Furue H, Niitani H, Nakao I, Hoshino A, Hasegawa K, Tsukagoshi S, Fujita H
Teikyo University.
Gan To Kagaku Ryoho. 1990 Jul;17(7):1287-94.
Phase I study with a new oral anticancer agents. MST-16 (Sobuzoxane), was conducted by 3 administration schedules: single, 5 consecutive days and 10-15 consecutive days. No toxicity was observed in the single administration at doses escalated up to 1,500 mg/m2. Dose-dependent leukopenia was observed from 560 mg/m2/day in consecutive 5 day administration, and median days to the nadir and recovery were about 2 and 1 week, respectively. GI-disorders were also observed sporadically from 800 mg/m2/day. One patient with Hodgkin's disease receiving 1,000 mg/m2/day achieved complete response. Consecutive administration for 10-15 days was carried out at a dose of 800 mg/m2/day. Six out of 7 evaluable patients demonstrated leukopenia, and all 2 patients treated for 15 days experienced leukopenia with a nadir corresponding to grade 3. Median days to nadir and recovery were both about 2 weeks. Doses recommended for phase II study were considered to be 1,600 mg/body/day for 5 days and 1,200 mg/body/day for 10-14 days.
一项针对新型口服抗癌药物MST-16（梭布佐生）的I期研究采用了3种给药方案：单次给药、连续5天给药和连续10 - 15天给药。在单次给药中，剂量递增至1500mg/m²时未观察到毒性。在连续5天给药中，从560mg/m²/天开始观察到剂量依赖性白细胞减少，白细胞计数最低点和恢复的中位天数分别约为2天和1周。从800mg/m²/天开始也偶尔观察到胃肠道紊乱。一名接受1000mg/m²/天治疗的霍奇金病患者实现了完全缓解。以800mg/m²/天的剂量进行连续10 - 15天给药。7名可评估患者中有6名出现白细胞减少，所有接受15天治疗的2名患者均出现白细胞减少，最低点对应3级。白细胞计数最低点和恢复的中位天数均约为2周。II期研究推荐的剂量被认为是连续5天1600mg/体/天和连续10 - 14天1200mg/体/天。
