Kornek G, Raderer M, Depisch D, Haider K, Fazeny B, Dittrich C, Scheithauer W
Department of Internal Medicine I, Vienna University Medical School.
Eur J Cancer. 1994;30A(3):398-400. doi: 10.1016/0959-8049(94)90264-x.
In a phase II study, 32 patients with advanced breast cancer previously unexposed to palliative cytotoxic chemotherapy were treated with amonafide, 800-900 mg intravenously over 3 h repeated every 4 weeks. Objective response was seen in 8 patients including 1 complete response, 10 patients had stable disease and 14 patients progressed so the overall response was 25% (95% confidence interval, 11-43%). The most frequently encountered side-effects were haematological (granulocytopenia > or = WHO grade 3 was encountered in 7/24 patients at 800 mg/m2 and in 3/8 patients at 900 mg/m2 amonafide) and nausea/vomiting (62%), despite prophylactic use of ondansetron. Non-haematological severe adverse reactions included neurotoxicity WHO grade 3 in 1 patient and orthostatic hypotension WHO grade 4 in another. In summary, the results of this trial suggest a limited therapeutic index of amonafide if used at this dose with this administration schedule.
在一项II期研究中，32例既往未接受过姑息性细胞毒性化疗的晚期乳腺癌患者接受了氨苯吖啶治疗，静脉注射800 - 900毫克，持续3小时，每4周重复一次。8例患者出现客观缓解，包括1例完全缓解，10例患者病情稳定，14例患者病情进展，因此总体缓解率为25%（95%置信区间，11 - 43%）。最常出现的副作用是血液学方面的（800毫克/平方米剂量时，24例患者中有7例出现粒细胞减少≥世界卫生组织3级；900毫克/平方米剂量时，8例患者中有3例出现粒细胞减少≥世界卫生组织3级）以及恶心/呕吐（62%），尽管预防性使用了昂丹司琼。非血液学严重不良反应包括1例患者出现世界卫生组织3级神经毒性，另1例患者出现世界卫生组织4级直立性低血压。总之，该试验结果表明，按照此剂量和给药方案使用氨苯吖啶，其治疗指数有限。
