Abstract：
OBJECTIVE: 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).
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.
摘要：
目的：评估雄激素受体靶向药物（ARTA）治疗转移性去势抵抗性前列腺癌（CRPC）后立体定向放疗（SBRT）对慢进性疾病（OPD）的毒性和患者生活质量。
方法：本II期试验纳入骨中有≤2个少进病变的转移性CRPC患者，淋巴结,肺，或者前列腺.所有患者在少进展时接受阿比特龙或恩扎鲁他胺的全身治疗。所有患者接受SBRT至OPD位点并继续当前的ARTA。患者在OPD部位分5次(隔天)接受30Gy。试验的主要终点是评估SBRT至OPD位点是否导致无进展生存期>6个月。此毒性分析的主要终点是SBRT后6个月内任何时间点的3级或更高的不良事件发生率。次要终点包括使用视觉模拟评分和EQ-5D健康问卷比较SBRT前后患者相关结果。
结果：40名入选患者在分析时进行了至少6个月的随访。使用常见术语标准记录的任何原因引起的3级或更高毒性不良事件和放射治疗肿瘤学组在8/40（20％）的患者中发现，但只有1/40（2.5％）被认为可能与SBRT有关。从基线到SBRT后每个时间点的平均EQ5D视觉模拟评分没有显着差异（p=0.449）。
结论：在CRPC环境中进行ARTA的OPD前瞻性II期临床试验中，我们报告SBRT后低度≥3级毒性。由于SBRT治疗，患者报告的生活质量没有明显变化。一旦进一步的随访完成，将报告SBRT治疗的无进展生存期和毒性的最终结果。
方法：本II期试验纳入骨中有≤2个少进病变的转移性CRPC患者，淋巴结,肺，或者前列腺.所有患者在少进展时接受阿比特龙或恩扎鲁他胺的全身治疗。所有患者接受SBRT至OPD位点并继续当前的ARTA。患者在OPD部位分5次(隔天)接受30Gy。试验的主要终点是评估SBRT至OPD位点是否导致无进展生存期>6个月。此毒性分析的主要终点是SBRT后6个月内任何时间点的3级或更高的不良事件发生率。次要终点包括使用视觉模拟评分和EQ-5D健康问卷比较SBRT前后患者相关结果。
结果：40名入选患者在分析时进行了至少6个月的随访。使用常见术语标准记录的任何原因引起的3级或更高毒性不良事件和放射治疗肿瘤学组在8/40（20％）的患者中发现，但只有1/40（2.5％）被认为可能与SBRT有关。从基线到SBRT后每个时间点的平均EQ5D视觉模拟评分没有显着差异（p=0.449）。
结论：在CRPC环境中进行ARTA的OPD前瞻性II期临床试验中，我们报告SBRT后低度≥3级毒性。由于SBRT治疗，患者报告的生活质量没有明显变化。一旦进一步的随访完成，将报告SBRT治疗的无进展生存期和毒性的最终结果。
