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）：骨骨折是影响乳腺癌幸存者，特别是绝经后乳腺癌幸存者的最常见疾病之一。有证据表明，乳腺癌患者的骨折风险远高于一般人群，并且在未来几年可能会恶化。首先，几项欧洲研究和妇女健康倡议发现，即使在他莫昔芬（可能提供一定程度的预防骨折作用）是最常见的激素药物的时代，乳腺癌幸存者的骨折风险也会增加。其次，绝经前女性的临床试验表明，细胞毒性辅助化疗后骨密度迅速下降。绝经后女性的证据更为有限，但动物研究和单中心人体研究表明，细胞毒性化疗也可能增加她们的骨折风险。最后，随着芳香酶抑制剂（AI）的引入，辅助激素治疗的进展表明骨质疏松症将成为未来的一个更大的问题。临床试验表明 AI 可以降低乳腺癌死亡率，但会使骨折风险增加约 40%。考虑到这些因素，我们建议确定绝经后 SEER-Medicare 乳腺癌幸存者与年龄匹配的 Medicare 参保者的人群样本中髋部和全非椎骨骨折的五年发病率。该研究还将检查包含甲氨蝶呤和蒽环类药物的常见辅助化疗方案与同一绝经后乳腺癌幸存者样本中骨折的关系。最后，本研究将探讨绝经后乳腺癌最常用的辅助激素疗法（他莫昔芬和芳香酶抑制剂）与基于人群的绝经后乳腺癌幸存者调查队列中髋部和全非椎骨骨折的关系。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及其与初始全身辅助治疗的关系的有效性数据。它将为乳腺癌幸存者骨质疏松症的咨询和治疗举措提供重要指导。其基于早期芳香酶抑制剂使用者群体的初步研究结果应该为未来使用医疗保险 D 部分或其他管理数据研究各种类型激素疗法的长期骨骼影响提供重要的试点数据。公众健康相关性：骨骨折是影响乳腺癌幸存者（尤其是绝经后乳腺癌幸存者）的最常见问题之一。我们将调查绝经后乳腺癌幸存者与未患乳腺癌的女性相比的骨折风险，然后探讨乳腺癌治疗（化疗或芳香酶抑制剂）对骨折风险的影响。这项研究应该为乳腺癌幸存者骨质疏松症的咨询和治疗举措提供重要指导。