Postmastectomy chest wall radiotherapy for breast cancer (SUPREMO): 5-year quality-of-life results from a randomised, controlled, phase 3 trial.

The quality of life (QOL) substudy of SUPREMO (UK patients only) examines the effects of chest wall radiotherapy in patients with intermediate-risk breast cancer 1 year, 2 years, 5 years, and 10 years after treatment.

SUPREMO的生存质量（QOL）子研究（仅限英国患者）检查了在治疗后1年、2年、5年和10年，胸部壁放射治疗对中危乳腺癌患者的影响。

Here, we report 5-year QOL results (a secondary endpoint), including prespecified subgroup analyses.

在这里，我们报告了5年的QOL结果（次要终点），包括预先设定的亚组分析。

Methods

SUPREMO is an international, parallel-group, randomised, controlled, phase 3 trial. Women aged 18 years or older with intermediate-risk breast cancer (defined as pT1-2N1 or pT3N0 or pT2N0 with histological grade 3, or lymphovascular invasion, or both) who had undergone mastectomy (and axillary surgery) were randomly assigned (1:1) to receive chest wall radiotherapy (40-50 Gy in 15-25 fractions) or no radiotherapy.

SUPREMO是一项国际性的平行组、随机、对照、3期试验。年龄在18岁或以上的女性，如果患有中危乳腺癌（定义为pT1-2N1或pT3N0或pT2N0且组织学分级为3级，或有淋巴血管侵犯，或两者都有），并且已经接受了乳房切除术（和腋窝手术），则被随机分配（1:1）接受胸部壁放射治疗（40-50 Gy，分15-25次）或不接受放射治疗。

Randomisation was in permuted blocks with varying block length, stratified by centre, without masking of patients or investigators.

随机分配是使用变化的块长度的置换块进行的，按中心进行分层，没有对患者或研究人员进行遮蔽。

All UK patients were invited to the QOL substudy.

所有英国患者都被邀请参加QOL子研究。

Consenting patients completed validated questionnaires (European Organisation for Research and Treatment of Cancer Quality of Life Core 30-item questionnaire; European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Module, 23 items; Body Image Scale; and Hospital Anxiety and Depression Scale) before randomisation and at 1 year, 2 years, 5 years, and 10 years.

同意参加的患者在随机分配前和随机分配后1年、2年、5年、10年完成了经过验证的问卷（欧洲癌症研究与治疗组织生活质量核心30项问卷；欧洲癌症研究与治疗组织生活质量问卷-乳腺癌模块，23项；身体形象量表；医院焦虑和抑郁量表）。

Here, we report the prespecified primary QOL outcomes of global QOL, fatigue, physical function, chest wall symptoms, shoulder and arm symptoms, body image, anxiety, and depression in the intention to treat population, using repeated measures mixed-effects models.

在这里，我们报告了在意向治疗人群中，使用重复测量混合效应模型的预先设定的主要QOL结果，包括全球QOL、疲劳、身体功能、胸部壁症状、肩部和手臂症状、身体形象、焦虑和抑郁。

This trial is registered with the ISRCTN registry, ISRCTN61145589 and is now completed.

该试验已在ISRCTN注册中心注册，注册号为ISRCTN61145589，目前已完成。

Results

Between Aug 4, 2006, and April 29, 2013, SUPREMO recruited 1691 patients internationally, of whom 1679 were randomly assigned to receive chest wall radiotherapy (n=845) or not (n=834).

在2006年8月4日至2013年4月29日期间，SUPREMO在全球范围内招募了1691名患者，其中1679名被随机分配接受胸部壁放射治疗（n=845）或不接受（n=834）。

Of 1233 patients from UK centres (619 in the chest wall radiotherapy group and 614 in the no chest wall radiotherapy group), 989 (80%) consented to the QOL substudy: 947 (96%) of 989 returned baseline questionnaires and 620 (75%) of 832 patients returned the expected year-5 questionnaires.

在来自英国中心的1233名患者中（胸部壁放射治疗组619名，无胸部壁放射治疗组614名），有989名（80%）同意参加QOL子研究：989名中的947名（96%）返回了基线问卷，832名患者中有620名（75%）返回了预期的5年问卷。

Chest wall symptoms were worse with chest wall radiotherapy (effect estimate 1·99 [95% CI 0·36-3·62]; p=0·017) with an improvement between years 1, 2, and 5.

胸部壁放射治疗组的胸部壁症状更严重（效果估计1·99 [95% CI 0·36-3·62]；p=0·017），但在第1年、第2年和第5年之间有所改善。

Chemotherapy was associated with less improvement over time (effect estimate 2·97 [95% CI 0·24-5·71]; p=0·033) but without interaction with chest wall radiotherapy.

化疗与随时间改善较少有关（效果估计2·97 [95% CI 0·24-5·71]；p=0·033），但与胸部壁放射治疗无交互作用。

No statistically significant differences were observed in other QOL domains (arm symptoms, body image, fatigue, pain, overall QOL, physical functioning, or anxiety and depression).

在其他QOL领域（手臂症状、身体形象、疲劳、疼痛、总体QOL、身体功能或焦虑和抑郁）未观察到统计学上显著的差异。

In the subgroup analyses, patients who had a sentinel lymph node biopsy followed up by an axillary lymph node clearance with chest wall radiotherapy had worse chest wall symptoms than those having a single axillary operation (difference chest wall radiotherapy vs no chest wall radiotherapy -5·29 [95%CI -8·53 to -2·05]; p=0·0015).

在亚组分析中，接受哨兵淋巴结活检后进行腋窝淋巴结清扫并接受胸部壁放射治疗的患者，其胸部壁症状比仅进行单次腋窝手术的患者更严重（胸部壁放射治疗与无胸部壁放射治疗之间的差异为-5·29 [95%CI -8·53至-2·05]；p=0·0015）。

interpretation

The 5-year QOL findings showed worse chest wall toxicity and no effect on other QOL domains.

5年的QOL结果显示胸部壁毒性更严重，对其他QOL领域无影响。

The subgroup analyses suggested a potential negative effect of chemotherapy and axillary clearance after sentinel node biopsy.

亚组分析表明，化疗和哨兵淋巴结活检后进行腋窝清扫可能带来潜在的负面效果。

funding

UK Medical Research Council, National Institute for Health and Care Research, European Organisation for Research and Treatment of Cancer, Edinburgh Trustees of Breast Cancer Institute in Edinburgh and the Edinburgh Cancer Centre NHS Endowment funds, The Dutch Cancer Society, Trustees of the Hong Kong and Shanghai Banking Corporation.

英国医学研究理事会、国家健康与护理研究所、欧洲癌症研究与治疗组织、爱丁堡乳腺癌研究所信托基金以及爱丁堡癌症中心NHS基金、荷兰癌症协会、香港上海汇丰银行信托基金。