Vittrup Anders S, Tanderup Kari, Bentzen Søren M, Jensen Nina B K, Spampinato Sofia, Fokdal Lars U, Lindegaard Jacob C, Sturdza Alina, Schmid Maximilian, Segedin Barbara, Jürgenliemk-Schulz Ina M, Bruheim Kjersti, Mahantshetty Umesh, Haie-Meder Christine, Rai Bhavana, Cooper Rachel, van der Steen-Banasik Elzbieta, Sundset Marit, Huang Fleur, Nout Remi A, Villafranca Elena, Van Limbergen Erik, Pieters Bradley R, Tan Li Tee, Lutgens Ludy C H W, Hoskin Peter, Pötter Richard, Kirchheiner Kathrin
Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.
Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.
Int J Radiat Oncol Biol Phys. 2021 Jan 1;109(1):161-173. doi: 10.1016/j.ijrobp.2020.08.044. Epub 2020 Aug 25.
This report describes the persistence of late substantial treatment-related patient-reported symptoms (LAPERS) in the multi-institutional EMBRACE study on magnetic resonance image guided adaptive brachytherapy in locally advanced cervical cancer (LACC).
Patient-reported symptoms (European Organization for Research and Treatment of Cancer [EORTC]-C30/CX24) and physician-assessed morbidity (Common Terminology Criteria for Adverse Events [CTCAE], version 3.0) were assessed at baseline and regular timepoints during follow-up. Patients with sufficient EORTC follow-up (baseline and ≥3 late follow-up visits) were analyzed. LAPERS events were defined as the presence of substantial EORTC symptoms (quite a bit/very much) for at least half of the assessments (persistence) and progression beyond baseline condition (treatment-related). For each EORTC symptom, the ratio between LAPERS rates and crude incidence rates of substantial symptoms was calculated to represent the proportion of symptomatic patients with persisting symptoms. For 9 symptoms with a corresponding EORTC/CTCAE assessment, the overlap of LAPERS and severe morbidity events (grades 3-5) was evaluated.
Of 1047 patients with EORTC available, 741 had sufficient follow-up for the LAPERS analyses. The median follow-up was 59 months (interquartile range, 42-70 months). Across all symptoms, the proportion of patients with LAPERS events (LAPERS rates) was in median 4.6% (range, 0.0% vaginal bleeding to 20.4% tiredness). Urinary frequency, neuropathy, fatigue, insomnia, and menopausal symptoms revealed LAPERS rates of >10%. Vomiting, blood in stool, urinary pain/burning, and abnormal vaginal bleeding displayed LAPERS rates of <1%. A median of 19% of symptomatic patients (interquartile range, 8.0%-28.5%) showed persistent long-term symptoms (LAPERS events). In symptoms with a corresponding EORTC/CTCAE assessment, 12% of LAPERS events were accompanied by a severe CTCAE event.
Within this large cohort of survivors of LACC, a subgroup of patients with persistent symptoms (LAPERS events) was identified. For symptoms with a corresponding EORTC/CTCAE assessment, the vast majority of LAPERS events occurred in patients without corresponding severe physician-assessed morbidity. These findings emphasize the importance of distinguishing between transient and persisting symptoms in the aftercare of LACC survivors.
本报告描述了在多机构开展的关于磁共振成像引导下适形近距离放射治疗局部晚期宫颈癌（LACC）的EMBRACE研究中，患者报告的晚期严重治疗相关症状（LAPERS）的持续情况。
在基线和随访期间的常规时间点评估患者报告的症状（欧洲癌症研究与治疗组织[EORTC]-C30/CX24）和医生评估的发病率（不良事件通用术语标准[CTCAE]，第3.0版）。对有足够EORTC随访数据（基线及≥3次晚期随访）的患者进行分析。LAPERS事件定义为在至少一半的评估中出现严重的EORTC症状（相当多/非常多）（持续存在）且症状程度超过基线状况（与治疗相关）。对于每种EORTC症状，计算LAPERS发生率与严重症状粗发病率之间的比值，以代表有症状且症状持续的患者比例。对于9种有相应EORTC/CTCAE评估的症状，评估LAPERS事件与严重发病事件（3 - 5级）的重叠情况。
在1047例有EORTC数据的患者中，741例有足够的随访数据用于LAPERS分析。中位随访时间为59个月（四分位间距，42 - 70个月）。在所有症状中，发生LAPERS事件的患者比例（LAPERS发生率）中位数为4.6%（范围，从阴道出血的0.0%到疲劳的20.4%）。尿频、神经病变、疲劳、失眠和更年期症状的LAPERS发生率>10%。呕吐、便血、尿痛/烧灼感和异常阴道出血的LAPERS发生率<1%。有症状的患者中，中位数为19%（四分位间距，8.0% - 28.5%）显示有长期持续症状（LAPERS事件）。在有相应EORTC/CTCAE评估的症状中，12%的LAPERS事件伴有严重的CTCAE事件。
在这个大型LACC幸存者队列中，识别出了一组有持续症状（LAPERS事件）的患者亚组。对于有相应EORTC/CTCAE评估的症状，绝大多数LAPERS事件发生在医生评估无相应严重发病情况的患者中。这些发现强调了在LACC幸存者的后续护理中区分短暂症状和持续症状的重要性。
