Internal Mammary and Medial Supraclavicular Irradiation in Breast Cancer
Internal Mammary and Medial Supraclavicular Irradiation in Breast Cancer
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DOI：
10.1056/nejmoa1415369
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发表时间：
2015-07-23
影响因子：
158.5
通讯作者：
van den Bogaert, W.
中科院分区：
文献类型：
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作者：
Poortmans, P. M.;Collette, S.;van den Bogaert, W.
背景手术后，在全乳腺或胸壁照射的基础上，内乳和内侧锁骨上淋巴结照射（区域淋巴结照射）对早期乳腺癌女性生存的影响尚不清楚。方法我们将原发肿瘤位于中央或内侧的女性随机分配，无论是否累及腋窝，或肿瘤位于腋窝外部。 除了局部淋巴结照射（淋巴结照射组）或单独进行全乳房或胸壁照射（对照组）外，还接受全乳房或胸壁照射。主要终点是总生存期。次要终点是无病生存率、无远处疾病生存率和乳腺癌死亡率。 结果 1996 年至 2004 年间，共有 4004 名患者接受了随机分组。大多数患者（76.1%）接受了保乳手术。乳房切除术后，两组73.4%的患者接受了胸壁照射。几乎所有淋巴结阳性疾病患者 (99.0%) 和 66.3% 淋巴结阴性疾病患者接受了辅助全身治疗。中位随访时间为 10.9 年，有 811 名患者死亡。 10 年时，淋巴结照射组的总生存率为 82.3%，对照组为 80.7%（淋巴结照射死亡风险比，0.87；95% 置信区间 [CI]，0.76 至 1.00；P = 0.06）。淋巴结照射组的无病生存率为 72.1%，对照组为 69.1%（疾病进展或死亡的风险比为 0.89；95% CI，0.80 至 1.00；P = 0.04），远处无病生存率为 78.0% 与 75.0%（风险比为 0.86；95% CI， 0.76 至 0.98； 0.02），乳腺癌死亡率分别为 12.5% 和 14.4%（风险比，0.82；95% CI，0.70 至 0.97；P = 0.02）。区域淋巴结照射的急性副作用是适度的。结论在早期乳腺癌患者中，区域淋巴结照射对总生存期具有边际效应。无病生存率和远处无病生存率得到改善，乳腺癌死亡率降低。
BACKGROUNDThe effect of internal mammary and medial supraclavicular lymph-node irradiation (regional nodal irradiation) added to whole-breast or thoracic-wall irradiation after surgery on survival among women with early-stage breast cancer is unknown.METHODSWe randomly assigned women who had a centrally or medially located primary tumor, irrespective of axillary involvement, or an externally located tumor with axillary involvement to undergo either whole-breast or thoracic-wall irradiation in addition to regional nodal irradiation (nodal-irradiation group) or whole-breast or thoracic-wall irradiation alone (control group). The primary end point was overall survival. Secondary end points were the rates of disease-free survival, survival free from distant disease, and death from breast cancer.RESULTSBetween 1996 and 2004, a total of 4004 patients underwent randomization. The majority of patients (76.1%) underwent breast-conserving surgery. After mastectomy, 73.4% of the patients in both groups underwent chest-wall irradiation. Nearly all patients with node-positive disease (99.0%) and 66.3% of patients with node-negative disease received adjuvant systemic treatment. At a median follow-up of 10.9 years, 811 patients had died. At 10 years, overall survival was 82.3% in the nodal-irradiation group and 80.7% in the control group (hazard ratio for death with nodal irradiation, 0.87; 95% confidence interval [CI], 0.76 to 1.00; P = 0.06). The rate of disease-free survival was 72.1% in the nodal-irradiation group and 69.1% in the control group (hazard ratio for disease progression or death, 0.89; 95% CI, 0.80 to 1.00; P = 0.04), the rate of distant disease-free survival was 78.0% versus 75.0% (hazard ratio, 0.86; 95% CI, 0.76 to 0.98; P = 0.02), and breast-cancer mortality was 12.5% versus 14.4% (hazard ratio, 0.82; 95% CI, 0.70 to 0.97; P = 0.02). Acute side effects of regional nodal irradiation were modest.CONCLUSIONSIn patients with early-stage breast cancer, irradiation of the regional nodes had a marginal effect on overall survival. Disease-free survival and distant disease-free survival were improved, and breast-cancer mortality was reduced.