Evidence map›Paper›PMID 36103041›Full record

ArticleClinical hematology international2022

FIRE Study: Real-World Effectiveness and Safety of Ibrutinib in Clinical Practice in Patients with CLL and MCL.

Caroline Dartigeas, Borhane Slama, Margaret Doyle, Christoph Tapprich, Claire Albrecht, Sandrine Dupuis, Robert Wapenaar, Charlotte Schmidt-Hieber, Veronique Leblond

Registry-linked trialOpen access · diamondAbstract read
In one paragraph

Article in Clinical hematology international, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03425591 (A Retro-Prospective Observational Study of Ibrutinib Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 11% of its field
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.

NCT03425591 completednot on this map

A Retro-Prospective Observational Study of Ibrutinib Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice

TypeobservationalSponsorJanssen-Cilag Ltd.Ran2016 to 2022Enrolled508ConditionsLeukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-CellArmsIbrutinib
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Observational
  6. Article
  7. 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

9 authors at 8 institutions in 4 countries.

Caroline DartigeasService Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Tours, France. C.DARTIGEAS@chu-tours.fr.
Borhane SlamaCH Henri Duffaut, Avignon, France.
Margaret DoyleJanssen Sciences Ireland, Dublin, Ireland.
Christoph TapprichEMEA Medical Affairs, Janssen-Cilag, Neuss, Germany.
Claire AlbrechtJanssen France, Issy-les-Moulineaux, France.
Sandrine DupuisJanssen France, Issy-les-Moulineaux, France.
Robert WapenaarJanssen-Cilag B.V., Breda, The Netherlands.
Charlotte Schmidt-HieberAPHP, Hôpital Saint-Louis, Hemato-Oncologie, Université de Paris, Paris, France.
Veronique LeblondHematology Department, Hopital Pitie-Salpêtrière, Paris, France.
Janssen (France) · FRCentre Hospitalier Universitaire de Tours · FRHenri Gastaut Hospital · FRHôpital Saint-Louis · FRJanssen (Germany) · DEJanssen (Ireland) · IEJanssen (Netherlands) · NLSorbonne Université · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The FIRE study investigated the real-world effectiveness and safety of ibrutinib in prospectively observed patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and mantle cell lymphoma (MCL) in France. Patients were mostly relapsed/refractory with high-risk features. First-line CLL/SLL patients had del17p and/or TP53 mutations. In this interim analysis, the median follow-up time for patients with CLL/SLL and MCL was 17.7 and 15.1 months, respectively. In the effectiveness populations for CLL/SLL (n = 200) and MCL (n = 59), the median progression-free survival was not estimable and 12.4 months, respectively; the 12-month overall survival rates were 88.5% and 65.8%, respectively. Treatment-emergent adverse events of interest for patients with CLL/SLL (n = 202) and MCL (n = 59) included: infections and infestations (53.5% and 32.2%), major bleeding (5.0% and 5.1%), and atrial fibrillation (5.9% and 8.5%); 135 (66.8%) and 20 (33.9%) patients were continuing treatment at the time of data cutoff. Future analyses will report on longer-term follow-up (Trial registration: ClinicalTrials.gov, NCT03425591. Registered 1 February 2018-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03425591 ).

Indexed as

Chronic lymphocytic leukemiaEffectivenessIbrutinibMantle cell lymphomaReal-world evidenceSafety

Identifiers

PMID36103041
PMCPMC9492818
OpenAlexW4295679005

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.