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2016年6月5日，美国麻省（马萨诸塞州）医学会官方期刊《新英格兰医学杂志》在线发表麻省总医院（马萨诸塞州综合医院）癌症中心、雅芳国际乳腺癌研究计划、哈佛医学院、达纳法伯癌症研究所、梅奥医院、美国肿瘤网弗吉尼亚癌症专家、北卡罗来纳大学莱恩伯格综合癌症中心、华盛顿大学医学院、科罗拉多癌症研究计划、约翰·霍普金斯大学金梅尔癌症中心、纪念斯隆·凯特琳癌症中心（纽约肿瘤医院）、亚利桑那大学、海兰兹肿瘤学组织、加拿大多伦多森尼布鲁克·奥黛特癌症中心、温哥华不列颠哥伦比亚癌症研究所、维多利亚女王大学、加拿大癌症组织、麦克马斯特大学、达尔豪斯大学蒙克顿医院、奥地利维也纳威尔海姆医院的MA.17R随机对照研究报告，发现激素受体阳性早期乳腺癌患者的激素疗法持续时间从5年延长至10年可降低乳腺癌复发风险及对侧乳腺癌风险。 该研究入组了1918例绝经女性，与安慰剂对照组（959例）相比，芳香酶抑制剂来曲唑组（959例）治疗5年延长至10年可降低34%的乳腺癌复发或对侧乳腺癌风险。中位随访6.3年，来曲唑组、安慰剂对照组乳腺癌复发或发生对侧乳腺癌分别为67例（7%）、98例（10.2%）。来曲唑组、安慰剂对照组的5年无病生存率分别为95%、91%（HR=0.66，P=0.01），5年总生存率分别为93%、94%（HR=0.97，P=0.83）。来曲唑组与安慰剂对照组相比，骨相关毒性作用发生率较高，包括骨痛、骨折和新发骨质疏松症。两组生活质量评分无显著差异。 因此，芳香酶抑制剂辅助治疗延长至10年与安慰剂相比，无病生存率显著提高，对侧乳腺癌发生率显著降低，但是总生存率未提高。 N Engl J Med. 2016 Jun 5. [Epub ahead of print] Extending Aromatase-Inhibitor Adjuvant Therapy to 10 Years. Goss PE, Ingle JN, Pritchard KI, Robert NJ, Muss H, Gralow J, Gelmon K, Whelan T, Strasser-Weippl K, Rubin S, Sturtz K, Wolff AC, Winer E, Hudis C, Stopeck A, Beck JT, Kaur JS, Whelan K, Tu D, Parulekar WR. Massachusetts General Hospital Cancer Center, Avon International Breast Cancer Research Program, Harvard Medical School, Dana-Farber Cancer Institute, Boston; Mayo Clinic, Rochester, MN; Sunnybrook Odette Cancer Centre, Toronto, British Columbia Cancer Agency, Vancouver, Canadian Cancer Trials Group, Queen's University, Kingston, ON; McMaster University, Hamilton, ON; Dalhousie University Faculty of Medicine, Moncton Hospital, Moncton, NB, Canada; Virginia Cancer Specialists-US Oncology Network, Fairfax; University of North Carolina-Lineberger Comprehensive Cancer Center, Chapel Hill; University of Washington School of Medicine, Seattle; Wilheminen Hospital, Vienna; Colorado Cancer Research Program, Denver; Johns Hopkins Kimmel Cancer Center, Baltimore; Memorial Sloan Kettering Cancer Center, New York; University of Arizona, Tucson; Highlands Oncology Group, Fayetteville, AR. BACKGROUND: Treatment with an aromatase inhibitor for 5 years as up-front monotherapy or after tamoxifen therapy is the treatment of choice for hormone-receptor-positive early breast cancer in postmenopausal women. Extending treatment with an aromatase inhibitor to 10 years may further reduce the risk of breast-cancer recurrence. METHODS: We conducted a double-blind, placebo-controlled trial to assess the effect of the extended use of letrozole for an additional 5 years. Our primary end point was disease-free survival. RESULTS: We enrolled 1918 women. After a median follow-up of 6.3 years, there were 165 events involving disease recurrence or the occurrence of contralateral breast cancer (67 with letrozole and 98 with placebo) and 200 deaths (100 in each group). The 5-year disease-free survival rate was 95% (95% confidence interval [CI], 93 to 96) with letrozole and 91% (95% CI; 89 to 93) with placebo (hazard ratio for disease recurrence or the occurrence of contralateral breast cancer, 0.66; P=0.01 by a two-sided log-rank test stratified according to nodal status, prior adjuvant chemotherapy, the interval from the last dose of aromatase-inhibitor therapy, and the duration of treatment with tamoxifen). The rate of 5-year overall survival was 93% (95% CI, 92 to 95) with letrozole and 94% (95% CI, 92 to 95) with placebo (hazard ratio, 0.97; P=0.83). The annual incidence rate of contralateral breast cancer in the letrozole group was 0.21% (95% CI, 0.10 to 0.32), and the rate in the placebo group was 0.49% (95% CI, 0.32 to 0.67) (hazard ratio, 0.42; P=0.007). Bone-related toxic effects occurred more frequently among patients receiving letrozole than among those receiving placebo, including a higher incidence of bone pain, bone fractures, and new-onset osteoporosis. No significant differences between letrozole and placebo were observed in scores on most subscales measuring quality of life. CONCLUSIONS: The extension of treatment with an adjuvant aromatase inhibitor to 10 years resulted in significantly higher rates of disease-free survival and a lower incidence of contralateral breast cancer than those with placebo, but the rate of overall survival was not higher with the aromatase inhibitor than with placebo. Funded: Canadian Cancer Society and others ClinicalTrials.gov number: NCT00754845 PMID: 27264120 DOI: 10.1056/NEJMoa1604700
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