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Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma

Franck Morschhauser 1 Nathan H Fowler 2 Pierre Feugier 3 Reda Bouabdallah 4 Hervé Tilly 5, 6 M Lia Palomba Christophe Fruchart 7 Edward N Libby René-Olivier Casasnovas 8 Ian W Flinn Corinne Haioun 9 Hervé Maisonneuve 10 Loic Ysebaert 11 Nancy L Bartlett Kamal Bouabdallah 12 Pauline Brice 13 Vincent Ribrag 14 Nicolas Daguindau 15 Steven Le Gouill 16, 17 Gian M Pica 18 Alejandro Martin Garcia-Sancho Armando Lopez-Guillermo Jean-François Larouche Kiyoshi Ando Maria Gomes da Silva Marc André Pierre Zachee Laurie H Sehn Kensei Tobinai Guillaume Cartron 19 David Liu Jianming Wang Luc Xerri Gilles Salles 20 
Abstract : BACKGROUND: Rituximab plus chemotherapy has been shown to be effective in patients with advanced-stage, previously untreated follicular lymphoma; nevertheless, most patients will have a relapse. Combination immunotherapy with lenalidomide and rituximab is an immunomodulatory regimen that has shown promising activity in patients with indolent B-cell non-Hodgkin's lymphoma. METHODS: We conducted this multicenter, international, phase 3 superiority trial to evaluate rituximab plus lenalidomide, as compared with rituximab plus chemotherapy, in patients with previously untreated follicular lymphoma. Patients were randomly assigned to receive one of the two regimens, followed by maintenance monotherapy with rituximab. Treatment with rituximab plus lenalidomide consisted of 18 cycles of the two drugs, followed by rituximab maintenance therapy every 8 weeks for 12 cycles (six additional doses). Treatment with rituximab plus chemotherapy consisted of the investigator's choice of one of three rituximab-based regimens, followed by maintenance monotherapy with rituximab every 8 weeks for 12 cycles. The primary end points were complete response (confirmed or unconfirmed) at 120 weeks and progression-free survival. RESULTS: A total of 1030 patients were randomly assigned to receive rituximab plus lenalidomide (513 patients) or rituximab plus chemotherapy (517 patients). The rate of confirmed or unconfirmed complete response at 120 weeks was similar in the two groups: 48% (95% confidence interval [CI], 44 to 53) in the rituximab-lenalidomide group and 53% (95% CI, 49 to 57) in the rituximab-chemotherapy group (P=0.13). The interim 3-year rate of progression-free survival was 77% (95% CI, 72 to 80) and 78% (95% CI, 74 to 82), respectively. A higher percentage of patients in the rituximab-chemotherapy group had grade 3 or 4 neutropenia (32% vs. 50%) and febrile neutropenia of any grade (2% vs. 7%), and a higher percentage of patients in the rituximab-lenalidomide group had grade 3 or 4 cutaneous reactions (7% vs. 1%). CONCLUSIONS: Among patients with previously untreated follicular lymphoma, efficacy results were similar with rituximab plus lenalidomide and rituximab plus chemotherapy (with both regimens followed by rituximab maintenance therapy). The safety profile differed in the two groups. (Funded by Celgene; RELEVANCE numbers, NCT01476787 and NCT01650701 , and EudraCT number, 2011-002792-42 .).
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Franck Morschhauser, Nathan H Fowler, Pierre Feugier, Reda Bouabdallah, Hervé Tilly, et al.. Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma. New England Journal of Medicine, Massachusetts Medical Society, 2018, 379 (10), pp.934 - 947. ⟨10.1056/nejmoa1805104⟩. ⟨inserm-01934589⟩



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