Leblanc T, Deméocq F, Leverger G, Baruchel A, Lemerle S, Vannier J P, Nelken B, Guillot T, Schaison G
Hôpital Saint-Louis, Paris, Hôtel-Dieu, France.
Med Pediatr Oncol. 1994;22(2):119-24. doi: 10.1002/mpo.2950220211.
Bisantrene is an anthracene derivative which has demonstrated activity in acute myeloblastic leukemia (AML) and in lymphoma. The present study was designed to assess the reinduction rate and toxicity of bisantrene (250 mg/m2/d x 5) associated with aracytine (100 mg/m2 twice a day x 5) in refractory and relapsed acute childhood leukemia. Patients who relapsed after bone marrow transplantation were eligible. Twenty-six children were included. Diagnoses were as follows: 13 AML, 9 acute lymphoblastic leukemia (ALL), and 4 undifferentiated leukemia (AUL). All patients had been very highly pretreated, especially with anthracyclines, and most of them were of poor prognosis. The overall response rate was 46% with a 95% confidence interval ranging from 27-65%. According to diagnosis, complete remission (CR) rates are: AML: 5/13, ALL: 5/9, and AUL: 2/4. Four children died, three from infection and one from acute lysis syndrome. The major toxicity was infection with grade 3 and 4 episodes occurring in 42% of patients. No significant cardiac toxicity was noted. Hepatic and renal toxicity was noted. Hepatic and renal toxicity were limited and transient. Bisantrene in association with aracytine is effective in both AML and ALL of childhood. Bisantrene should be evaluated with a five-day schedule in other pediatric malignancies. In children with acute leukemia previously treated with high dose aracytine, new combination regimen is warranted.
比生群是一种蒽衍生物，已在急性髓性白血病（AML）和淋巴瘤中显示出活性。本研究旨在评估比生群（250mg/m²/天×5天）联合阿糖胞苷（100mg/m²，每日两次×5天）用于难治性和复发性儿童急性白血病的再诱导率和毒性。骨髓移植后复发的患者符合条件。纳入了26名儿童。诊断如下：13例AML，9例急性淋巴细胞白血病（ALL），4例未分化白血病（AUL）。所有患者均接受过非常高强度的预处理，尤其是蒽环类药物，且大多数患者预后较差。总缓解率为46%，95%置信区间为27%-65%。根据诊断，完全缓解（CR）率分别为：AML：5/13，ALL：5/9，AUL：2/4。4名儿童死亡，3名死于感染，1名死于急性溶解综合征。主要毒性是感染，42%的患者发生3级和4级感染事件。未观察到明显的心脏毒性。观察到肝脏和肾脏毒性。肝脏和肾脏毒性有限且为一过性。比生群联合阿糖胞苷对儿童AML和ALL均有效。比生群应按五日疗程在其他儿科恶性肿瘤中进行评估。对于先前接受过高剂量阿糖胞苷治疗的急性白血病儿童，有必要采用新的联合方案。
