Zhou Ke-Shu, Wang Yan-Ying, Zhao Yao-Zhong, Yi Shu-Hua, Qian Lin-Sheng, Wang Guo-Rong, Yu Zhen, Wang Ying, Wang Jian-Xiang, Qiu Lu-Gui
State Key Laboratory of Experimental Hematology, Institute of Hematology and Hospital of Blood Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin 30020, China.
Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2010 Feb;18(1):208-12.
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 1 (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 = 0.026), but there was no significant difference in progression-free survival between them. Univariate analysis for efficacy of Imatinib mesylate revealed that WBC count < 100 x 10(9)/L (p = 0.024), Hb level > or = 130 g/L (p = 0.036), and peripheral basophil count < or = 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.
本研究的目的是评估伊马替尼对慢性期慢性髓性白血病（CML）患者的疗效，并分析其影响因素。85例患者接受甲磺酸伊马替尼治疗，剂量为每日口服300 - 600mg，并对血液学、细胞遗传学和分子反应进行评估。结果显示，中位随访时间为21（范围9 - 78）个月。累积完全血液学缓解（CHR）率为100%，主要细胞遗传学缓解（MCyR）率为80%，完全细胞遗传学缓解（CCyR）率为67.1%，完全分子缓解（CMoR）率为36.4%。达到完全血液学缓解（CHR）的中位时间为1（范围1 - 3）个月，达到完全细胞遗传学缓解（CCyR）的中位时间为6（范围1 - 24）个月。接受伊马替尼治疗1年、2年、3年患者的估计总生存率分别为（98.7±1.3）%、（96.5±2.5）%和（90.1±6.6）%。1年、2年、3年的估计无进展生存率分别为（97.6±1.6）%、（96.1±2.2）%和（90.0±1.4）%。根据Sokal评分系统，低危、中危和高危组之间以及初治组和复治组之间的CHR、MCyR和CCyR均无差异。达到MCyR或CCyR的患者的总生存率优于仅达到血液学缓解的患者（p = 0.026），但它们之间的无进展生存率无显著差异。甲磺酸伊马替尼疗效的单因素分析显示，治疗前白细胞计数<100×10⁹/L（p = 0.024）、血红蛋白水平≥130g/L（p = 0.036）和外周血嗜碱性粒细胞计数≤0.05（p = 0.024）是实现MCyR或CCyR的独立有利因素。结论是，伊马替尼治疗慢性期CML患者可获得最佳血液学缓解和较高的细胞遗传学缓解，应认为伊马替尼是未治疗和已治疗CML患者的一线治疗药物。
