Gabriel 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.
J Clin Oncol. 2017 Jan 20;35(3):298-305. doi: 10.1200/JCO.2016.68.2914. Epub 2016 Oct 31.
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.
对于慢性髓性白血病（CML）患者，在达到至少 2 年的不可检测微小残留疾病（UMRD）后，伊马替尼（IM）可安全停药。我们报告了具有长期随访的停止伊马替尼（STIM1）研究的最终结果。
前瞻性地停止了 100 例 CML 患者的 IM 治疗，这些患者的 UMRD 持续至少 2 年。分子复发（MR）定义为在定量逆转录聚合酶链反应（qRT-PCR）检测中 BCR-ABL 转录本阳性，该检测由第二个分析点确认，该分析点表明与前一个分析点相比，在连续两次评估中增加了一个对数，或者在一个点上失去了主要的分子反应。
停药后分子随访的中位数为 77 个月（范围，9 至 95 个月）。61 例患者在中位数为 2.5 个月（范围，1 至 22 个月）后失去了 UMRD，1 例患者在 10 个月时因 UMRD 死亡。6 个月时无分子复发生存（MFS）为 43%（95%CI，33%至 52%），60 个月时为 38%（95%CI，29%至 47%）。57 例 MR 患者中，55 例患者在中位时间为 4 个月（范围，1 至 16 个月）后再次达到 UMRD，并重新开始治疗。没有患者发生 CML 进展。对研究人群特征的分析表明，Sokal 风险评分和 IM 治疗的持续时间与 MR 的可能性显著相关。
在停药后中位随访超过 6 年的情况下，STIM1 研究表明，在持续深度分子反应且无晚期 MR 的患者中，IM 可安全停药。
