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
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