Association of breast cancer and its therapies with fracture

乳腺癌及其治疗与骨折的关系

• 批准号: 7530364
• 负责人: JOAN Marie NEUNER
• 金额: $ 17.34万
• 依托单位: MEDICAL COLLEGE OF WISCONSIN
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-08-15 至 2010-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7530364
• 关键词: Adjuvant; Adjuvant Chemotherapy; Adjuvant Therapy; Adverse event; Affect; Age; Algorithms; American; Animals; Anthracycline Antibiotics; Anthracyclines; Aromatase Inhibitors; Bone Density; Breast Cancer Treatment; Cancer Patient; Cancer Survivor; Chemotherapy-Oncologic Procedure; Clinical; Clinical Trials; Counseling; Cytotoxic Chemotherapy; Data; Databases; Diagnosis; Effectiveness; European; Fracture; Future; General Population; Hip region structure; Hormonal; Hormones; Incidence; Link; Long-Term Effects; Longitudinal Surveys; Malignant Neoplasms; Medicare; Methotrexate; Morbidity - disease rate; Numbers; Observational Study; Oncologist; Osteoporosis; Population; Postmenopause; Premenopause; Public Health; Recruitment Activity; Risk; Sampling; Societies; Staging; Surveys; Tamoxifen; Technology Assessment; Time; Woman; Women' s Health; aged; base; bone; breast cancer diagnosis; cancer risk; chemotherapy; cohort; cytotoxic; hormone therapy; human study; malignant breast neoplasm; mortality; neoplasm registry; osteoporosis with pathological fracture

DESCRIPTION (provided by applicant): Bony fractures are among the most common morbidities affecting breast cancer survivors, particularly postmenopausal breast cancer survivors. There is evidence to suggest that the fracture risk for breast cancer patients is substantially higher than the general population, and that it is likely to worsen in coming years. First, several European studies and the Women's Health Initiative identified an increased fracture risk among breast cancer survivors even in the era when tamoxifen, which may offer some protection against fractures, was the most common hormonal agent. Second, clinical trials in premenopausal women have shown rapid losses in bone density after cytotoxic adjuvant chemotherapy. Evidence is more limited among postmenopausal women, but animal studies and single-center human studies suggest that cytotoxic chemotherapy might also increase their fracture risk. Finally, advances in adjuvant hormonal therapy with the introduction of aromatase inhibitors (AIs) suggest that osteoporosis will become a greater problem in the future. Clinical trials suggest that AIs reduce breast cancer mortality but increase fracture risk by approximately 40%. Given these considerations, we propose to determine the five-year incidence of hip and total nonvertebral fractures among a population-based sample of postmenopausal SEER-Medicare breast cancer survivors compared with age-matched Medicare enrollees. The study will also examine any association of common adjuvant chemotherapy regimens containing methotrexate and anthracyclines with fractures among the same sample of postmenopausal breast cancer survivors. Finally, this study will explore the association of the most commonly used adjuvant hormonal therapies for postmenopausal breast cancer (tamoxifen and aromatase inhibitors) with hip and total nonvertebral fractures among a population-based surveyed cohort of postmenopausal breast cancer survivors. This study will provide effectiveness data regarding the occurrence of osteoporotic fractures in older breast cancer patients and their relationship to initial systemic adjuvant therapies. It will provide important guidance for counseling and treatment initiatives for osteoporosis among breast cancer survivors. Its preliminary findings from a population-based cohort of early aromatase inhibitor users should provide important pilot data for future study into longer-term bone effects of various types of hormonal therapies using Medicare Part D or other administrative data. PUBLIC HEALTH RELEVANCE: Bony fractures are among the most common problems affecting breast cancer survivors, particularly postmenopausal breast cancer survivors. We will investigate the risk of fracture among postmenopausal breast cancer survivors compared with women without breast cancer, and then will explore the contribution of breast cancer treatments (chemotherapy or aromatase inhibitors) to fracture risk. This study should provide importance guidance for counseling and treatment initiatives for osteoporosis among breast cancer survivors.

描述（由申请人提供）：骨质骨折是影响乳腺癌幸存者的最常见的病因之一，尤其是绝经后乳腺癌幸存者。有证据表明，乳腺癌患者的骨折风险大大高于一般人群，并且在未来几年中可能会恶化。首先，几项欧洲研究和妇女健康计划确定了乳腺癌幸存者的骨折风险增加，即使在可能对骨折有害的他莫昔芬是最常见的荷尔蒙药物的那个时代。其次，绝经前妇女的临床试验表明，细胞毒性辅助化疗后骨密度迅速损失。绝经后妇女的证据更为有限，但是动物研究和单一中心研究表明，细胞毒性化疗也可能增加其骨折风险。最后，通过引入芳香酶抑制剂（AIS）的辅助激素治疗的进步表明，骨质疏松症将来将成为一个更大的问题。临床试验表明，AIS降低了乳腺癌的死亡率，但会使骨折风险增加约40％。考虑到这些考虑，我们建议确定与年龄匹配的Medicare Prolellees相比，绝经后中期 - 中期 - 中期乳腺癌乳腺癌幸存者的髋关节和总非脊椎骨折的发生率。该研究还将检查任何含有甲氨蝶呤和蒽环类药物的常见辅助化疗方案与绝经后乳腺癌幸存者相同样本中的裂缝的任何关联。最后，这项研究将探讨最常用的绝经后乳腺癌辅助激素疗法（他莫昔芬和芳香酶抑制剂）与髋关节和总非脊椎骨折中基于人群调查的绝经后乳腺癌后乳腺癌幸存者中的关联。这项研究将提供有关老年乳腺癌患者骨质疏松性骨折的发生的有效数据及其与初始全身辅助疗法的关系。它将为乳腺癌幸存者中骨质疏松症的咨询和治疗计划提供重要的指导。它来自基于人群的早期芳香酶抑制剂使用者的同类群体的初步发现应提供重要的试点数据，以便将来研究使用Medicare D部分或其他行政数据来研究各种类型的激素疗法的长期骨骼影响。公共卫生相关性：骨质骨折是影响乳腺癌幸存者的最常见问题之一，尤其是绝经后乳腺癌幸存者。与没有乳腺癌的女性相比，我们将研究绝经后乳腺癌幸存者骨折的风险，然后探索乳腺癌治疗（化学疗法或芳香酶抑制剂）对骨折风险的贡献。这项研究应为乳腺癌幸存者中骨质疏松症的咨询和治疗计划提供重要的指导。