常规剂量比卡鲁胺治疗雄激素非依赖性前列腺癌(附44例报告)

Conventional-dose bicalutamide as the second-line hormonal therapy for androgen independent prostate cancer(report of 44 cases)

目的探讨采用常规剂量比卡鲁胺(50 mg/d)治疗我国雄激素非依赖性前列腺癌(androgen independent prostate cancer,AIPCa)患者的疗效。方法遴选AIPCa患者44例,采用常规剂量比卡鲁胺(50mg/d)进行二线内分泌治疗。以血清前列腺抗原(prostate-specific antigen,PSA)作为主要疗效评估指标,PSA下降≥50%为治疗有效,同时观察治疗的不良反应。结果常规剂量比卡鲁胺耐受性良好,未发生严重不良反应。PSA总有效率为38.6%(17/44),中位有效时间5个月。治疗前出现氟他胺撤除综合征(flutamindewithdrawl syndrome,FWS)者以及入组PSA水平较低者(≤20 ng/mL),有效率高于无氟他胺撤除综合征者和PSA较高者(64.7%vs.7.4%,61.1%vs.23.1%)。另外,Kaplan-Meier生存分析显示,无氟他胺撤除综合征者和入组PSA水平较高者(>20 ng/mL)具有较高的死亡风险度(P=0.044 9,0.025 2)。结论常规剂量比卡鲁胺(50 mg/d)作为二线内分泌治疗方案应用于中国雄激素非依赖性前列腺癌患者具有确切的疗效;治疗前是否有氟他胺撤除综合征及入组PSA水平可能是预测疗效和患者生存的独立影响因子。

Objective To investigate the therapeutic effect of conventional-dose bicalutamide at 50 mg/d in Chinese male with androgen independent prostate cancer（AIPCa）. Methods Forty-four eligible AIPCa cases were treated with bicalutamide at 50 mg/d as the second-line hormonal therapy.Serum prostate-specific antigen（PSA） was taken as the primary determinant for treatment outcome assessment.Treatment response was defined as PSA reduction over 50%.The presence of adverse events was also evaluated. Results The conventional-dose bicalutamide was in general well tolerated without severe adverse event.The overall treatment response rate was 38.6%（17/44） with median duration time of 5 months.Patients with the presence of flutaminde withdrawl syndrome（FWS） and lower PSA entry level（≤ 20 ng/mL） showed significantly higher treatment response rate than others（64.7% vs.7.4%,61.1% vs.23.1%）.In addition,Kaplan-Meier survival curves for patients stratified according to the presence of FWS and PSA entry level showed that the absence of FWS and higher PSA entry level（20 ng/mL） was significantly associated with mortality risk（P=0.044 9,0.025 2）. Conclusions Conventional-dose bicalutamide at 50 mg/d as the second-line hormonal treatment can achieve credible treatment outcomes in Chinese AIPCa patients.The presence of FWS and PSA entry level might be considered as independent factors for predicting treatment effect and survival rate.