Department of Radiation Oncology, Medical University of Vienna, Austria; Department of Radiation Oncology, University Hospitals Leuven, Belgium.
Department of Radiation Oncology, Medical University of Vienna, Austria.
Radiother Oncol. 2018 Jun;127(3):440-448. doi: 10.1016/j.radonc.2018.03.009. Epub 2018 Apr 5.
To evaluate the pattern of manifestation of fatigue, insomnia and hot flashes within the prospective, observational, multi-center EMBRACE study.
Morbidity was prospectively assessed according to CTCAE v.3 and patient-reported outcome with EORTC QLQ-C30/CX24 at baseline and regular follow-up. Analyses of crude incidence, prevalence rates and actuarial estimates were performed.
A total of 1176 patients were analyzed with a median follow-up of 27 months. At baseline, CTCAE G1/G2 prevalence rates for fatigue were 29%/6.2%, for insomnia 18%/3.1% and for hot flashes 7.9%/1.6% with respective 3-year prevalence rates of 29%/6.8%, 17%/4.4% and 19%/5.9%. Similar patterns of manifestation were seen in patient-reported EORTC outcomes. The 3-year actuarial estimates for G ≥ 3 CTCAE fatigue, insomnia and hot flashes were 5.5%, 4.7% and 1.9%. Younger age was associated with significantly higher risk for fatigue, insomnia and hot flashes.
Fatigue, insomnia and hot flashes occurred mainly in the mild to moderate range. Fatigue and insomnia were already present before treatment and showed minor fluctuations or recovery during follow-up, whereas hot flashes showed a considerable increase after treatment. More research is needed to evaluate contributing risk factors in order to define intervention strategies.
评估前瞻性、观察性、多中心 EMBRACE 研究中疲劳、失眠和热潮红的表现模式。
根据 CTCAE v.3 和 EORTC QLQ-C30/CX24，前瞻性评估发病率，在基线和定期随访时进行患者报告的结局。进行了粗发病率、患病率和累积估计分析。
共分析了 1176 例患者，中位随访时间为 27 个月。基线时，疲劳的 CTCAE G1/G2 患病率为 29%/6.2%，失眠为 18%/3.1%，热潮红为 7.9%/1.6%，相应的 3 年患病率为 29%/6.8%、17%/4.4%和 19%/5.9%。患者报告的 EORTC 结局也呈现出类似的表现模式。G≥3 CTCAE 疲劳、失眠和热潮红的 3 年累积估计发生率分别为 5.5%、4.7%和 1.9%。年龄较轻与疲劳、失眠和热潮红的风险显著增加相关。
疲劳、失眠和热潮红主要发生在轻度至中度范围内。疲劳和失眠在治疗前已经存在，并在随访期间出现轻微波动或恢复，而热潮红在治疗后出现明显增加。需要进一步研究以评估相关的风险因素，以便确定干预策略。
