伊马替尼治疗新诊断与重组人干扰素α2b治疗失败的慢性髓性白血病患者疗效比较

Imatinib mesylate for chronic myeloid leukemia:in patients with initial treatment versus those with Recombinant Human IFN-α2b treatment failure

目的：回顾性分析和比较伊马替尼治疗新诊断和重组人干扰素α2b （以下简称干扰素）治疗失败的慢性髓性白血病患者的疗效。方法：收集86例应用伊马替尼（每天400mg）治疗的慢性髓性白血病患者的临床资料，其中新诊断患者61例，干扰素治疗失败患者25例；采用R显带技术和实时定量PCR检测细胞遗传学和BCR-ABL融合基因进行疗效分析比较。结果：新诊断组和干扰素治疗失败组治疗6个月时就获得部分细胞遗传学缓解的患者分别为50／61（81.9％）和9／25（36.0％）；两组获得完全细胞遗传学缓解的患者分别为53／61例（86.9％）和17／25例（68.0％），差异有统计学意义（ P＜0.001）；两组患者达到完全细胞遗传学缓解的中位时间分别为10个月（3～34个月）和5个月（1～17个月），差异有统计学意义（ P＝0.001）。新诊断组和干扰素治疗失败组获得完全分子生物学反应分别为43／61（70.4％）和10／25（40.0％），差异有统计学意义（ P＝0.033）。两组患者中有28例是细胞遗传学耐药，新诊断组为14例（22.9％），其中原发性细胞遗传学耐药4例；干扰素治疗失败组为14例（56.0％），均为原发性细胞遗传学耐药。结论：干扰素治疗失败的慢性髓性白血病患者应用伊马替尼治疗，其原发耐药发生率高，治疗6个月和12个月获得最佳反应的患者比例低；提示这些患者应适时更换第二代酪氨酸激酶抑制剂治疗。

Objective： To evaluate the efficacy of imatinib mesylate （ IM ） for patients with newly diagnosed chronic myeloid leukemia （ CML ） and patients after failure of Recombinant Human interferon-α2b （ IFN-α2b） therapy.Methods： A total of 86 patients with CML in chronic-phase , including 61 newly diagnosed cases and 25 cases of IFN-α2b failure, who received IM at 400 mg daily were retrospectively analyzed . Conventional cytogenetic analysis of R-banding was used to detect chromosome abnormalities and real-time PCR was used to detect BCR-ABL fusion gene . Results：81.9% of newly diagnosed patients and 36.0% of IFN-α2b failure patients achieved partial cytogenetic response （ PCyR） by 6 months.In addition, 86.9% of newly diagnosed patients and 68.0% of IFN-α2b failure patients achieved complete cytogenetic response （ CCyR） in 24 months.There was significant difference between two groups （ P〈0 .001 ） .The median time achieved CCyR in newly diagnosed group and IFN-α2b failure group were 6 months and 15 months, respectively.Compared with newly diagnosed group , IFN-α2 b failure group showed lower rate of complete molecular remission （CMR） （70.4%vs 40.0%, P=0.033）.There are 14 patients （22.9%） in newly diagnosed patients with cytogenetic resistance , among whom 4 with primary cytogenetic resistance;while there were 14 patients （56.0%） in IFN-α2b failure group with cytogenetic resistance , all of whom with primary resistance . Conclusion：Compared with newly diagnosed patients , CML patients after failure of IFN-α2b therapy have a high rate of primary cytogenetic resistance and low response rate to IM .