A Phase II Trial of Stereotactic Body Radiation Therapy and Androgen Deprivation for Oligometastases in Prostate Cancer (SBRT-SG 05)

IF 3.4 3区医学 Q2 ONCOLOGY Practical Radiation Oncology Pub Date : 2024-09-01 DOI:10.1016/j.prro.2024.04.022

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引用次数: 0

Abstract

Purpose

SBRT-Spanish Group-05 (ClinicalTrials.gov.Identifier: NCT02192788) is a collaborative (SBRT-SG, Grupo de Investigación Clínica en Oncología Radioterápica, and Sociedad Española de Oncología Radioterápica) prospective multicenter phase II trial testing stereotactic body radiation therapy (SBRT) and androgen deprivation therapy (ADT) in patients with oligorecurrent prostate cancer.

Methods and Materials

Two cohorts of patients with prostate cancer in an oligorecurrent stage (hormone-sensitive in the principal cohort and castration-resistant in the exploratory cohort) were assigned to receive ADT and SBRT for at least 24 months from the time of the enrollment. Concomitant treatment with chemotherapy, abiraterone, or enzalutamide was not allowed. Oncologic outcomes were assessed in both cohorts. Toxicity was prospectively analyzed.

Results

From 2014 to 2019, 81 patients with a total of 126 lesions from 14 centers met the inclusion criteria, 14 of whom were castration-resistant. With a median follow-up of 40 months (12-58 months), 3-year local recurrence-free survival was 92.5% (95% CI, 79.9%-96.3%) and 85.7% (95% CI, 48.2%-95.6%) in the principal and exploratory cohorts, respectively. In the principal cohort, biochemical relapse-free survival and metastasis progression-free survival at 1, 2, and 3 years were 91% (95% CI, 81%-95.8%), 73.7% (95% CI, 61.1%-82.8%), 50.6% (95% CI, 36.2%-63.3%), and 92% (95% CI, 83%-97%), 81% (95% CI, 70%-89%), and 67% (95% CI, 53%-77%), respectively. In the exploratory cohort, metastasis progression-free survival at 1, 2, and 3 years was 64% (95% CI, 34%-83%), 43% (95% CI, 18%-66%), and 26% (95% CI, 7%-51%), respectively. None of the patients developed grade III or higher toxicity or symptoms related to local progression, and only 2 (2.4%) patients developed grade II toxicity.

Conclusions

The combination of SBRT and ADT is safe and shows favorable clinical outcomes in patients with hormone-sensitive and castration-resistant prostate cancer. Validation studies are needed in patients with castration-resistant prostate cancer.

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立体定向体放射治疗和雄激素剥夺治疗前列腺癌寡转移灶的 II 期试验（SBRT-SG 05）。

目的：SBRT-西班牙组-05（ClinicalTrials.gov.Identifier：NCT02192788）是一项合作性（SBRT-SG、Grupo de Investigación Clínica en Oncología Radioterápica和Sociedad Española de Oncología Radioterápica）前瞻性多中心II期试验，测试立体定向体放射疗法（SBRT）和雄激素剥夺疗法（ADT）在少流期前列腺癌患者中的应用：两组处于少发期的前列腺癌患者（主要组别为激素敏感型，探索组别为阉割耐药型）被分配接受 ADT 和 SBRT 治疗，治疗时间自注册时算起至少 24 个月。不允许同时接受化疗、阿比特龙或恩杂鲁胺治疗。两组患者均接受了肿瘤学结果评估。对毒性进行了前瞻性分析：2014年至2019年，来自14个中心的81名患者共126个病灶符合纳入标准，其中14名患者为阉割耐药。中位随访时间为40个月（12-58个月），主要队列和探索队列的3年无局部复发生存率分别为92.5%（95% CI，79.9%-96.3%）和85.7%（95% CI，48.2%-95.6%）。在主要队列中，1年、2年和3年的无生化复发生存率和无转移进展生存率分别为91%（95% CI，81%-95.8%）、73.7%（95% CI，61.1%-82.8%）、50.6%（95% CI，36.2%-63.3%）和92%（95% CI，83%-97%）、81%（95% CI，70%-89%）和67%（95% CI，53%-77%）。在探索性队列中，1年、2年和3年的无转移进展生存率分别为64%（95% CI，34%-83%）、43%（95% CI，18%-66%）和26%（95% CI，7%-51%）。没有一名患者出现III级或以上毒性或与局部进展相关的症状，只有2名（2.4%）患者出现II级毒性：结论：SBRT和ADT联合治疗对激素敏感型和阉割耐药型前列腺癌患者是安全的，并显示出良好的临床效果。需要对阉割耐药前列腺癌患者进行验证研究。

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来源期刊

Practical Radiation Oncology Medicine-Radiology, Nuclear Medicine and Imaging

CiteScore

5.20

自引率

6.10%

发文量

177

审稿时长

34 days

期刊介绍： The overarching mission of Practical Radiation Oncology is to improve the quality of radiation oncology practice. PRO''s purpose is to document the state of current practice, providing background for those in training and continuing education for practitioners, through discussion and illustration of new techniques, evaluation of current practices, and publication of case reports. PRO strives to provide its readers content that emphasizes knowledge "with a purpose." The content of PRO includes: Original articles focusing on patient safety, quality measurement, or quality improvement initiatives Original articles focusing on imaging, contouring, target delineation, simulation, treatment planning, immobilization, organ motion, and other practical issues ASTRO guidelines, position papers, and consensus statements Essays that highlight enriching personal experiences in caring for cancer patients and their families.