前立腺癌内分泌療法 : LH-RH analogue, ICI 118630(Zoladexｮ)と去勢術あるいはエストロゲン療法との臨床比較試験

Abstract

前立腺癌患者82例に対し, 「Zoladex療法」あるいはその対照として去勢術またはエストロゲン療法」を施行し, 臨床効果, 内分泌効果, 安全性および有用度について比較検討した.臨床効果は, 対象病巣改善度でZoladex群33例中21例に, 対照群33例中22例にPR以上の改善が, 自覚症状総合改善度ではZoladex群24例中21例, 対照群30例中24例が改善した.いずれも両群間に有意差はなかった.内分泌効果では両群とも全例に去勢効果が得られた.副作用はZoladex群39例中14例, 対照群34例中19例にみられたが, 発現率では両群に差はない.有用度については, やや有用以上でみると, Zoladex群, 対照群ともに33例中29例, 87.9%に有用と判定されている

A multicenter randomized clinical trial was carried out between May, 1986 and May, 1987 involving 82 patients with stage B-D prostatic carcinoma from 29 centers. The clinical efficacy, endocrine effect, safety and usefulness of the luteinizing hormone-releasing hormone (LH-RH) analogue and other endocrine manipulations in the treatment of prostatic carcinoma. Zoladex depot containing 3.6 mg of ICI 118, 630, an LH-RH analogue, was administered every four weeks 3 times in total. Patients in the control group received either 300 mg of diethylstilbestrol diphosphate orally daily for 12 weeks or orchidectomy. An antitumor effect (CR + PR) was observed in 21 of the 33 patients (63.6%) in the Zoladex group and in 22 of the 33 (66.7%) in the control group, showing no significant difference between the two groups. There was no significant difference in overall subjective response either; 21 of the 24 (87.5%) in the Zoladex group and 24 of the 30 (80.0%) in the control group. In both groups, 100% endocrine effect was obtained as shown by achievement of castration in all patients. Adverse reactions were observed in 14 of the 39 (35.9%) patients treated with Zoladex as compared with 19 of the 34 (55.9%) control patients, resulting in no significant difference in the incidence between the two groups. These adverse reactions were not so severe as to require withdrawal from the study. In both groups, the treatment was assessed as slightly or more useful in 29 of the 33 (87.9%) patients. From these results, it is concluded that Zoladex, 3.6 mg depot, is a useful drug for treatment of prostatic cancer, having clinical efficacy and endocrine effects comparable to those of the conventional endocrine manipulations, being safe, and causing less physiological and psychological pain.