Leeds Institute of Cancer and Pathology, University of Leeds, Leeds Cancer Centre, St James's University Hospital, Leeds, UK.
Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.
Lancet Oncol. 2018 Nov;19(11):1516-1529. doi: 10.1016/S1470-2045(18)30515-1. Epub 2018 Oct 15.
BACKGROUND: Postmastectomy radiotherapy in patients with four or more positive axillary nodes reduces breast cancer mortality, but its role in patients with one to three involved nodes is controversial. We assessed the effects of postmastectomy radiotherapy on quality of life (QOL) in women with intermediate-risk breast cancer. METHODS: SUPREMO is an open-label, international, parallel-group, randomised, controlled trial. Women aged 18 years or older with intermediate-risk breast cancer (defined as pT1-2N1; pT3N0; or pT2N0 if also grade III or with lymphovascular invasion) who had undergone mastectomy and, if node positive, axillary surgery, were randomly assigned (1:1) to receive chest wall radiotherapy (50 Gy in 25 fractions or a radiobiologically equivalent dose of 45 Gy in 20 fractions or 40 Gy in 15 fractions) or no radiotherapy. Randomisation was done with permuted blocks of varying block length, and stratified by centre, without masking of patients or investigators. The primary endpoint is 10-year overall survival. Here, we present 2-year results of QOL (a prespecified secondary endpoint). The QOL substudy, open to all UK patients, consists of questionnaires (European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-BR23, Body Image Scale, Hospital Anxiety and Depression Scale [HADS], and EQ-5D-3L) completed before randomisation, and at 1, 2, 5, and 10 years. The prespecified primary outcomes within this QOL substudy were global QOL, fatigue, physical function, chest wall symptoms, shoulder and arm symptoms, body image, and anxiety and depression. Data were analysed by intention to treat, using repeated mixed-effects methods. This trial is registered with the ISRCTN registry, number ISRCTN61145589. FINDINGS: Between Aug 4, 2006, and April 29, 2013, 1688 patients were enrolled internationally and randomly assigned to receive chest wall radiotherapy (n=853) or not (n=835). 989 (79%) of 1258 patients from 111 UK centres consented to participate in the QOL substudy (487 in the radiotherapy group and 502 in the no radiotherapy group), of whom 947 (96%) returned the baseline questionnaires and were included in the analysis (radiotherapy, n=471; no radiotherapy, n=476). At up to 2 years, chest wall symptoms were worse in the radiotherapy group than in the no radiotherapy group (mean score 14·1 [SD 15·8] in the radiotherapy group vs 11·6 [14·6] in the no radiotherapy group; effect estimate 2·17, 95% CI 0·40-3·94; p=0·016); however, there was an improvement in both groups between years 1 and 2 (visit effect -1·34, 95% CI -2·36 to -0·31; p=0·010). No differences were seen between treatment groups in arm and shoulder symptoms, body image, fatigue, overall QOL, physical function, or anxiety or depression scores. INTERPRETATION: Postmastectomy radiotherapy led to more local (chest wall) symptoms up to 2 years postrandomisation compared with no radiotherapy, but the difference between groups was small. These data will inform shared decision making while we await survival (trial primary endpoint) results. FUNDING: Medical Research Council, European Organisation for Research and Treatment of Cancer, Cancer Australia, Dutch Cancer Society, Trustees of Hong Kong and Shanghai Banking Corporation.
背景:对于腋窝淋巴结转移 4 个及以上的乳腺癌患者,术后放疗可降低乳腺癌死亡率,但对于腋窝淋巴结转移 1-3 个的患者,术后放疗的作用仍存在争议。我们评估了术后放疗对中危乳腺癌患者生活质量(QOL)的影响。
方法:SUPREMO 是一项开放标签、国际、平行组、随机、对照试验。纳入年龄 18 岁及以上、经病理确诊为中危乳腺癌(定义为 pT1-2N1;pT3N0;或 pT2N0 且为 III 级或有脉管侵犯)且已行乳房切除术及腋窝手术(如果淋巴结阳性)的患者,按 1:1 比例随机分配(分层因素为中心)至接受胸部放疗(50 Gy/25 次或生物等效剂量 45 Gy/20 次或 40 Gy/15 次)或不接受放疗。随机分组采用不同长度的随机区组,且不设盲。主要终点为 10 年总生存率。本研究报告了 QOL 的 2 年结果(次要终点)。该 QOL 子研究向所有英国患者开放,包含问卷调查(欧洲癌症研究与治疗组织 EORTC QLQ-C30 和 QLQ-BR23、体像量表、医院焦虑抑郁量表[HADS]和 EQ-5D-3L),分别在随机分组前和 1、2、5、10 年进行。该 QOL 子研究的预设主要结局指标为总体 QOL、疲劳、躯体功能、胸壁症状、肩臂症状、体像和焦虑抑郁。采用重复混合效应方法进行意向性治疗分析。该试验在 ISRCTN 注册中心注册,编号为 ISRCTN61145589。
结果:2006 年 8 月 4 日至 2013 年 4 月 29 日期间,国际上共纳入了 1688 例患者并随机分配接受胸部放疗(n=853)或不接受放疗(n=835)。来自 111 个英国中心的 1258 例患者中有 989 例(79%)同意参加 QOL 子研究(放疗组 487 例,无放疗组 502 例),其中 947 例(96%)患者返回基线问卷并纳入分析(放疗组 471 例,无放疗组 476 例)。在 2 年时,放疗组的胸壁症状比无放疗组更严重(放疗组的平均评分 14.1[15.8],无放疗组的平均评分 11.6[14.6];效应估计 2.17,95%CI 0.40-3.94;p=0.016);但两组在 1 年至 2 年之间均有所改善(访视效应 -1.34,95%CI -2.36 至 -0.31;p=0.010)。两组在肩臂症状、体像、疲劳、总体 QOL、躯体功能或焦虑抑郁评分方面均无差异。
结论:与不接受放疗相比,术后放疗导致随机分组后 2 年内局部(胸壁)症状更多,但两组之间的差异较小。这些数据将为我们等待生存(试验主要终点)结果的同时,为决策提供参考。
资金:英国医学研究理事会、欧洲癌症研究与治疗组织、澳大利亚癌症协会、荷兰癌症协会、香港上海汇丰银行有限公司。
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