Whole-breast irradiation with or without a boost for patients treated with breast-conserving surgery for early breast cancer: 20-year follow-up of a randomised phase 3 trial
Whole-breast irradiation with or without a boost for patients treated with breast-conserving surgery for early breast cancer: 20-year follow-up of a randomised phase 3 trial
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DOI：
10.1016/s1470-2045(14)71156-8
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发表时间：
2015-01-01
期刊：
影响因子：
51.1
通讯作者：
Collette, Laurence
中科院分区：
文献类型：
--
作者：
Bartelink, Harry;Maingon, Philippe;Collette, Laurence
背景：自从乳腺癌保乳治疗开始，乳房肿瘤切除术后的放射剂量就有了不同的应用。在一项3期随机对照试验中，我们研究了接受保乳治疗的I期和II期乳腺癌患者与未接受加强治疗的患者相比，16戈伊的放射加强治疗对总生存率、局部控制和纤维化的影响。在这里，我们提出了20年的随访结果。方法显微镜下完全切除的浸润性疾病，然后在5周内全乳房照射50戈伊的患者进行了集中随机（1：1）与最小化算法，以接受16戈伊加强或不加强，与最小化的年龄，绝经状态，存在广泛的导管原位癌，临床肿瘤大小，淋巴结状态，和机构。患者和研究者均未对治疗分配设盲。主要终点是意向治疗人群的总生存期。该试验注册于ClinicalTrials.gov，编号NCT 02295033。结果在1989年5月24日至1996年6月25日期间，2657名患者被随机分配接受无放射增强，2661名患者被随机分配接受放射增强。中位随访时间为17.2年（IQR 13.0-19.0）。20-加强组的1年总生存率为59.7%（99%CI 56.3-63.0），而未加强组为61.1%（57.6-64.3），风险比（HR）为1.05（99%CI 0.92-1.19，p=0.323）。同侧乳腺肿瘤复发是首次治疗失败，未加强组有354例患者（13%），加强组有237例患者（9%），HR 0.65（99%CI 0.52-0.81，p
Background Since the introduction of breast-conserving treatment, various radiation doses after lumpectomy have been used. In a phase 3 randomised controlled trial, we investigated the effect of a radiation boost of 16 Gy on overall survival, local control, and fibrosis for patients with stage I and II breast cancer who underwent breast-conserving treatment compared with patients who received no boost. Here, we present the 20-year follow-up results.Methods Patients with microscopically complete excision for invasive disease followed by whole-breast irradiation of 50 Gy in 5 weeks were centrally randomised (1:1) with a minimisation algorithm to receive 16 Gy boost or no boost, with minimisation for age, menopausal status, presence of extensive ductal carcinoma in situ, clinical tumour size, nodal status, and institution. Neither patients nor investigators were masked to treatment allocation. The primary endpoint was overall survival in the intention-to-treat population. The trial is registered with ClinicalTrials.gov, number NCT02295033.Findings Between May 24, 1989, and June 25, 1996, 2657 patients were randomly assigned to receive no radiation boost and 2661 patients randomly assigned to receive a radiation boost. Median follow-up was 17.2 years (IQR 13.0-19.0). 20-year overall survival was 59.7% (99% CI 56.3-63.0) in the boost group versus 61.1% (57.6-64.3) in the no boost group, hazard ratio (HR) 1.05 (99% CI 0.92-1.19, p=0.323). Ipsilateral breast tumour recurrence was the first treatment failure for 354 patients (13%) in the no boost group versus 237 patients (9%) in the boost group, HR 0.65 (99% CI 0.52-0.81, p