新疆地区多中心阿比特龙和多西他赛治疗转移性去势抵抗性前列腺癌的临床疗效和安全性的对比分析
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摘要
目的分析和比较新疆地区醋酸阿比特龙联合泼尼松+雄激素剥夺治疗(ADT)和多西他赛联合泼尼松+雄激素剥夺治疗(ADT)治疗转移性去势抵抗性前列腺癌(mCRPC)的临床疗效和安全性。方法回顾性分析新疆地区7家医院泌尿外科2016年6月至2018年1月收治的mCRPC患者的临床资料。阿比特龙组患者46名,多西他赛组患者48名,观察比较两组临床疗效和安全性的差异。结果中位随访时间15个月。中位影像学无进展生存期(rPFS)阿比特龙组和多西他赛组分别为15个月和11个月,中位前列腺特异性抗原无进展生存期(PSAPFS)阿比特龙组和多西他赛组分别为13个月和9个月。PSA反应率阿比特龙组63.04%,多西他赛组41.67%。在安全性方面,3～5级不良反应的比例阿比特龙组45.65%,多西他赛组47.92%。结论醋酸阿比特龙联合泼尼松+ADT治疗mCRPC相对于多西他赛联合泼尼松+ADT,改善患者rPFS、PSAPFS,提高PSA反应率。在不良反应方面,两种治疗方案无明显差异。
Objective To analyze and compare the clinical efficacy and safety of abiraterone acetate combined with prednisone plus androgen deprivation therapy(ADT)and docetaxel combined with prednisone plus ADT in the treatment of metastatic castration-resistant prostate cancer(mCRPC).Methods The clinical data of mCRPC patients admitted to the urological department of 7 hospitals in Xinjiang during June 2016 and January 2018 were retrospectively analyzed,including 46 patients in the abiraterone group and 48 patients in the docetaxel group.The differences in clinical efficacy and safety were analyzed and compared between the two groups.Results During the median follow-up of 15 months,the median radiographic progression-free survival(rPFS)was 15 months in the abiraterone group and 11 months in the docetaxel group;the median prostate specific antigen progression-free survival(PSAPFS)was 13 months in the abiraterone group and 9 months in the docetaxel group.The PSA response rate was 63.04% in the abiraterone group and 41.67% in the docetaxel group.In terms of safety,the incidence of grade III-V adverse reactions was 45.65%in the abiraterone group and 47.92% in the docetaxel group.Conclusions Compared with docetaxel combined with prednisone plus ADT,abiraterone acetate combined with prednisone plus ADT improved rPFS,PSAPFS and increased PSA response rate.In terms of adverse reactions,there was no significant difference between the two treatment regimens.
Objective To analyze and compare the clinical efficacy and safety of abiraterone acetate combined with prednisone plus androgen deprivation therapy(ADT)and docetaxel combined with prednisone plus ADT in the treatment of metastatic castration-resistant prostate cancer(mCRPC).Methods The clinical data of mCRPC patients admitted to the urological department of 7 hospitals in Xinjiang during June 2016 and January 2018 were retrospectively analyzed,including 46 patients in the abiraterone group and 48 patients in the docetaxel group.The differences in clinical efficacy and safety were analyzed and compared between the two groups.Results During the median follow-up of 15 months,the median radiographic progression-free survival(rPFS)was 15 months in the abiraterone group and 11 months in the docetaxel group;the median prostate specific antigen progression-free survival(PSAPFS)was 13 months in the abiraterone group and 9 months in the docetaxel group.The PSA response rate was 63.04% in the abiraterone group and 41.67% in the docetaxel group.In terms of safety,the incidence of grade III-V adverse reactions was 45.65%in the abiraterone group and 47.92% in the docetaxel group.Conclusions Compared with docetaxel combined with prednisone plus ADT,abiraterone acetate combined with prednisone plus ADT improved rPFS,PSAPFS and increased PSA response rate.In terms of adverse reactions,there was no significant difference between the two treatment regimens.
引文
[1]中国抗癌协会泌尿肿瘤专业委员会.中国去势抵抗性前列腺癌诊治专家共识[J].中华外科杂志,2016,54(7):481-484.
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[4]汪洋,杨丽,孔东波,等.阿比特龙治疗老年去势抵抗性前列腺癌疗效和安全性研究[J].中国药业,2018(11).66-68.
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[6]中华医学会泌尿外科学分会,中国前列腺癌联盟.转移性前列腺癌化疗中国专家共识(2017版)[J].中华泌尿外科杂志,2017,38(3):161-165.
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[9]DE BONO JS,OUDARD S,OZGUROGLU M,et al.Prednisone,cabazit-axel,mitoxantrone,prostate cancer,docetaxel[J].Eur Urol,2011,59(4):1147-1154.
[10]FIZAZI K,SCHER HI,MOLINA A,et al.Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer:final overall survival analysis of the COU-AA-301randomised,double-blind,placebo-controlled phase 3study[J].Lancet Oncol,2012,13(10):983-992.
[11]WALSH PC.RE:Sipuleucel-T immunotherapy for castration-resistant prostate cancer[J].J Urol,2011,185(3):897-898.
[12]RYAN CJ,SMITH MR,FIZAZI K,et al.Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapynaive men with metastatic castration-resistant prostate cancer(COU-AA-302):final overall survival analysis of a randomised,double-blind,placebo-controlled phase 3study[J].LancetOncol,2015,16(2):152-160.
[13]GALLETTI G,LEACH BI,LAM L,et al.Mechanisms of resistance to systemic therapy in metastatic castration-resistant prostate cancer[J].Cancer Treat Rev,2017,57:16-27.
[14]CATTRINI C,ZANARDI E,VALLOME G,et al.Targeting androgen-ind-ependent pathways:new chances for patients with prostate cancer?[J].Crit Re-v Oncol Hematol,2017,118:42-53.
[15]唐志,张丹,廖湘辉,等.多西他赛联合强的松治疗激素抵抗性前列腺癌36例疗效观察[J].海南医学,2016,27(1):120-122.
[16]樊连城,董柏君,迟辰斐,等.阿比特龙联合泼尼松治疗未经化疗转移性去势抵抗性前列腺癌的有效性和安全性[J].上海交通大学学报:医学版,2016,36(9):1306-1310.
[17]SYDES MR,et al.Adding abiraterone or docetaxel to long-term hormone therapy for prostate cancer:directly randomised data from the STAMPEDE mu-lti-arm,multi-stage platform protocol.Ann[J].Oncol,2018,29(5):1235-1248.
[2]GRAVIS G,BOHER JM,JOLY F,et al.Androgen deprivation therapy(adt)plus docetaxel versus adt alone in metastatic non castrate prostate cancer:impact of metastatic burden and longterm survival analysis of the randomized phase 3getug-afu15trial[J].Eur Urol,2016,70(2):256-262.
[3]FIZAZI K,TRAN N,FEIN L,et al.Abiraterone plus prednisone in metastatic,castration-sensitive prostate cancer[J].NEJ Med,2017,377(4):352-360.
[4]汪洋,杨丽,孔东波,等.阿比特龙治疗老年去势抵抗性前列腺癌疗效和安全性研究[J].中国药业,2018(11).66-68.
[5]RATHKOPF DE,SMITH MR,BONO J SD,et al.Updated interim efficacy analysis and long-term safety of abiraterone acetate in metastatic castration-resistant prostate cancer patients without prior chemotherapy(COU-AA-302)[J].Eur Urol,2014,66(5):815-825.
[6]中华医学会泌尿外科学分会,中国前列腺癌联盟.转移性前列腺癌化疗中国专家共识(2017版)[J].中华泌尿外科杂志,2017,38(3):161-165.
[7]范欣荣,李汉忠,李永强,等.转移性去势抵抗性前列腺癌化疗长期疗效观察[J].中华泌尿外科杂志,2013,34(12):885-890.
[8]SCHER HI,FIZAZI K,SAAD F,et al.Increased survival withenzalutamide in prostate cancer after chemotherapy[J].NEJ Med,2012,367(13):1187.
[9]DE BONO JS,OUDARD S,OZGUROGLU M,et al.Prednisone,cabazit-axel,mitoxantrone,prostate cancer,docetaxel[J].Eur Urol,2011,59(4):1147-1154.
[10]FIZAZI K,SCHER HI,MOLINA A,et al.Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer:final overall survival analysis of the COU-AA-301randomised,double-blind,placebo-controlled phase 3study[J].Lancet Oncol,2012,13(10):983-992.
[11]WALSH PC.RE:Sipuleucel-T immunotherapy for castration-resistant prostate cancer[J].J Urol,2011,185(3):897-898.
[12]RYAN CJ,SMITH MR,FIZAZI K,et al.Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapynaive men with metastatic castration-resistant prostate cancer(COU-AA-302):final overall survival analysis of a randomised,double-blind,placebo-controlled phase 3study[J].LancetOncol,2015,16(2):152-160.
[13]GALLETTI G,LEACH BI,LAM L,et al.Mechanisms of resistance to systemic therapy in metastatic castration-resistant prostate cancer[J].Cancer Treat Rev,2017,57:16-27.
[14]CATTRINI C,ZANARDI E,VALLOME G,et al.Targeting androgen-ind-ependent pathways:new chances for patients with prostate cancer?[J].Crit Re-v Oncol Hematol,2017,118:42-53.
[15]唐志,张丹,廖湘辉,等.多西他赛联合强的松治疗激素抵抗性前列腺癌36例疗效观察[J].海南医学,2016,27(1):120-122.
[16]樊连城,董柏君,迟辰斐,等.阿比特龙联合泼尼松治疗未经化疗转移性去势抵抗性前列腺癌的有效性和安全性[J].上海交通大学学报:医学版,2016,36(9):1306-1310.
[17]SYDES MR,et al.Adding abiraterone or docetaxel to long-term hormone therapy for prostate cancer:directly randomised data from the STAMPEDE mu-lti-arm,multi-stage platform protocol.Ann[J].Oncol,2018,29(5):1235-1248.