康士得(比卡鲁胺)治疗局部晚期无远处转移前列腺癌的疗效及安全性研究

Cascodex(Bicalutamide)therapy for locally advanced prostate cancer

目的评价康士得150 mg和药物去势治疗局部晚期无远处转移的前列腺癌的疗效及单一治疗的安全性和耐受性。方法采用随机、平行、开放、对照的研究方案,符合入选和排除标准的受试者按照1:1的比例,随机进入治疗组和对照组。治疗组:康士得片150 mg,每日1片;对照组:诺雷得(醋酸戈舍瑞林)植入剂,每28 d在腹前壁皮下注射1次,每次3.6 mg,共3次,最初2周合用康士得50 mg,每日1片。在治疗12周时,观察前列腺特异性抗原(PSA)的抑制百分比及药物的安全性和耐受性。结果在治疗12周后,口服治疗组和对照组PSA的抑制率分别为62.18%和68.03%,两组之间差异无统计学意义(P>0.05)。治疗组的总体安全性和耐受性良好,治疗中无严重不良事件发生,与药物相关的不良事件分别为乳房疼痛1例,男性乳腺发育1例,不需采取任何治疗措施。结论在局部晚期、无远处转移的前列腺癌患者中,口服康士得150 kg的总体安全性和耐受性良好,其近期治疗效果与目前常规标准药物去势治疗相似。

Objective To investigate the tolerability and effects on endocrinology of cascodex （Bicalutamlde, 150mg/day）monotherapy and medical castration therapy in patients with nonmetastatic locally advanced prostate cancer. Methods This was a doublelind,parallel-group, multi-centre trial in Which a total of 58 patients with locally advanced prostate cancer were randomized to receive 150rag Bicalutamide daily or castration （3.6 mg goserelin acetate every 28 days）in a 1：1 ratio for 12 weeks.Cascodex （50mg/g） were administered to castration group for 2 weeks. Serum PSA levels were observed after 12 weeks treatment. Results The inhibit rate of decline in serum PSA levels in cascodex monotherapy and castration therapy were 62.18% and 68.03% at 12 weeks, showed a significant decline than that of before treatment.respectively.but there was no significant difference between the two groups （P〉0.05）.The prostate volume became smaller after treatment, the change rate of prostate volume were 36.23% and 42.59% in the groups （P〉0.05）. Bicalutamide （150mg/d）monotherapy offered better tolerability with few drug telated withdrawals from study,and no new safety issues were identified during treatment. The highest incidences of adverse events were breast pain and gynecomastia in the bicalutamide group. Conclusion Nonsteroidal antiandrogen monotherapy with 150 mg bicalutamide is an attractive and effective alternative to castration in patients with locally advanced prostate cancer. The recent treatment effect of Bicalutamide monotherapy for some patients with advanced prostate cancer is same as conventional castration therapy.