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Discontinuation of ...
Discontinuation of tyrosine kinase inhibitor therapy in chronic myeloid leukaemia (EURO-SKI) : a prespecified interim analysis of a prospective, multicentre, non-randomised, trial
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- Saussele, Susanne (författare)
- Heidelberg University,Heidelberg Univ, Dept Haematol & Oncol, Univ Hosp Mannheim, Mannheim, Germany
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- Richter, Johan (författare)
- Skåne University Hospital,Skane Univ Hosp, Dept Haematol Oncol & Radiat Phys, Lund, Sweden
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- Guilhot, Joelle (författare)
- Poitiers University Hospital,Ctr Hosp Univ CHU Poitiers, Ctr Invest Clin 1402, INSERM, Poitiers, France
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- Gruber, Franz X. (författare)
- University Hospital of North Norway,Univ Hosp North Norway, Dept Haematol, Tromso, Norway
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- Hjorth-Hansen, Henrik (författare)
- St. Olav’s University Hospital,St Olavs Hosp, Dept Haematol, Trondheim, Norway
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- Almeida, Antonio (författare)
- Instituto Português de Oncologia do Porto Francisco Gentil (IPO),Inst Portugues Oncol Francisco Gentil, Lisbon, Portugal
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- Janssen, Jeroen J.W.M. (författare)
- Amsterdam UMC - Vrije Universiteit Amsterdam,Vrije Univ Amsterdam Med Ctr, Dept Haematol, Amsterdam, Netherlands,Masaryk Univ, Dept Internal Med Haematol & Oncol, Brno, Czech Republic;Univ Hosp Brno, Brno, Czech Republic,Masaryk University,University Hospital Brno
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- Mayer, Jiri (författare)
- Masaryk University,University Hospital Brno
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- Koskenvesa, Perttu (författare)
- Helsinki University Central Hospital,University of Helsinki,Univ Helsinki, Haematol Res Unit Helsinki, Helsinki, Finland;Helsinki Univ Hosp, Ctr Comprehens Canc, Helsinki, Finland
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- Panayiotidis, Panayiotis (författare)
- National and Kapodistrian University of Athens,Univ Athens, Dept Internal Med 1, Laikon Gen Hosp, Athens, Greece
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- Olsson-Strömberg, Ulla (författare)
- Uppsala universitet,Hematologi,Uppsala University Hospital
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- Martinez-Lopez, Joaquin (författare)
- 12 de Octubre University Hospital,Univ Complutense Madrid, Hosp Univ Octubre 12, Ctr Nacl Invest Oncol, Ctr Invest Biomed Red Canc, Madrid, Spain
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- Rousselot, Philippe (författare)
- Versailles Saint-Quentin-en-Yvelines University,Univ Paris Saclay, Dept Haematol & Oncol, Univ Versailles St Quentin En Yvelines, Ctr Hosp Versailles,Inserm,Unite Mixte Rech 1173, Le Chesnay, France
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- Vestergaard, Hanne (författare)
- Odense University Hospital,Odense Univ Hosp, Dept Haematol, Odense, Denmark
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- Ehrencrona, Hans (författare)
- Lund University,Lunds universitet,Avdelningen för klinisk genetik,Institutionen för laboratoriemedicin,Medicinska fakulteten,Division of Clinical Genetics,Department of Laboratory Medicine,Faculty of Medicine,Off Med Serv, Dept Clin Genet & Pathol, Lab Med, Lund, Sweden;Lund Univ, Div Clin Genet, Lund, Sweden
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- Kairisto, Veli (författare)
- Turku University Hospital,Turku Univ, Cent Hosp, Dept Clin Chem, Turku, Finland;Turku Univ, Cent Hosp, Dept Genet, Turku, Finland
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- Machová Poláková, Katerina (författare)
- Institute of Hematology and Blood Transfusion, Prauge,Inst Hematol & Blood Transfus, Prague, Czech Republic
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- Müller, Martin C. (författare)
- Institute for Hematology and Oncology (IHO),Inst Hematol & Oncol, Mannheim, Germany
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- Mustjoki, Satu (författare)
- University of Helsinki,Helsinki University Central Hospital,Univ Helsinki, Haematol Res Unit Helsinki, Helsinki, Finland;Univ Helsinki, Dept Clin Chem & Haematol, Helsinki, Finland;Helsinki Univ Hosp, Ctr Comprehens Canc, Helsinki, Finland
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- Berger, Marc G. (författare)
- University of Auvergne,CHU Estaing, Hematol Biol & Equipe Accueil Hemopaties Chron He, Clermont Ferrand, France;Univ Clermont Auvergne, Clermont Ferrand, France
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- Fabarius, Alice (författare)
- Heidelberg University,Heidelberg Univ, Dept Haematol & Oncol, Univ Hosp Mannheim, Mannheim, Germany
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- Hofmann, Wolf Karsten (författare)
- Heidelberg University,Heidelberg Univ, Dept Haematol & Oncol, Univ Hosp Mannheim, Mannheim, Germany
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- Hochhaus, Andreas (författare)
- Universitätsklinikum Jena,Univ Klinikum Jena, Klin Innere Med 2, Jena, Germany
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- Pfirrmann, Markus (författare)
- Ludwig-Maximilian University of Munich,Ludwig Maximilians Univ Munchen, Inst Med Informat Verarbeitung Biometrie & Epidem, Munich, Germany
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- Mahon, Francois Xavier (författare)
- University of Bordeaux,Univ Bordeaux, Bergonie Canc Inst, INSERM, Unit 916, Bordeaux, France
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(creator_code:org_t)
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- Elsevier, 2018
- 2018
- Engelska.
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Ingår i: The Lancet Oncology. - : Elsevier. - 1470-2045 .- 1474-5488. ; 19:6, s. 747-757
- Relaterad länk:
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http://dx.doi.org/10...
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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https://urn.kb.se/re...
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Abstract
Ämnesord
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- Background: Tyrosine kinase inhibitors (TKIs) have improved the survival of patients with chronic myeloid leukaemia. Many patients have deep molecular responses, a prerequisite for TKI therapy discontinuation. We aimed to define precise conditions for stopping treatment. Methods: In this prospective, non-randomised trial, we enrolled patients with chronic myeloid leukaemia at 61 European centres in 11 countries. Eligible patients had chronic-phase chronic myeloid leukaemia, had received any TKI for at least 3 years (without treatment failure according to European LeukemiaNet [ELN] recommendations), and had a confirmed deep molecular response for at least 1 year. The primary endpoint was molecular relapse-free survival, defined by loss of major molecular response (MMR; >0·1% BCR-ABL1 on the International Scale) and assessed in all patients with at least one molecular result. Secondary endpoints were a prognostic analysis of factors affecting maintenance of MMR at 6 months in learning and validation samples and the cost impact of stopping TKI therapy. We considered loss of haematological response, progress to accelerated-phase chronic myeloid leukaemia, or blast crisis as serious adverse events. This study presents the results of the prespecified interim analysis, which was done after the 6-month molecular relapse-free survival status was known for 200 patients. The study is ongoing and is registered with ClinicalTrials.gov, number NCT01596114. Findings: Between May 30, 2012, and Dec 3, 2014, we assessed 868 patients with chronic myeloid leukaemia for eligibility, of whom 758 were enrolled. Median follow-up of the 755 patients evaluable for molecular response was 27 months (IQR 21–34). Molecular relapse-free survival for these patients was 61% (95% CI 57–64) at 6 months and 50% (46–54) at 24 months. Of these 755 patients, 371 (49%) lost MMR after TKI discontinuation, four (1%) died while in MMR for reasons unrelated to chronic myeloid leukaemia (myocardial infarction, lung cancer, renal cancer, and heart failure), and 13 (2%) restarted TKI therapy while in MMR. A further six (1%) patients died in chronic-phase chronic myeloid leukaemia after loss of MMR and re-initiation of TKI therapy for reasons unrelated to chronic myeloid leukaemia, and two (<1%) patients lost MMR despite restarting TKI therapy. In the prognostic analysis in 405 patients who received imatinib as first-line treatment (learning sample), longer treatment duration (odds ratio [OR] per year 1·14 [95% CI 1·05–1·23]; p=0·0010) and longer deep molecular response durations (1·13 [1·04–1·23]; p=0·0032) were associated with increasing probability of MMR maintenance at 6 months. The OR for deep molecular response duration was replicated in the validation sample consisting of 171 patients treated with any TKI as first-line treatment, although the association was not significant (1·13 [0·98–1·29]; p=0·08). TKI discontinuation was associated with substantial cost savings (an estimated €22 million). No serious adverse events were reported. Interpretation: Patients with chronic myeloid leukaemia who have achieved deep molecular responses have good molecular relapse-free survival. Such patients should be considered for TKI discontinuation, particularly those who have been in deep molecular response for a long time. Stopping treatment could spare patients from treatment-induced side-effects and reduce health expenditure. Funding: ELN Foundation and France National Cancer Institute.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
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Saussele, Susann ...
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Richter, Johan
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Guilhot, Joelle
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Gruber, Franz X.
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Hjorth-Hansen, H ...
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Almeida, Antonio
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visa fler...
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Janssen, Jeroen ...
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Mayer, Jiri
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Koskenvesa, Pert ...
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Panayiotidis, Pa ...
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Olsson-Strömberg ...
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Martinez-Lopez, ...
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Rousselot, Phili ...
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Vestergaard, Han ...
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Ehrencrona, Hans
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Kairisto, Veli
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Machová Poláková ...
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Müller, Martin C ...
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Mustjoki, Satu
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Berger, Marc G.
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Fabarius, Alice
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Hofmann, Wolf Ka ...
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Hochhaus, Andrea ...
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Pfirrmann, Marku ...
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Mahon, Francois ...
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Cancer och onkol ...
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The Lancet Oncol ...
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Lunds universitet
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Uppsala universitet