Lenalidomide plus rituximab for previously untreated advanced follicular lymphoma: the 10-year RELEVANCE trial analysis
Abstract
Abstract In the multinational, phase 3 RELEVANCE trial, 1030 patients with previously untreated follicular lymphoma were randomized to receive rituximab + lenalidomide (R2; n = 513) or rituximab-based immunochemotherapy (R-Chemo; n = 517). In the final analysis, at 120 months of follow-up, median progression-free survival (PFS) was comparable between the treatment groups: 110.6 months with R2 vs 102.8 months with R-Chemo, according to the independent review committee assessment. The 10-year PFS rates were 46.4% for R2 and 46.6% for R-chemo. Median overall survival (OS) and time-to-next lymphoma treatment (TTNLT) were not reached in either arm; 10-year OS rates were 82.4% for R2 and 81.1% for R-chemo, and 10-year TTNLT rates were 62.2% for R2 and 66.3% for R-chemo. Overall, patients with progression of disease within 24 months (POD24) had a poorer prognosis than those without POD24 (hazard ratio, 6.215; P< .0001); however, no difference was observed between the study groups. The incidence of second primary malignancies (SPMs) was 2.11 cases per 100 patient-years (95% confidence interval, 1.80-2.46). Only 9 transformations occurred after 24 months (3 with R2 vs 6 with R-chemo). In each study group, 87 patients died, mainly because of lymphoma progression and SPMs. This long-term follow-up of RELEVANCE confirmed that R2 provides a chemotherapy-free alternative to immunochemotherapy in this patient population. This trial was registered at www.clinicaltrials.gov as NCT01476787 and NCT01650701 and at EudraCT as 2011-002792-42.
Article Details
Authors (42)
Nicolas Gower
1Service des Maladies du Sang, Centre Hospitalier Universitaire de Lille, Université de Lille, Lille, France
Pierre Feugier
2Service Hématologie, Centre Hospitalier Régional Universitaire de Nancy–Hôpital Brabois, Université de Lorraine, Nancy, France
Jason Westin
3Department of Lymphoma and Myeloma, MD Anderson Cancer Center, Houston, TX
Jean-Marc Schiano De Colella
4Département Hématologie, Institut Paoli Calmettes, Marseille, France
Hervé Tilly
5Service Hématologie, Centre Henri Becquerel, Rouen, France
M. Lia Palomba
5Memorial Sloan Kettering Cancer Center, New York, NY
Edith Julia
Gandhi-Laurent Damaj
8Institut d’Hématologie de Basse Normandie, Caen, France
Amandine Durand
9Service Hématologie Clinique, Centre Hospitalier Universitaire Dijon Bourgogne, Dijon, France
Ian Flinn
10OneOncology and Tennessee Oncology, Nashville, TN
François Lemonnier
Princess Margaret Cancer Centre, University Health Network
Nadine Morineau
12Service Hématologie, Centre Hospitalier Départemental Vendée, La Roche-sur-Yon, France
Loic Ysebaert
13Service Hématologie, Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse, France
Nancy Bartlett
14Department of Hematology and Oncology, Washington University School of Medicine Siteman Cancer Center Hematology Labs, St. Louis, MO
Catherine Thieblemont
15Assistance Publique–Hôpitaux de Paris, Hôpital Saint-Louis, Hémato-Oncologie and Université Paris Cité, Paris, France
Vincent Ribrag
16Département d’hématologie-Département d’Innovation Thérapeutique et des Essais Précoces, Gustave Roussy, Villejuif, France
Thomas Gastinne
Arthur Dony
18Service Hématologie, Centre Hospitalier Metropole Savoie Chambéry, Chambéry, France
Ludovic Fouillet
19Service Hématologie, Institut de Cancérologie et d’Hématologie Universitaire de Saint-Étienne, Saint-Priest-en-Jarez, France
Stephanie Guidez
20Service d'Oncologie Hématologique et Thérapie Cellulaire, Centre Hospitalier Universitaire de Poitiers–Hôpital de la Miletrie, Poitiers, France
Roch Houot
21Service d’Hématologie, Centre Hospitalier Universitaire Pontchaillou, Rennes, France
Maria Gomes Da Silva
22Departamento Hematologia, Instituto Português de Oncologia de Lisboa Francisco Gentil, Lisboa, Portugal
Jeffrey Barnes
23Department of Hematology and Oncology, Harvard Medical School, Massachusetts General Hospital, Boston, MA
Fontanet Bijou
24Service d'Hématologie, Institut Bergonie, Bordeaux, France
Guillaume Cartron
CHU Montpellier UMR5535, Montpellier, France
Alejandro Martin Garcia-Sancho
Herbert Eradat
27Department of Hematology and Oncology, Santa Monica Cancer Care, Santa Monica, CA
Morgane Cheminant
28Service Hématologie Adultes, Hôpital Universitaire Necker-Enfants Malades, Assistance Publique–Hôpitaux de Paris, Université Paris Cité, Paris, France
Armando Lopez Guillermo
29Department of Hematology, Hospital Clinic Barcelona, Barcelona, Spain
Pau Abrisqueta
Julie Abraham
31Service Hématologie Clinique et Thérapie Cellulaire, Centre Hospitalier Universitaire de Limoges–Hôpital Dupuytren, Limoges, France
Clémentine Sarkozy
32Service Hématologie, Institut Curie–Site Saint-Cloud, Saint-Cloud, France
Koji Izutsu
National Cancer Center Hospital, Tokyo, Japan
Gilles Crochet
35Service Hématologie, Centre Hospitalier Universitaire UCL Namur–Site Godinne, Yvoir, Belgium
Laurie H. Sehn
8Division of Medical Oncology, BC Cancer Centre for Lymphoid Cancer and The University of British Columbia, Vancouver, Canada
Argyrios Gkasiamis
37Bristol Myers Squibb, Boudry, Switzerland
Marie Laurence Yge
37Bristol Myers Squibb, Boudry, Switzerland
Loic Chartier
38Biostatistics Department, Lymphoma Study Academic Research Organisation, Centre Hospitalier Lyon Sud, Pierre Benite Cedex, France
Nathan Fowler
39Department of Hematology and Oncology, MD Anderson Cancer Center, Houston, TX
Luc Xerri
40Aix Marseille Université, INSERM, Centre National de la Recherche Scientifique, Institut Paoli-Calmettes, Cancer Research Center of Marseille, Marseille, France
Gilles Salles
41Lymphoma Service, Memorial Sloan Kettering Cancer Center, New York, NY
Franck Morschhauser
Centre Hospitalier Universitaire de Lille, Groupe de Recherche sur les formes Injectables et les Technologies Associées, Lille, France