Skip to Main content Skip to Navigation
Journal articles

Obinutuzumab versus Rituximab in young patients with advanced DLBCL, a PET-guided and randomized phase 3 study by LYSA

Steven Le Gouill 1, * Hervé Ghesquieres 2 Lucie Obéric 3 Franck Morschhauser 4 Herve Tilly 5 Vincent Ribrag 6, 7 Thierry Lamy 8, 9 Catherine Thieblemont 10 Herve Gerard Maisonneuve 11 Remy Gressin 12 Krimo Bouabdallah 13 Corinne Haioun 14 Gandhi Damaj 15 Luc-Matthieu Fornecker 16 Reda Bouabdallah 17 Pierre Feugier 18, 19 David Sibon 20 Guillaume Cartron 21 Christophe Bonnet 22 Marc André 23 Loic Chartier 24 Philippe Ruminy 5 F Kraeber-Bodere 1 C Bodet-Milin 1 Alina Berriolo-Riedinger 25 Josette Briere 26 Jean-Philippe Jais 27 Thierry Molina 20 Emmanuel Itti 14 Olivier Casasnovas 28
* Corresponding author
Abstract : 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 high-dose 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.
Complete list of metadata

https://hal.archives-ouvertes.fr/hal-03122586
Contributor : Laurent Jonchère <>
Submitted on : Friday, February 5, 2021 - 12:18:15 PM
Last modification on : Wednesday, March 24, 2021 - 3:33:29 AM
Long-term archiving on: : Friday, May 7, 2021 - 8:26:50 AM

File

 Restricted access
To satisfy the distribution rights of the publisher, the document is embargoed until : 2021-05-19

Please log in to resquest access to the document

Identifiers

Citation

Steven Le Gouill, Hervé Ghesquieres, Lucie Obéric, Franck Morschhauser, Herve Tilly, et al.. Obinutuzumab versus Rituximab in young patients with advanced DLBCL, a PET-guided and randomized phase 3 study by LYSA. Blood, American Society of Hematology, 2020, ⟨10.1182/blood.2020008750⟩. ⟨hal-03122586⟩

Share

Metrics

Record views

177