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@article{1477995,
author = {Cheson, B.D. and Chua, N. and Mayer, Jiří and Dueck, G. and Trneny, M. and Bouabdallah, K. and Fowler, N. and Delwail, V. and Press, O. and Salles, G. and Gribben, J.G. and Lennard, A. and Lugtenburg, P.J. and FingerleandRowson, G. and Mattiello, F. and Knapp, A. and Sehn, L.H.},
article_location = {ALEXANDRIA},
article_number = {22},
doi = {http://dx.doi.org/10.1200/JCO.2017.76.3656},
keywords = {Rituximab; non-Hodgkin lymphoma},
language = {eng},
issn = {0732-183X},
journal = {Journal of clinical oncology},
title = {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},
volume = {36},
year = {2018}
}
TY - JOUR
ID - 1477995
AU - Cheson, B.D. - Chua, N. - Mayer, Jiří - Dueck, G. - Trneny, M. - Bouabdallah, K. - Fowler, N. - Delwail, V. - Press, O. - Salles, G. - Gribben, J.G. - Lennard, A. - Lugtenburg, P.J. - Fingerle-Rowson, G. - Mattiello, F. - Knapp, A. - Sehn, L.H.
PY - 2018
TI - 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
JF - Journal of clinical oncology
VL - 36
IS - 22
SP - "2259"-"+"
EP - "2259"-"+"
PB - Lippincott Williams & Wilkins
SN - 0732183X
KW - Rituximab
KW - non-Hodgkin lymphoma
N2 - 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.
ER -
CHESON, B.D., N. CHUA, Jiří MAYER, G. DUECK, M. TRNENY, K. BOUABDALLAH, N. FOWLER, V. DELWAIL, O. PRESS, G. SALLES, J.G. GRIBBEN, A. LENNARD, P.J. LUGTENBURG, G. FINGERLE-ROWSON, F. MATTIELLO, A. KNAPP and L.H. SEHN. 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. \textit{Journal of clinical oncology}. ALEXANDRIA: Lippincott Williams \&{} Wilkins, 2018, vol.~36, No~22, p.~''2259''-''+'', 10 pp. ISSN~0732-183X. Available from: https://dx.doi.org/10.1200/JCO.2017.76.3656.
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