Five-year follow-up of patients receiving imatinib for chronic myeloid leukemia
Five-year follow-up of patients receiving imatinib for chronic myeloid leukemia
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DOI：
10.1056/nejmoa062867
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发表时间：
2006-12-07
影响因子：
158.5
通讯作者：
Larson, Richard A.
中科院分区：
文献类型：
--
作者：
Druker, Brian J.;Guilhot, Francois;Larson, Richard A.
背景：慢性粒细胞白血病（CML）的病因是一种组成性激活的BCR-ABL酪氨酸激酶。伊马替尼抑制这种激酶，在一项短期研究中，对于新诊断的慢性期CML，伊马替尼优于干扰素α +阿糖胞苷。5年来，我们随访了接受伊马替尼作为初始治疗的CML患者。方法：我们随机分配553例患者接受伊马替尼治疗，553例患者接受α-干扰素加阿糖胞苷治疗，然后评估他们的总体和无事件生存率;进展为加速期CML或急变期;血液学、细胞遗传学和分子学反应;和不良事件。结果：中位随访时间为60个月。接受伊马替尼治疗的患者的累积最佳完全细胞遗传学缓解率的Kaplan-Meier估计值在12个月时为69%，在60个月时为87%。估计有7%的患者进展为加速期CML或急变，接受伊马替尼作为初始治疗的患者的估计总生存率为60个月时的89%。细胞遗传学完全缓解或BCR-ABL转录水平下降至少3 log的患者与无细胞遗传学完全缓解的患者相比，疾病进展的风险显著降低（P
BACKGROUND:The cause of chronic myeloid leukemia (CML) is a constitutively active BCR-ABL tyrosine kinase. Imatinib inhibits this kinase, and in a short-term study was superior to interferon alfa plus cytarabine for newly diagnosed CML in the chronic phase. For 5 years, we followed patients with CML who received imatinib as initial therapy.METHODS:We randomly assigned 553 patients to receive imatinib and 553 to receive interferon alfa plus cytarabine and then evaluated them for overall and event-free survival; progression to accelerated-phase CML or blast crisis; hematologic, cytogenetic, and molecular responses; and adverse events.RESULTS:The median follow-up was 60 months. Kaplan-Meier estimates of cumulative best rates of complete cytogenetic response among patients receiving imatinib were 69% by 12 months and 87% by 60 months. An estimated 7% of patients progressed to accelerated-phase CML or blast crisis, and the estimated overall survival of patients who received imatinib as initial therapy was 89% at 60 months. Patients who had a complete cytogenetic response or in whom levels of BCR-ABL transcripts had fallen by at least 3 log had a significantly lower risk of disease progression than did patients without a complete cytogenetic response (P