Evidence map›Paper›PMID 27198718›Full record

ArticleHaematologica2016

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.

Maria Winqvist, Anna Asklid, P O Andersson, Karin Karlsson, Claes Karlsson, Birgitta Lauri, Jeanette Lundin, Mattias Mattsson, Stefan Norin, Anna Sandstedt and 2 more

Abstract read
In one paragraph

Article in Haematologica, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 58 papers.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

58 citing papers in PubMed.

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  11. Fitness in CLL.Cancers · 2026
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  12. Observational
  13. Article
  14. Article
  15. Article
  16. Article
  17. Secondary Hypogammaglobulinemia in Patients with Chronic Lymphocytic Leukemia Receiving Ibrutinib Therapy.Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion · 2022
    Article
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Maria WinqvistDepartment of Hematology, Karolinska University Hospital, Stockholm, Sweden.
Anna AsklidDepartment of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.
P O AnderssonDepartment of Hematology, South Älvsborg Hospital, Borås, Sweden.
Karin KarlssonDepartment of Hematology and Vascular Disorders, Skåne University Hospital, Lund, Sweden.
Claes KarlssonDepartment of Hematology, Karolinska University Hospital, Stockholm, Sweden.
Birgitta LauriDepartment of Hematology, Sunderby Hospital, Sunderbyn Luleå, Sweden.
Jeanette LundinDepartment of Hematology, Karolinska University Hospital, Stockholm, Sweden.
Mattias MattssonDepartment of Hematology, Uppsala University Hospital, Uppsala, Sweden.
Stefan NorinDepartment of Hematology, Karolinska University Hospital, Stockholm, Sweden.
Anna SandstedtDepartment of Hematology, Linköping University Hospital, Linköping, Sweden.
Lotta HanssonDepartment of Hematology, Karolinska University Hospital, Stockholm, Sweden lotta.hansson@karolinska.se.
Anders ÖsterborgDepartment of Hematology, Karolinska University Hospital, Stockholm, Sweden.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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 health-care 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.

Indexed as

AdenineAgedAged, 80 and overAntineoplastic AgentsChromosome AberrationsCompassionate Use TrialsDisease ProgressionDrug Resistance, NeoplasmFemaleHumansKaplan-Meier EstimateLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedNeoplasm StagingPiperidinesAdenineAntineoplastic AgentsibrutinibPiperidinesProtein Kinase InhibitorsPyrazolesPyrimidines

Identifiers

PMID27198718
PMCPMC5479603

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.