Long-Term Outcomes of Imatinib Treatment for Chronic Myeloid Leukemia.
Long-Term Outcomes of Imatinib Treatment for Chronic Myeloid Leukemia.
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DOI：
10.1056/nejmoa1609324
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发表时间：
2017-03-09
期刊：
影响因子：
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通讯作者：
IRIS Investigators
中科院分区：
文献类型：
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作者：
Hochhaus A;Larson RA;Guilhot F;Radich JP;Branford S;Hughes TP;Baccarani M;Deininger MW;Cervantes F;Fujihara S;Ortmann CE;Menssen HD;Kantarjian H;O'Brien SG;Druker BJ;IRIS Investigators
伊马替尼是一种选择性BCR-ABL 1激酶抑制剂，可改善慢性粒细胞白血病（CML）患者的预后。我们对接受伊马替尼初始治疗的CML患者进行了超过10年的随访，并在此基础上进行了疗效和安全性分析。在这项开放标签、多中心、交叉设计的试验中，我们将新诊断的慢性期CML患者随机分配接受伊马替尼或干扰素α联合阿糖胞苷治疗。长期分析包括总生存率、治疗反应和严重不良事件。中位随访时间为10.9年。考虑到随机分配接受干扰素α +阿糖胞苷治疗的患者交叉率高（65.6%），且这些患者交叉前的治疗持续时间短（中位数为0.8年），当前的分析重点关注随机分配接受伊马替尼治疗的患者。在伊马替尼组的患者中，估计10年总生存率为83.3%。大约一半（48.3%）随机分配至伊马替尼组的患者完成了伊马替尼研究治疗，82.8%的患者获得了完全细胞遗传学缓解。研究者认为与伊马替尼相关的严重不良事件并不常见，最常发生在治疗的第一年。近11年的随访表明，伊马替尼的疗效随着时间的推移而持续，长期服用伊马替尼与不可接受的累积或晚期毒性作用无关。（由Novartis Pharmaceuticals资助; IRIS ClinicalTrials.gov编号，NCT 00006343和NCT 00333840。）
Imatinib, a selective BCR-ABL1 kinase inhibitor, improved the prognosis for patients with chronic myeloid leukemia (CML). We conducted efficacy and safety analyses on the basis of more than 10 years of follow-up in patients with CML who were treated with imatinib as initial therapy. In this open-label, multicenter trial with crossover design, we randomly assigned patients with newly diagnosed CML in the chronic phase to receive either imatinib or interferon alfa plus cytarabine. Long-term analyses included overall survival, response to treatment, and serious adverse events. The median follow-up was 10.9 years. Given the high rate of crossover among patients who had been randomly assigned to receive interferon alfa plus cytarabine (65.6%) and the short duration of therapy before crossover in these patients (median, 0.8 years), the current analyses focused on patients who had been randomly assigned to receive imatinib. Among the patients in the imatinib group, the estimated overall survival rate at 10 years was 83.3%. Approximately half the patients (48.3%) who had been randomly assigned to imatinib completed study treatment with imatinib, and 82.8% had a complete cytogenetic response. Serious adverse events that were considered by the investigators to be related to imatinib were uncommon and most frequently occurred during the first year of treatment. Almost 11 years of follow-up showed that the efficacy of imatinib persisted over time and that long-term administration of imatinib was not associated with unacceptable cumulative or late toxic effects. (Funded by Novartis Pharmaceuticals; IRIS ClinicalTrials.gov numbers, NCT00006343 and NCT00333840.)