SBRT plus abiraterone acetate and ADT versus abiraterone acetate and ADT in oligometastatic castrate-resistant prostate cancer (ARTO): long-term, unplanned overall survival analysis of an open-label, randomised, phase 2 trial.

The aim of this analysis is to explore the long-term impact of MDT on overall survival.

本分析的目的是探讨MDT对总生存期的长期影响。

Methods

ARTO was a multicentre, phase 2, randomised trial conducted in 16 academic and community centres across Italy.

ARTO 是一项在意大利16个学术和社区中心进行的多中心、II期、随机试验。

All patients included were aged 18 years or older and had a diagnosis of prostate adenocarcinoma with metastatic castrate-resistant prostate cancer, no more than three metastatic sites, and no previous systemic therapy for metastatic castrate-resistant prostate cancer status.

所有纳入的患者年龄均在18岁或以上，且被诊断为前列腺腺癌伴有转移性去势抵抗性前列腺癌，转移部位不超过三个，并且之前没有接受过针对转移性去势抵抗性前列腺癌的系统治疗。

Patients were randomly assigned (1:1, using random permuted blocks; stratified by treating centre, Eastern Cooperative Oncology Group performance status, and number of metastases) in an open-label design to androgen deprivation therapy plus oral abiraterone acetate 1000 mg daily with or without SBRT to all sites of metastatic disease (one to five fractions providing a biologically effective dose ≥100 Gy).

患者按1:1的比例随机分配（使用随机排列的区块；按治疗中心、东部肿瘤协作组表现状态和转移灶数量进行分层），在一个开放标签设计中接受雄激素剥夺治疗加上每天口服阿比特龙醋酸酯1000毫克，有或没有对所有转移病灶进行立体定向放射治疗（给予一至五次分割，生物有效剂量≥100 Gy）。

The primary endpoint was 6-month biochemical response (PSA decrease of ≥50% compared with baseline) and has been reported previously.

主要终点是6个月的生化反应（与基线相比，PSA降低≥50%）并已在之前报告。

After meeting its primary endpoint, the power calculation was updated post-hoc to assess overall survival, finalised before data unmasking.

在达到主要终点后，我们进行了事后的功效计算以评估总生存期，该计算在数据解盲前完成。

We present an unplanned long-term follow-up focusing on overall survival. All analyses were performed on an intention-to-treatbasis.

我们呈现了一项非计划的长期随访研究，重点关注总生存期。所有分析均基于意向治疗原则进行。

The trial is registered on ClinicalTrials.gov (NCT03449719) and is now closed.

该试验已在ClinicalTrials.gov上注册（NCT03449719），目前试验已关闭。

Results

Between Jan 2, 2019, and Sept 7, 2022, 157 patients were randomly assigned to the control (n=82) and experimental (n=75) groups.

在2019年1月2日至2022年9月7日期间，共有157名患者被随机分配到对照组（n=82）和实验组（n=75）。

No data about race or ethnicity were collected.

未收集有关种族或民族的数据。

After a median follow up of 53 months (IQR 43-60), median overall survivalwas 50 months (95% CI 36-not reached [NR]) in the control group versus NR (55-NR) in the experimental group (HR 0·55, 95% CI 0·33-0·92, p=0·021).

经过中位随访53个月（四分位数间距43-60），对照组的中位总生存期为50个月（95%置信区间36-未达到[NR]），而实验组为未达到（55-未达到）（风险比HR 0·55，95%置信区间0·33-0·92，p=0·021）。

Most common grade 3-4 adverse events recorded were infectious complications (five in the control group vs zero in the experimental group) and cardiovascular disorders (three in the control group vs three in the experimental group).

记录的最常见3-4级不良事件是感染并发症（对照组有五例，实验组零例）和心血管疾病（对照组有三例，实验组也有三例）。

One treatment-related death occurred in the control group due to myocardial failure.

对照组中有一例与治疗相关的死亡，原因是心肌衰竭。

interpretation

The ARTO trial showed significant benefit in overall survivalwith the addition of MDT to systemic therapy versus systemic therapy alone.

ARTO试验显示，与单纯系统治疗相比，将MDT加入系统治疗中可显著提高总生存期。

funding

Fondazione Radioterapia Oncologica.

放射肿瘤学基金会