由欧洲癌症治疗与研究组织 EORTC（European Organisation for Research and Treatment of Cancer）资助的一项临床研究EORTC10801实验旨在比较实行改良根治术（MRM）和保乳治疗（BCT）两种不同治疗方式的乳腺癌患者（患者癌肿直径小于等于5cm,无论腋窝淋巴结阴性或阳性）的长期生存时间。研究者根据20年的随访结果发现：与保乳治疗（BCT）相比，改良根治术（MRM）虽然在局部肿瘤病变控制方面更优于前者，但总生存率、远处转移所需时间二者没有差异。
EORTC10801实验始于1980年-1986年，在英国、荷兰、比利时和南非的八个试验中心开展。采用随机分组的方法将患者分为两组，448例进入BCT组、420例进入MRM组。分层因素包括研究中心，肿瘤分期（I或II），绝经状态。
研究中位随访时间22.1年（IQR为18.5-23.8），远处转移发生情况为：MRM组175例（42％），BCT组207例（46％）。此外，死亡的情况为：506例（58％），其中，MRM组232例（55％），BCT组274例（61％）。远处转移时间BCT组和MRM组之间无显著差异，危险比（1.13，95％CI:0.92-1.38，P= 0.23），死亡时间亦无差异（1.11，0.94-1.33;0.23）。20年远处转移的累积发生率的情况为：MRM组为42.6％（95％CI:37.8-46.5），BCT组46.9％（42.2-51.6）。20年总生存率的情况为：MRM组44.5％（95％CI:39.3-49.5），BCT组39.1%（34.4-43.9）。不同年龄的远处转移时间和总生存率没有差异（远处转移时间：<50岁1.09[95％CI:0.79-1.51] ； ≥50岁1.16[0 .90-1.50];总生存率：<50岁1.17[0.86-1.59] ； ≥50岁1.10[0.89-1.37]）。
这项研究为保乳治疗，包括放射治疗，作为早期乳腺癌患者的标准治疗提供了进一步的支持，因为经过长期随访，BCT和MRM的生存率是类似的。
（转载自丁香园）
附：英文摘要原文
Breast conserving therapy versus mastectomy for stage I—II breast cancer:
20 year follow-up of the EORTC 10801 phase 3 randomised trial
Saskia Litière PhD a, Gustavo Werutsky MD a, Ian S Fentiman MD b, Prof Emiel Rutgers MD c, Prof Marie-Rose Christiaens MD d, Prof Erik Van Limbergen MD d, Margreet HA Baaijens MD e, Jan Bogaerts PhD a, Prof Harry Bartelink MD c
Summary
Background
The EORTC 10801 trial compared breast-conserving therapy (BCT) with modified radical mastectomy (MRM) in patients with tumours 5 cm or smaller and axillary node negative or positive disease. Compared with BCT, MRM resulted in better local control, but did not affect overall survival or time to distant metastases. We report 20-year follow-up results.
Methods
The EORTC 10801 trial was open for accrual between 1980 and 1986 in eight centres in the UK, the Netherlands, Belgium, and South Africa. 448 patients were randomised to BCT and 420 to MRM. Randomisation was done centrally, stratifying patients by institute, carcinoma stage (I or II), and menopausal status. BCT comprised of lumpectomy and complete axillary clearance, followed by breast radiotherapy and a tumour-bed boost. The primary endpoint was time to distant metastasis. This analysis was done on all eligible patients, as they were randomised.
Findings
After a median follow-up of 22·1 years (IQR 18·5—23·8), 175 patients (42%) had distant metastases in the MRM group versus 207 (46%) in the BCT group. Furthermore, 506 patients (58%) died (232 [55%] in the MRM group and 274 [61%] in the BCT group). No significant difference was observed between BCT and MRM for time to distant metastases (hazard ratio 1·13, 95% CI 0·92—1·38; p=0·23) or for time to death (1·11, 0·94—1·33; 0·23). Cumulative incidence of distant metastases at 20 years was 42·6% (95% CI 37·8—47·5) in the MRM group and 46·9% (42·2—51·6) in the BCT group. 20-year overall survival was estimated to be 44·5% (95% CI 39·3—49·5) in the MRM group and 39·1% (34·4—43·9) in the BCT group. There was no difference between the groups in time to distant metastases or overall survival by age (time to distant metastases: <50 years 1·09 [95% CI 0·79—1·51] vs ≥50 years 1·16 [0·90—1·50]; overall survival <50 years 1·17 [0·86—1·59] vs ≥50 years 1·10 [0·89—1·37]).
Interpretation
BCT, including radiotherapy, offered as standard care to patients with early breast cancer seems to be justified, since long-term follow-up in this trial showed similar survival to that after mastectomy.
Funding
European Organisation for Research and Treatment of Cancer (EORTC).
（The Lancet Oncology, EarlyOnline Publication, 27 February 2012；doi:10.1016/S1470-2045(12)70042-6）
