SweDCIS: Radiotherapy after sector resection for ductal carcinoma in situ of the breast. Results of a randomised trial in a population offered mammography screening

SweDCIS: Radiotherapy after sector resection for ductal carcinoma in situ of the breast. Results of a randomised trial in a population offered mammography screening
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DOI:
10.1080/02841860600681569
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发表时间:
2006-07-01
期刊:
影响因子:
3.1
通讯作者:
Wallgren, Arne
Wallgren, Arne
中科院分区:
医学3区
文献类型:
--
作者:
Emdin, Stefan O.;Granstrand, Bengt;Wallgren, Arne

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我们研究了乳腺导管原位癌(DCIS)扇形切除术后的术后放射治疗(RT)的效果。研究方案规定根治性手术,但不强制要求显微镜下清晰的边缘。我们在1987年至1999年期间将1046名手术妇女随机分配到术后RT组或对照组。主要终点为同侧局部复发。次要终点为对侧乳腺癌、远处转移和死亡。中位随访5.2年(范围0.1-13.8)后,RT组有44例复发,对应的累积发生率为0.07(95%置信区间(CI)0.05-0.10)。对照组中有117例复发,累积发生率为0.22(95% CI 0.18-0.26),总体风险比为0.33(95% CI 0.24-0.47,p < 0.0001)。22%的患者有显微镜下未知或累及的切缘。我们没有发现RT对浸润性或原位复发的相对风险有不同影响的证据。次要终点无差异。在基于人群的筛查性乳腺X线摄影条件下接受DCIS扇形切除术的女性受益于术后乳房RT。7例患者需要RT治疗以防止1例复发。
We studied the effect of postoperative radiotherapy (RT) after breast sector resection for ductal carcinoma in situ (DCIS). The study protocol stipulated radical surgery but microscopically clear margins were not mandatory. We randomised 1046 operated women to postoperative RT or control between 1987 and 1999. The primary endpoint was ipsilateral local recurrence. Secondary endpoints were contralateral breast cancer, distant metastasis and death. After a median follow-up of 5.2 years (range 0.1-13.8) there were 44 recurrences in the RT group corresponding to a cumulative incidence of 0.07 (95% confidence interval (CI) 0.05-0.10). In the control group there were 117 recurrences giving a cumulative incidence of 0.22 (95% CI 0.18-0.26) giving an overall hazard ratio of 0.33 (95% CI 0.24-0.47, p < 0.0001). Twenty two percent of the patients had microscopically unknown or involved margins. We found no evidence for different effects of RT on the relative risk of invasive or in situ recurrence. Secondary endpoints did not differ. Women undergoing sector resection for DCIS under conditions of population based screening mammography benefit from postoperative RT to the breast. Seven patients needed RT-treatment to prevent one recurrence.