Chronic myeloid leukemia (CML)-study IV was designed to explore whether treatment with imatinib (IM) at 400 mg/day (n=400) could be optimized by doubling the dose (n=420), adding interferon (IFN) (n=430) or cytarabine (n=158) or using IM after IFN-failure (n=128). From July 2002 to March 2012, 1551 newly diagnosed patients in chronic phase were randomized into a 5-arm study. The study was powered to detect a survival difference of 5% at 5 years. After a median observation time of 9.5 years, 10-year overall survival was 82%, 10-year progression-free survival was 80% and 10-year relative survival was 92%. Survival between IM400 mg and any experimental arm was not different. In a multivariate analysis, risk group, major-route chromosomal aberrations, comorbidities, smoking and treatment center (academic vs other) influenced survival significantly, but not any form of treatment optimization. Patients reaching the molecular response milestones at 3, 6 and 12 months had a significant survival advantage. For responders, monotherapy with IM400 mg provides a close to normal life expectancy independent of the time to response. Survival is more determined by patients' and disease factors than by initial treatment selection. Although improvements are also needed for refractory disease, more life-time can currently be gained by carefully addressing non-CML determinants of survival.

中文翻译：

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伊马替尼作为慢性粒细胞白血病的一线治疗的评估：随机CML研究IV的10年生存结果以及非CML决定因素的影响。

设计慢性粒细胞白血病（CML）-研究IV以探讨是否可以通过将剂量增加一倍（n = 420），添加干扰素（IFN）来优化以400 mg / day（n = 400）的伊马替尼（IM）治疗= 430）或阿糖胞苷（n = 158）或在IFN失败后使用IM（n = 128）。从2002年7月至2012年3月，将1551名新诊断的慢性期患者随机分为5组研究。这项研究能够检测5年生存率5％。在中位观察时间为9.5年之后，10年总生存率为82％，10年无进展生存率为80％，10年相对生存率为92％。IM400 mg与任何实验组之间的存活率没有差异。在多因素分析中，风险组，主要途径的染色体畸变，合并症，吸烟和治疗中心（学术与其他）对生存率有显着影响，但不是任何形式的治疗优化。在3、6和12个月达到分子反应里程碑的患者具有明显的生存优势。对于反应者，IM400 mg的单一疗法可提供接近正常的预期寿命，而与反应时间无关。存活率更多地取决于患者和疾病因素，而不是最初的治疗选择。尽管还需要改善难治性疾病，但目前可以通过谨慎解决非CML生存决定因素来延长寿命。和疾病因素要比通过初始治疗选择。尽管还需要改善难治性疾病，但目前可以通过谨慎解决非CML生存决定因素来延长寿命。和疾病因素要比通过初始治疗选择。尽管还需要改善难治性疾病，但目前可以通过谨慎解决非CML生存决定因素来延长寿命。