LH-RH analogue ICI 118630 連日皮下投与による前立腺癌内分泌療法

Abstract

前立腺癌患者33例に対し, LH-RH analogue, ICI 118630 125 μg, 250 μg, 500 μgを連日12週間皮下投与し, 用量別臨床効果, 安全性および内分泌動態への影響について検討した.臨床効果は, 対象病巣改善度で125 μg投与群44.4%, 250 μg投与群50.0%, 500 μg投与群42.9%の改善がみられたが, 3群間に有意差はなかった.自覚症状総合改善度も75.0%, 62.5%, 85.7%と改善がみられたが, 有意差はなかった.内分泌効果は効果ありと判定されたものは, 125 μg投与群58.3%, 250 μg投与群66.7%, 500 μg投与群100%であった.3群間に有意差はなく, また平均去勢時期は全例で4.1±2.0週であった.副作用は37°Cの発熱が125 μg投与群13例中1例, 7.3%, 注射部位の熱感およびflareが500 μg投与群8例中各1例, 12.5%にみられたが, いずれも軽微なものであり, 特別な処置を必要とせず治療の継続により臨床効果が得られた

Between April, 1984 and March, 1985 in 14 centers, 33 patients with prostatic cancer of our 14 centers were randomized to subcutaneously receive either 125, 250, or 500 micrograms/day of ICI 118, 630, an LH-RH analogue, for 12 weeks, and the clinical efficacy, safety and endocrinal effects of the drug by dose were examined. An objective partial response was obtained in 44.4% of the 125 micrograms-treated group, in 50.0% of the 250 micrograms-treated group, and 42.9% of the 500 micrograms-treated group, showing no significant difference between the groups. General subjective response rates in these three groups were respectively 75.0%, 62.5%, and 85.7%, not differing from each other significantly. No significant difference was observed in endocrinal effect which was seen in 58.3%, 66.7%, and 100% of 125 micrograms, 250 micrograms, and 500 micrograms groups, respectively. Medical castration was attained in 4.1 +/- 2.0 weeks on average. Adverse reactions observed included fever up to 37 degrees C in 1 of the 13 (7.3%) patients treated with 125 micrograms, and hot feeling at the injection site and flare in 1 of the 8 (12.5%) patients treated with 500 micrograms, which were all mild. These patients responded to further ICI 118, 630 therapy without requiring any treatment for the adverse reactions.