From the Department of Radiation Oncology, Radboud University Medical Center, Nijmegen (P.M.P.), Department of Radiation Oncology, Institute Verbeeten, Tilburg (P.M.P., K.D.W.), Department of Radiation Oncology, Medisch Centrum Haaglanden, The Hague (H.S.), Department of Radiation Oncology, University Medical Center Utrecht, Utrecht (H.S., C.R.), Department of Radiation Oncology, Institute for Radiation Oncology Radiotherapeutisch Instituut Stedendriehoek en Omstreken, Deventer (E.V.), Department of Radiation Oncology, Academic Medical Center (G.T.), and Department of Radiation Oncology, the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital (H.B.), Amsterdam - all in the Netherlands; European Organization for Research and Treatment of Cancer (EORTC) Headquarters (S.C., L.C.) and Department of Radiation Oncology, University Hospital Saint-Luc, Université Catholique de Louvain (C.K.), Brussels, and Department of Radiation Oncology, University Hospital Gasthuisberg, Leuven (E.V.L., W.V.B.) - all in Belgium; Department of Radiation Oncology, Charité University Medicine Berlin, Berlin (V.B., S.M.), and Department of Radiation Oncology, University Hospital, Tübingen (N.W.) - both in Germany; Department of Radiation Oncology, Institut Curie, Paris (A.F.), Department of Radiation Oncology, Centre Georges-François Leclerc, Dijon (P.M., I.B.), Department of Radiation Oncology, Université François Rabelais, Tours (I.B.), and Department of Radiation Oncology, Gustave Roussy Cancer Center, Villejuif (H.M.) - all in France; Department of Radiation Oncology, Ospedale Regionale di Bellinzona e Valli, Bellinzona (M.V.), and Department of Radiation Oncology, University Hospital Zurich (C.G.) - both in Switzerland; Department of Radiation Oncology, Sant'Anna Hospital, Como, Italy (M.V., L.S.); Department of Radiation Oncology, Rambam Medical Center, Haifa, Israel (A.K.); and Grupo Oncológico Cooperativo Chileno de Investigación, Santiago, Chile (R.A.).
N Engl J Med. 2015 Jul 23;373(4):317-27. doi: 10.1056/NEJMoa1415369.
BACKGROUND: The 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. METHODS: We 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. RESULTS: Between 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. CONCLUSIONS: In 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. (Funded by Fonds Cancer; ClinicalTrials.gov number, NCT00002851.).
背景：对于早期乳腺癌患者，手术后继以胸壁和/或内乳及锁骨上区域淋巴结放疗（区域淋巴结放疗）与单纯胸壁和/或乳腺放疗相比，能否改善生存结局尚不清楚。
方法：我们将中央或内侧肿瘤（无论腋窝淋巴结状态如何）或外侧肿瘤伴腋窝淋巴结转移的患者随机分为两组，一组行胸壁和/或乳腺放疗+区域淋巴结放疗（淋巴结放疗组），另一组仅行胸壁和/或乳腺放疗（对照组）。主要终点为总生存。次要终点为无病生存、无远处转移生存和乳腺癌死亡。
结果：1996 年至 2004 年，共 4004 例患者被随机分组。大多数患者（76.1%）接受保乳手术，两组中均有 73.4%的乳房切除术患者接受了胸壁放疗。几乎所有淋巴结阳性（99.0%）和 66.3%淋巴结阴性患者均接受了辅助全身治疗。中位随访 10.9 年时，811 例患者死亡。10 年时，淋巴结放疗组总生存率为 82.3%，对照组为 80.7%（淋巴结放疗死亡风险比，0.87；95%置信区间，0.76 至 1.00；P=0.06）。淋巴结放疗组无病生存率为 72.1%，对照组为 69.1%（疾病进展或死亡风险比，0.89；95%置信区间，0.80 至 1.00；P=0.04），远处无病生存率为 78.0%和 75.0%（风险比，0.86；95%置信区间，0.76 至 0.98；P=0.02），乳腺癌死亡率为 12.5%和 14.4%（风险比，0.82；95%置信区间，0.70 至 0.97；P=0.02）。区域淋巴结放疗的急性不良反应较轻。
结论：对于早期乳腺癌患者，区域淋巴结放疗对总生存仅有轻微影响，但可改善无病生存和远处无病生存，并降低乳腺癌死亡风险。（由 Fonds Cancer 资助；ClinicalTrials.gov 注册号，NCT00002851）。
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