Haematologica (Sep 2018)

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

  • Paul M. Barr,
  • Tadeusz Robak,
  • Carolyn Owen,
  • Alessandra Tedeschi,
  • Osnat Bairey,
  • Nancy L. Bartlett,
  • Jan A. Burger,
  • Peter Hillmen,
  • Steven Coutre,
  • Stephen Devereux,
  • Sebastian Grosicki,
  • Helen McCarthy,
  • Jianyong Li,
  • David Simpson,
  • Fritz Offner,
  • Carol Moreno,
  • Cathy Zhou,
  • Lori Styles,
  • Danelle James,
  • Thomas J. Kipps,
  • Paolo Ghia

DOI
https://doi.org/10.3324/haematol.2018.192328
Journal volume & issue
Vol. 103, no. 9

Abstract

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Results of RESONATE-2 (PCYC-1115/1116) supported approval of ibrutinib for first-line treatment of chronic lymphocytic leukemia. 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