Six-Year Results From RELEVANCE: Lenalidomide Plus Rituximab (R2) Versus Rituximab-Chemotherapy Followed by Rituximab Maintenance in Untreated Advanced Follicular Lymphoma

Author(s): Franck Morschhauser, MD, PhD1; Loretta Nastoupil, MD2; Pierre Feugier, MD, PhD3; Jean-Marc Schiano de Colella, MD4; Hervé Tilly, MD5; Maria Lia Palomba, MD6; Emmanuel Bachy, MD, PhD7; Christophe Fruchart, MD8; Edward N. Libby, MD9; Rene-Olivier Casasnovas, MD10; Ian W. Flinn, MD, PhD11; Corinne Haioun, MD12; Hervé Maisonneuve, MD13; Loic Ysebaert, MD, PhD14; Nancy L. Bartlett, MD15; Kamal Bouabdallah, MD16; Pauline Brice, MD17; Vincent Ribrag, MD18; Steven Le Gouill, MD, PhD19; Nicolas Daguindau, MD20; Stéphanie Guidez, MD21; Gian Matteo Pica, MD22; Alejandro Martín García-Sancho, MD, PhD23; Armondo López-Guillermo, MD24; Jean-François Larouche, MD25; Kiyoshi Ando, MD26; Maria Gomes da Silva, MD, PhD27; Marc André, MD28; Wu Kalung, MD29; Laurie H. Sehn, MD, MPH30; Koji Izutsu, MD, PhD31; Guillaume Cartron, MD, PhD32; Argyrios Gkasiamis, MD33; Russell Crowe, MA33; Luc Xerri, MD, PhD4; Nathan H. Fowler, MD2; and Gilles Salles, MD6
Source: 10.1200/JCO.22.00843 Journal of Clinical Oncology 40, no. 28 (October 01, 2022) 3239-3245

Dr. Maen Hussein's Thoughts

Confirming that RR can be an alternative to R chemotherapy as a first line therapy  in advanced stage follicular lymphoma.

ABSTRACT

The RELEVANCE trial (ClinicalTrials.gov identifier: NCT01650701) showed that lenalidomide plus rituximab (R2) 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 R2 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 R2 and R-chemo, respectively (hazard ratio 5 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 R2 and R-chemo groups, respectively. The transformation rate per year in the R2 and R-chemo groups was 0.68% and 0.45%, and secondary primary malignancies occurred in 11% and 13% (P 5 .34), respectively. No new safety signals were observed. R2 continues to demonstrate comparable, durable efficacy and safety versus R-chemo in previously untreated patients with FL and provides an acceptable chemo-free alternative.

Author Affiliations

1University of Lille, CHU Lille, Lille, France; 2The University of Texas MD Anderson Cancer Center, Houston, TX; 3Nancy University Hospital, Vandoeuvre-lès-Nancy, France; 4Institut Paoli Calmettes, CRCM, AMU, Marseille, France; 5Centre Henri Becquerel, Rouen, France; 6Memorial Sloan Kettering Cancer Center, New York, NY; 7Hospices Civils de Lyon and Claude Bernard Lyon 1 Université, Lyon, France; 8CH de Dunkerque, Dunkerque, France; 9University of Washington, Seattle, WA; 10CHU Dijon-Bourgogne, Dijon, France; 11Sarah Cannon Research Institute and Tennessee Oncology, Nashville, TN; 12Henri Mondor Université Hôpital, UPEC, Créteil, France; 13Centre Hospitalier Départemental Vendée, La Roche-sur-Yon, France; 14Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse, France; 15Washington University School of Medicine, St Louis, MO; 16Bordeaux University Hospital, Bordeaux, France; 17Hôpital Saint-Louis, Paris, France; 18Institut Gustave Roussy, Villejuif, France; 19Institut Curie, Paris, France; 20Annecy Hôpital, Annecy, France; 21CHU de Poitiers, Poitiers, France; 22Centre Hospitalier Métropole Savoie Chambéry, Chambéry, France; 23Hospital Universitario de Salamanca, IBSAL, CIBERONC, Salamanca, Spain; 24Hospital Clínic de Barcelona, Barcelona, Spain; 25CHU de Québec, Québec, Canada; 26Tokai University School of Medicine, Kanagawa, Japan; 27Instituto Português de Oncologia de Lisboa, Lisboa, Portugal; 28CHU UCL Namur, Yvoir, Belgium; 29ZNA Stuivenberg, Antwerp, Belgium; 30BC Cancer Centre for Lymphoid Cancer, Vancouver, Canada; 31National Cancer Center Hospital, Tokyo, Japan; 32CHU Montpellier, Montpellier, France; 33Bristol Myers Squibb, Princeton, NJ

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