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目的:确定马来酸氨柔比星静脉给药在人体的剂量限制性毒性(DLT)及最大耐受剂量(MTD);初步观察其对晚期实体瘤患者的疗效。方法:单次给药设60,70,75,80,90,100和110 mg.m-27个剂量组;多次给药设25,30,35和38 mg.m-24个剂量组。单次给药为d 1给药,多次给药为d 1～d 3给药,21 d重复。2周期后评价疗效。结果:DLT为Ⅳ度骨髓抑制及Ⅲ度胃肠道反应。其他不良反应包括乏力、腹泻、头痛、心悸、心前区疼痛、黏膜炎等,均很轻微。2周期后4例患者为疾病部分缓解(PR),6例患者为病变稳定(SD)。结论:人体对马来酸氨柔比星耐受良好,晚期肿瘤患者中多次给药和单次给药的MTD分别是35和100 mg.m-2。初步观察到马来酸氨柔比星有广谱抗肿瘤活性,推荐Ⅱ期临床给药方式为单次给药100 mg.m-2,3周重复。
OBJECTIVE: To determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of intravenous injection of amrubicin maleate in human, and to observe its curative effect on patients with advanced solid tumors. Methods: A single administration of 60, 70, 75, 80, 90, 100 and 110 mg.m-27 dose groups; multiple administration of 25, 30, 35 and 38 mg.m-24 dose groups. A single administration for d 1 administration, multiple d 1 d 3 administration, 21 d repeat. After 2 cycles evaluation of efficacy. Results: DLT was grade Ⅳ bone marrow suppression and Ⅲ degree gastrointestinal reaction. Other adverse reactions include fatigue, diarrhea, headache, palpitations, precordial pain, mucositis, etc., are mild. Four patients were partially relieved (PR) after 2 cycles and six were stable (SD). CONCLUSION: The human body is well tolerated with amrubicin maleate and the MTD for multiple and single doses in patients with advanced cancer is 35 and 100 mg.m-2, respectively. Preliminary observation of amrubicin maleate broad-spectrum anti-tumor activity, the recommended phase Ⅱ clinical administration of a single administration of 100 mg.m-2,3 weeks repeated.