Julien J P, Bijker N, Fentiman I S, Peterse J L, Delledonne V, Rouanet P, Avril A, Sylvester R, Mignolet F, Bartelink H, Van Dongen J A
Department of Surgery, Centre Henri Becquerel, Rouen, France.
Lancet. 2000 Feb 12;355(9203):528-33. doi: 10.1016/s0140-6736(99)06341-2.
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.
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.
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 4-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.
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.
乳腺导管原位癌(DCIS)是一种日益常见的疾病,因为它可能表现为微钙化,可通过乳腺钼靶筛查检测到。鉴于部分浸润性癌女性患者可通过保乳治疗安全治愈,而全乳切除术却仍是DCIS的标准治疗方法,这显得自相矛盾。我们开展了一项III期随机临床试验,以研究DCIS完整局部切除术后放疗的作用。
1986年至1996年间,对临床或乳腺钼靶检查发现的DCIS病灶直径小于或等于5 cm的女性患者,先对病灶进行完整局部切除,然后随机分为不再接受进一步治疗组(n = 503)或放疗组(n = 507;全乳5周内给予50 Gy放疗)。中位随访时间为4.25年(最长12.0年)。所有分析均采用意向性分析。
不再接受进一步治疗组有500例患者接受随访,放疗组有502例。不再接受进一步治疗组有83例女性出现局部复发(44例DCIS复发,40例浸润性乳腺癌)。放疗组有53例女性出现局部复发(29例DCIS复发,24例浸润性乳腺癌)。单纯局部切除组4年局部无复发生存率为84%,局部切除加放疗组为91%(对数秩检验p = 0.005;风险比0.62)。浸润性(40%,p = 0.04)和非浸润性(35%,p = 0.06)局部复发风险也有类似程度降低。
与单纯局部切除相比,DCIS局部切除术后放疗在中位随访4.25年时,降低了同侧乳腺浸润性和非浸润性复发的总数。