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绝经后乳腺癌患者芳香化酶抑制剂辅助治疗的持续时间
Duration of Adjuvant Aromatase-Inhibitor Therapy in Postmenopausal Breast Cancer


Michael Gnant ... 肿瘤 • 2021.07.29
NEJM 动画解读

激素受体阳性乳腺癌的治疗
相关阅读
• 寻找乳腺癌辅助内分泌治疗的最佳时长 • 早期乳腺癌高龄患者的辅助内分泌治疗 • 指导乳腺癌辅助治疗的临床和基因组风险

摘要


背景

对于绝经后激素受体阳性乳腺癌患者,芳香化酶抑制剂辅助治疗的最有效持续时间尚未明确。

 

方法

在此项前瞻性3期试验中,我们将已接受5年辅助内分泌治疗的绝经后激素受体阳性乳腺癌患者随机分组,两组分别再接受2年(2年组,共接受7年治疗)或再接受5年(5年组,共接受10年治疗)芳香化酶抑制剂阿那曲唑治疗。主要终点是无病生存率。主要分析包括随机分组后2年(即2年组治疗结束时)仍在参与试验且无复发的所有患者。次要终点包括总生存率、对侧乳腺癌、第二原发癌和临床骨折。

 

结果

在纳入试验的3,484例患者中,3,208例在完成随机分组后的2年阿那曲唑延长治疗后仍在参与试验且无疾病进展。在这些患者中,在8年时的主要分析集中,每组各有335例患者发生疾病进展或死亡(风险比,0.99;95%置信区间[CI],0.85~1.15;P=0.90)。所有次要终点均无组间差异,亚组分析也未显示任何亚组有差异。5年组的临床骨折风险高于2年组(风险比,1.35;95% CI,1.00~1.84)。

 

结论

在已接受5年辅助内分泌治疗的绝经后激素受体阳性乳腺癌患者中,将激素治疗延长5年并未产生超过延长2年的益处,且与较高的骨折风险相关(由阿斯利康及奥地利乳腺癌和结直肠癌研究组[Austrian Breast and Colorectal Cancer Study Group]资助,ABCSG-16/SALSA在ClinicalTrials.gov注册号为NCT00295620)。





作者信息

Michael Gnant, M.D., Florian Fitzal, M.D., Gabriel Rinnerthaler, M.D., Guenther G. Steger, M.D., Sigrun Greil-Ressler, M.D., Marija Balic, M.D., Dietmar Heck, M.D., Raimund Jakesz, M.D., Josef Thaler, M.D., Daniel Egle, M.D., Diether Manfreda, M.D., Vesna Bjelic-Radisic, M.D., Ursula Wieder, M.D., Christian F. Singer, M.D., Elisabeth Melbinger-Zeinitzer, M.D., Ferdinand Haslbauer, M.D., Paul Sevelda, M.D., Harald Trapl, M.D., Viktor Wette, M.D., Kerstin Wimmer, M.D., Simon P. Gampenrieder, M.D., Rupert Bartsch, M.D., Stephanie Kacerovsky-Strobl, M.D., Christoph Suppan, M.D., Christine Brunner, M.D., Christine Deutschmann, M.D., Lidija Soelkner, M.Sc., Christian Fesl, Ph.D., and Richard Greil, M.D. for the Austrian Breast and Colorectal Cancer Study Group*
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.). Address reprint requests to Dr. Gnant at the Comprehensive Cancer Center, Medical University of Vienna, Waehringer Guertel 18-20, A-1090 Vienna, Austria, or at michael.gnant@meduniwien.ac.at. *A full list of investigators in the Austrian Breast and Colorectal Cancer Study Group Trial 16 is provided in the Supplementary Appendix, available at NEJM.org.

 

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