LH-RH analogue ICI 118,630(Zoladex)の前立腺癌患者に対する長期投与時の臨床効果の検討

Abstract

黄体, 分泌刺激ホルモンanalogue, Zoladex(R) depot製剤(3.6 mg)を40週以上継続投与された前立腺癌患者53例に就て, 1)臨床効果は, 病巣改善度で12週時50例中32例, 40週時51例中35例の改善が得られ, 2)自覚症状総合改善度は12週時, 40週時ともに47例中42例と安定した.3)内分泌効果は, 評価可能症例47全例で40週以上持続した.4)副作用は, 73例中19例26.0%に認められたが, 12週までに73例中15例, 12週から40週までは71例中3例, 40週以降では53例中5例と少なく, いずれも治療は継続し得た.5) 52例中51例にやや有用以上の判定がなされた

The Zoladex (ICI 118, 630) multicenter trial included 149 patients with stage B +o D prostatic cancer recruited from 1984 to date. Of them 53 clinical responders on the treatment for 40 weeks or longer were subjected to assessment of antitumour response, overall subjective response, endocrinological response, safety and usefulness. The responders consistently showed a clinical response as evidenced by antitumour response in 32 of 50 patients (64.0%) at week 12 and in 35 of 51 (68.6%) at week 40, and overall subjective response in 42 out of 47 patients (89.4%) at both week 12 and week 40. Endocrinologically, all of the 47 eligible patients maintained a 40-week or longer response. Adverse reactions were observed in 19 out of 73 patients (26.0%), subdivided by the time of occurrence as 15/73 (20.5%) up to week 12, 3/71 (4.6%) between week 12 and week 40, and 5/53 (9.4%) in and after week 40. No patient required the discontinuance of treatment. Usefulness of the drug was observed in 51 out of 52 patients (98.1%). The results indicated that Zoladex in a once monthly regimen may be of great advantage to elderly patients with prostatic cancer, and allow an improved patient compliance: Zoladex may not only produce clinical remission but also improve the quality of life.