柳葉刀腫瘤分冊：用多導管近距離放療進行部分乳腺加速放療可作為全乳放療的替代選擇

全乳放療需3~6周，對於低危患者可使用部分乳腺加速放療（APBI），其療程短（僅 2~5 天）、效率高、減少乳房及身體其他部位射線暴露。APBI有多種方式，從外照射到近距離放療，從多導管到單球囊裝置，劑量、分割方式、時間安排多種多樣。

——《桓興醫訊》按

《柳葉刀腫瘤分冊》2018年4月22日在線先發

早期乳腺癌保乳術後用組織間短距離放療進行部分乳腺加量放療對比全乳放療的生活質量分析（GEC-ESTRO）：一項隨機3期試驗的5年結果

背景

GEC-ESTRO試驗的既往結果顯示，在早期乳腺癌保乳術後的治療中，就局部控制和總生存而言，使用多導管近距離放療進行部分乳腺加速放療（APBI）並不劣於全乳放療。在此，我們提供了患者報告的生活質量的5年結果。

方法

我們在7個歐洲國家的16家醫院和醫療中心進行了這項隨機對照3期臨床試驗。將≥40歲、0-IIA期乳腺癌患者在保乳術後（切緣≥2mm）隨機分組（1：1），一組接受50Gy全乳放療聯合10Gy的局部加量，另一組接受用多導管近距離放療進行的部分乳腺加速放療（APBI）。區組大小為10，採用自動動態演算法，根據研究中心、腫瘤類型和絕經狀態進行分層隨機。這項試驗對患者或調查者非盲。主要研究終點是同側局部複發。在此，我們給出生活質量的5年結果（預設的次要終點）。在放療前（基線1）、放療後即刻（基線2）和隨訪期間完成生活質量問卷（歐洲癌症研究與治療組織QLQ-C30、乳腺癌模塊QLQ-BR23）。我們根據患者所接受的治療（作為治療人群）進行了數據分析。招募工作於2009年完成，仍在進行長期隨訪。該試驗在ClinicalTrials.gov網站註冊，編號為NCT00402519。

結果

2004年4月20日至2009年7月30日，633例患者接受了部分乳腺加速放療、551例進行了全乳放療。部分乳腺加速放療（APBI）組633例患者中334例（53％）有基線1生活質量問卷結果，全乳放療組551例中314例（57％）有基線1生活質量問卷結果，隨訪期間兩組問卷回答率相似。兩組整體健康狀況（範圍0-100）穩定：在基線1，部分乳腺加速放療（APBI）組平均分為65.5（標準差20.6）、全乳放療組64.6（19.6），p=0.37；5年時，部分乳腺加速放療（APBI）組為66.2（22.2）、全乳放療組66.0（21.8），p=0.94。發現兩組中唯一有一定顯著性差異的是乳房癥狀量表評分（相差10-20分）。在基線2（平均相差13.6，95％CI，9.7-17.5；p

解釋

與全乳放療相比，用多導管近距離放療進行部分乳腺加速放療（APBI）不會惡化生活質量。這一結果支持將部分乳腺加速放療（APBI）作為早期乳腺癌患者保乳術後的替代治療選擇。

《桓興醫訊》孫莉

Quality-of-life results for accelerated partial breastirradiation with interstitial brachytherapy versus whole-breast irradiation inearly breast cancer after breast-conserving surgery (GEC-ESTRO): 5-year resultsof a randomised, phase 3 trial

Background

Previous results from the GEC-ESTRO trial showed that accelerated partial breast irradiation (APBI) using multicatheter brachytherapy in the treatment of early breast cancer after breast-conserving surgery was non-inferior to whole-breast irradiation in terms of local control and overall survival. Here, we present 5-year results of patient-reported quality of life.

Methods

We did this randomised controlled phase 3 trial at 16 hospitals and medical centres in seven European countries. Patients aged 40 years or older with 0–IIA breast cancer were randomly assigned (1:1) after breast-conserving surgery (resection margins ≥2 mm) to receive either whole-breast irradiation of 50 Gy with a boost of 10 Gy or APBI using multicatheter brachytherapy. Randomisation was stratified by study centre, tumour type, and menopausal status, with a block size of ten and an automated dynamic algorithm. There was no masking of patients or investigators. The primary endpoint of the trial was ipsilateral local recurrence. Here, we present 5-year results of quality of life (a prespecified secondary endpoint). Quality-of-life questionnaires (European Organisation for Research and Treatment of Cancer QLQ-C30, breast cancer module QLQ-BR23) were completed before radiotherapy (baseline 1), immediately after radiotherapy (baseline 2), and during follow-up. We analysed the data according to treatment received (as-treated population). Recruitment was completed in 2009, and long-term follow-up is continuing. The trial is registered at ClinicalTrials.gov, number NCT00402519.

Findings

Between April 20, 2004, and July 30, 2009, 633 patients had accelerated partial breast irradiation and 551 patients had whole-breast irradiation. Quality-of-life questionnaires at baseline 1 were available for 334 (53%) of 663 patients in the APBI group and 314 (57%) of 551 patients in the whole-breast irradiation group; the response rate was similar during follow-up. Global health status (range 0–100) was stable in both groups: at baseline 1, APBI group mean score 65·5 (SD 20·6) versus whole-breast irradiation group 64·6 (19·6), p=0·37; at 5 years, APBI group 66·2 (22·2) versus whole-breast irradiation group 66·0 (21·8), p=0·94. The only moderate, significant difference (difference of 10–20 points) between the groups was found in the breast symptoms scale. Breast symptom scores were significantly higher (ie, worse) after whole-breast irradiation than after APBI at baseline 2 (difference of means 13·6, 95% CI 9·7–17·5; p

Interpretation

APBI with multicatheter brachytherapy was not associated with worse quality of life compared with whole-breast irradiation. This finding supports APBI as an alternative treatment option after breast-conserving surgery for patients with early breast cancer.

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