前立腺癌に対するRU23908(Nilutamide)の臨床評価

Abstract

前立腺癌に対するRU 23908の有効性および安全性を検討するため, stage C, Dの前立腺癌患者47例に1日1回150または300 mg経口投与による早期第2相臨床試験を行った.対象病巣に対する効果では, 総合効果判定は40例中CR+PRが34例, 部位別効果は原発巣では40例中CR+PRが35例, 骨転移では22例中10例, リンパ節転移では6例中5例, 肺転移は1例のみにみられCRであり, PAP判定では34例中CR+PRは33例であった.臨床症状に対する改善率は骨疼痛8/9例, 排尿障害25/30例, P.S. 15/33例であった.副作用は調査症例数47例中29例にみられ, 中止例は7例あった.特殊な副作用として間質性肺炎が試験期間の12週以後の継続投与期間も含めて6例に認められ, その他2例では出現の可能性が否定できないと判定された

To investigate the efficacy and the safety of RU23908 for the treatment of prostatic cancer, an early phase 2 study with the oral administration of 150 or 300 mg daily was performed in 47 patients with stage C or D prostatic cancer at 15 institutions from April 1987 to June 1988. Forty patients were evaluable for efficacy. Concerning the effect on the object lesion, the results of the overall evaluation revealed that complete or partial response (CR + PR) was obtained in 34 of the 40 cases (85.0%). As to the effect classified by site, CR + PR were observed in 35 out of the 40 cases with primary lesion (87.5%), in 10 of the 22 cases with bone metastasis (45.5%), in 5 of the 6 cases with lymph node metastasis (83.3%) and CR was observed in one case with lung metastasis. In the PAP evaluation, 33 out of the 34 cases were judged to be CR + PR (97.1%). The improvement rate of clinical symptoms was 88.9% for bone pain, 83.3% for dysuria and 45.5% for performance status. Adverse reactions were observed in 29 of the 47 cases (61.7%) investigated and 7 cases (14.9%) were withdrawn. During the study period of 12 weeks and the subsequent period of continued administration, 6 cases (12.8%) and 2 possible cases of interstitial pneumonia were diagnosed. From the above results, the treatment of prostatic cancer with RU23908 150 mg/day or 300 mg/day in combination with surgical castration showed an excellent clinical effect compared to conventional endocrine therapy, but has a problem of safety. Therefore, this drug may be expected to be a highly useful therapeutic drug, if safely is improved in the future by reviewing the dose.