Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial.

Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial.

MedLine Citation:	PMID: 20965785 Owner: NLM Status: MEDLINE
Abstract/OtherAbstract:	BACKGROUND: Imatinib treatment significantly improves survival in patients with chronic myeloid leukaemia (CML), but little is known about whether treatment can safely be discontinued in the long term. We aimed to assess whether imatinib can be discontinued without occurrence of molecular relapse in patients in complete molecular remission (CMR) while on imatinib. METHODS: In our prospective, multicentre, non-randomised Stop Imatinib (STIM) study, imatinib treatment (of >2 years duration) was discontinued in patients with CML who were aged 18 years and older and in CMR (>5-log reduction in BCR-ABL and ABL levels and undetectable transcripts on quantitative RT-PCR). Patients who had undergone immunomodulatory treatment (apart from interferon α), treatment for other malignancies, or allogeneic haemopoietic stem-cell transplantation were not included. Patients were enrolled at 19 participating institutions in France. In this interim analysis, rate of relapse was assessed by use of RT-PCR for patients with at least 12 months of follow-up. Imatinib was reintroduced in patients who had molecular relapse. This study is registered with ClinicalTrials.gov, number NCT00478985. FINDINGS: 100 patients were enrolled between July 9, 2007, and Dec 17, 2009. Median follow-up was 17 months (range 1-30), and 69 patients had at least 12 months follow-up (median 24 months, range 13-30). 42 (61%) of these 69 patients relapsed (40 before 6 months, one patient at month 7, and one at month 19). At 12 months, the probability of persistent CMR for these 69 patients was 41% (95% CI 29-52). All patients who relapsed responded to reintroduction of imatinib: 16 of the 42 patients who relapsed showed decreases in their BCR-ABL levels, and 26 achieved CMR that was sustained after imatinib rechallenge. INTERPRETATION: Imatinib can be safely discontinued in patients with a CMR of at least 2 years duration. Imatinib discontinuation in this setting yields promising results for molecular relapse-free survival, raising the possibility that, at least in some patients, CML might be cured with tyrosine kinase inhibitors.

Authors:	François-Xavier Mahon; Delphine Réa; Joëlle Guilhot; François Guilhot; Françoise Huguet; Franck Nicolini; Laurence Legros; Aude Charbonnier; Agnès Guerci; Bruno Varet; Gabriel Etienne; Josy Reiffers; Philippe Rousselot;
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Publication Detail:	Type: Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't Date: 2010-10-19
Journal Detail:	Title: The lancet oncology Volume: 11 ISSN: 1474-5488 ISO Abbreviation: Lancet Oncol. Publication Date: 2010 Nov
Date Detail:	Created Date: 2010-11-05 Completed Date: 2010-12-07 Revised Date: 2011-04-08
Medline Journal Info:	Nlm Unique ID: 100957246 Medline TA: Lancet Oncol Country: England
Other Details:	Languages: eng Pagination: 1029-35 Citation Subset: IM
Copyright Information:	Copyright © 2010 Elsevier Ltd. All rights reserved.
Affiliation:	Laboratoire d'Hématologie et Service des Maladies du Sang, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France. francois-xavier.mahon@umr5540.u-bordeaux2.fr
Data Bank Information
Bank Name/Acc. No.:	ClinicalTrials.gov/NCT00478985
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MeSH Terms
Descriptor/Qualifier:	Adult Aged Aged, 80 and over Antineoplastic Agents / administration & dosage* Drug Administration Schedule Female France Fusion Proteins, bcr-abl / antagonists & inhibitors, genetics Gene Expression Regulation, Leukemic Humans Kaplan-Meier Estimate Leukemia, Myelogenous, Chronic, BCR-ABL Positive / drug therapy, enzymology, genetics, mortality Male Middle Aged Piperazines / administration & dosage Prospective Studies Protein Kinase Inhibitors / administration & dosage* Proto-Oncogene Proteins c-abl / antagonists & inhibitors, genetics Pyrimidines / administration & dosage* Recurrence Remission Induction Reverse Transcriptase Polymerase Chain Reaction Survival Rate Time Factors Treatment Outcome
Chemical
Reg. No./Substance:	0/Antineoplastic Agents; 0/Fusion Proteins, bcr-abl; 0/Piperazines; 0/Protein Kinase Inhibitors; 0/Pyrimidines; 0/abl-bcr fusion protein, human; 152459-95-5/imatinib; EC 2.7.10.2/Proto-Oncogene Proteins c-abl
Comments/Corrections
Comment In:	Lancet Oncol. 2010 Nov;11(11):1010-1 [PMID: 20965784 ] Nat Rev Clin Oncol. 2011 Mar;8(3):127-8 [PMID: 21283128 ] Lancet Oncol. 2011 Feb;12(2):118 [PMID: 21277547 ]

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