Extended follow-up and impact of high-risk prognostic factors from the phase 3 RESONATE study in patients with previously treated CLL/SLL
Brown, J.R. (Dana-Farber Cancer Institute (Boston, Estats Units d'Amèrica))
Hillmen, Peter (St James Institute of Oncology)
O'Brien, S. (MD Anderson Cancer Center)
Barrientos, J.C. (Hofstra Northwell School of Medicine)
Reddy, N.M. (Vanderbilt-Ingram Cancer Center)
Coutre, S.E. (Stanford University)
Tam, Constantine S (Peter MacCallum Cancer Centre. St Vincent's Hospital)
Mulligan, S.P. (Royal North Shore Hospital)
Jaeger, U. (Medical University of Vienna)
Barr, P.M. (University of Rochester Cancer Center)
Furman, R.R. (New York Presbyterian Hospital)
Kipps, Thomas J (UCSD Moores Cancer Center)
Cymbalista, F. (Hôpital Avicenne)
Thornton, P. (Beaumont Hospital (Dublín, Irlanda))
Caligaris-Cappio, F. (Universita Vita-Salute San Raffaele)
Delgado, J. (Hospital Clínic i Provincial de Barcelona)
Montillo, M. (Niguarda Hospital)
DeVos, S. (David Geffen School of Medicine at UCLA)
Moreno, Carol (Institut d'Investigació Biomèdica Sant Pau)
Pagel, J.M. (Swedish Cancer Institute)
Munir, Talha (St James Institute of Oncology)
Burger, Jan A (MD Anderson Cancer Center)
Chung, D. (Pharmacyclics LLC. AbbVie Company)
Lin, J. (Pharmacyclics LLC. AbbVie Company)
Gau, L. (Pharmacyclics LLC. AbbVie Company)
Chang, B. (Pharmacyclics LLC. AbbVie Company)
Cole, G. (Pharmacyclics LLC. AbbVie Company)
Hsu, E. (Pharmacyclics LLC. AbbVie Company)
James, D.F. (Pharmacyclics LLC. AbbVie Company)
Byrd, J.C. (Ohio State University)
Universitat Autònoma de Barcelona

Data:	2018
Resum:	In the phase 3 RESONATE study, ibrutinib demonstrated superior progression-free survival (PFS), overall survival (OS) and overall response rate (ORR) compared with ofatumumab in relapsed/refractory CLL patients with high-risk prognostic factors. We report updated results from RESONATE in these traditionally chemotherapy resistant high-risk genomic subgroups at a median follow-up of 19 months. Mutations were detected by Foundation One Heme Panel. Baseline mutations in the ibrutinib arm included TP53 (51%), SF3B1 (31%), NOTCH1 (28%), ATM (19%) and BIRC3 (14%). Median PFS was not reached, with 74% of patients randomized to ibrutinib alive and progression-free at 24 months. The improved efficacy of ibrutinib vs ofatumumab continues in all prognostic subgroups including del17p and del11q. No significant difference within the ibrutinib arm was observed for PFS across most genomic subtypes, although a subset carrying both TP53 mutation and del17p had reduced PFS compared with patients with neither abnormality. Reduced PFS or OS was not evident in patients with only del17p. PFS was significantly better for ibrutinibtreated patients in second-line vs later lines of therapy. The robust clinical activity of ibrutinib continues to show ongoing efficacy and acceptable safety consistent with prior reports, independent of various known high-risk mutations.
Drets:	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.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Publicat a:	Leukemia, Vol. 32 Núm. 1 (january 2018) , p. 83-91, ISSN 1476-5551

DOI: 10.1038/leu.2017.175
PMID: 28592889

9 p, 500.3 KB

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