摘要
目的 观察低剂量酮康唑治疗晚期去势抵抗性前列腺癌（CRPC）的临床疗效并探讨相关预测因子.方法 收集2006年8月至2011年8月71例CRPC患者采用低剂量酮康唑治疗的资料.酮康唑口服200 mg/次,3次/d,同时口服泼尼松5 mg/次,2次/d.治疗后血清前列腺特异抗原（PSA）下降超过基线水平50％定义为治疗有效.采用多因素Logistic回归分析和受试者工作特征曲线评估有效治疗的预测因子及其准确性.结果 22例（31.0％） CRPC患者低剂量酮康唑治疗有效,PSA倍增时间和基线血清睾酮与疗效正相关.PSA倍增时间≥3个月和＜3个月的患者治疗有效率分别为64.3％和22.8％,风险比（HR）=0.149 （95％ CI 0.029～0.766）,P=0.023,曲线下面积（AUC）=0.707；基线血清睾酮≥0.1和＜0.1 μg/L的患者治疗有效率为55.6％和5.7％,HR=0.068（95％ CI 0.012～0.380）,P=0.002,AUC=0.749.低剂量酮康唑治疗常见不良反应包括肝功能异常12例（17.9％）、肾功能异常11例（16.4％）、乏力8例（11.9％）等.结论 低剂量酮康唑是CRPC患者一种疗效肯定、不良反应轻微的内分泌治疗选项,PSA倍增时间≥3个月和基线睾酮水平≥0.1μg/L是患者取得理想疗效的预测因子.
Objective To assess the efficacy of low dose ketoconazole therapy for Chinese patients with castration resistant prostate cancer （CRPC） and explore possible prognosis factors.Methods From August 2006 to August 2011,71 patients with CRPC were analyzed retrospectively,who received oral ketoconazole 200 mg,three times a day with prednisone 5 mg,twice a day.Prostate specific antigen（PSA） response rate was defined as the percentage of patients with PSA decline ≥50% compared to baseline PSA level during low dose ketoconazole therapy.Multivariate Logistic regression analysis and receiver operating characteristic curve were used to assess the prognostic factors and their accuracy.Results The mean initial serum PSA level was （ 205 ＋ 38 ） ng/ml for these patients with mean age （ 69 ＋ 1 ） years old.After first androgen deprivation therapy failure,the prostate cancer progressed into castration resistant stage. The baseline PSA was （93 _＋ 24）ng/ml and the baseline serum testosterone was （0.13 ＋ 0.02）ng/ml.During the low dose ketoconazole therapy,31 patients （43.7%） had PSA decrease and 22 cases （ 31.0% ） were effective with PSA decline more than 50%.PSA doubling time and baseline serum testosterone were positive correlation with PSA response rate by multivariate Logistic regression analysis.Patients with PSA doubling time of ≥3.0 months had a PSA response rate of 64.3% and the PSA response rate in those with 〈 3.0 months decreased to 22.8%,hazard rate （HR） =0.149 （ 95% confidence interval[CI]0.029 - 0.766 ）,P =0.023,area under the curve （AUC） =0.707.The PSA response rate for patients with baseline serum testosterone ≥ 0.1 and 〈 0.1 μg/L were 55.6% and 5.7%,respectively,HR =0.068 （95% CI 0.012 -0.380）,P =0.002,AUC =0.749.The common adverse reactions included liver dysfunction （17.9%）,renal dysfunction （ 16.4% ）,fatigue （ 11.9% ）,nausea （ 6.0% ） and anorexia （ 4.5% ） and so on.Conclusions Low dose ketoconazole therapy was a moderate,low toxic
出处
《中华医学杂志》
CAS
CSCD
北大核心
2012年第8期520-523,共4页
National Medical Journal of China
基金
基金项目：复旦大学“985工程”三期肿瘤研究项目II（985Ⅲ·YFX0102）
关键词
前列腺肿瘤
酮康唑
治疗效果
Prostatic neoplasms
Ketoconazole
Drug effect
