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《CALGB 协议 369901:老年乳腺癌女性的虚弱与辅助激素治疗依从性》。

Frailty and adherence to adjuvant hormonal therapy in older women with breast cancer: CALGB protocol 369901.

机构信息

Vanessa B. Sheppard, Leigh Anne Faul, George Luta, Jonathan D. Clapp, Judy Huei-yu Wang, Claudine Isaacs, Michelle Tallarico, and Jeanne S. Mandelblatt, Georgetown University Medical Center and Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC; Rachel L. Yung and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Gretchen Kimmick, William T. Barry, Brandelyn N. Pitcher, and Harvey J. Cohen, Duke University Medical Center; William T. Barry and Brandelyn N. Pitcher, Cancer and Leukemia Group B Statistical Center, Durham; Hyman B. Muss, University of North Carolina Chapel Hill, Chapel Hill, NC; Clifford Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY; and Arti Hurria, City of Hope, Los Angeles, CA.

出版信息

J Clin Oncol. 2014 Aug 1;32(22):2318-27. doi: 10.1200/JCO.2013.51.7367. Epub 2014 Jun 16.

Abstract

PURPOSE

Most patients with breast cancer age ≥ 65 years (ie, older patients) are eligible for adjuvant hormonal therapy, but use is not universal. We examined the influence of frailty on hormonal therapy noninitiation and discontinuation.

PATIENTS AND METHODS

A prospective cohort of 1,288 older women diagnosed with invasive, nonmetastatic breast cancer recruited from 78 sites from 2004 to 2011 were included (1,062 had estrogen receptor-positive tumors). Interviews were conducted at baseline, 6 months, and annually for up to 7 years to collect sociodemographic, health care, and psychosocial data. Hormonal initiation was defined from records and discontinuation from self-report. Baseline frailty was measured using a previously validated 35-item scale and grouped as prefrail or frail versus robust. Logistic regression and proportional hazards models were used to assess factors associated with noninitiation and discontinuation, respectively.

RESULTS

Most women (76.4%) were robust. Noninitiation of hormonal therapy was low (14%), but in prefrail or frail (v robust) women the odds of noninitiation were 1.63 times as high (95% CI, 1.11 to 2.40; P = .013) after covariate adjustment. Nonwhites (v whites) had higher odds of noninitiation (odds ratio, 1.71; 95% CI, 1.04 to 2.80; P = .033) after covariate adjustment. Among initiators, the 5-year continuation probability was 48.5%. After adjustment, the risk of discontinuation was higher with increasing age (P = .005) and lower for stage ≥ IIB (v stage I) disease (P = .003).

CONCLUSION

Frailty is associated with noninitiation of hormonal therapy, but it does not seem to be a major predictor of early discontinuation in older patients.

摘要

目的

大多数年龄≥65 岁的乳腺癌患者(即老年患者)适合接受辅助激素治疗,但并非普遍使用。本研究旨在探讨衰弱对激素治疗起始和终止的影响。

方法

本研究纳入了 2004 年至 2011 年间来自 78 个地点的 1288 例确诊为浸润性、非转移性乳腺癌的老年女性(1062 例患者的肿瘤雌激素受体阳性),对其进行了前瞻性队列研究。在基线、6 个月和每年进行访谈,以收集社会人口学、医疗保健和心理社会数据。通过记录确定激素治疗起始,通过自我报告确定激素治疗终止。使用先前验证的 35 项量表测量基线衰弱,并分为虚弱前期或虚弱与健壮。使用逻辑回归和比例风险模型分别评估与起始和终止相关的因素。

结果

大多数女性(76.4%)身体健壮。激素治疗起始率较低(14%),但在虚弱前期或虚弱期(与健壮期相比)女性中,经过协变量调整后,起始率的比值比为 1.63(95%置信区间,1.11 至 2.40;P=0.013)。与白人相比,非白人(黑人和西班牙裔)的起始率更高(比值比,1.71;95%置信区间,1.04 至 2.80;P=0.033),且经过协变量调整后。在起始治疗的患者中,5 年的持续治疗率为 48.5%。调整后,随着年龄的增加,停药风险更高(P=0.005),而对于 IIB 期及以上(I 期)疾病(P=0.003),停药风险更低。

结论

衰弱与激素治疗起始相关,但似乎不是老年患者早期停药的主要预测因素。

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