前立腺癌に対するEstracyのPhase 4 Study 続報 : 長期的投与成績

Abstract

1984～1987年の間に検討した前立腺癌200例中, 本剤経口投与開始から1年以上継続観察し得た96例について検討した.96例中33例では主治療に本剤を用い, 63例では本剤治療前に他の薬物が用いられていた.12例は本剤単独で, 84例は合併療法であった.初回治療38例, 維持療法37例, 再燃時治療11例, その他10例であった.本剤の効果判定可能67例では, 著効10例, 有効16例, やや有効15例, 無効26例であった.1, 3及び5年生存率はそれぞれ92.6%, 66.0%, 及び46.3%であった.22例で副作用がみられ, 中3例で投与を中止した

Two hundred patients with prostatic cancer were enrolled in our previous study between 1984 and 1987. In this study, 96 patients of them were observed for 1 year or more after oral administration of Estracyt (estramustine sodium phosphate). Of these 96 cases, 33 patients were treated with Estracyt as primary treatment and 63 patient had been treated with other treatments before Estracyt treatment. Twelve patients were treated only with Estracyt and 84 patients also received other treatments. Thirty-eight patients were on primary therapy, 37 patients were on maintenance therapy, and 11 patients were on primary therapy, 37 patients were on maintenance therapy, and 11 patients were on the re-activated stage therapy and 10 patients were others. In conclusion, among the 67 cases in which the due judgement of the effect was possible, Estracyt was markedly effective in 10 cases (14.9%), effective in 16 cases (23.9%), slightly effective in 15 cases (22.4%) and ineffective in 26 cases (38.8%). The survival rate was 92.6% at the first year, 66.0% at the third year and 46.3% at the fifth year in the follow-up study. Adverse reactions were observed in 22 cases (22.9%), among which the administration was discontinued in 3 cases.