Lopez M, Di Lauro L, Papaldo P, Lazzaro B, Ganzina F, Di Pietro N
Invest New Drugs. 1986;4(1):39-42. doi: 10.1007/BF00172014.
Idarubicin, a new analogue of daunorubicin, was administered to 27 patients with advanced breast cancer in a phase II trial. The drug was given orally at a dose of 30-35 mg/m2 every 3 weeks. Twenty-two patients were evaluable for response. All evaluable patients were previously treated with one or more chemotherapeutic regimens, including an anthracycline in more than 50% of the cases. Partial remissions were obtained in 5 patients, for a response rate of 23%. The median duration of response was 191 days. Mild nausea and vomiting were common. Diarrhea, which occurred in less than 50% of the patients, was usually short-lived. Alopecia was generally minimal. Myelosuppression was the dose-limiting toxic effect. Leukopenia was frequently seen, with full recovery by day 28 in 81% of the courses. Thrombocytopenia was less common than leukopenia. Four cases of grade 1 acute cardiac toxicity were recorded. This study suggests that idarubicin can induce regressions in advanced carcinoma of the breast, and justifies further studies in combination with other agents.
伊达比星是柔红霉素的一种新类似物，在一项II期试验中给予27例晚期乳腺癌患者使用。该药物每3周口服一次，剂量为30 - 35 mg/m²。22例患者可评估疗效。所有可评估的患者此前均接受过一种或多种化疗方案治疗，其中超过50%的病例使用过蒽环类药物。5例患者获得部分缓解，缓解率为23%。缓解的中位持续时间为191天。轻度恶心和呕吐很常见。腹泻发生率不到50%的患者，通常持续时间较短。脱发一般很轻微。骨髓抑制是剂量限制性毒性作用。经常出现白细胞减少，81%的疗程在第28天白细胞完全恢复。血小板减少比白细胞减少少见。记录到4例1级急性心脏毒性病例。本研究表明伊达比星可使晚期乳腺癌消退，并证明与其他药物联合进行进一步研究是合理的。
