伊马替尼治疗慢性粒细胞白血病各期疗效比较及影响因素分析

目的 对比伊马替尼治疗慢性粒细胞白血病(CML)慢性期与进展期的临床疗效及生存情况,探讨相关影响因素.方法 85例CML慢性期、24例加速期及19例急变期患者口服伊马替尼,检测血液学、细胞遗传学及分子学疗效,评估总生存及疾病进展情况并分析相关影响因素,观察其副作用.结果 ①CML慢性期完全血液学缓解率、完全细胞遗传学缓解率、完全分子学缓解率分别为100%、82.4%和21.2%,预计5年总生存率、无疾病进展生存率(PFS)分别为92.1%、84.7%,均明显高于加速期及急变期患者(P＜0.0001).②CML慢性期中初治42例患者完全细胞遗传学缓解率、完全分子学缓解率、5年总生存率及无疾病进展生存率分别为92.9%、26.3%、100%和95.2%,与干扰素治疗失败组比较差异有统计学意义(P＜0.001).③CML慢性期严重血细胞减少明显少于加速期及急变期(P＜0.0001),非血液学副作用均少见且轻微.④多因素分析显示伊马替尼治疗前有干扰索等其他治疗及停药时间长为影响CML慢性期患者获得细胞遗传学缓解、PFS的独立不利因素.结论 CML早期应用伊马替尼疗效佳、安全性好,伊马替尼应作为其一线治疗药物.

Therapeutic effects of imatinib on chronic myeloid leukemia in different phases and the factors affecting the effects

OBJECTIVE: To evaluate the therapeutic effect of imatinib on chronic myeloid leukemia (CML) in different phases and analyze the factors that may affect the effects. METHODS: Eighty-five patients with CML in chronic phase, 24 in accelerated phase and 19 in blastic phase patients were treated with imitinib. The hematologic response, cytogenetic response, molecular response, overall survival (OS), progression-free survival (PFS) and adverse events were analyzed in these groups. RESULTS: The rates of complete hematologic response (CHR), complete cytogenetic response (CCyR) and complete molecular response (CMoR) of the patients in chronic phase were 100%, 82.4% and 21.2%, respectively, and the 5-year OS and PFS of these patients were 92.1% and 84.7%. All these rates were significantly higher than those in patients in accelerated and blastic phases (P<0.0001). The CCyR, CMoR, 5-year OS and PFS in the 42 newly diagnosed patients in chronic phase were 92.9%, 26.3%, 100% and 95.2%, respectively, all significantly higher than those in patients with interferon therapy failure (P<0.001). Severe leukocytopenia and thrombocytopenia occurred at greater frequencey in AP and BP patients than in chronic phase patients (P<0.0001). Non-hematologic toxicity was rarer and milder in patients in chronic phase. Multivariate analysis showed that interferon therapy prior to imitinib treatment and prolonged drug cessation were the independent factors that affected the achievement of cytogenetic response and PFS. CONCLUSION: Early imitinib therapy can be effective and safe, and should be used as the first line drug for CML.