Department of Oncology, Aarhus University Hospital, Denmark.
Department of Radiation Oncology, Medical University of Vienna, Austria.
Radiother Oncol. 2018 Jun;127(3):423-430. doi: 10.1016/j.radonc.2018.05.002. Epub 2018 May 18.
The EMBRACE study is a prospective multi-institutional study on MRI guided adaptive brachytherapy (IGABT) in locally advanced cervix cancer (LACC). This analysis describes early to late urinary morbidity assessed by physicians and patients (PRO).
A total of 1176 patients were analysed. Median follow up (FU) was 27 (1-83) months. Morbidity (CTCAE v.3) and PRO (EORTC QLQ-C30&CX24) was prospectively assessed at baseline (BL), and during FU.
The most frequent symptoms were frequency/urgency, incontinence, and cystitis with grade 2-4 prevalence rates of 4.3%, 5.0% and 1.7% and grade 1-4 prevalence rates of 24.5%, 16.1% and 5.8% at 3-years. The most frequent PRO endpoints were "urinary frequency" and "leaking of urine". Prevalence of "Quite a bit" or "very much" bother fluctuated from 14.0% to 21.5% for "frequency", while "leaking of urine" increased from 4.6% at BL to 9.3% at 3-years. Actuarial 3-year incidence of grade 3-4 urinary morbidity was 5.3% with most events being urinary frequency, incontinence and ureteral strictures. Grade 3-4 fistula, bleeding, spasm and cystitis were all <1.0% at 3/5-years. No grade 5 toxicity occurred.
Urinary grade 3-4 morbidity with IGABT was limited. Urinary morbidity grade 2-4 comprises mainly frequency/urgency, incontinence and cystitis and has considerable prevalence in PRO. Various urinary morbidity endpoints have different patterns of manifestation and time course.
EMBRACE 研究是一项关于局部晚期宫颈癌（LACC）中 MRI 引导自适应近距离放疗（IGABT）的前瞻性多中心研究。本分析描述了由医生和患者评估的早期到晚期尿系并发症（PRO）。
共分析了 1176 例患者。中位随访时间（FU）为 27（1-83）个月。在基线（BL）和 FU 期间，前瞻性地评估了发病率（CTCAE v.3）和 PRO（EORTC QLQ-C30&CX24）。
最常见的症状是尿频/尿急、尿失禁和膀胱炎，其 2-4 级的发生率分别为 4.3%、5.0%和 1.7%，1-4 级的发生率分别为 24.5%、16.1%和 5.8%，均在 3 年时。最常见的 PRO 终点是“尿频率”和“漏尿”。“非常困扰”或“相当困扰”的发生率从 BL 时的 14.0%波动到 3 年时的 21.5%，而“漏尿”则从 BL 时的 4.6%增加到 3 年时的 9.3%。3 年时，3-4 级尿系发病率为 5.3%，多数事件为尿频、尿失禁和输尿管狭窄。3/5 年时，3-4 级瘘管、出血、痉挛和膀胱炎的发生率均<1.0%。未发生 5 级毒性。
IGABT 的 3-4 级尿系发病率有限。2-4 级尿系发病率主要包括尿频/尿急、尿失禁和膀胱炎，在 PRO 中有相当大的发生率。各种尿系发病率终点的表现和时间过程各不相同。
