학술논문
Idelalisib plus rituximab versus ibrutinib in the treatment of relapsed/refractory chronic lymphocytic leukaemia: A real‐world analysis from the Chronic Lymphocytic Leukemia Patients Registry (CLLEAR).
Document Type
Article
Author
Špaček, Martin; Smolej, Lukáš; Šimkovič, Martin; Nekvindová, Lucie; Křístková, Zlatuše; Brychtová, Yvona; Panovská, Anna; Mašlejová, Stanislava; Bezděková, Lucie; Écsiová, Dominika; Vodárek, Pavel; Zuchnická, Jana; Mihályová, Jana; Urbanová, Renata; Turcsányi, Peter; Lysák, Daniel; Novák, Jan; Brejcha, Martin; Líkařová, Tereza; Vodička, Prokop
Source
Subject
*LYMPHOCYTIC leukemia
*CHRONIC lymphocytic leukemia
*BRUTON tyrosine kinase
*MEDICAL registries
*CHRONIC leukemia
*RITUXIMAB
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Language
ISSN
0007-1048
Abstract
Summary: Idelalisib (idela), a phosphatidylinositol 3‐kinase inhibitor, and ibrutinib, a Bruton tyrosine kinase inhibitor, were the first oral targeted agents approved for relapsed/refractory (R/R) chronic lymphocytic leukaemia (CLL). However, no randomised trials of idelalisib plus rituximab (R‐idela) versus ibrutinib have been conducted. Therefore, we performed a real‐world retrospective analysis of patients with R/R CLL treated with R‐idela (n = 171) or ibrutinib (n = 244). The median age was 70 versus 69 years, with a median of two previous lines. There was a trend towards higher tumour protein p53 (TP53) aberrations and complex karyotype in the R‐idela group (53% vs. 44%, p = 0.093; 57% vs. 46%, p = 0.083). The median progression‐free survival (PFS) was significantly longer with ibrutinib (40.5 vs. 22.0 months; p < 0.001); similarly to overall survival (OS; median 54.4 vs. 37.7 months, p = 0.04). In multivariate analysis, only PFS but not OS remained significantly different between the two agents. The most common reasons for treatment discontinuation included toxicity (R‐idela, 39.8%; ibrutinib, 22.5%) and CLL progression (27.5% vs. 11.1%). In conclusion, our data show significantly better efficacy and tolerability of ibrutinib over R‐idela in patients with R/R CLL treated in routine practice. The R‐idela regimen may still be considered a reasonable option in highly selected patients without a suitable treatment alternative. [ABSTRACT FROM AUTHOR]