绝经后乳腺癌辅助芳香化酶抑制剂治疗的持续时间。
Duration of Adjuvant Aromatase-Inhibitor Therapy in Postmenopausal Breast Cancer.
机构信息
From the Comprehensive Cancer Center (M.G., C.F.S., C.D., F.F., K.W., S.K.-S.), the Department of General Surgery (F.F., K.W., S.K.-S.), the Department of Internal Medicine I, Division of Oncology (G.G.S., R.B.), and the Department of Obstetrics and Gynecology (C.F.S., C.D.), Medical University of Vienna, Austrian Breast and Colorectal Cancer Study Group (M.G., R.J., L.S., C.F.), Breast Care Center, Hanusch Hospital (U.W.), the Department of Gynecology, Hospital Hietzing, and Karl Landsteiner Institute for Gynecological Oncology and Senology (P.S.), Vienna, the Department of Internal Medicine III and Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, Paracelsus Medical University Salzburg, Salzburg (G.R., S.G.-R., S.P.G., R.G.), the Departments of Oncology (M.B., C.S.) and Gynecology (V.B.-R.), Medical University Graz, Graz, the Department of Surgery, Ordensklinikum Linz, Linz (D.H.), the Department of Internal Medicine IV, Klinikum Wels-Grieskirchen, Wels (J.T.), the Department of Gynecology, Medical University Innsbruck, Innsbruck (D.E., C.B.), Doctor's Office Manfreda, Klagenfurt (D.M.), the Department of Surgery, Hospital Wolfsberg, Wolfsberg (E.M.-Z.), the Department of Internal Medicine, Hospital Vöcklabruck, Vöcklabruck (F.H.), the Department of Surgery, General Hospital Baden, Baden (H.T.), and the Breast Center, Doctor's Office Wette, Sankt Veit an der Glan (V.W.) - all in Austria; and the Breast Unit, University Hospital Helios, University Witten Herdecke, Wuppertal, Germany (V.B.-R.).
出版信息
N Engl J Med. 2021 Jul 29;385(5):395-405. doi: 10.1056/NEJMoa2104162.
BACKGROUND
For postmenopausal women with hormone-receptor-positive breast cancer, the most effective duration for adjuvant therapy with an aromatase inhibitor remains unclear.
METHODS
In this prospective, phase 3 trial, we randomly assigned postmenopausal women with hormone-receptor-positive breast cancer who had received 5 years of adjuvant endocrine therapy to receive the aromatase inhibitor anastrozole for an additional 2 years (2-year group, receiving a total of 7 years) or an additional 5 years (5-year group, receiving a total of 10 years). The primary end point was disease-free survival. The primary analysis included all the patients who were still participating in the trial and who had no recurrence 2 years after randomization (i.e., when treatment in the 2-year group had ended). Secondary end points were overall survival, contralateral breast cancer, second primary cancer, and clinical bone fracture.
RESULTS
Among the 3484 women who were enrolled in the trial, 3208 remained in the trial without disease progression after the first 2 years of extended anastrozole treatment following randomization. Among these women, disease progression or death occurred in 335 women in each treatment group in the primary-analysis set at 8 years (hazard ratio, 0.99; 95% confidence interval [CI], 0.85 to 1.15; P = 0.90). No between-group differences occurred in most secondary end points, and subgroup analyses did not indicate differences in any particular subgroup. The risk of clinical bone fracture was higher in the 5-year group than in the 2-year group (hazard ratio, 1.35; 95% CI, 1.00 to 1.84).
CONCLUSIONS
In postmenopausal women with hormone-receptor-positive breast cancer who had received 5 years of adjuvant endocrine therapy, extending hormone therapy by 5 years provided no benefit over a 2-year extension but was associated with a greater risk of bone fracture. (Funded by AstraZeneca and the Austrian Breast and Colorectal Cancer Study Group; ABCSG-16/SALSA ClinicalTrials.gov number, NCT00295620.).
背景
对于激素受体阳性乳腺癌的绝经后妇女，辅助治疗中使用芳香化酶抑制剂的最有效持续时间仍不清楚。
方法
在这项前瞻性、III 期临床试验中，我们将接受过 5 年辅助内分泌治疗的激素受体阳性乳腺癌绝经后妇女随机分为接受芳香化酶抑制剂阿那曲唑治疗 2 年（2 年组，共 7 年）或 5 年（5 年组，共 10 年）的两组。主要终点为无病生存期。主要分析纳入了仍在试验中且随机分组后 2 年内无复发的所有患者（即 2 年组治疗结束时）。次要终点为总生存期、对侧乳腺癌、第二原发癌和临床骨折。
结果
在 3484 名入组试验的患者中，3208 名在接受随机分组后延长阿那曲唑治疗的前 2 年后仍在试验中且无疾病进展。在这些女性中，在主要分析集的 8 年时，每个治疗组中有 335 名患者发生疾病进展或死亡（风险比，0.99；95%置信区间[CI]，0.85 至 1.15；P=0.90）。大多数次要终点在两组之间没有差异，亚组分析也没有表明任何特定亚组存在差异。5 年组的临床骨折风险高于 2 年组（风险比，1.35；95%CI，1.00 至 1.84）。
结论
在接受过 5 年辅助内分泌治疗的激素受体阳性乳腺癌绝经后妇女中，将激素治疗延长 5 年并不优于 2 年的延长，但与更高的骨折风险相关。（由 AstraZeneca 和奥地利乳腺癌和结直肠癌研究组资助；ABC SG-16/SALSA ClinicalTrials.gov 编号，NCT00295620。）
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