The Role of Stereotactic Body Radiotherapy in Oligoprogressive Malignant Disease (RADIANT): Oncologic Outcomes From a Phase 2 Nonrandomized Controlled Trial

IF 6.4 1区医学 Q1 ONCOLOGY

International Journal of Radiation Oncology Biology Physics Pub Date : 2025-02-01 DOI:10.1016/j.ijrobp.2024.09.002

Rachel M. Glicksman MD, MSc , Srinivas Raman MD , Xiang Y. Ye MSc , Philippe L. Bedard MD , Scott Bratman MD , Eric Chen MD , Peter Chung MBChB , Laura A. Dawson MD , Andrew Hope MD , Ali Hosni MBBCh , Joanna Javor CSRT , Patricia Lindsay PhD , Ciara O'Brien MD , Rebecca Wong MD , Aisling Barry MD , Joelle Helou MD

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引用次数: 0

Abstract

Purpose

In oligoprogressive (OP) cancer, there are a limited number of metastatic areas progressing on a background of stable or responding to widespread cancer. Although the standard of care for OP is changing systemic therapy (ST), stereotactic body radiation therapy (SBRT) is being explored as an alternative local therapy targeting the sites of progression.

Methods and Materials

RADIANT (NCT04122469) was a single-center phase 2 study of patients with metastatic genitourinary (GU), breast, and gastrointestinal (GI) cancers, receiving ST for ≥3 months, with radiographic OP disease in ≤5 sites. Patients received SBRT for all OP disease in 1 to 5 fractions and were maintained on ST. The primary endpoint was the cumulative incidence of change in ST, which was estimated using the Aalen-Johansen method. Secondary endpoints included progression-free survival (PFS) and overall survival estimated using the Kaplan-Meier method, as well as toxicity and health-related quality of life. Comparisons between diagnosis groups were done using the log-rank test. A 2-sided p value <.05 was considered statistically significant.

Results

Seventy patients were analyzed, with a median age of 69 years; 32 patients (46%) were women; the median number of lines of prior ST was 3. Primary sites were GU (n = 32; 46%), breast (n = 23; 33%), and GI (n = 15; 21%). The median follow-up was 12.3 months (IQR, 8.2-21.6 months). At 1 year, change in ST occurred in 47% (95% CI, 36%-61%) (GU 45%, breast 41%, and GI 60%; p = .23). PFS at 1 year was 32% (95% CI, 23%-45%), and median PFS was 4.7 months (95% CI, 3.8-8.1) (GU 4.8, breast 6.5, and GI 3.2), which significantly differed by disease type (p = .006). Overall survival was 75% at 1 year (95% CI, 65%-87%), which significantly differed between cancer types (GU 86%, breast 96%, and GI 22%; p < .001). The cumulative incidence of late grade ≥2 toxicity was 1.2%, with 1 patient experiencing late grade 3 toxicity and no grade 4 to 5 acute or late toxicities. Health-related quality of life declined from the mean (SD) of 66.9 (20.2) at baseline to 60.5 (22.2) at 6 months, which did not meet the threshold for a minimal clinically important difference.

Conclusions

SBRT for OP metastases delayed change in ST in approximately half of patients, warranting investigation in randomized trials.

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立体定向体放射治疗在少进展性恶性疾病（RADIANT）中的作用：一项第二阶段非随机对照试验的肿瘤学结果。

背景在少进展性癌症（OP）中，有少数转移区域是在稳定或有反应的广泛癌症背景下进展的。虽然 OP 的标准治疗方法是不断变化的全身治疗（ST），但立体定向体放射治疗（SBRT）作为一种针对进展部位的替代局部治疗方法正在被探索之中。材料/方法 XXXX（NCTXXX）是一项单中心 2 期研究，研究对象为转移性泌尿生殖系统（GU）癌、乳腺癌和胃肠道（GI）癌患者，接受 ST 治疗时间超过 3 个月，其中 2 例患者出现放射性 OP 疾病，毒性反应为 1.2%，1 例患者出现晚期 3 级毒性反应，无 4-5 级急性或晚期毒性反应。HRQOL 从基线时的平均值（标准差）66.9（20.2）下降到 6 个月时的 60.5（22.2），未达到最小临床重要差异的阈值。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

International Journal of Radiation Oncology Biology Physics 医学-核医学

CiteScore

11.00

自引率

7.10%

发文量

2538

审稿时长

6.6 weeks

期刊介绍： International Journal of Radiation Oncology • Biology • Physics (IJROBP), known in the field as the Red Journal, publishes original laboratory and clinical investigations related to radiation oncology, radiation biology, medical physics, and both education and health policy as it relates to the field. This journal has a particular interest in original contributions of the following types: prospective clinical trials, outcomes research, and large database interrogation. In addition, it seeks reports of high-impact innovations in single or combined modality treatment, tumor sensitization, normal tissue protection (including both precision avoidance and pharmacologic means), brachytherapy, particle irradiation, and cancer imaging. Technical advances related to dosimetry and conformal radiation treatment planning are of interest, as are basic science studies investigating tumor physiology and the molecular biology underlying cancer and normal tissue radiation response.