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醋酸阿比特龙和泼尼松用于未经化疗的前列腺癌患者:理论依据、证据及临床应用

Abiraterone acetate and prednisone in chemotherapy-naïve prostate cancer patients: rationale, evidence and clinical utility.

作者信息

Crawford E David, Shore Neal D, Petrylak Daniel P, Higano Celestia S, Ryan Charles J

机构信息

Professor of Surgery/Urology/Radiation Oncology, Head Urologic Oncology, University of Colorado, Denver, Mail Stop #F 710, PO Box #6510, Aurora, CO 80045, USA.

Carolina Urologic Research Center, Myrtle Beach, SC, USA.

出版信息

Ther Adv Med Oncol. 2017 May;9(5):319-333. doi: 10.1177/1758834017698644. Epub 2017 Mar 22.

DOI:10.1177/1758834017698644
PMID:28529549
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5424866/
Abstract

Abiraterone acetate 1000 mg/day, combined with prednisone 5 mg PO twice daily, is indicated for the treatment of metastatic castration-resistant prostate cancer (mCRPC). Abiraterone acetate is the oral prodrug of abiraterone, a specific CYP17 inhibitor that blocks androgen biosynthesis within the adrenal glands, testes and tumor microenvironment. In a phase III trial of men with asymptomatic or minimally symptomatic, chemotherapy-naïve mCRPC, treatment with oral abiraterone acetate plus prednisone led to a statistically significant improvement in the co-primary endpoints of overall survival and radiographic progression-free survival when compared with placebo plus prednisone. In long-term follow-up of phase III trials, the incidence of corticosteroid-associated adverse events was 25.5% in the abiraterone acetate plus prednisone arm compared with 23.3% in the placebo plus prednisone arm. The need for regular patient monitoring and appropriate management of symptoms during long-term use of prednisone must be placed in context with the improvement in survival seen with abiraterone plus prednisone. Within the multidisciplinary environment that is emerging to meet quality and cost imperatives, abiraterone acetate plus prednisone is suitable for use in the chemotherapy-naïve population with minimal symptoms as well as in patients who have been treated with docetaxel and may have symptomatic disease. Ongoing trials are evaluating the role of abiraterone acetate plus prednisone in patients with nonmetastatic CRPC and metastatic hormone-sensitive prostate cancer, while further trials in the mCRPC setting are evaluating its use in combination regimens.

摘要

醋酸阿比特龙1000毫克/天,联合泼尼松5毫克口服,每日两次,适用于治疗转移性去势抵抗性前列腺癌(mCRPC)。醋酸阿比特龙是阿比特龙的口服前体药物,阿比特龙是一种特异性CYP17抑制剂,可阻断肾上腺、睾丸和肿瘤微环境中的雄激素生物合成。在一项针对无症状或症状轻微、未接受过化疗的mCRPC男性患者的III期试验中,与安慰剂加泼尼松相比,口服醋酸阿比特龙加泼尼松治疗在总生存期和影像学无进展生存期这两个共同主要终点方面有统计学显著改善。在III期试验的长期随访中,醋酸阿比特龙加泼尼松组中皮质类固醇相关不良事件的发生率为25.5%,而安慰剂加泼尼松组为23.3%。在长期使用泼尼松期间,必须在考虑其对生存的改善情况的背景下,对患者进行定期监测并对症状进行适当管理。在为满足质量和成本要求而兴起的多学科环境中,醋酸阿比特龙加泼尼松适用于症状轻微的未接受过化疗的人群以及接受过多西他赛治疗且可能患有症状性疾病的患者。正在进行的试验正在评估醋酸阿比特龙加泼尼松在非转移性CRPC和转移性激素敏感性前列腺癌患者中的作用,而在mCRPC环境中的进一步试验正在评估其在联合治疗方案中的应用。

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