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醋酸阿比特龙治疗去势抵抗性前列腺癌患者的临床疗效研究。

A Study on the Clinical Outcome of Abiraterone Acetate in Castration Resistant Prostate Cancer Patients.

作者信息

James Aloysius, Vincent Bini, Sivadas Akhila, Pavithran K

机构信息

Department of Pharmacy Practice, Amrita School of Pharmacy, Amrita Vishwa Vidyapeetham, Kochi, India.

Department of Medical Oncology and Hematology, Amrita Institute of Medical Sciences and Research Centre, Amrita Vishwa Vidyapeetham, Kochi, India.

出版信息

Int J Hematol Oncol Stem Cell Res. 2018 Jan 1;12(1):4-7.

Abstract

Abiraterone acetate was approved by FDA and EMA in April and September 2011, respectively for treatment of patients with casteration resistant prostate cancer and those previously treated with docetaxel. It is a selective inhibitor of androgen biosynthesis which potentially and irreversibly blocks CYP17, a crucial enzyme in oestrogen and testosterone synthesis. This retrospective study was conducted to evaluate the safety and efficacy of abiraterone acetate in the treatment of castration resistant prostate cancer patients. Twenty-two male patients diagnosed with CRPC and experienced treatment failure with one or more lines of treatment (hormonal manipulation or chemotherapy) were selected and administered abiraterone acetate (1,000 mg daily) along with prednisone (5 mg twice daily). Out of 22 patients, 32% had a good response in reduction of PSA values, while 22% had progression in disease and 45% had a stable disease. Potassium, Haemoglobin, and serum sreatinine levels were not affected by the drug. Due to severe GI intolerance, the drug had to be stopped for one patient. The results of this study showed that abiraterone acetate significantly lowered the PSA values and prolonged progression- free survival in metastatic castration resistant prostate cancer patients who had progressed after first-line or second-line treatment. The overall average median survival and the median duration of drug exposure for CRPC who received AA was found to be 11.1 months [range 3-18]. Since AA plus prednisolone are available as oral dosage forms, they can be given in outpatient setting. Abiraterone acetate is a drug of choice for CRPC and also for those who had previously received one or two chemotherapy regimens. Since it is a new therapeutic regimen, this study included small sample size, but there are a few studies indicating the therapeutic efficacy of AA among patients with castration-resistant prostate cancer.

摘要

醋酸阿比特龙分别于2011年4月和9月获得美国食品药品监督管理局(FDA)和欧洲药品管理局(EMA)批准,用于治疗去势抵抗性前列腺癌患者以及先前接受过多西他赛治疗的患者。它是一种雄激素生物合成的选择性抑制剂,可能会不可逆地阻断CYP17,这是雌激素和睾酮合成中的一种关键酶。本回顾性研究旨在评估醋酸阿比特龙治疗去势抵抗性前列腺癌患者的安全性和有效性。选取了22名被诊断为CRPC且经历过一线或多线治疗(激素治疗或化疗)失败的男性患者,给予醋酸阿比特龙(每日1000毫克)联合泼尼松(每日两次,每次5毫克)治疗。在22名患者中,32%的患者前列腺特异性抗原(PSA)值降低反应良好,22%的患者疾病进展,45%的患者疾病稳定。血钾、血红蛋白和血清肌酐水平不受该药物影响。由于严重的胃肠道不耐受,一名患者不得不停药。这项研究的结果表明,醋酸阿比特龙显著降低了转移性去势抵抗性前列腺癌患者的PSA值,并延长了一线或二线治疗后进展患者的无进展生存期。接受醋酸阿比特龙治疗的CRPC患者的总体平均中位生存期和药物暴露中位持续时间为11.1个月[范围3 - 18个月]。由于醋酸阿比特龙加泼尼松龙有口服剂型,可在门诊给药。醋酸阿比特龙是CRPC患者以及先前接受过一或两种化疗方案患者的首选药物。由于这是一种新的治疗方案,本研究样本量较小,但有一些研究表明醋酸阿比特龙在去势抵抗性前列腺癌患者中的治疗效果。

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