@article{Emmanuel Bachy_Roch Houot_Franck Morschhauser_Anne Sonet_Pauline Brice_Karim Belhadj_Guillaume Cartron_Bruno Audhuy_Christophe Fermé_Pierre Feugier_Catherine Sebban_Vincent Delwail_Hervé Maisonneuve_Steven Le Gouill_Sophie Lefort_Nicole Brousse_Charles Foussard_Gilles Salles_2013, place={Pavia, Italy}, title={Long-term follow up of the FL2000 study comparing CHVP-interferon to CHVP-interferon plus rituximab in follicular lymphoma}, volume={98}, url={https://haematologica.org/article/view/6721}, DOI={10.3324/haematol.2012.082412}, abstractNote={Anti-CD20-containing chemotherapy regimens have become the standard of care for patients with follicular lymphoma needing cytotoxic therapy. Four randomized trials demonstrated a clinical benefit for patients treated with rituximab. However, no long-term follow up (i.e. > 5 years) of these trials is yet available. Between May 2000 and May 2002, 358 newly diagnosed patients with high tumor burden follicular lymphoma were randomized to receive cyclophosphamide, adriamycin, etoposide and prednisolone plus interferon-α2a or a similar chemotherapy-based regimen plus rituximab, and outcome was up-dated. With a median follow up of 8.3 years, addition of rituximab remained significantly associated with prolonged event-free survival (primary end point) (<em>P</em>=0.0004) with a trend towards a benefit for overall survival (<em>P</em>=0.076). The Follicular Lymphoma International Prognostic Index score was strongly associated with outcome for both event-free and overall survival in univariate analysis and its prognostic value remained highly significant after adjusting for other significant covariates in multivariate models (<em>P</em><0.0001 and <em>P</em>=0.001, respectively). Considering long-term toxicity, the addition of rituximab in the first-line setting was confirmed as safe with regards to development of secondary malignancies. Long-term follow up of patients with follicular lymphoma treated in the FL2000 study confirms the sustained clinical benefit of rituximab without long-term toxicity. <em>This study was registered at <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> (Identifier:00136552).</em&gt;}, number={7}, journal={Haematologica}, author={Emmanuel Bachy and Roch Houot and Franck Morschhauser and Anne Sonet and Pauline Brice and Karim Belhadj and Guillaume Cartron and Bruno Audhuy and Christophe Fermé and Pierre Feugier and Catherine Sebban and Vincent Delwail and Hervé Maisonneuve and Steven Le Gouill and Sophie Lefort and Nicole Brousse and Charles Foussard and Gilles Salles}, year={2013}, month={Jun.}, pages={1107-1114} }