tsai Hsiao_Wing-Yan Au_Sonja Burgstaller_Gerhard Weidinger_Felix Keil_Christian Dittrich_Cathrin Skrabs_Anton Klingler_Andreas Chott_Michael A. Fridrik_Richard Greil_2015, place={Pavia, Italy}, title={Rituximab maintenance for patients with aggressive B-cell lymphoma in first remission: results of the randomized NHL13 trial}, volume={100}, url={https://haematologica.org/article/view/7441}, DOI={10.3324/haematol.2015.125344}, abstractNote={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 <em>versus</em> 76.5% for observation. This difference was not statistically significant for the intent-to-treat population (likelihood ratio <em>P</em>=0.0670). The hazard ratio by treatment arm was 0.79 (95% confidence interval 0.57–1.08; <em>P</em>=0.1433). The secondary endpoint, progression-free survival was also not met for the whole statistical model (likelihood ratio <em>P</em>=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; <em>P</em>=0.0120). Overall survival remained unchanged (92.0 <em>versus</em> 90.3%). In subgroup analysis male patients benefited from rituximab maintenance with regards to both event-free survival (84.1% <em>versus</em> 74.4%) (hazard ratio: 0.58; 95% confidence interval 0.36–0.94; <em>P</em>=0.0267) and progression-free survival (89.0% <em>versus</em> 77.6%) (hazard ratio: 0.45; 95% confidence interval 0.25–0.79; <em>P</em>=0.0058). Women had more grade 3/4 adverse events (<em>P</em>=0.0297) and infections (<em>P</em>=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 <em><a href="http://www.clinicaltrials.gov">www.clinicaltrials.gov</a></em> as <em>#<a class="external-ref external-ref-type-clintrialgov" href="/lookup/external-ref?link_type=CLINTRIALGOV&amp;access_num=NCT00400478&amp;atom=%2Fhaematol%2F100%2F7%2F955.atom">NCT00400478</a></em&gt;.}, number={7}, journal={Haematologica}, author={Ulrich Jaeger and Marek Trneny and Helen Melzer and Michael Praxmarer and Weerasak Nawarawong and Dina Ben Yehuda and David Goldstein and Bilijana Mihaljevic and Osman Ilhan and Veronika Ballova and Michael Hedenus and Liang-Tsai Hsiao and Wing-Yan Au and Sonja Burgstaller and Gerhard Weidinger and Felix Keil and Christian Dittrich and Cathrin Skrabs and Anton Klingler and Andreas Chott and Michael A. Fridrik and Richard Greil}, year={2015}, month={Jun.}, pages={955-963} }