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初治与再治中国慢性期慢性髓性白血病患者伊马替尼 7 年疗效。

Seven-year response to imatinib as initial treatment versus re-treatment in Chinese patients with chronic myelogenous leukemia in the chronic phase.

机构信息

The Institute of Hematology, People's Hospital of Peking University, No.11 Xizhimen South Street, Beijing 100044, China.

出版信息

Ann Hematol. 2011 Jan;90(1):41-6. doi: 10.1007/s00277-010-1031-0. Epub 2010 Jul 29.

Abstract

The purpose of our study is to compare the 7-year response to imatinib monotherapy as an initial treatment and re-treatment in Chinese patients with chronic myelogenous leukemia-chronic phase (CML-CP) patients in a single center in Beijing. A retrospective study of 171 CML-CP patients receiving imatinib monotherapy was done with 73 in the initial treatment group (disease course ≤ 6 months) and 98 in the re-treatment group (disease course > 6 months). Cumulative rates of complete cytogenetic response (CCyR) at 6, 12, and 36 months after imatinib treatment in the initial and re-treatment groups were 75%, 89%, and 96%, and 48%, 77% and 84% (p = 0.0002), respectively. The median time to CCyR in the initial and re-treatment groups was 6 months (95% CI, 3.3-8.3) and 9 months (95% CI, 6.4-11.6), respectively (p = 0.0002). Cumulative rates of major molecular responses at 9, 12, and 18 months after imatinib treatment in the initial and re-treatment groups were 31%, 48%, and 60%, and 15%, 25% and 37% (p = 0.017), respectively. The median time to the major molecular response in the initial and re-treatment groups was 15 months (95% CI, 12.3-17.7) and 36 months (95% CI, 25.9-46.0), respectively (p = 0.017). Progression-free survival at 84 months in the initial and re-treatment groups was 97% and 85%, respectively (p = 0.09). Event-free survival at 84 months in the initial and re-treatment groups was 92% and 70%, respectively (p = 0.049). Only two of the 171 patients discontinued imatinib therapy for grade 3/4 adverse events. Our study revealed that CML-CP patients would benefit from early treatment with imatinib.

摘要

我们的研究目的是比较伊马替尼单药治疗作为初始治疗和再治疗在单一中心的北京的中国慢性髓性白血病慢性期(CML-CP)患者的 7 年反应。回顾性研究了 171 例接受伊马替尼单药治疗的 CML-CP 患者,其中 73 例为初始治疗组(病程≤6 个月),98 例为再治疗组(病程>6 个月)。伊马替尼治疗后 6、12 和 36 个月时,初始治疗组和再治疗组的完全细胞遗传学反应(CCyR)累积率分别为 75%、89%和 96%和 48%、77%和 84%(p=0.0002)。初始治疗组和再治疗组的 CCyR 中位时间分别为 6 个月(95%CI,3.3-8.3)和 9 个月(95%CI,6.4-11.6)(p=0.0002)。伊马替尼治疗后 9、12 和 18 个月时,初始治疗组和再治疗组的主要分子反应累积率分别为 31%、48%和 60%和 15%、25%和 37%(p=0.017)。初始治疗组和再治疗组的主要分子反应中位时间分别为 15 个月(95%CI,12.3-17.7)和 36 个月(95%CI,25.9-46.0)(p=0.017)。初始治疗组和再治疗组的无进展生存 84 个月时分别为 97%和 85%(p=0.09)。初始治疗组和再治疗组的无事件生存 84 个月时分别为 92%和 70%(p=0.049)。171 例患者中仅有 2 例因 3/4 级不良事件停止伊马替尼治疗。我们的研究表明,CML-CP 患者将从伊马替尼的早期治疗中受益。

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