Temporary cessation of ibrutinib results in reduced grade 3‐4 infections and durable remissions—Interim analysis of an on‐off‐repeat Phase 1b/2 study in patients with chronic lymphocytic leukemia

Ibrutinib is used continuously in CLL. This phase 1b/2 study interim analysis explored on‐off‐repeat dosing to reduce toxicity. After 12 months, 16/22 patients (73%) remained in first off‐phase irrespective if initial CR/PR or TP53 aberration. Grade 3‐4 infections were reduced from 55% to 5% during...

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Autores principales: Lundin, Jeanette, Mulder, Tom A., Kättström, Magdalena, Wästerlid, Tove, Uddevik, Anders, Mellstedt, Håkan, Heimersson, Kia, Hansson, Lotta, Palma, Marzia, Österborg, Anders
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Short Reports
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9176042/
https://www.ncbi.nlm.nih.gov/pubmed/35844699
http://dx.doi.org/10.1002/jha2.261
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author Lundin, Jeanette
Mulder, Tom A.
Kättström, Magdalena
Wästerlid, Tove
Uddevik, Anders
Mellstedt, Håkan
Heimersson, Kia
Hansson, Lotta
Palma, Marzia
Österborg, Anders
author_facet Lundin, Jeanette
Mulder, Tom A.
Kättström, Magdalena
Wästerlid, Tove
Uddevik, Anders
Mellstedt, Håkan
Heimersson, Kia
Hansson, Lotta
Palma, Marzia
Österborg, Anders
author_sort Lundin, Jeanette
collection PubMed
description Ibrutinib is used continuously in CLL. This phase 1b/2 study interim analysis explored on‐off‐repeat dosing to reduce toxicity. After 12 months, 16/22 patients (73%) remained in first off‐phase irrespective if initial CR/PR or TP53 aberration. Grade 3‐4 infections were reduced from 55% to 5% during a similarly long off‐phase (P < .01). Treg and exhausted T‐cells increased (P = .01). Six patients restarted ibrutinib at early progression and remain drug‐sensitive. Our interim analysis shows a durable off‐phase in most patients, with reduced infections and cost‐saving potential. If toxicity‐driven permanent cessation of ibrutinib will be affected will be explored in the extended study.
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spelling pubmed-91760422022-07-14 Temporary cessation of ibrutinib results in reduced grade 3‐4 infections and durable remissions—Interim analysis of an on‐off‐repeat Phase 1b/2 study in patients with chronic lymphocytic leukemia Lundin, Jeanette Mulder, Tom A. Kättström, Magdalena Wästerlid, Tove Uddevik, Anders Mellstedt, Håkan Heimersson, Kia Hansson, Lotta Palma, Marzia Österborg, Anders EJHaem Short Reports Ibrutinib is used continuously in CLL. This phase 1b/2 study interim analysis explored on‐off‐repeat dosing to reduce toxicity. After 12 months, 16/22 patients (73%) remained in first off‐phase irrespective if initial CR/PR or TP53 aberration. Grade 3‐4 infections were reduced from 55% to 5% during a similarly long off‐phase (P < .01). Treg and exhausted T‐cells increased (P = .01). Six patients restarted ibrutinib at early progression and remain drug‐sensitive. Our interim analysis shows a durable off‐phase in most patients, with reduced infections and cost‐saving potential. If toxicity‐driven permanent cessation of ibrutinib will be affected will be explored in the extended study. John Wiley and Sons Inc. 2021-07-14 /pmc/articles/PMC9176042/ /pubmed/35844699 http://dx.doi.org/10.1002/jha2.261 Text en © 2021 The Authors. eJHaem published by British Society for Haematology and John Wiley & Sons Ltd. https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Short Reports
Lundin, Jeanette
Mulder, Tom A.
Kättström, Magdalena
Wästerlid, Tove
Uddevik, Anders
Mellstedt, Håkan
Heimersson, Kia
Hansson, Lotta
Palma, Marzia
Österborg, Anders
Temporary cessation of ibrutinib results in reduced grade 3‐4 infections and durable remissions—Interim analysis of an on‐off‐repeat Phase 1b/2 study in patients with chronic lymphocytic leukemia
title Temporary cessation of ibrutinib results in reduced grade 3‐4 infections and durable remissions—Interim analysis of an on‐off‐repeat Phase 1b/2 study in patients with chronic lymphocytic leukemia
title_full Temporary cessation of ibrutinib results in reduced grade 3‐4 infections and durable remissions—Interim analysis of an on‐off‐repeat Phase 1b/2 study in patients with chronic lymphocytic leukemia
title_fullStr Temporary cessation of ibrutinib results in reduced grade 3‐4 infections and durable remissions—Interim analysis of an on‐off‐repeat Phase 1b/2 study in patients with chronic lymphocytic leukemia
title_full_unstemmed Temporary cessation of ibrutinib results in reduced grade 3‐4 infections and durable remissions—Interim analysis of an on‐off‐repeat Phase 1b/2 study in patients with chronic lymphocytic leukemia
title_short Temporary cessation of ibrutinib results in reduced grade 3‐4 infections and durable remissions—Interim analysis of an on‐off‐repeat Phase 1b/2 study in patients with chronic lymphocytic leukemia
title_sort temporary cessation of ibrutinib results in reduced grade 3‐4 infections and durable remissions—interim analysis of an on‐off‐repeat phase 1b/2 study in patients with chronic lymphocytic leukemia
topic Short Reports
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9176042/
https://www.ncbi.nlm.nih.gov/pubmed/35844699
http://dx.doi.org/10.1002/jha2.261
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