CALGB STUDIES OF BREAST CANCER IN THE ELDERLY

在美国，超过一半的新诊断乳腺癌发生在 在65岁或以上的女性中。尽管#年乳腺癌的发病率很高 对于老年人来说，关于年龄相关方面的数据很少 这种恶行。癌症和白血病B组提出了一项全面的 研究老年妇女乳腺癌的项目。该项目包括一个 辅助性化疗试验与配套项目，以评估 治疗方案对患者生活质量的影响；评估患者的 坚持口服药物；研究肿瘤生物学及其相关性 以及治疗结果。拟议的辅助化疗试验将比较 卡培他滨治疗早期高危老年妇女的标准化疗 乳癌分期。这项治疗试验的目的是比较 标准化疗与单药化疗的疗效和耐受性比较 卡培他滨的主要终点是无病生存。总计 720名年龄在65岁或以上的女性将参加这项试验 四年了。生活质量伴侣将利用几个标准化 评估身体、认知、社会和职业功能的措施 患者在辅助治疗期间和之后。这是生活质量的伴侣 将包括来自每个研究分支的175名患者。第二项配套研究将 175例口服卡培他滨患者的依从性评价 电子监控装置。肿瘤生物学配套研究将是 根据北方大学的另一份拨款申请提交 卡罗莱纳。这项研究将包括检查来自 原发肿瘤前瞻性收集自所有登记的患者 佐剂试验。将对肿瘤的生物学特征进行检查和 与治疗结果相关。这个集成良好的项目提供了一个 多学科方法，将解决许多与 老年妇女乳腺癌的治疗。

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.