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桓兴医讯 早期乳腺癌保乳术后用组织间短距离放疗进行部分乳腺加
文章来源:北京市朝阳区桓兴肿瘤医院 点击数: 发布时间:2018-05-11 08:40
《柳叶刀肿瘤分册》2018年4月22日在线先发
早期乳腺癌保乳术后用组织间短距离放疗进行部分乳腺加量放疗对比全乳放疗的生活质量分析(GEC-ESTRO):一项随机3期试验的5年结果
背景
GEC-ESTRO试验的既往结果显示,在早期乳腺癌保乳术后的治疗中,就局部控制和总生存而言,使用多导管近距离放疗进行部分乳腺加量放疗(APBI)并不劣于全乳放疗。在此,我们提供了患者报告的生活质量的5年结果。
方法
我们在7个欧洲国家的16家医院和医疗中心进行了这项随机对照3期临床试验。将≥40岁、0-IIA期乳腺癌患者在保乳术后(切缘≥2mm)随机分组(1:1),一组接受50Gy全乳放疗联合10Gy的局部加量,另一组接受用多导管近距离放疗进行的部分乳腺加量放疗(APBI)。区组大小为10,采用自动动态算法,根据研究中心、肿瘤类型和绝经状态进行分层随机。这项试验对患者或调查者非盲。主要研究终点是同侧局部复发。在此,我们给出生活质量的5年结果(预设的次要终点)。在放疗前(基线1)、放疗后即刻(基线2)和随访期间完成生活质量问卷(欧洲癌症研究与治疗组织QLQ-C30、乳腺癌模块QLQ-BR23)。我们根据患者所接受的治疗(作为治疗人群)进行了数据分析。招募工作于2009年完成,仍在进行长期随访。该试验在ClinicalTrials.gov网站注册,编号为NCT00402519。
结果
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量放疗、551例进行了全乳放疗。部分乳腺加量放疗(APBI)组633例患者中334例(53%)有基线1生活质量问卷结果,全乳放疗组551例中314例(57%)有基线1生活质量问卷结果,随访期间两组问卷回答率相似。两组整体健康状况(范围0-100)稳定:在基线1,部分乳腺加量放疗(APBI)组平均分为65.5(标准差20.6)、全乳放疗组64.6(19.6),p=0.37;5年时,部分乳腺加量放疗(APBI)组为66.2(22.2)、全乳放疗组66.0(21.8),p=0.94。发现两组中唯一有一定显著性差异的是乳房症状量表评分(相差10-20分)。在基线2(平均相差13.6,95%CI,9.7-17.5;p<0.0001)、随访3个月时(平均相差12.7,95%CI,9.8-15.6;p<0.0001),全乳放疗后乳房症状评分明显高于(更差于)部分乳腺加量放疗(APBI)组。
解释
与全乳放疗相比,用多导管近距离放疗进行部分乳腺加量放疗(APBI)不会恶化生活质量。这一结果支持将部分乳腺加量放疗(APBI)作为早期乳腺癌患者保乳术后的替代治疗选择。
北京市朝阳区桓兴肿瘤医院 桓兴医讯编译组 孙莉
2018年5月11日 星期五
Quality-of-life results for accelerated partial breast irradiation with interstitial brachytherapy versus whole-breast irradiation in early breast cancer after breast-conserving surgery (GEC-ESTRO): 5-year results of 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<0·0001) and at 3-month follow-up (difference of means 12·7, 95% CI 9·8–15·6; p<0·0001).
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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