阿比特龙治疗转移性去势抵抗性前列腺癌的有效性和安全性初步评价

Preliminary evaluation on efficacy and safety of abiraterone in the treatment of metastatic castration resistant prostate cancer

摘要:

目的：收集并整理在我院泌尿外科治疗中心应用阿比特龙联合泼尼松治疗确诊为去势抵抗型前列腺癌（castration re－sistant prostate cancer，CRPC）的患者临床资料，分析包括PSA缓解率、药物不良事件以及无进展生存时间等早期疗效情况，为后续治疗提供经验。方法：本研究共纳入2015年10月至2017年10月接受阿比特龙联合泼尼松治疗12周以上的55例有效CRPC患者的临床资料，长期随访并记录治疗期间血清特异性前列腺抗原（PSA）、血清睾酮水平以及复查全身骨显像等其他影像学检查资料来动态观察患者疾病变化情况，分析其中。结果：数据分析后，按照PSA工作组（PSA workgroup，PSAWG）标准，55例患者PSA总体缓解率56.4%，低于国际多中心随机双盲对照实验COU-AA-302所报道的未经化疗的患者PSA缓解率（68%），有明显PSA缓解的31例患者均出现血清PSA值下降超过基线值50%，部分患者甚至下降达到90%以上，而临床症状也得到明显改善。按照基线情况不同分为：PSA基线值的不同可以分为PSA＜20 ng/mL、20~80 ng/mL、＞80 ng/mL，其PSA缓解率分别为63.6%、59.1%、55.6%；Gleason评分不同分为＜8分、8分、＞8分，其PSA缓解率为30.7%、58.1%、81.8%；有效内分泌治疗时间的不同可分为＜18个月、18~36个月、＞36个月，其PSA缓解率为63.2%、52%、54.5%。另外在早期使用阿比特龙的初期，我院泌尿外科治疗中心共观察并记录到15例（15/51，27.2%）患者出现PSA Flare现象。将患者分为缓解组和未缓解组，生存分析得出使用醋酸阿比特龙联合泼尼松治疗的CRPC患者PFS明显获益（17.06个月vs. 11.68个月）。结论：大部分使用醋酸阿比特龙联合泼尼松治疗的CRPC患者都在其中受益，临床症状明显改善，生活质量提高。除Gleason评分外，不同基线值患者的预期疗效并无关联，使用醋酸阿比特龙联合泼尼松治疗的CRPC患者PFS明显获益，并且发现PSA Flare现象会在一定程度上使肿瘤对药物的应答产生更积极的反应，影响患者达到PSA缓解的水平，对于不良事件的发生也应该严密监测，辅助治疗。

Abstract:

Objective：To collect and organize the clinical data of the patients who were diagnosed ascastration resistant prostate cancer（CRPC）and were treated by abiraterone in our hospital’s urology center，and to analyze the clinical data including the response rate，drug adverse event，early survival time，and the follow-up treatment. Methods：The clinical data of 55 CRPC patients who were treated with abiraterone from October 2015 to October 2017 were analyzed，including the treatment of the serum PSA，the serum testosterone level，the follow-up to the body bone imaging and other imaging studies. Results：Following data analysis，in accordance with PSA workgroup（PSAWG） standard，55 patients had a PSA overall relief rate of 56.4%，lower than that of 68% based on the international multicenter randomized double blind controlled trials，cp-aa-302.For 31 patients with a marked PSA relief，the serum PSA had been decreased by more than 50%，some patients even had decreased to more than 90%，and clinical symptoms were significantly im－proved. According to the baseline，PSA baseline value can be divided into different levels：PSA<20 ng/mL，20 to 80 ng/mL，>80 ng/mL，and the PSA response rates were 63.6%，59.1%，55.6%. The Gleason scores were divided into <8，8 and >8，with the PSA remission rate of 30.7%，58.1% and 81.8%. The difference of effective endocrine therapy time can be divided into <18 months，18 to 36 months，>36 months，and its PSA remission rateswere63.2%，52% and 54.5%. In addition，at the early stage of the early use of abiraterone，the occurrence of PSA Flare in 15 patients（15/51，27.2%）in the urosurgical treatment center in our hospital was observed and recorded. The patients were divide into ease and not alleviate group. The method of statistical Kaplan Meier-survival analysis was used and it is concluded that the use of combined therapy with prednisone and abiraterone acetatehad obvious benefit（17.06 monthsvs. 11.68 months）. Conclusion：Most of the CRPC patients who have been treated with abiraterone have benefited from it；the clinical symptoms and quality of life are improved. In addition to the Gleason rating，patients with different baseline values are expected to have an uncorrelated therapeutic effect and obvious benefit can be achieved for CRPC patient treated with the combination of the abiraterone. It has been found that the PSA Flare will pro－duce a more positive response to the response of the tumor to the drug，affecting the level of PSA relief. The occurrence of adverse events should also be closely monitored to assist in the treatment.