Taguchi T, Ogawa M, Izuo M, Terasawa T, Yoshida M, Nakajima M
Gan To Kagaku Ryoho. 1986 Dec;13(12):3498-507.
A randomized clinical trial comparing epirubicin (EPI) and doxorubicin (DX) was conducted in patients with advanced or recurrent breast cancer. The dosage employed was 60 mg/m2 for EPI and 40 mg/m2 for DX at intervals of three weeks. There were 40 patients entered into the EPI group and 39 into the DX group. Background factors analysed were well balanced in both groups. The response rate was 56.3% in the EPI group (5 CR and 13 PR among 32 evaluable patients), and 35.5% in the DX group (1 CR and 10 PR among 31 evaluable patients), and the difference between both groups was statistically significant (P less than 0.05) by U-test. The response duration and time to response showed no significant difference between both groups. The incidences and grades of hematologic and non-hematologic toxicities were nearly identical. We conclude that EPI is a useful drug for the treatment of advanced breast cancer.
一项针对晚期或复发性乳腺癌患者的随机临床试验,比较了表柔比星(EPI)和多柔比星(DX)。使用的剂量为表柔比星60mg/m²,多柔比星40mg/m²,每三周给药一次。表柔比星组入组40例患者,多柔比星组入组39例患者。两组分析的背景因素均衡良好。表柔比星组的缓解率为56.3%(32例可评估患者中5例完全缓解和13例部分缓解),多柔比星组为35.5%(31例可评估患者中1例完全缓解和10例部分缓解),两组间差异经U检验具有统计学意义(P<0.05)。缓解持续时间和至缓解时间两组间无显著差异。血液学和非血液学毒性的发生率及分级几乎相同。我们得出结论,表柔比星是治疗晚期乳腺癌的一种有效药物。