Detailed Information on Publication Record
2018
Overall Survival Benefit in Patients With Rituximab-Refractory Indolent Non-Hodgkin Lymphoma Who Received Obinutuzumab Plus Bendamustine Induction and Obinutuzumab Maintenance in the GADOLIN Study
CHESON, B.D., N. CHUA, Jiří MAYER, G. DUECK, M. TRNENY et. al.Basic information
Original name
Overall Survival Benefit in Patients With Rituximab-Refractory Indolent Non-Hodgkin Lymphoma Who Received Obinutuzumab Plus Bendamustine Induction and Obinutuzumab Maintenance in the GADOLIN Study
Authors
CHESON, B.D. (840 United States of America, guarantor), N. CHUA (124 Canada), Jiří MAYER (203 Czech Republic, belonging to the institution), G. DUECK (124 Canada), M. TRNENY (203 Czech Republic), K. BOUABDALLAH (250 France), N. FOWLER (840 United States of America), V. DELWAIL (250 France), O. PRESS (840 United States of America), G. SALLES (250 France), J.G. GRIBBEN (826 United Kingdom of Great Britain and Northern Ireland), A. LENNARD (826 United Kingdom of Great Britain and Northern Ireland), P.J. LUGTENBURG (528 Netherlands), G. FINGERLE-ROWSON (756 Switzerland), F. MATTIELLO, A. KNAPP (756 Switzerland) and L.H. SEHN (124 Canada)
Edition
Journal of clinical oncology, ALEXANDRIA, Lippincott Williams & Wilkins, 2018, 0732-183X
Other information
Language
English
Type of outcome
Článek v odborném periodiku
Field of Study
30204 Oncology
Country of publisher
United States of America
Confidentiality degree
není předmětem státního či obchodního tajemství
Impact factor
Impact factor: 28.349
RIV identification code
RIV/00216224:14110/18:00104907
Organization unit
Faculty of Medicine
UT WoS
000445665200004
Keywords in English
Rituximab; non-Hodgkin lymphoma
Tags
International impact, Reviewed
Změněno: 10/2/2019 17:14, Soňa Böhmová
Abstract
V originále
PurposeTo perform an updated analysis of the randomized phase III GADOLIN trial in patients with rituximab-refractory indolent non-Hodgkin lymphoma treated with obinutuzumab (GA101; G) and bendamustine (B).Patients and MethodsPatients with histologically documented, rituximab-refractory CD20(+) indolent non-Hodgkin lymphoma received G 1,000 mg (days 1, 8, and 15, cycle 1; day 1, cycles 2 to 6) plus B 90 mg/m(2)/d (days 1 and 2, all cycles) or B 120 mg/m(2)/d monotherapy. Patients who did not experience disease progression with G-B received G maintenance (1,000 mg every 2 months) for up to 2 years. The primary end point was progression-free survival (PFS).ResultsOf 413 randomly assigned patients (intention-to-treat [ITT]: G-B, n = 204; B monotherapy, n = 209), 335 had follicular lymphoma (FL; G-B, n = 164; B monotherapy, n = 171). After a median follow-up of 31.8 months, median PFS in ITT patients was 25.8 months (G-B) and 14.1 months (B monotherapy; hazard ratio [HR], 0.57; 95% CI, 0.44 to 0.73; P < .001). Overall survival (OS) also was prolonged (HR, 0.67; 95% CI, 0.47 to 0.96; P = .027). PFS and OS benefits were similar in patients with FL. Grade 3 to 5 adverse events (AEs) were reported by 148 (72.5%) and 133 (65.5%) patients in the G-B and B monotherapy arms, respectively, most commonly neutropenia (G-B, 34.8%; B monotherapy, 27.1%), thrombocytopenia (10.8% and 15.8%), anemia (7.4% and 10.8%), and infusion-related reactions (9.3% and 3.4%). Serious AEs occurred in 89 G-B patients (43.6%) and 75 B monotherapy patients (36.9%); fatal AEs occurred in 16 (7.8%) and 13 (6.4%), respectively.ConclusionThis updated analysis confirms the PFS benefit for G-B shown in the primary analysis. A substantial OS benefit also was demonstrated in the ITT population and in patients with FL. Toxicity was similar for both treatments.