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Long-Term Follow-Up of the French Stop Imatinib (STIM1) Study in Patients With Chronic Myeloid Leukemia
Gabriel Etienne1, Joëlle Guilhot1, Delphine Rea1
1Gabriel Etienne and François-Xavier Mahon, Institut Bergonié, Bordeaux; Joëlle Guilhot and François Guilhot, Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Universitaire (CHU) de Poitiers, Poitiers; Delphine Rea, Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris (AP-HP); Bruno Varet, Hôpital Necker, AP-HP et Université Paris Descartes, Paris; Françoise Rigal-Huguet, Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse; Franck Nicolini, Centre Hospitalier Lyon Sud, Pierre Bénite; Aude Charbonnier, Institut Paoli Calmette, Marseille; Agnès Guerci-Bresler, CHU Brabois Vandoeuvre, Nancy; Laurence Legros, Hôpital de l'Archet, Centre Hospitalier Universitaire de Nice, Nice; Martine Gardembas, CHU d'Angers, Angers; Viviane Dubruille, CHU Hôtel-Dieu, Nantes; Michel Tulliez, Hôpital Henri Mondor, Créteil; Marie-Pierre Noel, Hôpital Claude Huriez, Centre Hospitalier Regional Universitaire de Lille, Lille; Jean-Christophe Ianotto, CHU Morvan, Brest; Bruno Villemagne, Centre Hospitalier Départemental La Roche-Sur-Yon, La Roche-Sur-Yon; Martin Carré, Hôpital Albert Michallon, CHU de Grenoble, Grenoble; Philippe Rousselot, Hôpital André Mignot, Le Chesnay; and François-Xavier Mahon, CHU de Bordeaux, INSERM U1218, Bordeaux, France.
Abstract:
Purpose Imatinib (IM) can safely be discontinued in patients with chronic myeloid leukemia (CML) who have had undetectable minimal residual disease (UMRD) for at least 2 years. We report the final results of the Stop Imatinib (STIM1) study with a long follow-up. Patients and Methods IM was prospectively discontinued in 100 patients with CML with UMRD sustained for at least 2 years. Molecular recurrence (MR) was defined as positivity of BCR-ABL transcript in a quantitative reverse transcriptase polymerase chain reaction assay confirmed by a second analysis point that indicated an increase of one log in relation to the first analysis point at two successive assessments or loss of major molecular response at one point. Results The median molecular follow-up after treatment discontinuation was 77 months (range, 9 to 95 months). Sixty-one patients lost UMRD after a median of 2.5 months (range, 1 to 22 months), and one patient died with UMRD at 10 months. Molecular recurrence-free survival was 43% (95% CI, 33% to 52%) at 6 months and 38% (95% CI, 29% to 47%) at 60 months. Treatment was restarted in 57 of 61 patients with MR, and 55 patients achieved a second UMRD with a median time of 4 months (range, 1 to 16 months). None of the patients experienced a CML progression. Analyses of the characteristics of the study population identified that the Sokal risk score and duration of IM treatment were significantly associated with the probability of MR. Conclusion With a median follow-up of more than 6 years after treatment discontinuation, the STIM1 study demonstrates that IM can safely be discontinued in patients with a sustained deep molecular response with no late MR.
