前立腺癌に対するBuserelin (Hoe 766)の有効性および安全性に関する臨床的検討 --単回,連続投与時の内分泌学的検討を中心にして--

Abstract

黄体形成ホルモン分泌刺激ホルモン(LHRH)誘導体Buserelin (Hoe766)の前立腺癌に対する有効性と安全性, 内分泌動態に検討を加えた.試験1の単回投与は前立腺癌3例と前立腺肥大症7例, 試験2および3は病期BないしDの前立腺癌それぞれ40例, 70例を対象とした.試験1の単回投与で本剤がLHRHと同様の動態を示し, 試験2の3ヵ月間投与で至適用量を検討したところ, 500 μg×3/日が初期導入として優れていた.3ヵ月間投与後の有効率は従来の治療法である去勢あるいは抗男性ホルモン剤と遜色がなかった.本剤の長期投与の評価対象は経時的に減少し, 特に病期Dの減少率が高かったが, 組織分化度別の減少率はほぼ一定であった.副作用は本剤投与後3ヵ月以内に発現し, 中止に至った3例を除く6例は本薬の主作用によるもので症状も軽度であった.心血管系や肝障害などは見られなかった.以上より本剤は合併症の多い高齢者の前立腺癌に対し, 短期, 長期とも副作用の少ない有用性の高い薬剤であると結論できた

Seventy three patients with prostatic carcinoma (PC) and 7 patients with benign prostatic hypertrophy (BPH) in 12 institutes subcutaneously received single and multiple doses of Hoe 766, and clinical efficacy, safety and endocrine effects of drug were examined. In a single doses study, six doses were subcutaneously administered to 7 BPH and 3 with PC. Gonadotropin and testosterone levels in the blood were increased following all these doses. In a multiple study, 7 kinds of doses were given to 40 patients with PC. The optimum doses of subcutaneous injection was decided to be 500 x 3 micrograms/day based on gonadotropin and testosterone suppression. Objective response by NPCP's criteria was observed in 35.3% (complete response 5.9%, partial response 29.4%) following 3 months of Hoe 766 treatment. Adverse reactions were observed in 9 cases (12.8%): Treatment was discontinued in 3 cases (eruption in 2, nausea and vomiting in 1), and continued in 6 cases (8.6%) without any treatment required. Buserelin was thus considered to be an effective, safe drug to treat prostatic carcinoma.