共同研究によるエピルビシン(epirubicin,EPI)の膀胱癌,腎盂・尿管癌に対する第2相臨床試験成績 - 全身投与療法と膀胱腔内注入療法 -

Abstract

anthracycline系抗癌性抗生物質epirubicin (EPI)の第2相臨床試験を14施設の共同研究で, 膀胱癌, 腎盂・尿管癌を対象に行なった.1)全対象症例は71例で, 評価可能症例数は全身投与療法32例, 膀胱腔内注入療法30例であった.2)全身投与療法の奏効率は膀胱癌20.0%, 腎盂・尿管癌14.3%であった.原発性表在性膀胱癌を対象とした膀胱腔内注入療法の奏効率は66.7%であった.3)全身投与療法の副作用は食欲不振77.8%, 白血球減少64.9%, 脱毛48.7%, 貧血46.0%で, その他悪心, 嘔吐などが見られたが, 心毒性はなかった.膀胱腔内注入療法では膀胱刺激症状が66.7%に見られたが全身性副作用はなかった.4) EPIは尿路上皮癌に対して全身投与並びに膀胱腔内注入の両者において有用であった

A phase II study of a new anthracycline anti-cancer antibiotics, epirubicin (EPI), was undertaken in 71 patients with urothelial malignancies; 40 with advanced urothelial malignancies and 31 with superficial bladder cancer. Out of them 32 patients with advanced stage of urothelial cancer were evaluated for the systemic use of EPI, while 30 patients with superficial bladder cancer for intravesical use. Intravenous administration of this new anticancer antibiotic, at a dosage of 60 mg/m2 every three weeks, showed the response rate of 20.0% for advanced bladder cancer and 14.3% for renal pelvic and ureteral tumors. In cases of superficial bladder cancer, at a dosage of 60 mg/30 ml X 3 day every week in principal, the response rate was 66.7%. Eight out of 30 patients showed complete disappearance of the tumor. Twelve patients also showed more than 50% tumor regression. As for adverse effects no serious cardiotoxicity was demonstrated. Anorexia and other gastrointestinal side effects, such as nausea and vomiting, were also seen. Alopecia and myelosuppression were the major adverse effects among patients with systemic EPI administration. With intravesical use of EPI, cystitis syndrome was the major toxicity. However, no systemic side effects were noted in these cases. In conclusion, EPI was assumed to be effective for the treatment of advanced urothelial tumors and superficial bladder cancer.