van der Does-van den Berg A, van Wering E R, Suciu S, Solbu G, Rammeloo J A, de Koning J, van Zanen G E
Stichting Nederlandse Werkgroep Leukemie bij Kinderen (SNWLK), Den Haag.
Tijdschr Kindergeneeskd. 1988 Apr;56(2):61-6.
The Dutch Childhood Leukemia Study Group performed a phase III study (Study ALL V) to evaluate the effectiveness of addition of rubidomycin to induction treatment with vincristine, prednisone and L-asparaginase in children (0-15 years) with standard risk acute lymphoblastic leukemia: WBC less than 50.10(9)/l, absence of mediastinal mass and/or cerebromeningeal leukemia. Furthermore, the influence of some initial patient- en disease-characteristics on the outcome was analysed. Between May 1979 and December 1982 240 patients entered into the study and were randomized into 2 groups: group A (n = 122) received induction treatment with vincristine, prednisone and L-asparaginase; group B (n = 118) received induction treatment with vincristine, prednisone, L-asparaginase and rubidomycin. All patients received cranial irradiation (doses adjusted to age) and intrathecal methotrexate, followed by maintenance treatment with 6-mercaptopurine and methotrexate for 5 weeks, alternated with vincristine and prednisone for 2 weeks, up to 24 months. Complete remission rate was 94% in both groups. Event-free survival at 5 years after diagnosis was higher in group B (62% +/- 4.6%) than in group A (54.2% +/- 4.6%) but the difference was not significant. A higher initial WBC, age greater than or equal to 10 years and a positive acid phosphatase reaction of the leukemic cells were unfavorable prognostic factors (p less than 0.01). Sex, FAB-morphology, immunophenotype and place of treatment (center or general hospital) were not significant factors.
荷兰儿童白血病研究小组开展了一项III期研究（ALL V研究），以评估在标准风险急性淋巴细胞白血病（0至15岁）儿童中，柔红霉素添加至长春新碱、泼尼松和L-天冬酰胺酶诱导治疗中的有效性：白细胞计数低于50×10⁹/L，无纵隔肿块和/或脑膜白血病。此外，还分析了一些初始患者和疾病特征对预后的影响。1979年5月至1982年12月，240例患者进入研究并随机分为两组：A组（n = 122）接受长春新碱、泼尼松和L-天冬酰胺酶诱导治疗；B组（n = 118）接受长春新碱、泼尼松、L-天冬酰胺酶和柔红霉素诱导治疗。所有患者均接受颅脑照射（剂量根据年龄调整）和鞘内注射甲氨蝶呤，随后接受6-巯基嘌呤和甲氨蝶呤维持治疗5周，与长春新碱和泼尼松交替治疗2周，持续24个月。两组的完全缓解率均为94%。诊断后5年的无事件生存率B组（62%±4.6%）高于A组（54.2%±4.6%），但差异无统计学意义。初始白细胞计数较高、年龄大于或等于10岁以及白血病细胞酸性磷酸酶反应阳性是不良预后因素（p < 0.01）。性别、FAB形态学、免疫表型和治疗地点（中心医院或综合医院）不是显著因素。
