dc.contributor.author |
Burger, Jan A. |
dc.contributor.author |
Barr, Paul M. |
dc.contributor.author |
Robak, Tadeusz |
dc.contributor.author |
Owen, Carolyn |
dc.contributor.author |
Ghia, Paolo |
dc.contributor.author |
Tedeschi, Alessandra |
dc.contributor.author |
Bairey, Osnat |
dc.contributor.author |
Hillmen, Peter |
dc.contributor.author |
Coutre, Steven E. |
dc.contributor.author |
Devereux, Stephen |
dc.contributor.author |
Grosicki, Sebastian |
dc.contributor.author |
McCarthy, Helen |
dc.contributor.author |
Simpson, David |
dc.contributor.author |
Offner, Fritz |
dc.contributor.author |
Moreno, Carol |
dc.contributor.author |
Dai, Sandra |
dc.contributor.author |
Lal, Indu |
dc.contributor.author |
Dean, James P. |
dc.contributor.author |
Kipps, Thomas J. |
dc.contributor.author |
Universitat Autònoma de Barcelona |
dc.date |
2019 |
dc.identifier |
https://ddd.uab.cat/record/226649 |
dc.identifier |
urn:10.1038/s41375-019-0602-x |
dc.identifier |
urn:oai:ddd.uab.cat:226649 |
dc.identifier |
urn:pmid:31628428 |
dc.identifier |
urn:pmcid:PMC7214263 |
dc.identifier |
urn:pmc-uid:7214263 |
dc.identifier |
urn:articleid:14765551v34p787 |
dc.identifier |
urn:oai:pubmedcentral.nih.gov:7214263 |
dc.format |
application/pdf |
dc.language |
eng |
dc.publisher |
|
dc.relation |
Leukemia ; Vol. 34 (october 2019), p. 787-798 |
dc.rights |
open access |
dc.rights |
Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original. |
dc.rights |
https://creativecommons.org/licenses/by/4.0/ |
dc.subject |
Chronic lymphocytic leukaemia |
dc.subject |
Targeted therapies |
dc.title |
Long-term efficacy and safety of first-line ibrutinib treatment for patients with CLL/SLL : 5 years of follow-up from the phase 3 RESONATE-2 study |
dc.type |
Article |
dc.description.abstract |
Altres ajuts: This study was sponsored by Pharmacyclics LLC, an AbbVie Company. Medical writing support was provided by Valerie Hilliard, PhD, and funded by Pharmacyclics LLC, an AbbVie Company. |
dc.description.abstract |
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. |