TY - JOUR
T1 - Six-Year Results from RELEVANCE
T2 - Lenalidomide Plus Rituximab (R2) Versus Rituximab-Chemotherapy Followed by Rituximab Maintenance in Untreated Advanced Follicular Lymphoma
AU - Morschhauser, Franck
AU - Nastoupil, Loretta
AU - Feugier, Pierre
AU - De Colella, Jean Marc Schiano
AU - Tilly, Hervé
AU - Palomba, Maria Lia
AU - Bachy, Emmanuel
AU - Fruchart, Christophe
AU - Libby, Edward N.
AU - Casasnovas, Rene Olivier
AU - Flinn, Ian W.
AU - Haioun, Corinne
AU - Maisonneuve, Hervé
AU - Ysebaert, Loic
AU - Bartlett, Nancy L.
AU - Bouabdallah, Kamal
AU - Brice, Pauline
AU - Ribrag, Vincent
AU - Le Gouill, Steven
AU - Daguindau, Nicolas
AU - Guidez, Stéphanie
AU - Pica, Gian Matteo
AU - García-Sancho, Alejandro Martín
AU - López-Guillermo, Armondo
AU - Larouche, Jean François
AU - Ando, Kiyoshi
AU - Gomes Da Silva, Maria
AU - André, Marc
AU - Kalung, Wu
AU - Sehn, Laurie H.
AU - Izutsu, Koji
AU - Cartron, Guillaume
AU - Gkasiamis, Argyrios
AU - Crowe, Russell
AU - Xerri, Luc
AU - Fowler, Nathan H.
AU - Salles, Gilles
N1 - Funding Information:
Supported by Celgene, a Bristol Myers Squibb Company, and the Lymphoma Academic Research Organisation (LYSARC).
Funding Information:
The authors would like to thank patients, families, caregivers, and investigators who participated in the RELEVANCE clinical study, the Lymphoma Academic Research Organisation (LYSARC), and to the numerous research and study groups including the Australasian Leukaemia and Lymphoma Group (ALLG), the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG), the German Low Grade Lymphoma Study Group (GLSG), the Lymphoma Study Association (LYSA), and the Grupo Español de Linfomas y Trasplantes de Médula Ósea (GELTAMO) cooperative groups for participating in the study. Medical writing and editorial assistance were provided by Benjamin Levine, PhD, of Bio Connections LLC, funded by Bristol Myers Squibb. The authors directed development of the manuscript and were fully responsible for all content and editorial decisions for this manuscript.
Publisher Copyright:
© American Society of Clinical Oncology.
PY - 2022/10/1
Y1 - 2022/10/1
N2 - Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.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 = 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 =.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.
AB - Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.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 = 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 =.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.
UR - http://www.scopus.com/inward/record.url?scp=85139375988&partnerID=8YFLogxK
U2 - 10.1200/JCO.22.00843
DO - 10.1200/JCO.22.00843
M3 - Article
C2 - 35947804
AN - SCOPUS:85139375988
SN - 0732-183X
VL - 40
SP - 3239
EP - 3245
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 28
ER -