Radiation Oncology Unit, Azienda Ospedaliera Universitaria Careggi, University of Florence, Largo Brambilla 3, 50139, Florence, Italy.
Department of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy.
Radiol Med. 2022 Aug;127(8):912-918. doi: 10.1007/s11547-022-01511-7. Epub 2022 Jun 28.
ARTO trial was designed to evaluate the difference in terms of outcomes between patients affected by oligo metastatic castrate resistant prostate cancer (mCRPC) treated with Abiraterone acetate and randomized to receive or not SBRT on all sites of disease. Here, we present a preliminary analysis conducted on patients enrolled at promoting institution.
To present a preliminary overview about population features, clinical outcomes, adverse events, quality of life and explorative translational research.
DESIGN, SETTING, AND PARTICIPANTS: ARTO (NCT03449719) is a phase II trial including patients affected by oligo mCRPC, randomized to receive standard of care (GnRH agonist or antagonist plus abiraterone acetate 1000 mg and oral prednisone 10 mg daily) with or without SBRT on all metastatic sites of disease. All subjects have < 3 bone or nodal metastases. All patients are treated in I line mCRPC setting, no previous lines of treatment for mCRPC are allowed.
Data about a mono-centric cohort of 42 patients enrolled are presented in the current analysis, with focus on baseline population features, PSA drop at 3 months, biochemical response, and quality of life outcomes. Descriptive statistics regarding translational research are also presented.
Significant difference in terms of PSA drop at three months was not detected (p = 0.68). Biochemical response (PSA reduction > 50%) was reported in 73.7 versus 76.5% of patients in control vs SBRT arm, respectively (p = 0.84). All patients are alive. Progression occurred in 1 versus 0 patients in the control versus SBRT arm, respectively. After 3 months, an average decrease of 13 points in terms of Global Health Score was reported for the overall population. However, complete recovery was noticed at 6 months. Circulating tumor cells detection rate was 40%.
SBRT + Abiraterone treatment was safe and well tolerated, non-significant trend in terms of PSA drop and biochemical response at 3 months was detected in SBRT arm. Interestingly, CTCs detection in this selected cohort of oligo-mCRPC was lower if compared to historical data of unselected mCRPC patients.
ARTO 试验旨在评估接受醋酸阿比特龙治疗的寡转移去势抵抗性前列腺癌（mCRPC）患者在接受或不接受所有疾病部位 SBRT 治疗的情况下，其结局的差异。在这里，我们报告了在推广机构入组的患者中进行的初步分析。
介绍人群特征、临床结局、不良事件、生活质量和探索性转化研究的初步概述。
设计、地点和参与者：ARTO（NCT03449719）是一项 II 期试验，包括寡转移 mCRPC 患者，随机接受标准护理（促性腺激素释放激素激动剂或拮抗剂加醋酸阿比特龙 1000mg 和口服泼尼松 10mg 每日）加或不加所有疾病转移部位的 SBRT。所有患者均有<3 处骨或淋巴结转移。所有患者均在一线 mCRPC 治疗环境中接受治疗，不允许以前线 mCRPC 治疗。
目前的分析中报告了 42 例单中心队列患者的数据，重点是基线人群特征、3 个月时 PSA 下降、生化反应和生活质量结果。还介绍了转化研究的描述性统计数据。
3 个月时 PSA 下降的差异无统计学意义（p=0.68）。对照组和 SBRT 组患者的生化反应（PSA 降低>50%）分别为 73.7%和 76.5%（p=0.84）。所有患者均存活。对照组和 SBRT 组分别有 1 例和 0 例患者发生进展。3 个月后，总体人群的全球健康评分平均下降 13 分。然而，在 6 个月时观察到完全恢复。循环肿瘤细胞检测率为 40%。
SBRT+阿比特龙治疗安全且耐受良好，在 SBRT 组中检测到 3 个月时 PSA 下降和生化反应的非显著趋势。有趣的是，与未选择的 mCRPC 患者的历史数据相比，在这个寡转移 mCRPC 的选定队列中检测到的 CTCs 较低。
