EFFECTS OF VITAMIN-A ON SURVIVAL IN PATIENTS WITH CHRONIC MYELOGENOUS LEUKEMIA - A SWOG RANDOMIZED TRIAL
EFFECTS OF VITAMIN-A ON SURVIVAL IN PATIENTS WITH CHRONIC MYELOGENOUS LEUKEMIA - A SWOG RANDOMIZED TRIAL
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DOI：
10.1016/0145-2126(95)00032-j
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发表时间：
1995-09-01
影响因子：
2.7
通讯作者：
HYNES, H
中科院分区：
文献类型：
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作者：
MEYSKENS, FL;KOPECKY, KJ;HYNES, H
在153例慢性期慢性粒细胞白血病（CML）患者中进行了一项全国合作组试验，以确定口服维生素A是否可以延长急变期的时间并提高患者的生存率。1年内确诊的慢性期CML患者随机接受口服脉冲白消安或烷化剂加连续口服维生素A治疗。使用Kaplan和Meier方法估计临床进展和总生存期的分布。使用考克斯的比例风险回归方法分析这些终点与治疗和其他患者特征的相关性。这两个政权都得到了很好的容忍。白消安加维生素A组患者的临床无进展生存期（中位数46个月）和总生存期（51个月）略长于白消安组（中位数38和44个月）。然而，差异无统计学显著性（临床无进展生存期单侧P=0.11，生存期单侧P = 0.081）。在调整了额外的探索性多变量分析中确定的重要因素后，白消安患者的临床进展或死亡风险增加了53%（P=0.022），死亡风险增加了60%（P=0.014）。考虑到治疗组之间的差异相对较大，但无显著性，研究的统计功效有限，以及口服维生素A可能不是提供类维生素A治疗的最有效手段的可能性，我们得出结论，需要进一步研究慢性期CML中的类维生素A。
A national cooperative group trial was conducted in 153 patients with chronic myelogenous leukemia (CML) in chronic phase treated with oral pulse busulfan to determine if oral vitamin A can increase the time to blast crisis and enhance survival of patients. Patients diagnosed within 1 year and in the chronic phase of CML were randomized to receive oral pulse busulfan or the alkylator plus continuous oral vitamin A. Distributions of clinical progression and overall survival were estimated using the method of Kaplan and Meier. Associations of these endpoints with treatment and other patient characteristics were analyzed using the proportional hazards regression method of Cox. Both regimes were well tolerated. Patients in the busulfan plus vitamin A arm had somewhat longer durations of clinical progression-free survival (median 46 months) and overall survival (51 months) compared to those in the busulfan arm (medians 38 and 44 months). However, the differences were not statistically significant (one-tailed P=0.11 for clinical progression-free survival, 0.081 for survival). After adjustment for significant factors identified in an additional exploratory multivariate analysis, risk of clinical progression or death was 53% (P=0.022) greater and risk of death 60% (P=0.014) greater among busulfan patients. Given the relatively large though nonsignificant difference between treatment arms, the limited statistical power of the study, and the likelihood that oral vitamin A may not be the most effective means of delivering retinoid therapy, we conclude that further investigation of retinoids in chronic phase CML is warranted.