Department of Oncology, Aarhus University Hospital, Denmark.
Department of Oncology, Aarhus University Hospital, Denmark.
Radiother Oncol. 2021 May;158:312-320. doi: 10.1016/j.radonc.2021.01.019. Epub 2021 Feb 3.
To identify patient- and treatment-related risk factors for fistula, bleeding, cystitis, pain and difficulty in voiding in locally advanced cervical cancer patients treated with radio(chemo)therapy and image-guided adaptive brachytherapy (IGABT).
Morbidity within the EMBRACE-I study was prospectively reported for physician-assessed (CTCAE) fistula, bleeding and cystitis and patient-reported (EORTC) pain and difficulty in voiding. Analysis of risk factors was performed in patients without bladder infiltration. Risk factors were tested with Cox regression for grade (G) ≥ 3 cystitis, for G ≥ 2 fistula, bleeding and cystitis, and for EORTC "very much" and "quite a bit" or worse.
Of 1416 patients enrolled, 1153 and 884 patients without bladder infiltration were evaluable for the analysis of CTCAE and EORTC items, respectively. Median follow-up was 48[3-120] months. Crude incidence rates for G ≥ 2 fistula, bleeding and cystitis were 0.7%, 2.7% and 8.8%, respectively, and 16% and 14% for "quite a bit" or worse pain and difficulty in voiding, respectively. Baseline urinary morbidity and overweight/obesity were significant risk factors for most endpoints. Bladder D correlated with G ≥ 2 fistula, bleeding and cystitis, while ICRU bladder point dose correlated with EORTC pain "quite a bit" or worse. An increase from 75 Gy to 80 Gy in bladder D resulted in an increase from 8% to 13% for 4-year actuarial estimate of G ≥ 2 cystitis.
Clinical and treatment-related risk factors for bladder fistula, bleeding and cystitis were identified within a prospective and multi-institutional setting. A dose-effect was established with bladder D, reinforcing the importance of continued optimization during individualized IGABT planning.
确定接受放射（化疗）和图像引导自适应近距离放射治疗（IGABT）的局部晚期宫颈癌患者发生瘘、出血、膀胱炎、疼痛和排尿困难的患者和治疗相关的风险因素。
EMBRACE-I 研究前瞻性报告了医生评估的（CTCAE）瘘、出血和膀胱炎以及患者报告的（EORTC）疼痛和排尿困难的发病率。在没有膀胱浸润的患者中进行了风险因素分析。使用 Cox 回归分析了发生 G≥3 级膀胱炎、G≥2 级瘘、出血和膀胱炎以及 EORTC“非常”和“相当多”或更差的疼痛和排尿困难的风险因素。
在纳入的 1416 例患者中，1153 例和 884 例没有膀胱浸润的患者分别可用于 CTCAE 和 EORTC 项目的分析。中位随访时间为 48[3-120]个月。G≥2 级瘘、出血和膀胱炎的粗发生率分别为 0.7%、2.7%和 8.8%，“相当多”或更差的疼痛和排尿困难发生率分别为 16%和 14%。基线时的尿病发病率和超重/肥胖是大多数结局的显著风险因素。膀胱 D 与 G≥2 级瘘、出血和膀胱炎相关，而 ICRU 膀胱点剂量与 EORTC 疼痛“相当多”或更差相关。膀胱 D 从 75Gy 增加到 80Gy，4 年的 G≥2 级膀胱炎的估计发生率从 8%增加到 13%。
在前瞻性和多机构环境中确定了膀胱瘘、出血和膀胱炎的临床和治疗相关风险因素。建立了膀胱 D 的剂量效应，这强调了在个体化 IGABT 计划中持续优化的重要性。
