Additive therapy in the maintenance of remission in acute lymphoblastic leukemia of childhood: The effect of the initial leukocyte count
Additive therapy in the maintenance of remission in acute lymphoblastic leukemia of childhood: The effect of the initial leukocyte count
复制标题
儿童急性淋巴细胞白血病维持缓解的附加治疗：初始白细胞计数的影响
作者：
Denis R. Miller;M. Sonley;M. Karon;N. Breslow;D. Hammond
在407例接受泼尼松和每两周一次静脉注射甲氨蝶呤治疗的患者中，81%或329例患者出现M1骨髓缓解后，321例患者被随机分配到6种维持治疗方案中的一种，旨在评估添加剂放线菌素D、氮芥和5-氟尿嘧啶每两个月一次静脉冲击对儿童急性淋巴细胞白血病缓解持续时间的影响。在初始WBC低于20，000/mm 3的患者中，在方案1（放线菌素D +6 MP、氮芥+甲氨蝶呤）、方案2（放线菌素D +6 MP和甲氨蝶呤）和方案6（5-氟尿嘧啶+6 MP和甲氨蝶呤）中观察到添加剂的统计学显著有益作用。初始WBC高于20，000/mm 3的儿童预后最差;在该组中，添加剂似乎有不良影响，但差异不显著。与初始WBC高于20，000/mm 3的患者相比，初始WBC低于5000/mm 3的患者的生存期也显著延长。在不同的治疗方案中，血液学、胃肠道和肝脏毒性的程度或频率几乎没有差异。这些结果表明，添加剂治疗对预后最好的患者是有益的，并且在未来的方案设计、患者随机化和对照临床试验的数据分析中必须仔细考虑初始WBC的预后影响。
Following introduction of M1 marrow remission in 81% or 329 of 407 patients treated with prednisone and biweekly intravenous methotrexate, 321 patients were randomly assigned to one of six maintenance treatment regimens designed to evaluate the effect of bimonthly intravenous pulses of the additives actinomycin D, nitrogen mustard, and 5‐fluorouracil on the duration of remission in acute lymphoblastic leukemia of childhood. In patients with an initial WBC below 20,000/mm3, a statistically significant beneficial effect of additives was observed in Regimen 1 (actinomycin D with 6MP, nitrogen mustard with methotrexate), Regimen 2 (actinomycin D with 6MP and methotrexate), and Regimen 6 (5‐fluorouracil with 6MP and methotrexate). Children with an initial WBC above 20,000/mm3 had the least favorable prognosis; in this group additives appeared to have an adverse effect but the difference was not significant. Survival was also significantly longer in patients with an initial WBC of less than 5000/mm3, when compared to those with an initial WBC of above 20,000/mm3. Little difference in the degree or frequency of hematologic, gastrointestinal, and hepatic toxicity was encountered in the various regimens. These results indicate that additive therapy is beneficial in those patients with the most favorable prognosis and that the prognostic effects of the initial WBC must be given careful consideration in future protocol design, patient randomization, and data analysis of controlled clinical trials.
DOI：
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发表时间：
1972
期刊：
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影响因子：
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作者：
D. Cox
通讯作者：
D. Cox