A randomized trial comparing interferon-alpha with busulfan for newly diagnosed chronic myelogenous leukemia in chronic phase.
A randomized trial comparing interferon-alpha with busulfan for newly diagnosed chronic myelogenous leukemia in chronic phase.
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一项随机试验，比较干扰素 α 与白消安治疗新诊断的慢性粒细胞白血病的慢性期。
作者：
K. Ohnishi;R. Ohno;M. Tomonaga;N. Kamada;K. Onozawa;A. Kuramoto;H. Dohy;H. Mizoguchi;S. Miyawaki;K. Tsubaki
采用多中心随机对照研究，比较干扰素-α与白花丹治疗初诊慢性粒细胞白血病慢性期患者的疗效。从1988年10月至1991年10月，170名患者随机接受干扰素-α或白花丹治疗。在159例符合条件的患者中，干扰素-α组80例患者血液学完全缓解31例(38.8%)，白消组79例血液学完全缓解43例(54.4%)，干扰素-α组血液学部分缓解38.8%，白消组血液学部分缓解43.0%。干扰素-α治疗的80例患者中有7例(8.8%)和白花丹治疗的79例患者中有2例(2.5%)获得完全细胞遗传学应答，部分细胞遗传学应答分别为7.5%(6/80)和2.5%(2/79)。两组患者的主要(完全和部分)细胞遗传学反应差异有统计学意义(P=0.046)。在中位随访50个月时，干扰素-α组和白花丹组的5年预测存活率分别为54%和32%(P=.0290)，慢性期的5年预测存活率分别为41%和29%(P=.1165)。与无细胞遗传学反应的患者相比，在干扰素-α或白消安治疗后有细胞遗传学反应(完全、部分或轻微)的患者在慢性期持续时间上显著优于(干扰素-α组；P=0.0017；白消组；P=0.0010)，即使在里程碑式分析中校正了反应时间。然而，干扰素-α组的存活率没有显著差异(P=.1065)。在细胞遗传学反应(完全、部分或轻微)的患者中，干扰素-α组的存活率(P=.3923)和慢性期的持续时间(P=.6258)与白花丹组无显著差异。这些结果表明，干扰素-α治疗的细胞遗传学反应和存活率明显高于白花丹治疗，而且在少数存活率和慢性期延长的患者中，白消丹还能消除Ph阳性克隆。
A multicenter randomized study was conducted to compare the effect of interferon-alpha (IFN-alpha) with that of busulfan in newly diagnosed patients with chronic myelogenous leukemia (CML) in chronic phase. From October 1988 to October 1991, 170 patients were randomized to receive either IFN-alpha or busulfan. Of 159 eligible patients, 31 (38.8%) of 80 patients in the IFN-alpha group and 43 (54.4%) of 79 patients in the busulfan group achieved complete hematologic remission, and 38.8% in the IFN-alpha group and 43.0% in the busulfan group achieved partial hematologic remission. A complete cytogenetic response was induced in seven (8.8%) of 80 patients treated with IFN-alpha and two (2.5%) of 79 patients treated with busulfan, and a partial cytogenetic response was 7.5% (6/80) and 2.5% (2/79), respectively. The difference in major (complete and partial) cytogenetic response between the two groups was significant (P = .046). At a median follow-up of 50 months, the predicted 5-year survival rate was 54% in the IFN-alpha group and 32% in the busulfan group (P = .0290), and the predicted 5-year rate of remaining in chronic phase was 41% in the IFN-alpha group and 29% in the busulfan group (P = .1165). As compared with the patients with no cytogenetic response, the patients with any cytogenetic response (complete, partial or minor) after the IFN-alpha or busulfan treatment were significantly superior in the duration of chronic phase (IFN-alpha group; P = .0017, busulfan group; P = .0010) even after correction for the time to response using the landmark analysis. However, there was no significant difference in survival rate in the IFN-alpha group (P = .1065). There was no significant difference in survival rate (P = .3923) and the duration of chronic phase (P = .6258) between the IFN-alpha and the busulfan group in the patients with a cytogenetic response (complete, partial or minor). These results demonstrate that IFN-alpha treatment produces a significantly superior cytogenetic response and survival rate as compared with the busulfan treatment, and unexpectedly, that busulfan can also eliminate Philadelphia chromosome positive clone in a few patients who showed prolonged survival rate and duration of chronic phase.
干扰素诱导的慢性粒细胞白血病细胞遗传学缓解中的多克隆造血。
影响因子：
20.3
作者：
Claxton,D;Deisseroth,A;Talpaz,M;Reading,C;Kantarjian,H;Trujillo,J;Stass,S;Gooch,G;Spitzer,G
通讯作者：
Spitzer,G
通过聚合酶链反应检测干扰素治疗后费城染色体阳性慢性粒细胞白血病的微小残留病。
影响因子：
20.3
作者：
Lee,MS;Kantarjian,H;Talpaz,M;Freireich,EJ;Deisseroth,A;Trujillo,JM;Stass,SA
通讯作者：
Stass,SA