Long-term efficacy of first-line ibrutinib treatment for chronic lymphocytic leukaemia in patients with TP53 aberrations : a pooled analysis from four clinical trials
Allan, John N. (Weill Cornell Medicine)
Shanafelt, Tait (Stanford University Medical Center)
Wiestner, Adrian (National Heart, Lung, and Blood Institute)
Moreno, Carol (Institut d'Investigació Biomèdica Sant Pau)
O'Brien, Susan M. (University of California Irvine)
Li, Jianling (Pharmacyclics LLC)
Krigsfeld, Gabriel (Pharmacyclics LLC)
Dean, James P. (Pharmacyclics LLC)
Ahn, Inhye E. (National Heart, Lung, and Blood Institute)
Universitat Autònoma de Barcelona

Date:	2021
Abstract:	TP53 aberrations [del(17p) or TP53 mutation] predict poor survival with chemoimmunotherapy in patients with chronic lymphocytic leukaemia (CLL). We evaluated long-term efficacy and safety of first-line ibrutinib-based therapy in patients with CLL bearing TP53 aberrations in a pooled analysis across four studies: PCYC-1122e, RESONATE-2 (PCYC-1115/16), iLLUMINATE (PCYC-1130) and ECOG-ACRIN E1912. The pooled analysis included 89 patients with TP53 aberrations receiving first-line treatment with single-agent ibrutinib (n = 45) or ibrutinib in combination with an anti-CD20 antibody (n = 44). All 89 patients had del(17p) (53% of 89 patients) and/or TP53 mutation (91% of 58 patients with TP53 sequencing results available). With a median follow-up of 49·8 months (range, 0·1-95·9), median progression-free survival was not reached. Progression-free survival rate and overall survival rate estimates at four years were 79% and 88%, respectively. Overall response rate was 93%, including complete response in 39% of patients. No new safety signals were identified in this analysis. Forty-six percent of patients remained on ibrutinib treatment at last follow-up. With median follow-up of four years (up to eight years), results from this large, pooled, multi-study data set suggest promising long-term outcomes of first-line ibrutinib-based therapy in patients with TP53 aberrations. Registered at ClinicalTrials. gov (NCT01500733, NCT01722487, NCT02264574 and NCT02048813).
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Chronic lymphocytic leukaemia ; Del(17p) ; First-line ; Ibrutinib ; TP53 mutation
Published in:	British Journal of Haematology, Vol. 196 (december 2021) , p. 947-953, ISSN 1365-2141

DOI: 10.1111/bjh.17984
PMID: 34865212

7 p, 267.3 KB

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