Breast conserving therapy versus mastectomy for stage I-II breast cancer: 20 year follow-up of the EORTC 10801 phase 3 randomised trial
Breast conserving therapy versus mastectomy for stage I-II breast cancer: 20 year follow-up of the EORTC 10801 phase 3 randomised trial
复制标题
DOI：
10.1016/s1470-2045(12)70042-6
复制
发表时间：
2012-04-01
期刊：
影响因子：
51.1
通讯作者：
Bartelink, Harry
中科院分区：
文献类型：
--
作者：
Litiere, Saskia;Werutsky, Gustavo;Bartelink, Harry
EORTC 10801试验比较了肿瘤小于或等于5 cm且腋窝淋巴结阴性或阳性的患者的保乳治疗（BCT）与改良根治性乳房切除术（MRM）。与BCT相比，MRM导致更好的局部控制，但不影响总生存率或远处转移时间。我们报告20年的随访结果。方法EORTC 10801试验是开放的1980年和1986年之间在英国，荷兰，比利时和南非的8个中心的权责发生制。448例患者随机接受BCT，420例患者随机接受MRM。随机化集中进行，按研究所、癌症分期（I或II）和绝经状态对患者进行分层。BCT包括肿块切除术和腋窝完全清除，然后是乳房放疗和肿瘤床提升。主要终点是至远处转移的时间。这项分析是对所有符合条件的患者，因为他们是随机的。1年（IQR 18 . 5-23 . 8），MRM组有175例患者（42%）发生远处转移，BCT组有207例（46%）。此外，506例患者（58%）死亡（MRM组232例[55%]，BCT组274例[61%]）。在远处转移的时间方面，BCT和MRM之间没有观察到显著差异（风险比1。13，95% CI 0。92-1 . 38; p=0。23)或死亡时间（1。11，0。94-1 . 33; 0 . 23）。20年时远处转移的累积发生率为42。6%（95%CI 37 . 8-47 . 5)在MRM组和46 . 9%（42 . 2-51 . 6)在BCT组。20-总生存期估计为44年。5%（95% CI 39 . 3-49 . 5)在MRM组和39 .百分之三十四。4-43 . 9)在BCT组。两组之间在至远处转移的时间或总生存率方面没有年龄差异（至远处转移的时间：
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: