2026-04-13T01:54:21Zhttps://recercat.cat/oai/requestoai:recercat.cat:2072/4688142025-06-12T10:43:42Zcom_2072_98col_2072_378192
urn:hdl:2072/468814
Up to 6.5 years (median 4 years) of follow-up of first-line ibrutinib in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma and high-risk genomic features : integrated analysis of two phase 3 studies
Burger, Jan A
Robak, Tadeusz
Demirkan, Fatih
Bairey, Osnat
Moreno, Carolina
Simpson, David
Munir, Talha
Stevens, Don A.
Dai, Sandra
Cheung, Leo W.K
Kwei, Kevin
Lal, Indu
Hsu, Emily
Kipps, Thomas J
Tedeschi, Alessandra
Chronic lymphocytic leukemia
Ibrutinib
Chlorambucil
Obinutuzumab
Pooled analysis
Altres ajuts: Pharmacyclics LLC; AbbVie Company.
Genomic abnormalities, including del(17p)/TP53 mutation, del(11q), unmutated IGHV, and mutations in BIRC3, NOTCH1, SF3B1, and XPO1 predict poor outcomes with chemoimmunotherapy in chronic lymphocytic leukemia. To better understand the impact of these high-risk genomic features on outcomes with first-line ibrutinib-based therapy, we performed pooled analysis of two phase 3 studies with 498 patients randomized to receive ibrutinib- or chlorambucil-based therapy with median follow-up of 49.1 months. Ibrutinib-based therapy improved overall response rates (ORRs), complete response rates, and progression-free survival (PFS) versus chlorambucil-based therapy across all subgroups. In ibrutinib-randomized patients with versus without specified genomic features, ORR and PFS were comparable across subgroups. PFS hazard ratio (95% CI) for del(17p)/TP53 mutated/BIRC3 mutated: 1.05 (0.54-2.04); del(17p)/TP53 mutation, del(11q), and/or unmutated IGHV: 1.11 (0.69-1.77); unmutated IGHV: 1.79 (0.99-3.24); and NOTCH1 mutated 1.05 (0.65-1.69). This integrated analysis demonstrated efficacy of first-line ibrutinib-based treatment irrespective of cytogenetic and mutational risk features. Registered at ClinicalTrials.gov (NCT01722487 and NCT02264574).
2022
Article
Leukemia and Lymphoma ; Vol. 63 Núm. 6 (2022), p. 1375-1386
open access
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