Long-term efficacy and safety of first-line ibrutinib treatment for patients with CLL/SLL

RESONATE-2 is a phase 3 study of first-line ibrutinib versus chlorambucil in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Patients aged ≥65 years (n = 269) were randomized 1:1 to once-daily ibrutinib 420 mg continuously or chlorambucil 0.5-0.8 mg/kg for ≤12 cycles. With a med...

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Detalles Bibliográficos
Autores: Burger, Jan A.|||0000-0002-6177-7572, Barr, Paul M.|||0000-0002-9733-401X, Robak, Tadeusz|||0000-0002-3411-6357, Owen, Carolyn, Ghia, Paolo|||0000-0003-3750-7342, Tedeschi, Alessandra, Bairey, Osnat, Hillmen, Peter|||0000-0001-5617-4403, Coutre, Steven E.|||0000-0001-8420-5748, Devereux, Stephen, Grosicki, Sebastian|||0000-0003-2644-1050, McCarthy, Helen, Simpson, David, Offner, Fritz, Moreno, Carol|||0000-0003-3275-0271, Dai, Sandra, Lal, Indu, Dean, James P., Kipps, Thomas J.|||0000-0002-0064-4549
Tipo de recurso: artículo
Fecha de publicación:2019
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:226649
Acceso en línea:https://ddd.uab.cat/record/226649
https://dx.doi.org/urn:doi:10.1038/s41375-019-0602-x
Access Level:acceso abierto
Palabra clave:Chronic lymphocytic leukaemia
Targeted therapies
Descripción
Sumario:RESONATE-2 is a phase 3 study of first-line ibrutinib versus chlorambucil in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Patients aged ≥65 years (n = 269) were randomized 1:1 to once-daily ibrutinib 420 mg continuously or chlorambucil 0.5-0.8 mg/kg for ≤12 cycles. With a median (range) follow-up of 60 months (0.1-66), progression-free survival (PFS) and overall survival (OS) benefits for ibrutinib versus chlorambucil were sustained (PFS estimates at 5 years: 70% vs 12%; HR [95% CI]: 0.146 [0.098-0.218]; OS estimates at 5 years: 83% vs 68%; HR [95% CI]: 0.450 [0.266-0.761]). Ibrutinib benefit was also consistent in patients with high prognostic risk (TP53 mutation, 11q deletion, and/or unmutated IGHV) (PFS: HR [95% CI]: 0.083 [0.047-0.145]; OS: HR [95% CI]: 0.366 [0.181-0.736]). Investigator-assessed overall response rate was 92% with ibrutinib (complete response, 30%; 11% at primary analysis). Common grade ≥3 adverse events (AEs) included neutropenia (13%), pneumonia (12%), hypertension (8%), anemia (7%), and hyponatremia (6%); occurrence of most events as well as discontinuations due to AEs decreased over time. Fifty-eight percent of patients continue to receive ibrutinib. Single-agent ibrutinib demonstrated sustained PFS and OS benefit versus chlorambucil and increased depth of response over time.

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