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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
Karolinska University Hospital, Sweden; Karolinska Institute, Sweden.
Karolinska Institute, Sweden; Karolinska University Hospital, Sweden.
South Älvsborg Hospital, Sweden.
Skåne University Hospital, Sweden.
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2016 (English)In: Haematologica, ISSN 0390-6078, E-ISSN 1592-8721, Vol. 101, no 12, p. 1573-1580Article in journal (Refereed) Published
Abstract [en]

Ibrutinib, a Brutons 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 amp;gt;= 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 Richters 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.

Place, publisher, year, edition, pages
FERRATA STORTI FOUNDATION , 2016. Vol. 101, no 12, p. 1573-1580
National Category
Hematology
Identifiers
URN: urn:nbn:se:liu:diva-134790DOI: 10.3324/haematol.2016.144576ISI: 000392584400017PubMedID: 27198718OAI: oai:DiVA.org:liu-134790DiVA, id: diva2:1076999
Note

Funding Agencies|Swedish Cancer Society [15 0894]; Cancer Society in Stockholm [144142, 151313]; King Gustav V Jubilee Fund [144193]; Cancer and Allergy Foundation [150 420, 150 431]; StratCan Karolinska Institutet [2201]; AFA Insurance [130054]; Stockholm County Council, Sweden [20150070]

Available from: 2017-02-24 Created: 2017-02-24 Last updated: 2017-11-29

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Sandstedt, Anna
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Department of Social and Welfare StudiesDepartment of HaematologyFaculty of Medicine and Health Sciences
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