CALGB STUDIES OF BREAST CANCER IN THE ELDERLY

CALGB 对老年人乳腺癌的研究

• 批准号: 6649265
• 负责人: RICHARD L SCHILSKY
• 金额: $ 81.29万
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-30 至 2005-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6649265
• 关键词: antimetabolites; breast neoplasms; clinical research; clinical trials; combination cancer therapy; cooperative study; cyclophosphamide; doxorubicin; drug administration rate /duration; drug adverse effect; drug screening /evaluation; fluorouracil; functional ability; human old age (65+); human subject; human therapy evaluation; long term survivor; methotrexate; neoplasm /cancer chemotherapy; neoplasm /cancer pharmacology; neoplasm /cancer radiation therapy; oral administration; outcomes research; paclitaxel; quality of life; statistics /biometry; tamoxifen; therapy compliance; women's health

Over one-half of the newly diagnosed breast cancers in the United States occur in women 65 years or older. Despite the high prevalence of breast cancer in the elderly, there is a paucity of data regarding the age-associated aspects of this malignancy. The Cancer and Leukemia Group B proposes a comprehensive project to study breast cancer in elderly women. This project includes an adjuvant chemotherapy treatment trial with companion projects to evaluate the impact of treatment regimens on patients' quality of life; to assess patients' adherence to an oral medication; and to study tumor biology and correlations with treatment outcome. The proposed adjuvant chemotherapy trial will compare standard chemotherapy with capecitabine in elderly women with high risk, early stage breast cancer. The objectives of this treatment trial are to compare the efficacy and tolerability of standard chemotherapy versus single agent capecitabine with the primary endpoint being disease-free survival. A total of 720 women aged 65 years or older will enroll in this trial over a period of four years. The quality of life companion will utilize several standardized measures to assess physical, cognitive, social and vocational functioning in patients during and following adjuvant therapy. This quality of life companion will include 175 patients from each study arm. The second companion study will assess the adherence of 175 patients receiving oral capecitabine using an electronic monitoring device. The tumor biology companion study will be submitted under a separate grant application from the University of North Carolina. This study will involve examination of tissue blocks from the primary tumor collected prospectively from all patients enrolled in the adjuvant trial. Biologic characteristics of the tumor will be examined and correlated with treatment outcome. This well integrated project provides a multidisciplinary approach that will address many issues relevant to the treatment of elderly women with breast cancer.

在美国，超过一半的新诊断的乳腺癌发生在 65岁或以上的女性。尽管乳腺癌的发病率很高， 关于老年人，与年龄有关的数据很少。 这种恶性肿瘤。癌症和白血病小组B提出了一项全面的 研究老年妇女乳腺癌的项目。该项目包括一个 辅助化疗治疗试验及配套项目，以评估 治疗方案对患者生活质量的影响;评估患者 坚持口服药物;并研究肿瘤生物学和相关性 治疗结果。拟议的辅助化疗试验将比较 卡培他滨标准化疗在老年高危、早期 乳腺癌分期本治疗试验的目的是比较 标准化疗与单药化疗疗效和耐受性比较 卡培他滨，主要终点为无病生存期。共 将有720名年龄在65岁或以上的女性入组本试验， 四年生活质量伴侣将利用几个标准化的 评估残疾人身体、认知、社会和职业功能的措施 辅助治疗期间和之后的患者。这种高质量的生活伴侣 将包括来自每个研究组的175名患者。第二项伴随研究将 评估175例接受口服卡培他滨的患者的依从性， 电子监控装置肿瘤生物学伴随研究将是 根据北方大学的单独赠款申请提交 卡罗莱纳。本研究将包括检查来自 从所有入组的患者中前瞻性收集原发性肿瘤， 辅助试验将检查肿瘤的生物学特征， 与治疗结果相关。这个综合性很好的项目提供了一个 多学科的方法，将解决许多问题， 治疗老年女性乳腺癌。