Radiotherapy in breast-conserving treatment for ductal carcinoma in situ: first results of the EORTC randomised phase III trial 10853
Radiotherapy in breast-conserving treatment for ductal carcinoma in situ: first results of the EORTC randomised phase III trial 10853
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DOI：
10.1016/s0140-6736(99)06341-2
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发表时间：
2000-02-12
期刊：
影响因子：
168.9
通讯作者：
Van Dongen, JA
中科院分区：
文献类型：
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作者：
Julien, JP;Bijker, N;Van Dongen, JA
背景乳腺导管原位癌（DCIS）是一种越来越常见的疾病，因为它可能表现为微钙化，可以通过筛查乳腺X线摄影检测到。既然选择性的浸润性乳腺癌患者可以通过保乳治疗安全地进行治疗，那么全乳切除术仍然是DCIS的标准治疗方法是矛盾的。方法1986年至1996年，对503例经临床或钼靶X线检查发现直径小于或等于5cm的乳腺导管原位癌患者进行局部完全切除治疗，然后随机分为两组，一组不接受进一步治疗，另一组接受放射治疗（n=507; 5周内全乳50戈伊）。中位随访时间为4.25年（最长12.0年）。所有的分析都是通过意向治疗。结果500例患者在没有进一步的治疗组和502在放疗组进行了随访。在没有进一步治疗的组中，83名妇女局部复发（44名DCIS复发，40名浸润性乳腺癌）。放疗组53例局部复发（DCIS复发29例，浸润性乳腺癌复发24例）。单纯局部切除治疗组的局部无复发率为84%，而局部切除加放疗组为91%（对数秩检验p=0.005;风险比0.62）。类似的降低风险的侵入性（40%，p=0.04）和非侵入性（35%，p=0.06）局部复发seeed.Conclusions放射治疗后局部切除DCIS，与局部切除相比，单独，减少了整体数量的侵入性和非侵入性复发的同侧乳房中位随访时间为4.25年。
Background Ductal carcinoma in situ (DCIS) of the breast is a disorder that has become more common since it may manifest as microcalcifications that can be detected by screening mammography. Since selected women with invasive cancer can be treated safely with breast-conservation therapy it is paradoxical that total mastectomy has remained the standard treatment for DCIS. We did a randomised phase III clinical trial to investigate the role of radiotherapy after complete local excision of DCIS.Methods Between 1986 and 1996, women with clinically or mammographically detected DCIS measuring less than or equal to 5 cm were treated by complete local excision of the lesion and then randomly assigned to either no further treatment (n=503) or to radiotherapy (n=507; 50 Gy in 5 weeks to the whole breast). The median duration of follow-up was 4.25 years (maximum 12.0 years). All analyses were by intention to treat.Findings 500 patients were followed up in the no further treatment group and 502 in the radiotherapy group. In the no further treatment group 83 women had local recurrence (44 recurrences of DCIS, and 40 invasive breast cancer). In the radiotherapy group 53 women had local recurrences (29 recurrences of DCIS, and 24 invasive breast cancer). The or year local relapse-free was 84% in the group treated with local excision alone compared with 91% in the women treated by local excision plus radiotherapy (log rank p=0.005; hazard ratio 0.62). Similar reductions in the risk of invasive (40%, p=0.04) and non-invasive (35%, p=0.06) local recurrence were seen.Conclusions Radiotherapy after local excision for DCIS, as compared with local excision alone, reduced the overall number of both invasive and non-invasive recurrences in the ipsilateral breast at a median follow-up of 4.25 years.