甲磺酸伊马替尼治疗儿童慢性期慢性髓性白血病的疗效
Response to imatinib mesylate in childhood chronic myeloid leukemia in chronic phase.
作者信息
Linga Vijay Gandhi, Ganta Ranga Raman, Kalpathi Krishnamani Iyer, Gundeti Sadashivudu, Rajappa Senthil J, Digumarti Raghunadharao, Paul Tara Roshni, Tandon Ashwani
机构信息
Department of Medical Oncology, Nizams Institute of Medical Science, Hyderabad, India.
Department of Medical Oncology, Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad, India.
出版信息
South Asian J Cancer. 2014 Oct;3(4):203-5. doi: 10.4103/2278-330X.142961.
INTRODUCTION
Childhood chronic myeloid leukemia (CML) accounts for less than 3% of all childhood leukemias, hence, data on imatinib (IM) in adult CML patients has been largely extrapolated to children. We have analyzed our data to add to the existing literature.
AIMS
Primary objective is to assess the progression-free survival (PFS). Secondary objective are cytogenetic response, overall survival (OS), and toxicities.
SETTINGS AND DESIGN
This is a retrospective analysis from the case records from a single institution.
MATERIALS AND METHODS
Institutional ethics committee approval was obtained. All the children diagnosed CML in chronic phase (CML-CP) aged less than 18 years registered between 2000 and 2009 were enrolled. All the patients were started on IM at 260 mg/m(2).
STATISTICAL ANALYSIS
Kaplan-Meier curves were used to calculate the PFS and OS.
RESULTS
There were 64 children with median age of 13 years (range, 1-18) with male predominance (male:female (M: F) - 1.85:1). Sixty-one patients (95.4%) achieved complete hematological response (CHR) at median of 8 weeks. Thirty-seven (57.8%) patients had evaluation of cytogenetic response and were subjects for outcome analysis. The median time to best cytogenetic response evaluation was 13 months (range, 4-52). Twenty-nine patients (78.3%) achieved complete cytogenetic response (CCyR). At a median follow-up of 36 months (range 5-75), 21 (56.8%) remained progression free and 35 (94.5%) are alive. Adverse events were tolerable.
CONCLUSIONS
PFS at a median follow-up of 36 months is 56.8% and OS 94.5%.
引言
儿童慢性粒细胞白血病（CML）占所有儿童白血病的比例不到3%，因此，成人CML患者使用伊马替尼（IM）的数据大多被外推到儿童身上。我们分析了我们的数据，以补充现有文献。
目的
主要目标是评估无进展生存期（PFS）。次要目标是细胞遗传学反应、总生存期（OS）和毒性。
设置与设计
这是一项来自单一机构病例记录的回顾性分析。
材料与方法
获得了机构伦理委员会的批准。纳入了2000年至2009年间登记的所有年龄小于18岁、诊断为慢性期CML（CML-CP）的儿童。所有患者均开始使用260mg/m²的IM。
统计分析
采用Kaplan-Meier曲线计算PFS和OS。
结果
有64名儿童，中位年龄为13岁（范围1-18岁），男性占主导（男：女（M：F）-1.85：1）。61名患者（95.4%）在中位8周时达到完全血液学缓解（CHR）。37名（57.8%）患者进行了细胞遗传学反应评估，并作为结局分析的对象。达到最佳细胞遗传学反应评估的中位时间为13个月（范围4-52个月）。29名患者（78.3%）达到完全细胞遗传学缓解（CCyR）。中位随访36个月（范围5-75个月）时，21名（56.8%）患者无进展，35名（94.5%）患者存活。不良事件可耐受。
结论
中位随访36个月时，PFS为56.8%，OS为94.5%。
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