Hsueh Jessica Y, Gallagher Lindsey, Koh Min Ji, Shah Sarthak, Danner Malika, Zwart Alan, Ayoob Marilyn, Kumar Deepak, Leger Paul, Dawson Nancy A, Suy Simeng, Collins Sean P
Department of Radiation Medicine, MedStar Georgetown University Hospital, Washington, DC, United States.
Biotechnology Research Institute, North Carolina Central University, Durham, NC, United States.
Front Oncol. 2024 Aug 12;14:1412786. doi: 10.3389/fonc.2024.1412786. eCollection 2024.
Androgen deprivation therapy has been shown to improve cancer control when combined with radiotherapy. Relugolix is an oral GnRH receptor antagonist that achieves rapid profound testosterone suppression, which may increase the perception and/or impact of fatigue. This study sought to evaluate neoadjuvant relugolix-induced fatigue in prostate cancer patients prior to the start of stereotactic body radiation therapy (SBRT).
Relugolix was initiated at least two months before SBRT. The 13-item Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire was collected at baseline and one hour prior to SBRT initiation. A five-point scale was used to score individual items. Overall scores range from 0-52 and individual item scores were converted to 0-100, with higher scores reflecting less fatigue. Five "experience" items explored self-perceptions of fatigue, and eight "impact" items sought to evaluate the effect of fatigue on daily activities. Items were evaluated for statistical significance (paired t-test, p < 0.05) and clinical significance (minimally important difference (MID); 0.5 standard deviation from baseline).
Between March 2021 to December 2023, 89 men were treated at Georgetown with neoadjuvant relugolix and SBRT. Mean age was 71 years (range: 49-87). Median initiation of relugolix was 4.5 months prior to SBRT (range: 2-14.2 months). 93% patients achieved castration (testosterone levels ≤ 50 ng/dL) and 85% patients achieved profound castration (testosterone levels ≤ 20 ng/dL). 87 patients completed the FACIT-F questionnaire, with an average overall score of 45.6 at baseline and 41.0 at SBRT initiation. This difference was statistically and clinically significant (p < 0.01, MID = 3.55). Patients experienced an increase in fatigue for 12 of 13 items, with statistically significant changes for 11 items. Three of five experience items showed a clinically significant increase in fatigue. Only two of eight impact items were clinically significant.
Our study shows that relugolix significantly increases fatigue, affecting multiple areas of life. While the fatigue does not appear to generally impact a patient's ability to carry out normal activities, patients demonstrate frustration with being too tired for these activities. It is essential for clinicians to counsel prostate cancer patients on the impact of neoadjuvant relugolix on quality-of-life issues like fatigue.
雄激素剥夺疗法与放射治疗联合使用时已显示可改善癌症控制。relugolix是一种口服促性腺激素释放激素（GnRH）受体拮抗剂，可迅速显著抑制睾酮，这可能会增加疲劳感和/或疲劳的影响。本研究旨在评估在立体定向体部放射治疗（SBRT）开始前，新辅助使用relugolix引起的前列腺癌患者疲劳情况。
在SBRT至少两个月前开始使用relugolix。在基线时以及SBRT开始前一小时收集13项慢性病治疗功能评估-疲劳（FACIT-F）问卷。使用五点量表对各个项目进行评分。总分范围为0 - 52分，各个项目得分转换为0 - 100分，得分越高表明疲劳程度越低。五个“体验”项目探讨了对疲劳的自我认知，八个“影响”项目旨在评估疲劳对日常活动的影响。对项目进行统计学显著性评估（配对t检验，p < 0.05）和临床显著性评估（最小重要差异（MID）；与基线相差0.5个标准差）。
在2021年3月至2023年12月期间，89名男性在乔治敦接受了新辅助relugolix和SBRT治疗。平均年龄为71岁（范围：49 - 87岁）。relugolix的中位起始时间为SBRT前4.5个月（范围：2 - 14.2个月）。93%的患者实现了去势（睾酮水平≤50 ng/dL），85%的患者实现了深度去势（睾酮水平≤20 ng/dL）。87名患者完成了FACIT-F问卷，基线时平均总分为45.6分，SBRT开始时为41.0分。这种差异具有统计学和临床显著性（p < 0.01，MID = 3.55）。13个项目中有12个项目患者的疲劳感增加，11个项目有统计学显著变化。五个体验项目中有三个显示疲劳有临床显著性增加。八个影响项目中只有两个具有临床显著性。
我们的研究表明，relugolix显著增加疲劳感，影响生活的多个方面。虽然疲劳似乎一般不会影响患者进行正常活动的能力，但患者对因疲劳而无法进行这些活动感到沮丧。临床医生向前列腺癌患者咨询新辅助relugolix对疲劳等生活质量问题的影响至关重要。
