J 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.

Základní údaje

Originální název

Single-agent ibrutinib in RESONATE-2 (TM) and RESONATE (TM) versus treatments in the real-world PHEDRA databases for patients with chronic lymphocytic leukemia

Autoři

SALLES, Gilles (250 Francie, garant), Emmanuel BACHY (250 Francie), Lukáš SMOLEJ (203 Česká republika), Martin SIMKOVIC (203 Česká republika), Lucile BASEGGIO (250 Francie), Anna PANOVSKÁ (203 Česká republika, domácí), Herve BESSON (372 Irsko), Nollaig HEALY (826 Velká Británie a Severní Irsko), Jamie GARSIDE (826 Velká Británie a Severní Irsko), Wafae IRAQI (250 Francie), Joris DIELS (56 Belgie), Corinna PICK-LAUER (276 Německo), Martin SPACEK (203 Česká republika), Renata URBANOVA (203 Česká republika), Daniel LYSAK, Ruben HERMANS (826 Velká Británie a Severní Irsko), Jessica LUNDBOM (826 Velká Británie a Severní Irsko), Evelyne CALLET-BAUCHU (250 Francie) a Michael DOUBEK (203 Česká republika, domácí)

Vydání

Annals of hematology, New York, Springer Verlag, 2019, 0939-5555

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30205 Hematology

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Odkazy

Impakt faktor

Impact factor: 2.904

Kód RIV

RIV/00216224:14110/19:00112598

Organizační jednotka

Lékařská fakulta

DOI

UT WoS

000497186800001

Klíčová slova anglicky

Ibrutinib; Chronic lymphocytic leukemia; Real-world evidence; Randomized controlled trial; Progression-free survival; Overall survival

Štítky

Příznaky

Mezinárodní význam, Recenzováno
Změněno: 31. 3. 2020 22:16, Mgr. Pavla Foltynová, Ph.D.

Anotace

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.