保乳治疗与乳房切除术治疗 I 期- II 期乳腺癌的比较：EORTC 10801 期随机试验 20 年随访结果。
Breast conserving therapy versus mastectomy for stage I-II breast cancer: 20 year follow-up of the EORTC 10801 phase 3 randomised trial.
机构信息
European Organisation for Research and Treatment of Cancer, Brussels, Belgium.
出版信息
Lancet Oncol. 2012 Apr;13(4):412-9. doi: 10.1016/S1470-2045(12)70042-6. Epub 2012 Feb 27.
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).
背景
EORTC10801 试验比较了肿瘤直径 5cm 或更小且腋窝淋巴结阴性或阳性的患者中保乳治疗（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，但对总生存或远处转移时间没有影响。我们报告了 20 年的随访结果。
方法
EORTC10801 试验于 1980 年至 1986 年在英国、荷兰、比利时和南非的 8 个中心开放入组。448 例患者被随机分配至 BCT 组，420 例患者被随机分配至 MRM 组。随机分组在中央进行，按研究所、癌分期（I 期或 II 期）和绝经状态分层患者。BCT 包括乳房肿块切除术和完全腋窝清扫术，随后进行乳房放疗和肿瘤床加量。主要终点是远处转移时间。这一分析是在所有符合条件的患者中进行的，因为他们是随机分组的。
结果
中位随访 22.1 年（IQR 18.5-23.8）后，MRM 组 175 例（42%）患者发生远处转移，BCT 组 207 例（46%）患者发生远处转移。此外，506 例（58%）患者死亡（MRM 组 232 例[55%]，BCT 组 274 例[61%]）。BCT 与 MRM 相比，远处转移时间（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）均无显著差异。MRM 组 20 年远处转移累积发生率为 42.6%（95%CI 37.8-47.5），BCT 组为 46.9%（42.2-51.6）。MRM 组 20 年总生存率估计为 44.5%（95%CI 39.3-49.5），BCT 组为 39.1%（34.4-43.9）。两组间年龄对远处转移时间或总生存时间均无差异（远处转移时间：<50 岁 1.09[95%CI 0.79-1.51] vs ≥50 岁 1.16[0.90-1.50]；总生存时间 <50 岁 1.17[0.86-1.59] vs ≥50 岁 1.10[0.89-1.37]）。
解释
BCT，包括放疗，作为早期乳腺癌的标准治疗方法似乎是合理的，因为该试验的长期随访显示与乳房切除术相似的生存。
资金
欧洲癌症研究与治疗组织（EORTC）。
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