Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
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Morschhauser Franck, Fowler Nathan H, Feugier Pierre, Bouabdallah Reda, Tilly Hervé, Palomba M Lia, Fruchart Christophe, Libby Edward N, Casasnovas Rene-Olivier, Flinn Ian W, Haioun Corinne, Maisonneuve Hervé, Ysebaert Loic, Bartlett Nancy L, Bouabdallah Kamal, Brice Pauline, Ribrag Vincent, Daguindau Nicolas, Le Gouill Steven, Pica Gian M, Martin Garcia-Sancho Alejandro, López-Guillermo Armando, Larouche Jean-François, Ando Kiyoshi, Gomes da Silva Maria, André Marc, Zachée Pierre, Sehn Laurie H, Tobinai Kensei, Cartron Guillaume, Liu David, Wang Jianming, Xerri Luc, Salles Gilles A, RELEVANCE Trial Investigators
Аннотация
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 ClinicalTrials.gov numbers, NCT01476787 and NCT01650701 , and EudraCT number, 2011-002792-42 .).