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慢性髓性白血病中的性别因素:随机研究的长期结果

Gender aspects in chronic myeloid leukemia: long-term results from randomized studies.

作者信息

Berger U, Maywald O, Pfirrmann M, Lahaye T, Hochhaus A, Reiter A, Hasford J, Heimpel H, Hossfeld D K, Kolb H-J, Löffler H, Pralle H, Queisser W, Hehlmann R

机构信息

III. Medizinische Universitätsklinik, Fakultät für Klinische Medizin Mannheim, Universität Heidelberg, 68305 Mannheim, Germany.

出版信息

Leukemia. 2005 Jun;19(6):984-9. doi: 10.1038/sj.leu.2403756.

DOI:10.1038/sj.leu.2403756
PMID:15830009
Abstract

Gender-related aspects in chronic myeloid leukemia (CML) have not been studied well. We therefore analyzed 856 patients with Ph/BCR-ABL-positive CML from the German randomized CML-studies I (interferon alpha (IFN) vs hydroxyurea (HU) vs busulfan) and II (IFN+HU vs HU alone). The median observation time was 8.6 years. A total of 503 patients (59%) were male. Female patients were older (51 vs 46 years; P<0.0001), presented with lower hemoglobin (11.7 vs 12.5 g/dl; P<0.0001), higher platelet counts (459 vs 355 x 10(9)/l; P<0.0001), smaller spleen size (3 vs 4 cm below costal margin; P=0.0097), a lower rate of additional cytogenetic aberrations (9 vs 15%; P=0.018) and a less favorable risk profile (P=0.036). The transplantation rate was 14% for female (n=48) and 22% for male patients (n=113). Median survival was longer in female patients (58 vs 49 months; P=0.035) mainly attributable to better survival in the low- and intermediate-risk groups and, independent from risk groups, in the HU group. These results were confirmed by matched-pair analyses based on German population data (n=496, 59 vs 45 months; P=0.0006). This is the first analysis of gender aspects in CML using randomized trials. It demonstrates the relevance of analyses of gender differences in CML and in malignant disease at large.

摘要

慢性髓性白血病(CML)中与性别相关的方面尚未得到充分研究。因此,我们分析了来自德国CML随机研究I(干扰素α(IFN)与羟基脲(HU)与白消安)和II(IFN + HU与单独使用HU)的856例Ph/BCR-ABL阳性CML患者。中位观察时间为8.6年。共有503例患者(59%)为男性。女性患者年龄较大(51岁对46岁;P<0.0001),血红蛋白水平较低(11.7 g/dl对12.5 g/dl;P<0.0001),血小板计数较高(459×10⁹/L对355×10⁹/L;P<0.0001),脾脏较小(肋缘下3 cm对4 cm;P = 0.0097),额外细胞遗传学异常的发生率较低(9%对15%;P = 0.018),风险特征较差(P = 0.036)。女性患者(n = 48)的移植率为14%,男性患者(n = 113)为22%。女性患者的中位生存期较长(58个月对49个月;P = 0.035),这主要归因于低风险和中风险组以及独立于风险组的HU组中更好的生存率。基于德国人群数据的配对分析(n = 496,59个月对45个月;P = 0.0006)证实了这些结果。这是首次使用随机试验对CML中的性别方面进行分析。它证明了分析CML以及总体恶性疾病中性别差异的相关性。

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