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Blood, 1 January 2007, Vol. 109, No. 1, pp. 58-60.
Prepublished online as a Blood First Edition Paper on September 14, 2006; DOI 10.1182/blood-2006-03-011239.
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CLINICAL TRIALS AND OBSERVATIONS
Brief report
Imatinib mesylate discontinuation in patients with chronic myelogenous leukemia in complete molecular remission for more than 2 years
Philippe Rousselot1,2,
Francoise Huguet3,
Delphine Rea1,
Laurence Legros4,
Jean Michel Cayuela5,
Odile Maarek5,
Odile Blanchet6,
Gerald Marit7,
Eliane Gluckman1,
Josy Reiffers8,
Martine Gardembas9,
François-Xavier Mahon10,, The Intergroupe Français des Leucémies Myéloïdes Chronique (FI LMC)
1 Fédération d'hématologie et Centre d'Investigation Clinique, Hôpital Saint-Louis, Paris, France;
2 Service d'Hématologie et d'Oncologie, Hôpital Mignot, Versailles, France;
3 Service d'Hématologie, Hôpital de Purpan, Toulouse, France;
4 Service d'hématologie, Hôpital Larchet, Nice, France;
5 Laboratoire Central d'Hématologie, Institut National de la Santé et de la Recherche Médicale (INSERM) Unité (U) 728, Hôpital Saint-Louis, Paris, France;
6 Laboratoire d'hématologie, Centre Hospitalo-Universitaire (CHU) d'Angers, France;
7 Service des Maladies du Sang, CHU du Haut Lévèque, Pessac, France;
8 Institut Bergonié, Bordeaux, France;
9 Service d'Hématologie, CHU d'Angers, France;
10 Laboratoire Hématopoïèse normale et leucemique, Université Victor Ségalen Bordeaux 2, INSERM E217, France
In the present study, we address the issue of the discontinuation of imatinib mesylate (Gleevec) in chronic myelogenous leukemia with undetectable residual disease for more than 2 years. Twelve patients were included. The median duration of real-time quantitativepolymerase chain reaction (RTQ-PCR) negativity and imatinib therapy were, respectively, 32 months (range, 24-46 months) and 45 months (range, 32-56 months) before imatinib interruption. Six patients displayed a molecular relapse with a detectable BCR-ABL transcript at 1, 1, 2, 3, 4, and 5 months. Imatinib was then reintroduced and led to a novel molecular response in most patients. Six other patients (50%) still have an undetectable level of BCR-ABL transcript after a median follow-up of 18 months (range, 9-24 months). We hypothesize that relapses observed within 6 months reflect the kinetics of undetectable dividing chronic myelogenous leukemia (CML) cells. Those cells may be eradicated or controlled in long-term nonrelapsing patients, as described in our study.

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