ADJUVANT TAMOXIFEN THERAPY IN OLD AGE

老年他莫昔芬辅助治疗

• 批准号: 2895539
• 负责人: REBECCA A SILLIMAN
• 金额: $ 101.65万
• 依托单位: BOSTON MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-09-30 至 2002-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2895539
• 关键词: behavioral /social science research tag; breast neoplasms; clinical research; female; health care service evaluation; human old age (65+); human subject; neoplasm /cancer chemotherapy; quality of life; tamoxifen; therapy compliance

DESCRIPTION: This is a new application from Boston University that addresses the role of adjuvant tamoxifen therapy in older women with breast cancer. Although there has been interest in variations in the use of mastectomy vs. breast-conserving surgery + radiation therapy among older women, there has been little systematic study of the use of adjuvant therapy outside of clinical trials. The use of chemotherapy in older postmenopausal women remains controversial, however, adjuvant tamoxifen has been proven to be efficacious in reducing recurrences and mortality in older women, with no apparent decrement in efficacy by age, including those women 70 years of age and older. In spite of published guidelines recommending the use of tamoxifen in postmenopausal women with tumors > 1 cm, there is evidence that older women are being under-treated and that the rates of tamoxifen discontinuance are not inconsequential. This application proposes a prospective observational study of women > 70 years of age with stage I (> 1 cm) and stage II breast cancer and of their physicians in diverse health care settings in four different geographic regions (Los Angeles, the states of Minnesota and Rhode Island, and Western North Carolina), with differing rates of tamoxifen use. The four primary aims of this research are to identify predictors of 1) physicians' beliefs regarding the benefits and risks of adjuvant tamoxifen therapy in older women; 2) patients' beliefs regarding the benefits and risks of adjuvant tamoxifen therapy and of changes in these beliefs over a one-year period of time; 3) physicians' prescribing of tamoxifen; and 4) patients' adherence to tamoxifen therapy at three and twelve months post tamoxifen prescription. The two secondary aims of the research are to compare tamoxifen-treated and untreated women with respect to: 1) the prevalence of symptoms commonly attributed to tamoxifen therapy and 2) health-related quality of life.

描述：这是波士顿大学的一个新应用程序， 探讨了他莫昔芬辅助治疗在老年乳腺癌患者中的作用 癌 尽管人们对使用 老年人乳房切除术与保乳手术+放射治疗 女性，很少有系统的研究使用辅助治疗 在临床试验之外。 化疗在老年绝经后妇女中的应用 然而，辅助性他莫昔芬已被证明 有效降低老年妇女的复发率和死亡率， 疗效随年龄明显降低，包括70岁的女性 年纪也更大了 尽管已发布的指南建议使用 他莫昔芬在肿瘤> 1 cm的绝经后妇女中，有证据表明， 老年妇女的治疗不足， 中止并非无关紧要。 本申请提出了一项对> 70岁女性的前瞻性观察研究 年龄为1岁的I期（> 1 cm）和II期乳腺癌患者及其 四个不同地理区域的不同医疗保健机构的医生 地区（洛杉矶、明尼苏达州和罗得岛州，以及西 北卡罗来纳州），他莫昔芬使用率不同。 四个主要 这项研究的目的是确定1）医生信念的预测因素 关于他莫昔芬辅助治疗老年人的益处和风险， 女性; 2）患者对辅助治疗的益处和风险的信念 他莫昔芬治疗和这些信念的变化在一年的时间， 时间; 3）医生开他莫昔芬的处方; 4）患者对 在他莫昔芬处方后3个月和12个月进行他莫昔芬治疗。 该研究的两个次要目的是比较他莫昔芬治疗和 未经治疗的妇女在以下方面：1）症状的普遍性， 归因于他莫昔芬治疗和2）健康相关的生活质量。