Odom L F, Tubergen D G, Githens J H, Heideman R L, Blake M A
Med Pediatr Oncol. 1983;11(2):79-90. doi: 10.1002/mpo.2950110204.
Seventy-four children ranging in age from 6 months to 17.5 years with acute lymphoblastic leukemia newly diagnosed between 1976 and 1979 were entered on a study incorporating intermittent chemotherapy with or without the addition of bacillus Calmette-Guérin (BCG). The chemotherapy program consisted of induction with vincristine, dexamethasone, and intrathecal methotrexate, intensification with adriamycin and asparaginase, central nervous system treatment with cranial irradiation and intrathecal methotrexate, and continuation treatment with 5-day courses of combination chemotherapy administered every three weeks. The first phase of continuation therapy incorporated vincristine, adriamycin, 6-mercaptopurine, and dexamethasone. In the second phase, oral methotrexate was substituted for the adriamycin in non-T-cell patients; in T-cell patients, cytosine arabinoside or cyclophosphamide and methotrexate in alternating cycles were substituted for the adriamycin and asparaginase was added. Total duration of therapy was approximately 2.5 years. Connaught BCG was administered by Heaf gun on days 8 and 15 of each 3-week cycle for the first 8 months of treatment in approximately one-third of the patients. Actuarial disease-free survival with a median follow-up of 59 months shows no difference in outcome between the BCG and non-BCG poor-risk patients. However, there is an improvement in disease-free survival of BCG-treated good- and average-risk girls (P = 0.04). While patients were actively receiving BCG there was also a trend toward the development of fewer significant infections than when patients were not receiving BCG (P = 0.85). Toxicities from BCG administration included satellite rashes, local tenderness, lymphadenopathy, secondary infection, and residual scars. Overall disease-free survival by actuarial analysis is 60% at 6 years; for patients with unfavorable prognostic features it is 40%. In this trial the addition of BCG prolonged the disease-free survival of girls with good- and average-risk prognostic features and also may have decreased the susceptibility to infection while it was being administered. However, the benefit does not appear sufficient to warrant its routine use, especially in view of the toxicities encountered.
1976年至1979年间新诊断出患有急性淋巴细胞白血病的74名年龄在6个月至17.5岁之间的儿童参与了一项研究，该研究采用了间歇性化疗，部分患者添加了卡介苗（BCG），部分未添加。化疗方案包括用长春新碱、地塞米松和鞘内注射甲氨蝶呤进行诱导治疗，用阿霉素和天冬酰胺酶进行强化治疗，用颅脑照射和鞘内注射甲氨蝶呤进行中枢神经系统治疗，以及每三周进行为期5天的联合化疗进行维持治疗。维持治疗的第一阶段包括长春新碱、阿霉素、6-巯基嘌呤和地塞米松。在第二阶段，非T细胞患者用口服甲氨蝶呤替代阿霉素；在T细胞患者中，交替周期使用阿糖胞苷或环磷酰胺和甲氨蝶呤替代阿霉素，并添加天冬酰胺酶。治疗总时长约为2.5年。在大约三分之一的患者中，在治疗的前8个月里，每3周周期的第8天和第15天用Heaf枪接种Connaught BCG。中位随访59个月的精算无病生存率显示，BCG组和非BCG组的高危患者在预后方面没有差异。然而，接受BCG治疗的低危和中危女孩的无病生存率有所提高（P = 0.04）。在患者积极接受BCG治疗期间，与未接受BCG治疗时相比，发生严重感染的趋势也有所减少（P = 0.85）。接种BCG的毒性包括卫星状皮疹、局部压痛、淋巴结病、继发感染和残留疤痕。通过精算分析，6年时的总体无病生存率为60%；预后不良的患者为40%。在这项试验中，添加BCG延长了低危和中危预后特征女孩的无病生存期，并且在接种期间可能也降低了感染易感性。然而，这种益处似乎不足以保证其常规使用，特别是考虑到所遇到的毒性。
