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.
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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
Originální 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
Změnil Změnila: Soňa Böhmová, učo 232884. Změněno: 10. 2. 2019 17:14.
Anotace
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.
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