Summerfield G P, Gibbs T J, Bellingham A J
Br J Cancer. 1979 Nov;40(5):736-42. doi: 10.1038/bjc.1979.254.
Thirty-two adults with acute myeloid leukaemia (AML) were randomized to receive, from the time of diagnosis, either chemotherapy alone (C group) or chemotherapy plus Bacille Calmette-Guérin vaccine (BCG) (C+I group). After remission induction and consolidation, chemotherapy was stopped in both groups but BCG was continued in the C+I group. The overall survival of the C+I group was significantly increased (P less than 0.05). There was no significant increase in the duration of first remission in the C+I group (0.05 less than P less than 0.1) nor in the time from first relapse to death (0.05 less than P less than 0.1). There was no significant difference in the incidence of first or second remissions, and the time taken to enter remission did not differ significantly between the two groups. Comparison with the results of other trials suggests that the use of maintenance chemotherapy in addition to immunotherapy produces longer remissions. Five patients in the C group developed leukaemic central-nervous-system (CSN) involvement, in comparison with none in the C+I group. CNS relapse did not produce a significant decrease in remission length (P greater than 0.1) but reduction in survival after CNS relapse was highly significant (P = 0.001). These results suggest that administration of BCG from an early stage in the treatment of AML may protect the CNS against leukaemic infiltration and therefore serve as a simple, innocuous form of CNS prophylaxis.
32名成年急性髓系白血病（AML）患者从确诊时起被随机分组，分别接受单纯化疗（C组）或化疗加卡介苗（BCG）（C + I组）。诱导缓解和巩固治疗后，两组均停止化疗，但C + I组继续使用卡介苗。C + I组的总生存期显著延长（P < 0.05）。C + I组首次缓解期的持续时间没有显著延长（0.05 < P < 0.1），从首次复发到死亡的时间也没有显著延长（0.05 < P < 0.1）。两组首次或第二次缓解的发生率没有显著差异，进入缓解期所需的时间也没有显著差异。与其他试验结果比较表明，除免疫治疗外使用维持化疗可产生更长的缓解期。C组有5名患者发生白血病中枢神经系统（CSN）受累，而C + I组无此情况。中枢神经系统复发并没有使缓解期长度显著缩短（P > 0.1），但中枢神经系统复发后的生存期缩短非常显著（P = 0.001）。这些结果表明，在AML治疗早期给予卡介苗可能保护中枢神经系统免受白血病浸润，因此可作为一种简单、无害的中枢神经系统预防形式。
