Lopez M, Perno C F, Di Lauro L, Papaldo P, Ganzina F, Barduagni A
Invest New Drugs. 1984;2(3):319-22. doi: 10.1007/BF00175384.
Forty-two previously untreated patients with metastatic malignant melanoma were randomized to receive DTIC at a dose of 250 mg/m2/day 4 IV on days 1-5 or the same drug plus epirubicin (Epi-DX) at a dose of 90 mg/m2 on day 1. Cycles were repeated every 3 weeks. Partial responses were observed in two out of 22 patients (9.1%) treated with DTIC, and in four out of 19 evaluable patients (21.1%) treated with Epi-DX + DTIC. Overall, Epi-DX + DTIC combination was well tolerated, thus permitting administration after a 3-week interval of the full drug dosages in all but two patients. No major cardiotoxicity was observed. Although patients in the Epi-DX + DTIC group had a better response rate than those in the DTIC group, the difference was not statistically significant, and the 21.1% response rate observed with the two-drug combination does not differ from that reported with DTIC used alone.
42例既往未接受过治疗的转移性恶性黑色素瘤患者被随机分为两组，一组在第1 - 5天接受剂量为250 mg/m²/天的达卡巴嗪（DTIC）静脉注射，共4天；另一组在第1天接受相同剂量的DTIC加90 mg/m²表柔比星（Epi - DX）。每3周重复一个周期。接受DTIC治疗的22例患者中有2例（9.1%）出现部分缓解，接受Epi - DX + DTIC治疗的19例可评估患者中有4例（21.1%）出现部分缓解。总体而言，Epi - DX + DTIC联合方案耐受性良好，除2例患者外，其余患者均能在3周间隔后接受全剂量药物治疗。未观察到严重心脏毒性。虽然Epi - DX + DTIC组患者的缓解率高于DTIC组，但差异无统计学意义，且两药联合方案观察到的21.1%的缓解率与单独使用DTIC报道的缓解率无差异。
