Emdin Stefan O, Granstrand Bengt, Ringberg Anita, Sandelin Kerstin, Arnesson Lars-Gunnar, Nordgren Hans, Anderson Harald, Garmo Hans, Holmberg Lars, Wallgren Arne
Department of Surgery, Umeå University Hospital, Umeå, Sweden.
Acta Oncol. 2006;45(5):536-43. doi: 10.1080/02841860600681569.
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 1,046 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.
我们研究了乳腺区段切除术后放疗（RT）对原位导管癌（DCIS）的影响。研究方案规定进行根治性手术，但显微镜下切缘阴性并非必需。1987年至1999年间，我们将1046名接受手术的女性随机分为术后放疗组或对照组。主要终点是同侧局部复发。次要终点是对侧乳腺癌、远处转移和死亡。中位随访5.2年（范围0.1 - 13.8年）后，放疗组有44例复发，累积发病率为0.07（95%置信区间（CI）0.05 - 0.10）。对照组有117例复发，累积发病率为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%的患者显微镜下切缘情况不明或切缘阳性。我们没有发现放疗对浸润性或原位复发相对风险有不同影响的证据。次要终点无差异。在基于人群的乳腺筛查钼靶检查条件下接受DCIS区段切除的女性从术后乳腺放疗中获益。7名患者需要接受放疗以预防1例复发。
