de Boer Stephanie M, Nout Remi A, Jürgenliemk-Schulz Ina M, Jobsen Jan J, Lutgens Ludy C H W, van der Steen-Banasik Elzbieta M, Mens Jan Willem M, Slot Annerie, Stenfert Kroese Marika C, Oerlemans Simone, Putter Hein, Verhoeven-Adema Karen W, Nijman Hans W, Creutzberg Carien L
Department of Radiation Oncology, Leiden University Medical Center, Leiden, The Netherlands.
Department of Radiation Oncology, Leiden University Medical Center, Leiden, The Netherlands.
Int J Radiat Oncol Biol Phys. 2015 Nov 15;93(4):797-809. doi: 10.1016/j.ijrobp.2015.08.023. Epub 2015 Aug 18.
To evaluate the long-term health-related quality of life (HRQL) after external beam radiation therapy (EBRT) or vaginal brachytherapy (VBT) among PORTEC-2 trial patients, evaluate long-term bowel and bladder symptoms, and assess the impact of cancer on these endometrial cancer (EC) survivors.
In the PORTEC-2 trial, 427 patients with stage I high-intermediate-risk EC were randomly allocated to EBRT or VBT. The 7- and 10-year HRQL questionnaires consisted of EORTC QLQ-C30; subscales for bowel and bladder symptoms; the Impact of Cancer Questionnaire; and 14 questions on comorbidities, walking aids, and incontinence pads. Analysis was done using linear mixed models for subscales and (ordinal) logistic regression with random effects for single items. A two-sided P value <.01 was considered statistically significant.
Longitudinal HRQL analysis showed persisting higher rates of bowel symptoms with EBRT, without significant differences in global health or any of the functioning scales. At 7 years, clinically relevant fecal leakage was reported by 10.6% in the EBRT group, versus 1.8% for VBT (P=.03), diarrhea by 8.4% versus 0.9% (P=.04), limitations due to bowel symptoms by 10.5% versus 1.8% (P=.001), and bowel urgency by 23.3% versus 6.6% (P<.001). Urinary urgency was reported by 39.3% of EBRT patients, 25.5% for VBT, P=.05. No difference in sexual activity was seen between treatment arms. Long-term impact of cancer scores was higher among the patients who had an EC recurrence or second cancer.
More than 7 years after treatment, EBRT patients reported more bowel symptoms with impact on daily activities, and a trend for more urinary symptoms, without impact on overall quality of life or difference in cancer survivorship issues.
评估PORTEC - 2试验患者接受体外放射治疗（EBRT）或阴道近距离放射治疗（VBT）后的长期健康相关生活质量（HRQL），评估长期肠道和膀胱症状，并评估癌症对这些子宫内膜癌（EC）幸存者的影响。
在PORTEC - 2试验中，427例I期高中危EC患者被随机分配至EBRT组或VBT组。7年和10年的HRQL问卷包括欧洲癌症研究与治疗组织核心生活质量问卷（EORTC QLQ - C30）；肠道和膀胱症状子量表；癌症影响问卷；以及14个关于合并症、助行器和失禁垫的问题。使用线性混合模型分析子量表，并使用具有随机效应的（有序）逻辑回归分析单个项目。双侧P值<.01被认为具有统计学意义。
纵向HRQL分析显示，EBRT组肠道症状发生率持续较高，总体健康或任何功能量表无显著差异。7年时，EBRT组有10.6%报告有临床相关的粪便泄漏，而VBT组为1.8%（P = .03）；腹泻发生率分别为8.4%和0.9%（P = .04）；因肠道症状导致的功能受限分别为10.5%和1.8%（P = .001）；肠道急迫感分别为23.3%和6.6%（P < .001）。EBRT组有39.3%的患者报告有尿急，VBT组为25.5%，P = .05。治疗组之间在性活动方面未见差异。EC复发或患第二种癌症的患者中，癌症的长期影响评分更高。
治疗7年多后，接受EBRT的患者报告有更多影响日常活动的肠道症状，以及更多泌尿系统症状的趋势，但对总体生活质量无影响，在癌症生存问题上也无差异。
