Berthold F, Kaatsch P, Evers G, Harms D, Jürgens H, Niethammer D, Ritter J, Wahlen W, Treuner J, Lampert F
Klin Padiatr. 1984 May-Jun;196(3):143-9. doi: 10.1055/s-2007-1025597.
From June 1979 to June 1982 72 children with metastatic neuroblastoma older than 1 year of age at diagnosis were treated according to the protocol NB 79 of the German Society for Paediatric Oncology. The chemotherapy included three cycles of adriamycine, cyclophosphamide, vincristine, dacarbazine and five cycles of adriamycine and cyclophosphamide. 34 patients were randomized for additional beta-Interferon (Fiblaferon) treatment (10(5) U/kg daily for 3 weeks followed by 3 times a week for 21 weeks). 38 patients were not treated with Fiblaferon. The response rate was 96% including 35% complete and 61% partial remissions. Preoperative chemotherapy improved remarkably the resectability of the primary tumor without enhancing complication rates. The cumulative proportion surviving was 21% for the interferon group and 6% for the patients not treated with interferon. The cumulative recurrence free survival rate, however, was 5% for both groups. The median survival time was 19 months and the median recurrence free survival time 10 months. A serious side effect of chemotherapy was bone marrow depression (73%) resulting in 1 week delay of drug administration per cycle. The median of administered drug dosages was 87-100% of the recommended dosages. Side effects of beta-Interferon commonly decreased with time and were fever reactions (55%), shaking chills (29%), cardiovascular reactions (16%).(ABSTRACT TRUNCATED AT 250 WORDS)
1979年6月至1982年6月,72例诊断时年龄超过1岁的转移性神经母细胞瘤患儿按照德国儿科肿瘤学会的NB 79方案进行治疗。化疗包括三个周期的阿霉素、环磷酰胺、长春新碱、达卡巴嗪以及五个周期的阿霉素和环磷酰胺。34例患者被随机分配接受额外的β-干扰素(纤维母细胞干扰素)治疗(每日10⁵U/kg,共3周,随后每周3次,共21周)。38例患者未接受纤维母细胞干扰素治疗。缓解率为96%,其中完全缓解率为35%,部分缓解率为61%。术前化疗显著提高了原发肿瘤的可切除性,且未增加并发症发生率。干扰素组的累积生存率为21%,未接受干扰素治疗的患者为6%。然而,两组的无复发生存累积率均为5%。中位生存时间为19个月,中位无复发生存时间为10个月。化疗的一个严重副作用是骨髓抑制(73%),导致每个周期药物给药延迟1周。给药剂量中位数为推荐剂量的87 - 100%。β-干扰素的副作用通常随时间减轻,包括发热反应(55%)、寒战(29%)、心血管反应(16%)。(摘要截选至250字)