Article (Scientific journals)
Obinutuzumab versus Rituximab in young patients with advanced DLBCL, a PET-guided and randomized phase 3 study by LYSA.
Le Gouill, S.; Ghesquieres, H.; Obéric, L. et al.
2021In Blood, 137 (17), p. 2307-2320
Peer Reviewed verified by ORBi
 

Files


Full Text
Obinutuzumab vs rituximab for advanced DLBCL a PET-guided and randomized phase 3 study by LYSA.pdf
Author postprint (1.39 MB)
Download

All documents in ORBi are protected by a user license.

Send to



Details



Keywords :
diffuse large B-cell lymphoma; obinutuzumab; PET-driven
Abstract :
[en] Rituximab plus polychemotherapy is standard of care in diffuse large B-cell lymphoma (DLBCL). GAINED trial compares obinutuzumab to rituximab. GAINED (NCT01659099) is an open-label, randomized phase 3 trial. Transplant-eligible patients (18-60yrs) with untreated aged-adjusted international prognostic index (aaIPI) ≥1 DLBCL were randomized (1:1) between obinutuzumab or rituximab. Patients were stratified by aaIPI (1; 2-3) and chemotherapy regimen (ACVBP; CHOP). Consolidation treatment was determined according to response assessed by centrally reviewed interim semi-quantitative PET. Responders after cycle 2 and 4 (PET2-/PET4-) received planned immuno-chemotherapy consolidation. Responders only after cycle 4 (PET2+/4-) received highdose methotrexate plus transplantation. The primary objective was an 8% improvement (HR=0.73; 80% power; alpha risk 2.5%; one-sided) in 2-year event-free survival (EFS) in the obinutuzumab arm. Events included death, progression, PET 2 or 4 positivity, modification of planned treatment. From September 20, 2012, 670 patients were enrolled (obinutuzumab n=336; rituximab n=334). 383 (57.2%) were aaIPI 2-3, 339 (50.6%) received CHOP and 324 (48.4%) received ACVBP. Median follow-up was 38.7 months. The 2-year EFS were similar in obinutuzumab and rituximab groups (59.8% vs 56.6%; p=0.123; HR=0.88). The 2-year PFS in the whole cohort was 83.1% (95%CI 80–85.8). PET2-/4- and PET2+/4- had similar 2-year PFS and OS (89.9% vs 83.9%) and 94.8% vs 92.8%). The 2-year PFS and OS for PET4+ patients were 62% and 83.1%. Grade 3-5 infections were more frequent in the obinutuzumab arm (21% vs 12%). Obinutuzumab is not superior to rituximab in untreated aaIPI≥1 DLBCL transplant-eligible patients.
Disciplines :
Hematology
Author, co-author :
Le Gouill, S.
Ghesquieres, H.
Obéric, L.
Morschhauser, F.
Tilly, H.
Ribrag, V.
Lamy, T.
Thieblemont, C.
Maisonneuve, H.G.
Gressin, R.
Bouabdallah, K.
Haioun, C.
Damaj, G.
Fornecker, L.M.
Bouabdallah, R.
Feugier, P.
Sibon, D.
Cartron, G.
BONNET, Christophe ;  Centre Hospitalier Universitaire de Liège - CHU > Département de médecine interne > Service d'hématologie clinique
André, M.
Chartier, L.
Ruminy, P.
Kraeber-Bodere, F.
Bodet-Milin, C.
Berriolo-Riedinger, A.
Brière, J.
Jais, JP
Molina, T.
Itti, E.
Casasnovas, O.
More authors (20 more) Less
Language :
English
Title :
Obinutuzumab versus Rituximab in young patients with advanced DLBCL, a PET-guided and randomized phase 3 study by LYSA.
Publication date :
2021
Journal title :
Blood
ISSN :
0006-4971
eISSN :
1528-0020
Publisher :
American Society of Hematology, United States - District of Columbia
Volume :
137
Issue :
17
Pages :
2307-2320
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 29 January 2021

Statistics


Number of views
61 (11 by ULiège)
Number of downloads
164 (11 by ULiège)

Scopus citations®
 
48
Scopus citations®
without self-citations
36
OpenCitations
 
32

Bibliography


Similar publications



Contact ORBi