CALGB STUDIES OF BREAST CANCER IN THE ELDERLY

CALGB 对老年人乳腺癌的研究

• 批准号: 6792574
• 负责人: RICHARD L SCHILSKY
• 金额: $ 78.67万
• 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 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6792574
• 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，有超过一半的新诊断的已被诊断出的乳腺癌发生 在65岁以上的女性中。尽管乳腺癌患病率很高 老年人，关于年龄相关方面的数据很少 这种恶性肿瘤。癌症和白血病B组提出了全面的 项目研究老年妇女的乳腺癌。这个项目包括一个 辅助化学疗法治疗试验与同伴项目一起评估 治疗方案对患者生活质量的影响；评估患者 遵守口服药物；并研究肿瘤生物学和相关性 与治疗结果。拟议的辅助化疗试验将比较 高风险的老年妇女的标准化学疗法，早期 阶段乳腺癌。该治疗试验的目标是比较 标准化疗与单一药物的功效和耐受性 主要终点的代甲滨是无病生存的。总共 720名65岁或以上的妇女将在一段时间内参加此试验 四年。生活质量伴侣将利用几种标准化 评估身体，认知，社会和职业功能的措施 辅助治疗期间和之后的患者。这种生活质量伴侣 将包括每个研究部门的175名患者。第二个同伴研究将 评估使用使用A口腔代甲滨的175名患者的依从性 电子监控设备。肿瘤生物学伴侣研究将是 根据北大学的单独赠款申请提交 卡罗来纳州。这项研究将涉及检查来自 原发性肿瘤从所有参加的患者中前景收集 辅助试验。将检查肿瘤的生物学特征，并 与治疗结果相关。这个整合的项目提供了一个 多学科的方法将解决与该问题相关的许多问题 治疗老年乳腺癌妇女。

项目成果

Adjuvant chemotherapy in older women with early-stage breast cancer.

• DOI: 10.1056/nejmoa0810266
• 发表时间: 2009-05-14
• 期刊: The New England journal of medicine
• 作者: Muss HB;Berry DA;Cirrincione CT;Theodoulou M;Mauer AM;Kornblith AB;Partridge AH;Dressler LG;Cohen HJ;Becker HP;Kartcheske PA;Wheeler JD;Perez EA;Wolff AC;Gralow JR;Burstein HJ;Mahmood AA;Magrinat G;Parker BA;Hart RD;Grenier D;Norton L;Hudis CA;Winer EP;CALGB Investigators
• 通讯作者: CALGB Investigators