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 journalArticle

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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B-Cell Chronic Lymphocytic Leukemia
Chlorambucil
Therapeutics
Disease-Free Survival
PCI 32765
Confidence Intervals
Safety

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

In: Haematologica, Vol. 103, No. 9, 2018, p. 1502-1510.

Research output: Contribution to journalArticle

Barr, PM, Robak, T, Owen, C, Tedeschi, A, Bairey, O, Bartlett, NL, Burger, JA, Hillmen, P, Coutre, S, Devereux, S, Grosicki, S, McCarthy, H, Li, J, Simpson, D, Offner, F, Moreno, C, Zhou, C, Styles, L, James, D, Kipps, TJ & Ghia, P 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', Haematologica, vol. 103, no. 9, pp. 1502-1510. https://doi.org/10.3324/haematol.2018.192328
Barr, PM ; Robak, T ; Owen, C ; Tedeschi, A ; Bairey, O ; Bartlett, NL ; Burger, JA ; Hillmen, P ; Coutre, S ; Devereux, S ; Grosicki, S ; McCarthy, H ; Li, J ; Simpson, D ; Offner, F ; Moreno, C ; Zhou, C ; Styles, L ; James, D ; Kipps, TJ ; Ghia, P. / 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. In: Haematologica. 2018 ; Vol. 103, No. 9. pp. 1502-1510.
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AU - Bairey, O

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AU - Burger, JA

AU - Hillmen, P

AU - Coutre, S

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AU - McCarthy, H

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AU - Simpson, D

AU - Offner, F

AU - Moreno, C

AU - Zhou, C

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AU - Ghia, P

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