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
Burger, Jan A. (University of Texas MD Anderson Cancer Center. Department of Leukemia)
Barr, Paul M. (Wilmot Cancer Institute, University of Rochester Medical Center)
Robak, Tadeusz (Medical University of Lodz, Copernicus Memorial Hospital)
Owen, Carolyn (University of Calgary. Tom Baker Cancer Centre)
Ghia, Paolo (Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele)
Tedeschi, Alessandra (ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy)
Bairey, Osnat (Tel Aviv University. Rabin Medical Center, Petah Tikva, Israel and Sackler Faculty of Medicine)
Hillmen, Peter (University of Leeds. The Leeds Teaching Hospitals, St. James Institute of Oncology)
Coutre, Steven E. (Stanford University School of Medicine. Stanford Cancer Center)
Devereux, Stephen (NHS Foundation Trust. Kings College Hospital)
Grosicki, Sebastian (Silesiam Medical University. Department of Hematology and Cancer Prevention)
McCarthy, Helen (Royal Bournemouth General Hospital (Dorset, Regne Unit))
Simpson, David (North Shore Hospital)
Offner, Fritz (Universitair Ziekenhuis Gent)
Moreno, Carol (Institut d'Investigació Biomèdica Sant Pau)
Dai, Sandra (Pharmacyclics LLC, an AbbVie Company)
Lal, Indu (Pharmacyclics LLC, an AbbVie Company)
Dean, James P. (Pharmacyclics LLC, an AbbVie Company)
Kipps, Thomas J. (UCSD Moores Cancer Center)
Universitat Autònoma de Barcelona

Fecha:	2019
Resumen:	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.
Nota:	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.
Derechos:	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.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Chronic lymphocytic leukaemia ; Targeted therapies
Publicado en:	Leukemia, Vol. 34 (october 2019) , p. 787-798, ISSN 1476-5551

DOI: 10.1038/s41375-019-0602-x
PMID: 31628428

12 p, 1.8 MB

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