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保乳术后全乳放疗已被证实对于乳腺浸润癌的短期局部控制非常有效，长期生存结局也较好。不过，对于极低风险乳腺癌患者，术后大分割外放疗、术中或组织间技术进行部分乳房放疗已被作为有效的替代方法。近15年来，尤其对于绝经后老年女性亚组，总共开展了五项随机对照临床研究，探讨全身内分泌治疗能否取代全乳放疗。最新的荟萃分析汇总了各项研究回顾数据，证实内分泌治疗与内分泌治疗＋全乳放疗相比，乳腺局部复发风险高6.8倍、死亡风险相似。2007年，奥地利乳腺结直肠癌研究协作组报告了8A研究初步结果，中位随访53.8个月，内分泌治疗与全乳放疗＋内分泌治疗相比，5年乳腺局部复发风险高10.21倍、5年总复发风险高3.48倍、死亡风险相似。 2020年1月18日，欧洲癌症治疗研究组织、欧洲癌症组织、欧洲乳腺癌专科医师学会《欧洲癌症杂志》在线发表奥地利乳腺结直肠癌研究协作组、帕拉塞尔苏斯医科大学萨尔茨堡医院、维也纳医科大学、维也纳新城医院、林茨姐妹慈善医院、格拉茨医科大学、帕拉塞尔苏斯医科大学、哈努施医院、米斯特尔巴赫医院、居辛医院、沃尔夫斯堡医院、卡尔兰德施泰纳医科大学圣珀尔滕医院、格兰河畔圣法伊特兄弟慈善医院、德国维滕海德克大学的奥地利乳腺结直肠癌研究协助组8A研究10年结果报告，对激素受体阳性早期乳腺癌保乳手术＋内分泌治疗±全乳放疗的长期结果进行了比较。 该多中心随机对照临床研究1996年1月～2004年6月入组激素受体阳性早期乳腺癌保乳术后内分泌治疗患者869例，按1∶1随机分为两组：全乳放疗组439例、观察组430例。全乳放疗剂量平均51±4戈瑞，按常规进行分割，肿瘤部位追加10±2戈瑞。 结果，中位随访时间9.89年，全乳放疗组与观察组相比：
根据多因素比例风险回归模型分析，乳腺局部复发的独立预测因素：
根据亚组分析，对于仅1枚前哨淋巴结阳性患者，全乳放疗组与观察组相比：
不过，对于腋窝淋巴结清扫患者，全乳放疗组与观察组相比：
因此，该研究结果表明，对于激素受体阳性早期乳腺癌保乳术后患者，中位随访10年后，全乳放疗＋内分泌治疗与单纯内分泌治疗相比，局部控制和无病生存较好、无远处转移生存和总生存相似。全乳放疗和肿瘤分级为无局部复发生存的独立预测因素。对于腋窝淋巴结清扫患者，全乳放疗＋内分泌治疗与单纯内分泌治疗相比，无病生存相似。如果考虑放疗降级，必须进一步评估肿瘤分级等生物学风险。 Eur J Cancer. 2020 Jan 18;127:12-20. Endocrine therapy with or without whole breast irradiation in low-risk breast cancer patients after breast-conserving surgery: 10-year results of the Austrian Breast and Colorectal Cancer Study Group 8A trial. Gerd Fastner, Felix Sedlmayer, Joachim Widder, Martina Metz, Hans Geinitz, Karin Kapp, Christian Fesl, Lidija Solkner, Richard Greil, Raimund Jakesz, Werner Kwasny, Dietmar Heck, Vesna Bjelic-Radisic, Marija Balic, Herbert Stoger, Ursula Wieder, Ronald Zwrtek, Dagmar Semmler, Wilfried Horvath, Elisabeth Melbinger-Zeinitzer, Martin Wiesholzer, Viktor Wette, Michael Gnant. Paracelsus Medical University, University Hospital Salzburg, Landeskrankenhaus, Salzburg, Austria; Medical University of Vienna, Vienna, Austria; Wiener Neustadt Hospital, Wiener Neustadt, Austria; Ordensklinikum Linz Barmherzige Schwestern, Linz, Austria; Medical University of Graz, Graz, Austria; Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria; Paracelsus Medical University, Salzburg, Austria; University Witten/Herdecke, Witten, Germany; Hanusch Spital, Vienna, Austria; Mistelbach Hospital, Mistelbach, Austria; Guessing Hospital, Guessing, Austria; Wolfsberg Hospital, Wolfsberg, Austria; University Hospital St. Poelten, Karl Landsteiner University of Health Sciences, St. Polten, Austria; Krankenhaus der Barmherzigen Brüder St Veit an der Glan, St. Veit an der Glan, Austria. HIGHLIGHTS
PURPOSE: To investigate long-term results of patients with hormonal receptor-positive breast cancer treated with breast-conserving surgery (BCS) and consecutive endocrine therapy (ET) with or without whole breast irradiation (WBI). METHODS AND MATERIALS: Within the 8 A trial of the Austrian Breast and Colorectal Cancer Study Group, a total of 869 patients received ET after BCS which was randomly followed by WBI (n=439, group 1) or observation (n=430, group 2). WBI was applied up to a mean total dosage of 50 Gy (+/- 10 Gy boost) in conventional fractionation. RESULTS: After a median follow-up of 9.89 years, 10 in-breast recurrences (IBRs) were observed in group 1 and 31 in group 2, resulting in a 10-year local recurrence-free survival (LRFS) of 97.5% and 92.4%, respectively (P=0.004). This translated into significantly higher rates for disease-free survival (DFS): 94.5% group 1 vs 88.4% group 2, P=0.0156. For distant metastases-free survival (DMFS) and overall survival (OS), respective 10-year rates amounted 96.7% and 86.6% for group 1 versus 96.4% and 87.6%, for group 2 (ns). WBI (hazard ratio [HR]: 0.27, P<0.01) and tumour grading (HR: 3.76, P=0.03) were found as significant predictors for IBR in multiple cox regression analysis. CONCLUSIONS: After a median follow-up of 10 years, WBI resulted in a better local control and DFS compared with ET alone. The omission of WBI and tumour grading, respectively, were the only negative predictors for LRFS. KEYWORDS: Early breast cancer, Low risk, Whole breast irradiation, Endocrine therapy DOI: 10.1016/j.ejca.2019.11.024
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