Sackmann-Muriel F, Fernández-Barbieri M A, Santarelli M T, Matus-Ridley M, Rosso A, Negri-Aranguren P, Cerutti I, Gomel M, Kvicala R
Pediatric Section, Argentine Group for Treatment of Acute Leukemia (Grupo Argentino de Tratamiento de la Leucemia Aguda), Buenos Aires.
Semin Oncol. 1993 Dec;20(6 Suppl 8):34-8.
In April 1990, the Argentine Group for Treatment of Acute Leukemia began a multicenter trial for the treatment of previously untreated acute myeloblastic leukemia patients who were under 21 years of age. Initial treatment consisted of an 8-day induction phase with cytarabine together with idarubicin on days 3 to 5 and etoposide on days 6 to 8. A multidrug consolidation phase was subsequently administered and, after a treatment-free interval of 2 to 4 weeks, two 5-day intensification courses with high-dose cytarabine and etoposide were delivered with a 4-week interval between each course. Continuation therapy was started 2 to 4 weeks after the second course, with 6-thioguanine daily and cytarabine daily for 4 days every 4 weeks. Treatment was stopped after 18 months in children in continuous complete remission. A preliminary evaluation of this ongoing study included 36 patients with a mean age of 7.5 years (age range, 5 months to 16 years). The majority of patients had a French-American-British classification of M2 (n = 13) or M4 (n = 8). Complete remission was achieved by 91.7% of patients, while one died from sepsis in bone marrow hypoplasia and two were regarded as treatment failures. At a median follow-up of 12 months (range, 2 to 23 months) there were 12 adverse events: six bone marrow relapses, one bone marrow/skin relapse, and five deaths in complete remission (all deaths occurred during the consolidation phase). During the induction phase most of the patients experienced prolonged myelosuppression, and grade 3 to 4 toxicity (according to the Children's Cancer Group criteria) was frequently seen. Alopecia was universal. However, toxicity was manageable. We conclude that idarubicin in combination with cytarabine and etoposide is a highly effective regimen for induction in children with acute myeloblastic leukemia.
1990年4月，阿根廷急性白血病治疗小组开展了一项多中心试验，用于治疗21岁以下既往未接受过治疗的急性髓细胞性白血病患者。初始治疗包括一个为期8天的诱导期，第3至5天使用阿糖胞苷联合伊达比星，第6至8天使用依托泊苷。随后进行多药巩固期治疗，在2至4周的无治疗间隔期后，给予两个为期5天的大剂量阿糖胞苷和依托泊苷强化疗程，每个疗程间隔4周。在第二个疗程后2至4周开始维持治疗，每4周每日使用6-硫鸟嘌呤，同时每日使用阿糖胞苷，共4天。持续完全缓解的儿童在18个月后停止治疗。对这项正在进行的研究的初步评估纳入了36例患者，平均年龄为7.5岁（年龄范围为5个月至16岁）。大多数患者的法美英分类为M2（n = 13）或M4（n = 8）。91.7%的患者实现了完全缓解，其中1例死于骨髓发育不全伴败血症，2例被视为治疗失败。在中位随访12个月（范围为2至23个月）时，出现了12起不良事件：6例骨髓复发，1例骨髓/皮肤复发，5例在完全缓解期死亡（所有死亡均发生在巩固期）。在诱导期，大多数患者经历了长时间的骨髓抑制，3至4级毒性反应（根据儿童癌症小组标准）很常见。脱发普遍存在。然而，毒性反应是可控的。我们得出结论，伊达比星联合阿糖胞苷和依托泊苷是诱导治疗儿童急性髓细胞性白血病的高效方案。
