Six-Year Results From RELEVANCE: Lenalidomide Plus Rituximab (R) Versus Rituximab-Chemotherapy Followed by Rituximab Maintenance in Untreated Advanced Follicular Lymphoma

Autor: Morschhauser, Franck, Nastoupil, Loretta, Feugier, Pierre, Schiano de Colella, Jean-Marc, Tilly, Hervé, Palomba, Maria Lia, Bachy, Emmanuel, 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, Le Gouill, Steven, Daguindau, Nicolas, Guidez, Stéphanie, Pica, Gian Matteo, García-Sancho, Alejandro Martín, López-Guillermo, Armondo, Larouche, Jean-François, Ando, Kiyoshi, Gomes da Silva, Maria, André, Marc, Kalung, Wu, Sehn, Laurie H, Izutsu, Koji, Cartron, Guillaume, Gkasiamis, Argyrios, Crowe, Russell, Xerri, Luc, Fowler, Nathan H, Salles, Gilles
Přispěvatelé: UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - (MGD) Service d'hématologie
Jazyk: angličtina
Rok vydání: 2022
Zdroj: Journal of clinical oncology : official journal of the American Society of Clinical Oncology, Vol. 40, no. 28, p. 239-3245 (2022)
Popis: JCO The RELEVANCE trial (ClinicalTrials.gov identifier: NCT01650701) showed that lenalidomide plus rituximab (R) provided similar efficacy to rituximab plus chemotherapy (R-chemo) in patients with advanced-stage, previously untreated follicular lymphoma (FL). We report the second interim analysis of the RELEVANCE trial after 6 years of follow-up. Patients with previously untreated grade 1-3a FL were assigned 1:1 to R or R-chemo, followed by rituximab maintenance. Coprimary end points were complete response (confirmed/unconfirmed) at week 120 and progression-free survival (PFS). At median follow-up of 72 months, 6-year PFS was 60% and 59% for R and R-chemo, respectively (hazard ratio = 1.03 [95% CI, 0.84 to 1.27]). Six-year overall survival was estimated to be 89% in both groups. Median PFS and overall survival were not reached in either group. Overall response after progression was 61% and 59%, and 5-year estimated survival rate after progression was 69% and 74% in the R and R-chemo groups, respectively. The transformation rate per year in the R and R-chemo groups was 0.68% and 0.45%, and secondary primary malignancies occurred in 11% and 13% ( = .34), respectively. No new safety signals were observed. R continues to demonstrate comparable, durable efficacy and safety versus R-chemo in previously untreated patients with FL and provides an acceptable chemo-free alternative.
Databáze: OpenAIRE