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

J 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.

Základní údaje

Originální název

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

Autoři

CHESON, B.D. (840 Spojené státy, garant), N. CHUA (124 Kanada), Jiří MAYER (203 Česká republika, domácí), G. DUECK (124 Kanada), M. TRNENY (203 Česká republika), K. BOUABDALLAH (250 Francie), N. FOWLER (840 Spojené státy), V. DELWAIL (250 Francie), O. PRESS (840 Spojené státy), G. SALLES (250 Francie), J.G. GRIBBEN (826 Velká Británie a Severní Irsko), A. LENNARD (826 Velká Británie a Severní Irsko), P.J. LUGTENBURG (528 Nizozemské království), G. FINGERLE-ROWSON (756 Švýcarsko), F. MATTIELLO, A. KNAPP (756 Švýcarsko) a L.H. SEHN (124 Kanada)

Vydání

Journal of clinical oncology, ALEXANDRIA, Lippincott Williams & Wilkins, 2018, 0732-183X

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30204 Oncology

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Impakt faktor

Impact factor: 28.349

Kód RIV

RIV/00216224:14110/18:00104907

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1200/JCO.2017.76.3656

UT WoS

000445665200004

Klíčová slova anglicky

Rituximab; non-Hodgkin lymphoma

Štítky

14110212, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 10. 2. 2019 17:14, Soňa Böhmová

Anotace

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.

Citovat

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 a 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. Journal of clinical oncology. ALEXANDRIA: Lippincott Williams & Wilkins, 2018, roč. 36, č. 22, s. "2259"-"+", 10 s. ISSN 0732-183X. Dostupné z: https://dx.doi.org/10.1200/JCO.2017.76.3656.

@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 a 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, roč.~36, č.~22, s.~''2259''-''+'', 10 s. ISSN~0732-183X. Dostupné z: https://dx.doi.org/10.1200/JCO.2017.76.3656.

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