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PORTEC-2 试验中随机治疗的子宫内膜癌患者的 5 年生活质量及其与规范数据的比较。

Five-year quality of life of endometrial cancer patients treated in the randomised Post Operative Radiation Therapy in Endometrial Cancer (PORTEC-2) trial and comparison with norm data.

机构信息

Department of Clinical Oncology, Leiden University Medical Center, Leiden, The Netherlands.

出版信息

Eur J Cancer. 2012 Jul;48(11):1638-48. doi: 10.1016/j.ejca.2011.11.014. Epub 2011 Dec 14.

Abstract

BACKGROUND

The PORTEC-2 trial showed efficacy and reduced side-effects of vaginal brachytherapy (VBT) compared with external beam pelvic radiotherapy (EBRT) for patients with high-intermediate risk endometrial cancer. The current analysis was done to evaluate long-term health related quality of life (HRQL), and compare HRQL of patients to an age-matched norm population.

METHODS

Patients were randomly allocated to EBRT (n=214) or VBT (n=213). HRQL was assessed using EORTC QLQ-C30 and subscales from PR25 and OV28 (bladder, bowel, sexual symptoms); and compared to norm data.

FINDINGS

Median follow-up was 65 months; 348 (81%) patients were evaluable for HRQL (EBRT n=166, VBT n=182). At baseline, patient functioning was at lowest level, increasing during and after radiotherapy to reach a plateau after 12 months, within range of scores of the norm population. VBT patients reported better social functioning (p=0.005) and lower symptom scores for diarrhoea, faecal leakage, need to stay close to a toilet and limitation in daily activities due to bowel symptoms (p⩽0.001), compared to EBRT. There were no differences in sexual functioning or symptoms between the treatment groups; however, sexual functioning was lower and sexual symptoms more frequent in both treatment groups compared to the norm population.

INTERPRETATION

Patients who received EBRT reported clinically relevant higher levels of bowel symptoms and related limitations in daily activities with lower social functioning, 5 years after treatment. VBT provides a better HRQL, which remained similar to that of an age-matched norm population, except for sexual symptoms which were more frequent in both treatment groups.

摘要

背景

PORTEC-2 试验表明,与外部束盆腔放射治疗(EBRT)相比,阴道近距离放疗(VBT)在中高危子宫内膜癌患者中的疗效更高,副作用更小。目前的分析旨在评估长期健康相关生活质量(HRQL),并比较患者的 HRQL 与年龄匹配的常模人群。

方法

患者被随机分配到 EBRT(n=214)或 VBT(n=213)组。使用 EORTC QLQ-C30 以及 PR25 和 OV28 的子量表(膀胱、肠道、性功能障碍症状)评估 HRQL,并与常模数据进行比较。

结果

中位随访时间为 65 个月;348 名(81%)患者具有可评估的 HRQL(EBRT n=166,VBT n=182)。基线时,患者的功能处于最低水平,在放疗期间和之后增加,在 12 个月后达到平台,处于常模人群的评分范围内。与 EBRT 相比,VBT 患者报告的社会功能更好(p=0.005),腹泻、粪便渗漏、需要靠近厕所和因肠道症状限制日常活动的症状评分较低(p ⩽0.001)。两组之间的性功能障碍或症状没有差异;然而,与常模人群相比,两组治疗后的性功能障碍较低,性功能障碍更频繁。

结论

EBRT 治疗后 5 年,患者报告有更高水平的肠道症状,且因肠道症状相关的日常活动受限,社会功能下降,而 VBT 提供了更好的 HRQL,除了两组中更频繁的性功能障碍症状外,与年龄匹配的常模人群相似。

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