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Real-world results of ibrutinib in patients with relapsed or refractory chronic lymphocytic leukemia : Data from 95 consecutive patients treated in a compassionate use program. A study from the swedish chronic lymphocytic leukemia group

Winqvist, Maria; Asklid, Anna; Andersson, P. O. LU ; Karlsson, Karin LU ; Karlsson, Claes; Lauri, Birgitta; Lundin, Jeanette; Mattsson, Mattias; Norin, Stefan and Sandstedt, Anna, et al. (2016) In Haematologica 101(12). p.1573-1580
Abstract

Ibrutinib, a Bruton’s tyrosine kinase inhibitor is approved for relapsed/refractory and del(17p)/TP53 mutated chronic lymphocytic leukemia. Discrepancies between clinical trials and routine healthcare are commonly observed in oncology. Herein we report real-world results for 95 poor prognosis Swedish patients treated with ibrutinib in a compassionate use program. Ninety-five consecutive patients (93 chronic lymphocytic leukemia, 2 small lymphocytic leukemia) were included in the study between May 2014 and May 2015. The median age was 69 years. 63% had del(17p)/TP53 mutation, 65% had Rai stage III/IV, 28% had lymphadenopathy ≥10cm. Patients received ibrutinib 420 mg once daily until progression. At a median follow-up of 10. 2 months, the... (More)

Ibrutinib, a Bruton’s tyrosine kinase inhibitor is approved for relapsed/refractory and del(17p)/TP53 mutated chronic lymphocytic leukemia. Discrepancies between clinical trials and routine healthcare are commonly observed in oncology. Herein we report real-world results for 95 poor prognosis Swedish patients treated with ibrutinib in a compassionate use program. Ninety-five consecutive patients (93 chronic lymphocytic leukemia, 2 small lymphocytic leukemia) were included in the study between May 2014 and May 2015. The median age was 69 years. 63% had del(17p)/TP53 mutation, 65% had Rai stage III/IV, 28% had lymphadenopathy ≥10cm. Patients received ibrutinib 420 mg once daily until progression. At a median follow-up of 10. 2 months, the overall response rate was 84% (consistent among subgroups) and 77% remained progression-free. Progression-free survival and overall survival were significantly shorter in patients with del(17p)/TP53 mutation (P=0. 017 and P=0. 027, log-rank test); no other factor was significant in Cox proportional regression hazards model. Ibrutinib was well tolerated. Hematomas occurred in 46% of patients without any major bleeding. Seven patients had Richter's transformation. This real-world analysis on consecutive chronic lymphocytic leukemia patients from a well-defined geographical region shows the efficacy and safety of ibrutinib to be similar to that of pivotal trials. Yet, del(17p)/TP53 mutation remains a therapeutic challenge. Since not more than half of our patients would have qualified for the pivotal ibrutinib trial (RESONATE), our study emphasizes that real-world results should be carefully considered in future with regards to new agents and new indications in chronic lymphocytic leukemia.

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publication status
published
subject
keywords
refractory chronic lymphocytic leukemia
in
Haematologica
volume
101
issue
12
pages
8 pages
publisher
Ferrata Storti Foundation
external identifiers
  • scopus:85002378033
ISSN
0390-6078
DOI
10.3324/haematol.2016.144576
language
English
LU publication?
no
id
6b92b2cb-ee47-4cef-9a8d-11313f79d25b
date added to LUP
2016-12-29 12:34:06
date last changed
2017-11-05 05:11:43
@article{6b92b2cb-ee47-4cef-9a8d-11313f79d25b,
  abstract     = {<p>Ibrutinib, a Bruton’s tyrosine kinase inhibitor is approved for relapsed/refractory and del(17p)/TP53 mutated chronic lymphocytic leukemia. Discrepancies between clinical trials and routine healthcare are commonly observed in oncology. Herein we report real-world results for 95 poor prognosis Swedish patients treated with ibrutinib in a compassionate use program. Ninety-five consecutive patients (93 chronic lymphocytic leukemia, 2 small lymphocytic leukemia) were included in the study between May 2014 and May 2015. The median age was 69 years. 63% had del(17p)/TP53 mutation, 65% had Rai stage III/IV, 28% had lymphadenopathy ≥10cm. Patients received ibrutinib 420 mg once daily until progression. At a median follow-up of 10. 2 months, the overall response rate was 84% (consistent among subgroups) and 77% remained progression-free. Progression-free survival and overall survival were significantly shorter in patients with del(17p)/TP53 mutation (P=0. 017 and P=0. 027, log-rank test); no other factor was significant in Cox proportional regression hazards model. Ibrutinib was well tolerated. Hematomas occurred in 46% of patients without any major bleeding. Seven patients had Richter's transformation. This real-world analysis on consecutive chronic lymphocytic leukemia patients from a well-defined geographical region shows the efficacy and safety of ibrutinib to be similar to that of pivotal trials. Yet, del(17p)/TP53 mutation remains a therapeutic challenge. Since not more than half of our patients would have qualified for the pivotal ibrutinib trial (RESONATE), our study emphasizes that real-world results should be carefully considered in future with regards to new agents and new indications in chronic lymphocytic leukemia.</p>},
  author       = {Winqvist, Maria and Asklid, Anna and Andersson, P. O. and Karlsson, Karin and Karlsson, Claes and Lauri, Birgitta and Lundin, Jeanette and Mattsson, Mattias and Norin, Stefan and Sandstedt, Anna and Hansson, Lotta and Österborg, Anders},
  issn         = {0390-6078},
  keyword      = { refractory chronic lymphocytic leukemia},
  language     = {eng},
  number       = {12},
  pages        = {1573--1580},
  publisher    = {Ferrata Storti Foundation},
  series       = {Haematologica},
  title        = {Real-world results of ibrutinib in patients with relapsed or refractory chronic lymphocytic leukemia : Data from 95 consecutive patients treated in a compassionate use program. A study from the swedish chronic lymphocytic leukemia group},
  url          = {http://dx.doi.org/10.3324/haematol.2016.144576},
  volume       = {101},
  year         = {2016},
}