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Real-world results ...
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
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- Winqvist, Maria (author)
- Karolinska Institutet
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- Asklid, Anna (author)
- Karolinska Institutet
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- Andersson, P. O. (author)
- South Älvsborg Hospital, Sweden
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- Karlsson, Karin (author)
- Skåne University Hospital, Sweden
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- Karlsson, Claes (author)
- Karolinska Institutet
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- Lauri, Birgitta (author)
- Sunderby Hospital, Sweden
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- Lundin, Jeanette (author)
- Karolinska Institutet
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- Mattsson, Mattias (author)
- Uppsala universitet,Hematologi,University of Uppsala Hospital, Sweden
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- Norin, Stefan (author)
- Karolinska Institutet
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- Sandstedt, Anna (author)
- Linköpings universitet,Institutionen för samhälls- och välfärdsstudier,Medicinska fakulteten,Region Östergötland, Hematologiska kliniken US
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- Hansson, Lotta (author)
- Karolinska Institutet
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- Osterborg, Anders (author)
- Karolinska University Hospital, Sweden; Karolinska Institute, Sweden
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(creator_code:org_t)
- 2016-05-19
- 2016
- English.
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In: Haematologica. - : FERRATA STORTI FOUNDATION. - 0390-6078 .- 1592-8721. ; 101:12, s. 1573-1580
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https://doi.org/10.3...
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Abstract
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Hematologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Hematology (hsv//eng)
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Winqvist, Maria
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Asklid, Anna
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Andersson, P. O.
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Karlsson, Karin
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Karlsson, Claes
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Lauri, Birgitta
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Lundin, Jeanette
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Mattsson, Mattia ...
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Norin, Stefan
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Sandstedt, Anna
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Hansson, Lotta
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Osterborg, Ander ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Hematology
- Articles in the publication
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Haematologica
- By the university
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Linköping University
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Uppsala University
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Karolinska Institutet