Detailed Information on Publication Record
2019
Single-agent ibrutinib in RESONATE-2 (TM) and RESONATE (TM) versus treatments in the real-world PHEDRA databases for patients with chronic lymphocytic leukemia
SALLES, Gilles, Emmanuel BACHY, Lukáš SMOLEJ, Martin SIMKOVIC, Lucile BASEGGIO et. al.Basic information
Original name
Single-agent ibrutinib in RESONATE-2 (TM) and RESONATE (TM) versus treatments in the real-world PHEDRA databases for patients with chronic lymphocytic leukemia
Authors
SALLES, Gilles (250 France, guarantor), Emmanuel BACHY (250 France), Lukáš SMOLEJ (203 Czech Republic), Martin SIMKOVIC (203 Czech Republic), Lucile BASEGGIO (250 France), Anna PANOVSKÁ (203 Czech Republic, belonging to the institution), Herve BESSON (372 Ireland), Nollaig HEALY (826 United Kingdom of Great Britain and Northern Ireland), Jamie GARSIDE (826 United Kingdom of Great Britain and Northern Ireland), Wafae IRAQI (250 France), Joris DIELS (56 Belgium), Corinna PICK-LAUER (276 Germany), Martin SPACEK (203 Czech Republic), Renata URBANOVA (203 Czech Republic), Daniel LYSAK, Ruben HERMANS (826 United Kingdom of Great Britain and Northern Ireland), Jessica LUNDBOM (826 United Kingdom of Great Britain and Northern Ireland), Evelyne CALLET-BAUCHU (250 France) and Michael DOUBEK (203 Czech Republic, belonging to the institution)
Edition
Annals of hematology, New York, Springer Verlag, 2019, 0939-5555
Other information
Language
English
Type of outcome
Článek v odborném periodiku
Field of Study
30205 Hematology
Country of publisher
United States of America
Confidentiality degree
není předmětem státního či obchodního tajemství
References:
Impact factor
Impact factor: 2.904
RIV identification code
RIV/00216224:14110/19:00112598
Organization unit
Faculty of Medicine
UT WoS
000497186800001
Keywords in English
Ibrutinib; Chronic lymphocytic leukemia; Real-world evidence; Randomized controlled trial; Progression-free survival; Overall survival
Tags
International impact, Reviewed
Změněno: 31/3/2020 22:16, Mgr. Pavla Foltynová, Ph.D.
Abstract
V originále
After analyzing treatment patterns in chronic lymphocytic leukemia (CLL) (objective 1), we investigated the relative effectiveness of ibrutinib versus other commonly used treatments (objective 2) in patients with treatment-naive and relapsed/refractory CLL, comparing patient-level data from two randomized registration trials with two real-world databases. Hazard ratios (HR) and 95% confidence intervals (CIs) were estimated using a multivariate Cox proportional hazards model, adjusted for differences in baseline characteristics. Rituximab-containing regimens were often prescribed in clinical practice. The most frequently prescribed regimens were fludarabine + cyclophosphamide + rituximab (FCR, 29.3%), bendamustine + rituximab (BR, 17.7%), and other rituximab-containing regimens (22.0%) in the treatment-naive setting (n = 604), other non-FCR/BR rituximab-containing regimens (38.7%) and non-rituximab-containing regimens (28.5%) in the relapsed/refractory setting (n = 945). Adjusted HRs (95% CI) for progression-free survival (PFS) and overall survival (OS), respectively, with ibrutinib versus real-world regimens were 0.23 (0.14-0.37; p < 0.0001) and 0.40 (0.22-0.76; p = 0.0048) in the treatment-naive setting, and 0.21 (0.16-0.27; p < 0.0001) and 0.29 (0.21-0.41; p < 0.0001) in the relapsed/refractory setting. When comparing real-world use of ibrutinib (n = 53) versus other real-world regimens in relapsed/refractory CLL (objective 3), adjusted HRs (95% CI) were 0.37 (0.22-0.63; p = 0.0003) for PFS and 0.53 (0.27-1.03; p < 0.0624) for OS. This adjusted analysis, based on nonrandomized patient data, suggests ibrutinib to be more effective than other commonly used regimens for CLL.