Lazzarino M, Morra E, Brusamolino E, Inverardi D, Castelli G, Merante S, Bernasconi C
Am J Clin Oncol. 1986 Feb;9(1):45-9. doi: 10.1097/00000421-198602000-00012.
From 1975 to 1981, 92 patients with newly diagnosed Ph'-positive chronic granulocytic leukemia entered two consecutive studies. The initial trial (Study I, 1975-1978) tested the efficacy of hydroxyurea (HU) as single agent in 45 consecutive patients. In an effort to improve results obtained with HU alone, from 1978 to 1981, 47 new patients entered a second trial (Study II), which consisted of a continuous treatment with a combination of HU and 6-mercaptopurine (6-MP), at doses adjusted so as to maintain the leukocyte counts between 4 and 12 X 10(9)/L. The aim of this second study was to prolong the duration of chronic phase (CP) by the addition of 6-MP to HU and by a stricter continuous control of the size of the total granulocytic mass (TGM). Both regimens were well tolerated. Median duration of CP was 43 months in Study I and 41 months in Study II. Median survival was 51.5 months and 45 months respectively. These data indicate that neither the addition of 6-MP to HU alone, nor the effort to keep a smaller TGM, play a substantial role in postponement of blastic transformation in CGL.
1975年至1981年期间，92例新诊断的Ph'阳性慢性粒细胞白血病患者连续参与了两项研究。初始试验（研究I，1975 - 1978年）对45例连续患者测试了羟基脲（HU）作为单一药物的疗效。为了改善单独使用HU所取得的结果，1978年至1981年，47例新患者进入了第二项试验（研究II），该试验包括用HU和6 - 巯基嘌呤（6 - MP）联合进行持续治疗，调整剂量以维持白细胞计数在4至12×10⁹/L之间。第二项研究的目的是通过在HU中添加6 - MP以及更严格地持续控制总粒细胞量（TGM）的大小来延长慢性期（CP）的持续时间。两种治疗方案耐受性均良好。研究I中CP的中位持续时间为43个月，研究II中为41个月。中位生存期分别为51.5个月和45个月。这些数据表明，单独在HU中添加6 - MP以及维持较小的TGM，在延缓慢性粒细胞白血病的急变方面均未起到实质性作用。
