甲磺酸伊马替尼治疗85例慢性髓系白血病慢性期疗效及影响因素分析

Analysis of Efficacy and Related Factors in 85 Chronic Myeloid Leukemia Patients Treated with Imatinib Mesylate

本研究评价甲磺酸伊马替尼治疗慢性髓系白血病(CML)慢性期的疗效,并初步探讨影响甲磺酸伊马替尼疗效的因素。85例CML慢性期患者口服伊马替尼300-600 mg/d。监测血常规指标、染色体核型及bcr-abl P210转录本表达。结果表明:中位随访21(9-78)个月,累积获得的完全血液学缓解(CHR)率为100%,主要细胞遗传学缓解率(MCyR)为80%,完全细胞遗传学缓解(CCyR)率为67.1%,完全分子学缓解(CMoR)率为36.4%。中位达CHR时间为1(1-3)个月,中位达CCyR时间为6(1-24)个月,1年、2年和3年总生存(OS)率分别为(98.7±1.3)%、(96.5±2.5)%、(90.1±6.6)%;疾病无进展生存率(PFS)分别为(97.6±1.6)%、(96.1±2.2)%、(90.0±1.4)%。低危组、中危组、高危组获CHR、MCyR、CCyR率无统计学差异;初治组与复治组之间CHR、MCyR、CCyR率无统计学差异。达到主要细胞遗传学缓解(MCyR)或完全细胞遗传学缓解(CCyR)的患者OS与仅达到血液学缓解(CHR)的患者OS相比有显著性差异(p=0.026),但PFS尚无差别(p=0.20)。单因素分析显示:治疗前WBC数<100×109/L,Hb水平≥130 g/L,外周血嗜碱粒细胞比例≤0.05为预示患者易于达到MCyR或CCyR的独立有利因素(p值分别为0.024、0.036、0.024)。结论:伊马替尼治疗可以使CML慢性期患者获得极高的血液学缓解率和较高的细胞遗传学缓解率。无论对于初治患者还是复治患者,伊马替尼治疗均应作为一线治疗。

The objective of this study was to evaluate the efficacy of Imatinib on patients with chronic myeloid leukemia （CML） in chronic phase and to analyze its influencing factors. 85 patients received Imatinib mesylate at a dose of 300 - 600 mg orally per day, and were evaluated for hematologic, cytogenetic, and molecular responses. The results showed that the median follow-up was 21 （range 9 -78 ） months. Cumulative complete hematological remission （CHR） rate was 100%, major cytogenetic remission （MCyR） rate was 80%, complete cytogenetic remission （CCyR） rate was 67. 1% and complete molecular remission （CMoR） rate was 36.4%. The median time to complete hematological remission （CHR） was l （ range 1 - 3 ） month, to complete cytogenetic remission （CCyR） was 6 （ range 1 - 24 ） months. The estimated overall survival rates for patients who received Imatinib for 1,2,3 years were （ 98.7 _± 1.3 ） %, （ 96.5 _± 2.5 ） % and （90.1 ± 6.6 ） % respectively. The estimated progression-free survival rates at 1,2,3 years were （97.6 ± 1.6）%, （96. 1 ±2. 2）% and （90. 0± 1.4）% respectively. The CHR, MCyR and CCyR between low risk, intermediate risk and high risk groups according to the Sokal scoring system and between primarily treated and retreated groups all had no difference. The overall survival of patients who achieved MCyR or CCyR was better than that in patients only achieved hematologic remission （p = 13. 026）, hut there was no significant difference in progression-free survival between them. Univariate analysis for efficacy of Imatinib mesylate revealed that WBC count 〈 100× 10^9/L （p =0. 024）, Hb level ≥130 g/L （p =0. 036）, and peripheral basophil count ≤0.05 （p =0. 024） before therapy were independent favourable factors for achieving MCyR or CCyR. It is concluded that the patients with CML in chronic phase treated with Imatinib can achieve the best hematologic remission and higher cytogenetic remission, it should be considered that the imatinib is a drug of the first-line therapy for untreated and treated patients with CML.