Abstract：
Most patients experience stable quality of life (QoL) after stereotactic ablative radiotherapy (SABR) treatment for oligometastases. However, a subset of patients experience clinically relevant declines in QoL on post-treatment follow-up. This study aimed to identify risk factors for QoL decline.
The SABR-5 trial was a population-based single-arm phase II study of SABR to up to five sites of oligometastases. Prospective QoL was measured using treatment site-specific tools at pre-treatment baseline and 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months after treatment. The time to persistent QoL decline was calculated as the time from SABR to the first decline in QoL score meeting minimum clinically important difference with no improvement to baseline score on subsequent assessments. Univariable and multivariable logistic regression analyses were carried out to determine factors associated with QoL decline.
One hundred and thirty-three patients were included with a median follow-up of 32 months (interquartile range 25-43). Thirty-five patients (26%) experienced a persistent decline in QoL. The median time until persistent QoL decline was not reached. The cumulative incidence of QoL decline at 2 and 3 years were 22% (95% confidence interval 14.0-29.6) and 40% (95% confidence interval 28.0-51.2), respectively. In multivariable analysis, disease progression (odds ratio 5.23, 95% confidence interval 1.59-17.47, P = 0.007) and adrenal metastases (odds ratio 9.70, 95% confidence interval 1.41-66.93, P = 0.021) were associated with a higher risk of QoL decline. Grade 3 or higher (odds ratio 3.88, 95% confidence interval 0.92-16.31, P = 0.064) and grade 2 or higher SABR-associated toxicity (odds ratio 2.24, 95% confidence interval 0.85-5.91, P = 0.10) were associated with an increased risk of QoL decline but did not reach statistical significance.
Disease progression and adrenal lesion site were associated with persistent QoL decline following SABR. The development of grade 3 or higher toxicities was also associated with an increased risk, albeit not statistically significant. Further studies are needed, focusing on the QoL impact of metastasis-directed therapies.
The SABR-5 trial was a population-based single-arm phase II study of SABR to up to five sites of oligometastases. Prospective QoL was measured using treatment site-specific tools at pre-treatment baseline and 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months after treatment. The time to persistent QoL decline was calculated as the time from SABR to the first decline in QoL score meeting minimum clinically important difference with no improvement to baseline score on subsequent assessments. Univariable and multivariable logistic regression analyses were carried out to determine factors associated with QoL decline.
One hundred and thirty-three patients were included with a median follow-up of 32 months (interquartile range 25-43). Thirty-five patients (26%) experienced a persistent decline in QoL. The median time until persistent QoL decline was not reached. The cumulative incidence of QoL decline at 2 and 3 years were 22% (95% confidence interval 14.0-29.6) and 40% (95% confidence interval 28.0-51.2), respectively. In multivariable analysis, disease progression (odds ratio 5.23, 95% confidence interval 1.59-17.47, P = 0.007) and adrenal metastases (odds ratio 9.70, 95% confidence interval 1.41-66.93, P = 0.021) were associated with a higher risk of QoL decline. Grade 3 or higher (odds ratio 3.88, 95% confidence interval 0.92-16.31, P = 0.064) and grade 2 or higher SABR-associated toxicity (odds ratio 2.24, 95% confidence interval 0.85-5.91, P = 0.10) were associated with an increased risk of QoL decline but did not reach statistical significance.
Disease progression and adrenal lesion site were associated with persistent QoL decline following SABR. The development of grade 3 or higher toxicities was also associated with an increased risk, albeit not statistically significant. Further studies are needed, focusing on the QoL impact of metastasis-directed therapies.
摘要：
目的：立体定向消融放疗（SABR）治疗寡转移后，大多数患者的生活质量（QoL）稳定。然而,一部分患者在治疗后随访中经历了临床相关的QoL下降.本研究旨在确定QoL下降的危险因素。
方法：SABR-5试验是一项基于人群的单臂II期SABR研究，研究了多达5个寡核苷酸位点。在治疗前基线和治疗后3、6、9、12、15、18、21、24、30和36个月，使用治疗部位特异性工具测量前瞻性QoL。持续QoL下降的时间被计算为从SABR到QoL评分的第一次下降达到最小临床重要差异的时间,在随后的评估中基线评分没有改善。进行单变量和多变量逻辑回归分析以确定与QoL下降相关的因素。
结果：130名患者被纳入，中位随访时间为32个月（四分位距25-43）。35例患者（26%）经历了持续的QoL下降。未达到持续QoL下降的中位时间。2年和3年QoL下降的累积发生率分别为22％（95％置信区间14.0-29.6）和40％（95％置信区间28.0-51.2），分别。在多变量分析中，疾病进展(比值比5.23,95%置信区间1.59~17.47,P=0.007)和肾上腺转移(比值比9.70,95%置信区间1.41~66.93,P=0.021)与较高的QoL下降风险相关.3级或更高（比值比3.88，95％置信区间0.92-16.31，P=0.064）和2级或更高SABR相关毒性（比值比2.24，95％置信区间0.85-5.91，P=0.10）与QoL下降风险增加相关，但未达到统计学意义。
结论：疾病进展和肾上腺病变部位与SABR后持续的QoL下降相关。3级或更高毒性的发展也与风险增加有关，尽管没有统计学意义。需要进一步的研究,重点关注转移导向治疗的QoL影响。
方法：SABR-5试验是一项基于人群的单臂II期SABR研究，研究了多达5个寡核苷酸位点。在治疗前基线和治疗后3、6、9、12、15、18、21、24、30和36个月，使用治疗部位特异性工具测量前瞻性QoL。持续QoL下降的时间被计算为从SABR到QoL评分的第一次下降达到最小临床重要差异的时间,在随后的评估中基线评分没有改善。进行单变量和多变量逻辑回归分析以确定与QoL下降相关的因素。
结果：130名患者被纳入，中位随访时间为32个月（四分位距25-43）。35例患者（26%）经历了持续的QoL下降。未达到持续QoL下降的中位时间。2年和3年QoL下降的累积发生率分别为22％（95％置信区间14.0-29.6）和40％（95％置信区间28.0-51.2），分别。在多变量分析中，疾病进展(比值比5.23,95%置信区间1.59~17.47,P=0.007)和肾上腺转移(比值比9.70,95%置信区间1.41~66.93,P=0.021)与较高的QoL下降风险相关.3级或更高（比值比3.88，95％置信区间0.92-16.31，P=0.064）和2级或更高SABR相关毒性（比值比2.24，95％置信区间0.85-5.91，P=0.10）与QoL下降风险增加相关，但未达到统计学意义。
结论：疾病进展和肾上腺病变部位与SABR后持续的QoL下降相关。3级或更高毒性的发展也与风险增加有关，尽管没有统计学意义。需要进一步的研究,重点关注转移导向治疗的QoL影响。
