TAMOXIFEN THERAPY AND RISK OF COLORECTAL CANCER

他莫昔芬治疗与结直肠癌的风险

• 批准号: 2748891
• 负责人: Linda S Cook
• 金额: $ 4.14万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-07-01 至 1999-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2748891
• 关键词: breast neoplasm /cancer diagnosis; breast neoplasms; cancer registry /resource; cancer risk; chemoprevention; clinical research; colorectal neoplasms; drug adverse effect; drug screening /evaluation; human subject; human therapy evaluation; neoplasm /cancer chemotherapy; neoplasm /cancer epidemiology; outcomes research; questionnaires; tamoxifen

A recent report from three Scandinavian clinical trials evaluating tamoxifen therapy among breast cancer patients has raised concern that tamoxifen therapy could increase the risk of a subsequent colorectal malignancy. We propose to test the hypothesis that tamoxifen use among breast cancer patients is associated with an elevated risk of second primary colorectal cancer in a population-based study. The proposed study is a nested case-control investigation of new primary colon and retal cancers among women with a prior diagnosis of brest cancer. Women diagnosed with Stage I, II, or III breast cancer between January 1, 1978 and December 31, 1992 will be identified from the population-based Cancer Surveillance System (CSS) of western Washington. All women in the study cohort who are subsequently diagnosed with new primary colon or retal cancer as their secondary primary cancer at least six months following the unilateral diagnosis and before December 31, 1994 will be study cases (total, n=161). For each case, we will identify at least two controls from the study cohort matched on the following characteristics of the case at the time of unilateral diagnosis: calendar year, age (in 5 year age groups), stage of disease (I,II, or III) (n=361). Tamoxifen therapy and other study information, will be obtained by abstracting hospital medical records of cases and controls and through a self-administered questionnaire sent to physicians who were involved in each patients' care. Analyses will be conducted to compare the relative risk of colorectal cancer in relation to the duration and recency of tamoxifen use. The success of tamoxifen as a breast cancer therapy, coupled with the minimal short-term effects, has initiated interest in using tamoxifen prophylactically in primary prevention of breast cancer. It is reasonable to expect that long-term adverse effects will be accepted and tolerated by most breast cancer patients, since tamoxifen has demonstrated efficacy for this potentially life-threatening disease. Such effects may not be acceptable to healthy women, including those at higher than average risk for breast cancer. It is important to document all beneficial and adverse health effects associated with tamoxifen treatment so that an informed decision can be made with respect to the prophylactic use of the drug.

最近一份来自三个斯堪的纳维亚临床试验的报告， 他莫昔芬治疗乳腺癌引起了关注 他莫昔芬治疗可能会增加 结直肠恶性肿瘤 我们建议检验这个假设， 乳腺癌患者使用他莫昔芬与 第二原发性结直肠癌的风险增加， 基于人口的研究。 这项研究是一项巢式病例对照研究， 原发性结肠癌和直肠癌的女性， 乳腺癌的诊断 诊断为I、II或III期的女性 1978年1月1日至1992年12月31日之间的乳腺癌将 从基于人群的癌症监测中识别 华盛顿西部的CSS系统。 研究中的所有女性 随后被诊断为新的原发性结肠或 视网膜癌作为继发原发癌至少6个月 1994年12月31日之前， 将是研究病例（总计，n=161）。 对于每种情况，我们将确定 来自研究队列的至少两个对照组在 以下是案件单方面时的特点 诊断：日历年，年龄（5岁年龄组），阶段 疾病（I、II或III）（n=361）。 将获得他莫昔芬治疗和其他研究信息 通过提取病例和对照的医院医疗记录， 通过向医生发送自填式问卷， 参与到每个病人的护理中。 将进行分析 比较结直肠癌的相对风险与 他莫昔芬使用的持续时间和最近度。 他莫昔芬作为乳腺癌治疗的成功，加上 最小的短期影响，引发了使用的兴趣 他莫昔芬在乳腺癌一级预防中的应用 有理由预计，长期不利影响将是 大多数乳腺癌患者都接受并耐受，因为 他莫昔芬已经证明了对这种潜在的 危及生命的疾病。 这种影响可能是不可接受的， 健康女性，包括那些高于平均风险的女性， 乳腺癌 重要的是要记录所有有益的， 与他莫昔芬治疗相关的不良健康影响， 可以做出关于预防药物的知情决定 药物的使用。