文献标题：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
文献出处：Lancet Oncol,2010.11
期刊影响因子：14.470
文献类型：Research Support
伊马替尼治疗可显著改善慢性髓系白血病(CML)患者的生存，但尚不清楚长期治疗中能否安全停药。文章旨在评价获完全分子学缓解（CMR）的患者使用伊马替尼治疗时能否停药而不伴分子学复发，本文最新发表在《The Lancet Oncology》杂志上。
本项前瞻性多中心非随机化伊马替尼停药（STIM）研究中，18岁及以上获CMR（BCR—ABL 与 ABL水平下降 >5-log 水平，且转录本定量RT-PCR不能检出）已使用伊马替尼治疗>2年的CML患者中断伊马替尼治疗。排除标准：接受过免疫调理治疗（干扰素α除外）、其它恶性肿瘤治疗或异基因造血干细胞移植的患者。患者纳入法国19个参与机构中。期中分析，应用RT-PCR随访至少12个月评价复发率。出现分子学复发的患者，再次应用伊马替尼。本研究已在ClinicalTrials.gov注册，注册号 NCT00478985。
纳入2007年7月9日至2009年12月17日共100例患者。中位随访时间17月（范围1-30），69例患者至少随访12月（中位24月，范围13—30）。 上述69例患者中42 （61%）例患者复发（40例于前6月、1例于第7月、1例于第19月复发）。第12月，69例患者中顽固性CMR率为41% （95% CI 29—52）。所有复发患者再次应用伊马替尼治疗有效：复发的42例患者再次应用伊马替尼治疗后16例BCR—ABL 水平下降，26例 获持续CMR。
已获CMR达2年及以上的患者可安全停用伊马替尼。本试验场所进行的伊马替尼停药后无分子学复发生存结局良好，提出酪氨酸激酶抑制剂可治愈CML（至少部分患者）的可能。
医脉通推荐英文摘要
Lancet Oncol. 2010 Nov;11(11):1029-1035.
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
Mahon FX, Réa D, Guilhot J, Guilhot F, Huguet F, Nicolini F
（Laboratoire d'Hématologie et Service des Maladies du Sang, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France; Université Victor Ségalen Bordeaux 2, Bordeaux, France; INSERM U876, Bordeaux, France.）
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.
Funding
French Ministry of Health (Programme Hospitalier de Recherche 2006 grants), Institut National du Cancer (INCA).
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