研究动态
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立体定向全身放射治疗治疗去势抵抗性前列腺癌寡进展:TRAP 试验的早期毒性分析。

Stereotactic Body Radiotherapy for Oligoprogression in Castration-Resistant Prostate Cancer: Early Toxicity Analysis of the TRAP Trial.

发表日期:2024 Jun 18
作者: P H Patel, S Dreibe, A Reid, C Parker, J Murray, A Pathmanathan, A Tirona, J Guevara, Y-E Suh, J Frew, N Palaniappan, I Syndikus, G Attard, N Tunariu, A C Tree
来源: Bone & Joint Journal

摘要:

评估转移性去势抵抗性前列腺癌 (CRPC) 患者接受雄激素受体靶向药物 (ARTA) 治疗后,对少进展性疾病 (OPD) 进行立体定向放射治疗 (SBRT) 后的毒性和患者生活质量。这项 II 期试验纳入了转移性去势抵抗性前列腺癌 (CRPC) 患者。骨、淋巴结、肺或前列腺中 ≤ 2 个寡进行性病变的 CRPC。所有患者在寡进展时均接受阿比特龙或恩杂鲁胺的全身治疗。所有患者均接受了 OPD 部位的 SBRT 治疗并继续当前的 ARTA。患者在 OPD 部位分 5 次(隔天)接受 30 Gy 的照射。该试验的主要终点是评估 OPD 部位的 SBRT 是否导致无进展生存期 > 6 个月。该毒性分析的主要终点是 SBRT 后 6 个月内任何时间点 3 级或以上不良事件的发生率。次要终点包括比较使用视觉模拟量表评分和 EQ-5D 健康问卷报告的 SBRT 前后患者相关结果。40 名入组患者在分析时至少进行了 6 个月的随访。使用不良事件和放射治疗肿瘤学组的通用术语标准记录的任何原因导致的 3 级或更高毒性在 8/40 (20%) 的患者中被发现,但只有 1/40 (2.5%) 的患者被认为可能与 SBRT 相关。 SBRT 后,从基线到每个时间点的平均 EQ5D 视觉模拟量表评分没有显着差异 (p = 0.449)。 在这项针对 CRPC 环境中接受 ARTA 的 OPD 的前瞻性 II 期临床试验中,我们报告了 SBRT 后的低级别 ≥ 3 毒性。 SBRT。由于 SBRT 治疗,患者报告的生活质量没有明显变化。进一步随访完成后,将报告 SBRT 治疗的无进展生存期和毒性的最终结果。Crown 版权所有 © 2024。由 Elsevier Ltd 出版。保留所有权利。
To assess toxicity and patient quality of life after stereotactic body radiotherapy (SBRT) to oligoprogressive disease (OPD) in patients with metastatic castrate-resistant prostate cancer (CRPC) on androgen receptor targeted agents (ARTA).This phase II trial enrolled patients with metastatic CRPC with ≤ 2 oligoprogressive lesions in bone, lymph node, lung, or prostate. All patients were receiving systemic treatment with abiraterone or enzalutamide at the time of oligoprogression. All patients received SBRT to the OPD site(s) and continued the current ARTA. Patients received 30 Gy in 5 fractions (alternate days) to the OPD site. The primary endpoint of the trial is to assess if SBRT to OPD sites results in progression free survival of >6 months. The primary endpoint for this toxicity analysis is the rate of grade 3 or higher adverse events at any timepoint up to 6 months after SBRT. Secondary endpoints included comparing pre- and post-SBRT patient-related outcomes reported using visual analogue scale scores and EQ-5D health questionnaire.Forty enrolled patients had at least 6 months of follow-up at the time of analysis. Grade 3 or higher toxicity from any cause recorded using common terminology criteria for adverse events and radiation therapy oncology group was found in 8/40 (20%) of patients, but only 1/40 (2.5%) was deemed possibly related to SBRT. There was no significant difference in mean EQ5D visual analogue scale score from baseline to each timepoint after SBRT (p = 0.449).In this prospective phase II clinical trial for OPD whilst on ARTA in the CRPC setting, we report low grade ≥ 3 toxicity after SBRT. There is no discernible change in patient-reported quality of life due to SBRT treatment. The final results of progression-free survival and toxicity of SBRT treatment will be reported once further follow-up is complete.Crown Copyright © 2024. Published by Elsevier Ltd. All rights reserved.