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首页> 美国卫生研究院文献>Blood >Clinical Trials and Observations: Failure to achieve a major cytogenetic response by 12 months defines inadequate response in patients receiving nilotinib or dasatinib as second or subsequent line therapy for chronic myeloid leukemia
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Clinical Trials and Observations: Failure to achieve a major cytogenetic response by 12 months defines inadequate response in patients receiving nilotinib or dasatinib as second or subsequent line therapy for chronic myeloid leukemia

机译：临床试验和观察：在12个月内未达到主要的细胞遗传学应答则定义了接受尼洛替尼或达沙替尼作为慢性粒细胞白血病的二线或后续治疗药物的患者反应不足

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摘要

To determine when patients with incomplete responses on second-line tyrosine kinase inhibitor (2TKI) therapy should consider alternative treatment, we analyzed the outcome of 113 patients receiving nilotinib (n = 43) or dasatinib (n = 70) after imatinib failure. After 12 months of 2TKI therapy, patients achieving a major cytogenetic response (12MMCyR) had a significant survival advantage over patients in minor cytogenetic response or complete hematologic response, with a projected one-year survival of 97% and 84% respectively (P = .02). Projected 1-year progression to hematologic failure, accelerated phase, or blast phase was also significantly different (3% vs 17%, P = .003). Early cytogenetic response was strongly predictive of achievement of 12MMCyR, with less than 10% of patients showing no cytogenetic response at 3 to 6 months eventually attaining the target of 12MMCyR. These results suggest that patients receiving 2TKI with no cytogenetic response at 3 to 6 months should be considered for alternative therapies.
机译：为了确定对二线酪氨酸激酶抑制剂（2TKI）治疗反应不完全的患者何时应考虑替代治疗，我们分析了113名伊马替尼治疗失败后接受尼洛替尼（n = 43）或达沙替尼（n = 70）的患者的结局。经过2TKI治疗12个月后，达到主要细胞遗传学应答（12MMCyR）的患者比具有轻微细胞遗传学应答或完全血液学应答的患者具有明显的生存优势，预计一年生存率分别为97％和84％（P =。 02）。预期的1年进展为血液学衰竭，加速期或爆炸期也有显着差异（3％比17％，P = 0.003）。早期的细胞遗传学反应强烈预示了12MMCyR的实现，只有不到10％的患者在3到6个月内没有细胞遗传学反应，最终达到了12MMCyR的目标。这些结果表明，应考虑在3至6个月接受2TKI且无细胞遗传学应答的患者进行替代治疗。

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