Sustained efficacy and detailed clinical follow-up of first-line ibrutinib treatment in older patients with chronic lymphocytic leukemia: Extended phase 3 results from RESONATE-2

PM Barr, T Robak, C Owen, A Tedeschi, O Bairey, NL Bartlett, JA Burger, P Hillmen, S Coutre, S Devereux, S Grosicki, H McCarthy, J Li, D Simpson, F Offner, C Moreno, C Zhou, L Styles, D James, TJ KippsP Ghia

Research output: Contribution to journalArticlepeer-review

Abstract

Results of RESONATE-2 (PCYC-1115/1116) supported approval of ibrutinib for first-line treatment of chronic lymphocytic Rleukemia. Extended analysis of RESONATE-2 was conducted to determine long-term efficacy and safety of ibrutinib in older patients with chronic lymphocytic leukemia. A total of 269 patients aged ≥65 years with previously untreated chronic lymphocytic leukemia without del(17p) were randomized 1:1 to ibrutinib (n=136) or chlorambucil (n=133) on days 1 and 15 of a 28-day cycle for 12 cycles. Median ibrutinib treatment duration was 28.5 months. Ibrutinib significantly prolonged progression-free survival versus chlorambucil (median, not reached vs. 15 months; hazard ratio, 0.12; 95% confidence interval, 0.07-0.20; P
Original languageEnglish
Pages (from-to)1502-1510
Number of pages9
JournalHaematologica
Volume103
Issue number9
DOIs
Publication statusPublished - 2018

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