Marty M, Ferme C, Gisselbrecht C, Guy H, Clark M J, Bancillon A, Boiron M
Cancer Treat Rep. 1985 Jun;69(6):703-5.
A phase I study of bisantrene using a daily injection for 5 days was undertaken in adult patients with relapsing acute nonlymphoblastic leukemia. Seventeen patients received 27 courses, with daily doses ranging from 75 to 250 mg/m2. Although gastrointestinal toxicity and alopecia were rare, hematological toxicity occurred in 85% of the patients. There was cholestasis unrelated to infectious events in 27% of the courses, as well as reversible renal failure in eight of 27 evaluable courses. Responses (complete + partial) were obtained in 35% +/- 10% of the patients. The recommended dose for phase II study is 200 mg/m2/day X 7.
一项针对复发的急性非淋巴细胞白血病成年患者的Ⅰ期研究采用了每日注射一次、连续注射5天的方式使用比山屈。17名患者接受了27个疗程的治疗，每日剂量范围为75至250mg/m²。尽管胃肠道毒性和脱发较为罕见，但85%的患者出现了血液学毒性。27%的疗程中出现了与感染事件无关的胆汁淤积，在27个可评估疗程中有8个出现了可逆性肾衰竭。35%±10%的患者获得了缓解（完全缓解+部分缓解）。Ⅱ期研究的推荐剂量为200mg/m²/天×7天。
