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目的评价甲磺酸伊马替尼(伊马替尼)治疗 Ph 阳性(Ph~+)慢性粒细胞白血病(CML)加速期和急变期的疗效。方法对75例 Ph~+CML 加速期患者和49例急变期患者持续口服伊马替尼400 mg/d 或600 mg/d 进行疗效观察。结果加速期:中位追踪23.0(1.0～64.0)个月,累积获得的血液学总有效率为93.3%,包括完全血液学缓解(CHR)85.3%和回到慢性期(RCP)8.0%,无效6.7%。累积获得的主要细胞遗传学缓解(MCyR)率为33.0%,其中完全细胞遗传学缓解(CCyR)率为28.0%,获得 CCyR 患者中主要分子学缓解(MMoR)率为47.6%。治疗有效者中,预计4年无疾病进展生存(PFS)率和总生存(OS)率分别为48.2%和52.2%。全部患者中,严重白细胞、血红蛋白和血小板减少的发生率分别为37.3%、34.6%和45.3%。急变期:中位追踪4.5(0.3～63.0)个月,累积获得的血液学总有效率为63.3%,包括 CHR 44.9%和 RCP 18.4%,无效36.7%。累积获得的 MCyR 率和 CCyR率均为12.2%,其中 MMoR 率为33.3%。治疗有效者中,预计1年 PFS 率和 OS 率分别为32.8%和46.0%,2年 PFS 率和 OS 率分别为15.8%和21.0%。全部患者中,严再白细胞、血红蛋白和血小板减少的发生率分别为75.5%、71.4%和73.5%。结论①伊马替尼对 Ph~+CML 的疗效随疾病进展的程度递减,严重血液学毒性递增。②多数加速期患者 PFS 期明显延长,特别是获得持久 CCyR 甚至MMoR 者。③绝大部分急变期患者血液学效应短暂,复发率高。
Objective To evaluate the efficacy of imatinib mesylate (imatinib) in the treatment of Ph positive (Ph ~ +) chronic myeloid leukemia (CML) during both accelerated and abrupt phases. Methods 75 patients with accelerated phase Ph + CML and 49 patients with acute phase were treated with imatinib 400 mg / d or 600 mg / d orally. Results Acceleration: The median total hematologic success rate was 93.3% with a median follow-up of 23.0 (1.0-64.0) months, including 85.3% of complete hematological response (CHR) and 8.0% of returning to chronic phase 6.7%. The cumulative prevalence of major cytogenetic response (MCyR) was 33.0%, with a complete cytogenetic response (CCyR) rate of 28.0% and a major molecular remission (MMoR) rate of 47.6% in patients with CCyR. Among the treated patients, the 4-year progression-free survival (PFS) and overall survival (OS) rates were 48.2% and 52.2%, respectively. In all patients, the incidence of severe white blood cells, hemoglobin and thrombocytopenia were 37.3%, 34.6% and 45.3%, respectively. Emergency phase: median follow-up 4.5 (0.3 to 63.0) months, cumulative total hematology was 63.3%, including 44.9% CHR and RCP 18.4%, 36.7% invalid. The cumulative MCyR and CCyR rates were both 12.2%, with a MMoR rate of 33.3%. The effective rate of PFS and OS was estimated to be 32.8% and 46.0% at 1 year respectively. The 2-year PFS and OS rates were 15.8% and 21.0% respectively. In all patients, the incidence of strict white blood cells, hemoglobin and thrombocytopenia were 75.5%, 71.4% and 73.5%, respectively. Conclusion ① The efficacy of imatinib on Ph ~ + CML decreases with the progression of the disease, and the hematological toxicity increases significantly. ② Most patients with accelerated phase PFS significantly prolonged, in particular, access to persistent CCyR or MMoR were. ③ The vast majority of patients with acute hematological effects of short-term, high recurrence rate.