Six-year follow-up of patients receiving imatinib for the first-line treatment of chronic myeloid leukemia

Six-year follow-up of patients receiving imatinib for the first-line treatment of chronic myeloid leukemia
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DOI:
10.1038/leu.2009.38
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发表时间:
2009-06-01
期刊:
影响因子:
11.4
通讯作者:
Larson, R. A.
Larson, R. A.
中科院分区:
医学1区
文献类型:
--
作者:
Hochhaus, A.;O'Brien, S. G.;Larson, R. A.

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甲磺酸伊马替尼被认为是慢慢性骨髓性白血病(CML-CP)一线治疗的标准药物。在III期,随机,开放标签的国际随机干扰素与STI571 (IRIS)试验中,先前未治疗的CML-CP患者被随机分配到伊马替尼(n = 553)或干扰素- α (IFN)加阿糖胞苷(n = 553)组。这项为期6年的更新重点是随机接受伊马替尼作为新诊断CML-CP的一线治疗的患者。在研究治疗的第六年,没有疾病进展到加速期(AP)或blast危象(BC)的报告。毒性谱没有变化。累积最佳完全细胞遗传学反应(CCyR)率为82%;所有随机接受伊马替尼并仍在研究治疗的患者中,63%在最后评估时显示CCyR。估计6年无事件生存率为83%,估计从进展到AP和BC的自由率为93%。当仅考虑cml相关死亡时,估计总生存率为88%或95%。IRIS的6年更新强调了伊马替尼作为CML患者一线治疗的有效性和安全性。白血病杂志(2009)23,1054-1061;doi: 10.1038 / leu.2009.38;2009年3月12日在线发布
Imatinib mesylate is considered standard of care for first-line treatment of chronic phase chronic myeloid leukemia (CML-CP). In the phase III, randomized, open-label International Randomized Study of Interferon vs STI571 (IRIS) trial, previously untreated CML-CP patients were randomized to imatinib (n = 553) or interferon-alpha (IFN) plus cytarabine (n = 553). This 6-year update focuses on patients randomized to receive imatinib as first-line therapy for newly diagnosed CML-CP. During the sixth year of study treatment, there were no reports of disease progression to accelerated phase (AP) or blast crisis (BC). The toxicity profile was unchanged. The cumulative best complete cytogenetic response (CCyR) rate was 82%; 63% of all patients randomized to receive imatinib and still on study treatment showed CCyR at last assessment. The estimated event-free survival at 6 years was 83%, and the estimated rate of freedom from progression to AP and BC was 93%. The estimated overall survival was 88%-or 95% when only CML-related deaths were considered. This 6-year update of IRIS underscores the efficacy and safety of imatinib as first-line therapy for patients with CML. Leukemia (2009) 23, 1054-1061; doi: 10.1038/leu.2009.38; published online 12 March 2009