伊马替尼一线治疗慢性粒细胞白血病慢性期患者-单中心十年回顾性分析

Imatinib mesylate therapy for patients with chronic myeloid leukemia: long-term outcome from a single center in China

目的：总结以伊马替尼为一线治疗的慢性粒细胞白血病（chronicmyeloidleukemia，CML）初治患者的疗效和生存。方法：回顾性分析南昌大学第一附属医院2003年1月至2013年12月间收治的295例cML初治患者的临床资料，其中185例为入组格列卫全球患者援助项目（GIPAP）行伊马替尼治疗、30例为干扰素（IFN-α）治疗、50例为羟基脲单药治疗和30例为异基因外周血造血干细胞移植（allogeneichematopoieticstemcelltransplantation，Allo-HSCT）治疗的患者，分析各组患者的治疗疗效和生存情况。结果：伊马替尼治疗组和Allo-HSCT治疗组患者完全血液学缓解率（completehematologicremission，CHR）均为96．7％，完全细胞遗传学缓解率（completecytogeneticremission，CCyR）为89．7％和93．3％，完全分子学缓解率（completemolecularremission，CMoR）为49．7％和83．3％（P=0．001）；而干扰素和羟基脲治疗组CHR、CCyR和CMoR均明显低于伊马替尼治疗组和Allo-HSCT治疗组。伊马替尼组患者的总生存时间（overallsurvival，os）明显优于其他组（P〈0．001），甚至优于Allo-HSCT治疗组（10年OS为89．0％vs．67．O％，P〈0．001）。Cox多因素分析显示接受伊马替尼治疗（HR=5．267，95％CI为1．054～1．940，P=0．022）和获得CCyR（HR=9．541，95％CI为1．692～10．513，P=0．002）是影响本组患者预后良好的独立因素。结论：CML初治患者接受伊马替尼治疗可以获得更高的cHR和CCvR，且OS更优，伊马替尼适合作为中国初治cML患者的一线治疗。

Objective： Imatinib is extensively used as a first-line therapeutic agent for patients with chronic myeloid leukemia （CML） at the chronic phase （CP）. Although CML patients undergoing imatinib treatment are enrolled mainly in the Glivec International Patient Assistance Program （GIPAP） in China since 2003, limited data have been reported on the long-term outcome of these patients. This study aims to compare the treatment response and prognosis of CML-CP patients who received different treatments from January 2003 to December 2013 in the First Affiliated Hospital of Nanchang University. Methods： A total of 295 patients were enrolled, includ- ing 185, 30, 50, and 30 patients for imatinib, interferon-alpha （IFN-α） plus Ara-C, hydroxycarbamide （HU）, or allogeneic hematopoietic stem cell transplantation （Allo-HSCT） treatments, respectively. Results： Patients in imatinib and Allo-HSCT groups achieved excellent complete hematologic remission （CHR） （i.e., 96.7% vs. 96.7%）, complete cytogenetic response （CCyR） （i.e., 89.7% vs. 93.3%）, and com- plete molecular remission （CMoR） （i.e., 49.7% vs. 83.3%, P=0.001）. However, significantly low rates of CHR, CCyR, McyR, and CMoR were observed in IFN-α and HU groups. Moreover, patients from imatinib group showed longer overall survival （OS） time than patients from other groups （P〈0.001）, even patients in AIIo-HSCT group （10-year OS, 89.0% vs. 67.0%, P〈0.001） because of high risk of Allo- HSCT-related complication. Multivariate analysis showed that receiving imatinib treatment （HR=5.267, 95%Cl 1.054-1.940, P=0.022） and achieving CCyR （HR=9.541, 95%C1：1.692-10.513, P=0.002） were independent predictors for OS. Conclusion： Imatinib treatment may be an optimal first-line choice for Chinese patients with CML-CP who have not received any previous treatments.