Sakata Y, Yoshida Y
Gan To Kagaku Ryoho. 1986 May;13(5):1887-92.
A phase II clinical trial of epirubicin, a new anthracycline anticancer antibiotic, was carried out in 41 patients with inoperable or recurrent gastric cancer. Epirubicin was administered by i.v. injection; the dosages were either 40-60 mg/m2 every three weeks (Regimen A) or 20-30 mg/m2/day for 3 days every three weeks (Regimen B). Twenty-one patients were entered into Regimen A, and 20 into Regimen B. Of 31 evaluable patients, 16% (5/31) experienced objective response (PR); i.e., 20% (three of 15) treated with Regimen A and 13% (two of 16) with Regimen B, showing that there was no significant difference in the rate of response between the two regimens. Adverse effects observed were relatively mild in most cases and included anemia, leukopenia, thrombocytopenia, anorexia, nausea/vomiting, diarrhea, stomatitis and alopecia. Tachycardia and extrasystole were observed in 3 cases but disappeared upon discontinuation of the treatment. In conclusion, epirubicin seemed to have therapeutic activity comparable to that of doxorubicin in gastric cancer while being less toxic than doxorubicin, and is expected to become a better alternative to the latter drug.
对41例无法手术或复发的胃癌患者进行了一项关于新型蒽环类抗癌抗生素表柔比星的II期临床试验。表柔比星通过静脉注射给药；剂量为每三周40 - 60mg/m²（方案A）或每三周连续3天每天20 - 30mg/m²（方案B）。21例患者进入方案A，20例进入方案B。在31例可评估患者中，16%（5/31）出现客观缓解（PR）；即方案A治疗的患者中有20%（15例中的3例），方案B治疗的患者中有13%（16例中的2例），表明两种方案的缓解率无显著差异。观察到的不良反应在大多数情况下相对较轻，包括贫血、白细胞减少、血小板减少、厌食、恶心/呕吐、腹泻、口腔炎和脱发。3例患者出现心动过速和早搏，但停药后消失。总之，表柔比星在胃癌治疗中的活性似乎与阿霉素相当，但毒性比阿霉素小，有望成为后者更好的替代药物。
