Sampi K, Masaoka T, Shirakawa S, Shirai T, Abe T, Shibata H, Umeda M, Kobayashi T, Sugiyama H, Toki H
Anticancer Res. 1987 Jan-Feb;7(1):29-31.
A new doxorubicin analogue, epirubicin (EPI), was evaluated in 41 patients with acute leukemia at 11 Japanese institutions participating in a phase II study between January 1983 and July 1985; during this period 35 patients were considered evaluable. There were 25 males and 10 females with a median age of 43 years (range, 19-71 years) and the median PS of 2 (range, 0-4). EPI was given to 25 patients who had previously been treated with intensive combination chemotherapy, of whom 22 had already received anthracyclines. Ten patients had not been treated previously. Two dose schedules were explored. The higher dose schedule (18 cases) consisted of the administration of 24 to 60 mg/m2 for 3 to 5 consecutive days, and the lower dose schedule (17 cases) consisted of 11 to 20 mg/m2 for 5 to 7 days. Remissions were obtained in 7 patients (20%), 2 of whom showed complete remission and 5 partial remission. The remission duration was 2, 2, 3, 5, 16, 16 and 29+ weeks, respectively. The expected myelosuppression was universal. Stomatitis occurred in 15 patients, of which 7 cases were severe. This stomatitis occurred frequently in the higher dose schedule, and was thought to be a dose-limiting factor. In others, alopecia, G.I. symptoms, and diarrhoea (4 patients) were seen. These results from a cooperative group study indicated that EPI was an effective drug for the treatment of acute leukemia.
一种新的阿霉素类似物表柔比星（EPI），在1983年1月至1985年7月期间，于日本11家机构参与的一项II期研究中对41例急性白血病患者进行了评估；在此期间，35例患者被认为可评估。有25例男性和10例女性，中位年龄43岁（范围19 - 71岁），中位体能状态为2（范围0 - 4）。25例患者曾接受过强化联合化疗，其中22例已接受过蒽环类药物治疗。10例患者此前未接受过治疗。探索了两种给药方案。高剂量方案（18例）为连续3至5天给予24至60mg/m²，低剂量方案（17例）为5至7天给予11至20mg/m²。7例患者（20%）获得缓解，其中2例完全缓解，5例部分缓解。缓解持续时间分别为2、2、3、5、16、16和29 +周。预期的骨髓抑制普遍存在。15例患者发生口腔炎，其中7例严重。这种口腔炎在高剂量方案中频繁发生，被认为是剂量限制因素。其他方面，出现了脱发、胃肠道症状和腹泻（4例患者）。该合作组研究的这些结果表明，表柔比星是治疗急性白血病的一种有效药物。
