前立腺癌に対するEstracyt のPhase 4 Study

Abstract

東北の6大学およびその関連施設における前立腺癌200症例に対しEstracyt(R)を投与し, その制癌効果および副作用について検討した.投与量および投与方法:Estracyt(R)は1回2カプセル, 1日2回を6ヵ月間連続投与することを原則とし, 単独療法と合併療法あるいはprimaryとnonprimary caseを問わず対象とした.対象症例:総症例は200例でその内訳は, 本治験前に未治療であったもの68例, 既治療は132例であった.さらにEstracyt(R)単独療法37例, 合併療法163例であり, また初回治療75例, 維持療法71例, 再燃時治療27例, その他27例であった.1)項目別効果判定においては, 自覚症状で排尿困難が転移性疼痛より有効率が高く, 他覚所見では残尿量, 酸フォスファターゼ, 前立腺フォスファターゼが骨転移, 前立腺縮小効果より有効率が高かった.2)効果判定可能な190例の総合結果は, 著効40例, 有効例43例, やや有効38例, 無効69例であり, そのうち初回治療例は「やや有効」以上が93.2%で, 維持療法, 再燃時治療に比して有効率が高かった.3)副作用を認めた症例は67例(33.5%)であり, このうち投与を中止したものは18例であった.発現率は全般的に低い傾向にあり, 特に女性化乳房の出現率が低かった

Both anticancer and adverse reactions of Estracyt were investigated by oral administration to 200 patients with prostatic cancer. Two capsules of Estracyt were given twice a day and the administration was principally continued for more than six months. The 200 patients consisted of 68 and 132 patients who were previously untreated and treated, respectively. Thirty seven cases had been treated only with Estracyt and 132 cases also received other treatments. Seventy-five cases were of primary therapy, 71 cases were of maintenance therapy, and 27 cases were of the re-activated stage therapy and 27 cases were of other categories. In conclusion, among the 190 cases for which the due judgement of the effect was possible, Estracyt was markedly effective in 40 cases (21.1%), effective in 43 cases (22.6%), slightly effective in 38 cases (20.0%) and ineffective in 69 cases (36.3%). Adverse reactions were observed in 67 cases (33.5%), among which the administration was discontinued in 18 cases.