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 --鼻腔内投与量の検討を中心にして--

Abstract

新鮮例の前立腺癌患者114例にLHRHアナログ製剤ブセレリン500 μgを1日3回, 7日間連続皮下注後, 維持療法として1日600 μgあるいは900 μgを鼻腔内投与した時の用量別臨床効果および安全性について検討した.テストステロンの抑制は900 μg群で優れており, 維持療法におけるふさわしい用量といえた.腫瘍マーカーではACPで43.5%, A1-Pで20.0%, PAPで43.2%で改善が認められた.NPCPの評価ではPR以上が16.1%, 小山・斎藤斑の原発巣に対する評価ではPR以上が22.4%, NCまでを含めると93.3%であった.主治医判定では, 改善率は66.3%がやや改善以上であり, 有用度では88.7%がやや有用以上の評価であった.副作用は18.9%でみられたが, 投与中止に至った症例は1例のみであり, その他はいずれも一過性のものであり, 92.8%が安全あるいはほぼ完全の評価であった.ブセレリンは副作用も少なく, 前立腺癌の治療薬として有用であると考えられた

Patients with pathologically defined prostatic carcinoma (114 cases in 23 institutes) were subcutaneously administered 500 micrograms of Buserelin (Hoe 766) 3 times a day for 7 consecutive days, then randomized to intranasally administered 600 or 900 micrograms/day of Buserelin as maintenance treatment. We examined the clinical efficacy, safety and endocrinological effects of the drug by the intranasal dosage. Size of prostate decreased more than 25% in 21 cases (total 47 cases; measured at the start and 3 months treatment by ultrasonography. Complete response and partial response were observed in 13 cases (16.1%) by NPCP's criteria at 3 months Buserelin treatment. Grobal Improvement Rating (GIR) were respectively 64.3% (600 micrograms group) and 68.0% (900 micrograms group). Grobal Utility Rating (GUR) were respectively 85.7% (600 micrograms group) and 82.0% (900 micrograms group). No significance was observed in these two groups. Adverse reactions were observed in 21 cases (18.9%). Except in 1 case, they were slight and the Buserelin treatment could be continued. Objectively Safety Rating (OSR) was 92.8%. Five cases were treated for more than 2 years with Buserelin and these cases were well controlled. Buserelin was considered as an effective and safe drug to treat prostatic carcinoma.