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 Kipps; P Ghia

doi:10.3324/haematol.2018.192328

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

IRCCS Ospedale San Raffaele

Research output: Contribution to journal › Article › peer-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 language	English
Pages (from-to)	1502-1510
Number of pages	9
Journal	Haematologica
Volume	103
Issue number	9
DOIs	https://doi.org/10.3324/haematol.2018.192328
Publication status	Published - 2018

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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., ... 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, 103(9), 1502-1510. https://doi.org/10.3324/haematol.2018.192328

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 journal › Article › peer-review

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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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",

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AU - Robak, T

AU - Owen, C

AU - Tedeschi, A

AU - Bairey, O

AU - Bartlett, NL

AU - Burger, JA

AU - Hillmen, P

AU - Coutre, S

AU - Devereux, S

AU - Grosicki, S

AU - McCarthy, H

AU - Li, J

AU - Simpson, D

AU - Offner, F

AU - Moreno, C

AU - Zhou, C

AU - Styles, L

AU - James, D

AU - Kipps, TJ

AU - Ghia, P

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AB - 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

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DO - 10.3324/haematol.2018.192328

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