McCredie K B, Gehan E A, Freireich E J, Hewlett J S, Coltman C A, Hussein K K, Balcerzak S P, Chen T T
Cancer. 1983 Sep 15;52(6):958-66. doi: 10.1002/1097-0142(19830915)52:6<958::aid-cncr2820520604>3.0.co;2-z.
Five hundred forty three adult patients with acute leukemia were entered on the study designed to: (1) test efficacy of vincristine and prednisone used as primary drug therapy in patients with good prognosis as judged by a circulating blast cell count less than 30,000 cm2; (2) investigate the use of either simultaneously or sequentially administered Adriamycin plus cytosine arabinoside plus vincristine and prednisone; and (3) to assess the use of bacillus Calmette-Guerin (BCG) in the maintenance phase on both the response and duration of response. Complete remissions were seen in 21% of patients with the vincristine and prednisone arm. Complete remission rates were similar in both the simultaneously and sequentially administered chemotherapy with overall complete remission rates of 55%. Median durations of complete remission and survival were 35 and 62 weeks, respectively, for patients with AML; and 47 and 75, respectively, for patients with ALL. Toxicity was within acceptable limits. BCG administered during the maintenance phase of therapy caused no differences in duration of complete remission and survival. These results demonstrate an improved response and duration of response over previous studies done by this group.
543例成年急性白血病患者进入了该项研究，该研究旨在：(1) 对于循环原始细胞计数低于30,000/cm²判断为预后良好的患者，测试长春新碱和泼尼松作为主要药物治疗的疗效；(2) 研究同时或序贯给予阿霉素加阿糖胞苷加长春新碱和泼尼松的使用情况；(3) 评估卡介苗（BCG）在维持期对缓解反应及缓解持续时间的作用。长春新碱和泼尼松组21%的患者出现完全缓解。同时和序贯化疗的完全缓解率相似，总体完全缓解率为55%。急性髓细胞白血病（AML）患者的完全缓解和生存的中位持续时间分别为35周和62周；急性淋巴细胞白血病（ALL）患者分别为47周和75周。毒性在可接受范围内。治疗维持期给予的卡介苗在完全缓解持续时间和生存方面未造成差异。这些结果表明，与该研究小组之前进行的研究相比，缓解反应和缓解持续时间有所改善。
