甲磺酸伊马替尼治疗干扰素α治疗失败的慢性期慢性髓性白血病的长期随访结果。
Very long-term follow-up results of imatinib mesylate therapy in chronic phase chronic myeloid leukemia after failure of interferon alpha therapy.
机构信息
Leukemia Department, The University of Texas MD Anderson Cancer Center, Houston, Texas 77030, USA.
出版信息
Cancer. 2012 Jun 15;118(12):3116-22. doi: 10.1002/cncr.26568. Epub 2012 Feb 27.
BACKGROUND
The long-term outcome of patients with chronic phase chronic myeloid leukemia treated with imatinib after failure of interferon alpha therapy has not been detailed.
METHODS
In total, 368 patients were analyzed. Univariate and multivariate survival analyses were conducted using standard statistical methods.
RESULTS
Overall, 247 patients (67%) achieved a complete cytogenetic response (CCyR). Of the 327 patients who were studied, 207 patients (63%) achieved a major molecular response (MMR), and 99 patients (30%) had undetectable breakpoint cluster region/c-abl oncogene (BCR-ABL) levels at some time during therapy. The estimated 10-year survival rate was 68%, the progression-free survival rate was 67%, and the event-free survival rate was 51%. In multivariate analysis, age ≥ 60 years, hemoglobin <10 g/dL, bone marrow basophils ≥ 5%, any peripheral blasts, and clonal evolution were independent adverse factors for survival. The estimated 7-year survival rate according to the presence of no factors (n = 154), 1 or 2 factors (n = 190), or ≥ 3 factors (n = 24) were 93%, 70%, and 25%, respectively (P < .01). Achieving an MMR, a CCyR, or a partial cytogenetic response at 12 months was associated with significantly better 10-year survival rate in a landmark analysis (10-year survival rate, 80%-90%) compared with achieving a minor cytogenetic response or a complete hematologic response (10-year survival rate, 55%-65%) or another response (10-year survival rate, 10%). In a landmark analysis that included imatinib response at 12 months, achieving a major cytogenetic response or better (hazard ratio, 0.12; P < .001) and achieving a complete hematologic response or a minor cytogenetic response (hazard ratio, 0.36; P = .003) were significant favorable prognostic factors.
CONCLUSIONS
The current results indicated that the estimated 10-year survival rate of 68% for patients with chronic myeloid leukemia who receive imatinib after failure on interferon has improved.
背景
接受干扰素治疗失败后接受伊马替尼治疗的慢性期慢性髓性白血病患者的长期预后尚不清楚。
方法
共分析了 368 例患者。采用标准统计学方法进行单因素和多因素生存分析。
结果
总体而言，247 例患者（67%）达到完全细胞遗传学缓解（CCyR）。在 327 例可评估患者中，207 例（63%）达到主要分子学缓解（MMR），99 例（30%）在治疗过程中的某个时间点达到无法检测到的断裂点簇区/c-abl 致癌基因（BCR-ABL）水平。估计 10 年生存率为 68%，无进展生存率为 67%，无事件生存率为 51%。多因素分析显示，年龄≥60 岁、血红蛋白<10 g/dL、骨髓嗜碱性粒细胞≥5%、任何外周血原始细胞、克隆进化是生存的独立不良因素。根据无因素（n=154）、1 或 2 个因素（n=190）或≥3 个因素（n=24）的存在，估计 7 年生存率分别为 93%、70%和 25%（P<.01）。在里程碑分析中，与获得次要细胞遗传学缓解或完全血液学缓解或其他缓解（10 年生存率 55%-65%或 10%）相比，12 个月时获得 MMR、CCyR 或部分细胞遗传学缓解与显著更好的 10 年生存率相关（10 年生存率，80%-90%）。在包括伊马替尼 12 个月反应的里程碑分析中，获得主要细胞遗传学缓解或更好（危险比，0.12；P<.001）和获得完全血液学缓解或次要细胞遗传学缓解（危险比，0.36；P=.003）是显著的有利预后因素。
结论
目前的结果表明，接受干扰素治疗失败后接受伊马替尼治疗的慢性髓性白血病患者的估计 10 年生存率为 68%，有所提高。
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