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@article{1606864,
author = {Salles, Gilles and Bachy, Emmanuel and Smolej, Lukáš and Simkovic, Martin and Baseggio, Lucile and Panovská, Anna and Besson, Herve and Healy, Nollaig and Garside, Jamie and Iraqi, Wafae and Diels, Joris and PickandLauer, Corinna and Spacek, Martin and Urbanova, Renata and Lysak, Daniel and Hermans, Ruben and Lundbom, Jessica and CalletandBauchu, Evelyne and Doubek, Michael},
article_location = {New York},
article_number = {12},
doi = {http://dx.doi.org/10.1007/s00277-019-03830-8},
keywords = {Ibrutinib; Chronic lymphocytic leukemia; Real-world evidence; Randomized controlled trial; Progression-free survival; Overall survival},
language = {eng},
issn = {0939-5555},
journal = {Annals of hematology},
title = {Single-agent ibrutinib in RESONATE-2 (TM) and RESONATE (TM) versus treatments in the real-world PHEDRA databases for patients with chronic lymphocytic leukemia},
url = {http://dx.doi.org/10.1007/s00277-019-03830-8},
volume = {98},
year = {2019}
}
TY - JOUR
ID - 1606864
AU - Salles, Gilles - Bachy, Emmanuel - Smolej, Lukáš - Simkovic, Martin - Baseggio, Lucile - Panovská, Anna - Besson, Herve - Healy, Nollaig - Garside, Jamie - Iraqi, Wafae - Diels, Joris - Pick-Lauer, Corinna - Spacek, Martin - Urbanova, Renata - Lysak, Daniel - Hermans, Ruben - Lundbom, Jessica - Callet-Bauchu, Evelyne - Doubek, Michael
PY - 2019
TI - Single-agent ibrutinib in RESONATE-2 (TM) and RESONATE (TM) versus treatments in the real-world PHEDRA databases for patients with chronic lymphocytic leukemia
JF - Annals of hematology
VL - 98
IS - 12
SP - 2749-2760
EP - 2749-2760
PB - Springer Verlag
SN - 09395555
KW - Ibrutinib
KW - Chronic lymphocytic leukemia
KW - Real-world evidence
KW - Randomized controlled trial
KW - Progression-free survival
KW - Overall survival
UR - http://dx.doi.org/10.1007/s00277-019-03830-8
L2 - http://dx.doi.org/10.1007/s00277-019-03830-8
N2 - 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.
ER -
SALLES, Gilles, Emmanuel BACHY, Lukáš SMOLEJ, Martin SIMKOVIC, Lucile BASEGGIO, Anna PANOVSKÁ, Herve BESSON, Nollaig HEALY, Jamie GARSIDE, Wafae IRAQI, Joris DIELS, Corinna PICK-LAUER, Martin SPACEK, Renata URBANOVA, Daniel LYSAK, Ruben HERMANS, Jessica LUNDBOM, Evelyne CALLET-BAUCHU and Michael DOUBEK. Single-agent ibrutinib in RESONATE-2 (TM) and RESONATE (TM) versus treatments in the real-world PHEDRA databases for patients with chronic lymphocytic leukemia. \textit{Annals of hematology}. New York: Springer Verlag, 2019, vol.~98, No~12, p.~2749-2760. ISSN~0939-5555. Available from: https://dx.doi.org/10.1007/s00277-019-03830-8.
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