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桓兴医讯 淋巴结阴性、激素受体阳性的绝经前女性乳腺癌患者Ⅲ期
文章来源:北京市朝阳区桓兴肿瘤医院 点击数: 发布时间:2014-12-10 08:17
《柳叶刀肿瘤分册》2014年10月27日在线先发
淋巴结阴性、激素受体阳性的绝经前女性乳腺癌患者Ⅲ期比较他莫昔芬对比他莫昔芬加上卵巢功能抑制(E-3193,INT-0142):一项东部肿瘤协作组的试验
目的:
卵巢功能抑制(OFS)在总生存期上的效果和患者的报告结果已经在绝经前的女性随机分配到他莫昔芬加或不加卵巢功能抑制的Ⅱ期临床试验上证实。
病人和方法:
绝经前的女性、腋窝淋巴结阴性、激素受体阳性、肿瘤直径≤ 3 cm的乳腺癌患者随机分配到单独他莫昔芬组对比他莫昔加上OFS组;辅助化疗是不允许的。主要终点是无病生存(DFS)和总生存期(OS)。次要终点包括毒性和患者的报告结果。患者的报告结果数据包括生活健康相关质量,更年期症状和性功能。这些分别在基线、6个月、12个月和每年至登记后的5年进行评估。
结果:
总体而言,345名绝经前女性入组,171名在单独他莫昔芬组,174名在他莫昔芬加上OFS组。在中位随访的9.9年内,DFS(5年期利率:87.9%对89.7%;对数秩P =0.62)或者OS(5年期利率:95.2%V97.6%;对数秩P =0.67)没有显著的差异。3级以上的毒性在他莫昔芬加上OFS组(22.4%对12.3%,P =0.004)更为常见。他莫昔芬加上OFS组治疗的患者在3年的随访中有更多的更年期症状、低的性生活和低的生活健康相关质量(所有P <0.01)。在进一步的跟进中差异减少。 结论:加入他莫昔芬,OFS导致更多的更年期症状,性功能障碍,这些有助于自我报告劣质的生活相关质量。因为早期数据锁定,这项研究关于他莫昔芬加入OFS对于生存的影响的结论统计检力不足。
北京桓兴肿瘤医院 桓兴医讯编译组 孙晓莹
2014年11月27日 星期四
American Society of Clinical Oncology
Phase III Comparison of Tamoxifen Versus Tamoxifen Plus Ovarian Function Suppression in Premenopausal Women With Node-Negative, Hormone ReceptorPositive Breast Cancer (E-3193, INT-0142): A Trial of the Eastern Cooperative Oncology Group
Amye J. Tevaarwerk, 
Molin Wang, 
Fengmin Zhao, 
John H. Fetting,
David Cella, 
Lynne I. Wagner, 
Silvana Martino, 
James N. Ingle,
Joseph A. Sparano, 
Lawrence J. Solin, 
William C. Wood and
Nicholas J. Robert
+Author Affiliations
Amye J. Tevaarwerk, University of Wisconsin, Madison, WI; Molin Wang, Harvard University; Fengmin Zhao, Dana-Farber Cancer Institute, Boston, MA; John H. Fetting, Johns Hopkins University, Baltimore, MD; David Cella and Lynne I. Wagner, Northwestern University, Chicago, IL; Silvana Martino, Angeles Clinic and Research Institute, Santa Monica, CA; James N. Ingle, Mayo Clinic, Rochester, MN; Joseph A. Sparano, Montefiore Medical Center, Bronx, NY; Lawrence J. Solin, Albert Einstein Medical Center, Philadelphia, PA; William C. Wood, Emory University, Atlanta, GA; and Nicholas J. Robert, Virginia Cancer Specialists, Fairfax, VA.
Corresponding author: Amye J. Tevaarwerk, MD, University of Wisconsin, 1111 Highland Ave, WIMR 6037, Madison, WI 53705; e-mail: at4@medicine.wisc.edu.
Abstract
Purpose The effects of ovarian function suppression (OFS) on survival and patient-reported outcomes were evaluated in a phase III trial in which premenopausal women were randomly assigned to tamoxifen with or without OFS.
Patients and Methods Premenopausal women with axillary node-negative, hormone receptor–positive breast cancer tumors measuring ≤ 3 cm were randomly assigned to tamoxifen alone versus tamoxifen plus OFS; adjuvant chemotherapy was not permitted. Primary end points were disease-free survival (DFS) and overall survival (OS). Secondary end points included toxicity and patient-reported outcomes. Patient-reported outcome data included health-related quality of life, menopausal symptoms, and sexual function. These were evaluated at baseline, 6 months, 12 months, and then annually for up to 5 years after registration.
Results In all, 345 premenopausal women were enrolled: 171 on tamoxifen alone and 174 on tamoxifen plus OFS. With a median follow-up of 9.9 years, there was no significant difference between arms for DFS (5-year rate: 87.9% v 89.7%; log-rank P= .62) or OS (5-year rate: 95.2% v 97.6%; log-rank P = .67). Grade 3 or higher toxicity was more common in the tamoxifen plus OFS arm (22.4% v 12.3%; P = .004). Patients treated with tamoxifen plus OFS had more menopausal symptoms, lower sexual activity, and inferior health-related quality of life at 3-year follow-up (P < .01 for all). Differences diminished with further follow-up.
Conclusion When added to tamoxifen, OFS results in more menopausal symptoms and sexual dysfunction, which contributes to inferior self-reported health-related quality of life. Because of early closure, this study is underpowered for drawing conclusions about the impact on survival when adding OFS to tamoxifen.

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