The Royal Marsden NHS Foundation Trust, London, SM2 5PT, UK.
The Royal Marsden NHS Foundation Trust, London, SM2 5PT, UK.
Clin Oncol (R Coll Radiol). 2024 Sep;36(9):585-592. doi: 10.1016/j.clon.2024.06.047. Epub 2024 Jun 18.
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.
评估转移性去势抵抗性前列腺癌（mCRPC）患者在接受雄激素受体靶向治疗（ARTA）时发生寡进展性疾病（OPD）后，立体定向体部放疗（SBRT）的毒性和患者生活质量。
这项 II 期临床试验招募了 mCRPC 患者，这些患者的转移性疾病在骨骼、淋巴结、肺部或前列腺中仅有≤2 个寡进展性病变。所有患者在发生寡进展时均接受阿比特龙或恩扎卢胺的系统治疗。所有患者均接受 SBRT 治疗 OPD 部位，并继续使用当前的 ARTA。患者接受 OPD 部位 30Gy 分 5 次（隔日）照射。该试验的主要终点是评估 SBRT 治疗 OPD 部位是否能使无进展生存期超过 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 级或更高级别的不良事件发生率。次要终点包括比较 SBRT 前后使用视觉模拟量表评分和 EQ-5D 健康问卷报告的患者相关结局。
40 名入组患者在分析时至少有 6 个月的随访。使用不良事件通用术语标准和放射肿瘤学组记录的任何原因导致的 3 级或更高级别的毒性在 40 名患者中的 8 名（20%）中发现，但只有 1 名（2.5%）被认为可能与 SBRT 相关。SBRT 后每个时间点的 EQ5D 视觉模拟量表评分与基线相比均无显著差异（p=0.449）。
在这项 mCRPC 患者接受 ARTA 时治疗 OPD 的前瞻性 II 期临床试验中，我们报告了 SBRT 后低级别≥3 级毒性。SBRT 治疗后患者报告的生活质量没有明显变化。一旦完成进一步随访，将报告 SBRT 治疗无进展生存期和毒性的最终结果。
