TAMOXIFEN THERAPY AND RISK OF COLORECTAL CANCER
TAMOXIFEN THERAPY AND RISK OF COLORECTAL CANCER
批准号:
2748891
负责人:
Linda S Cook
金额:
$4.14万
依托单位国家:
美国
项目类别:
财政年份:
1997
资助国家:
美国
项目状态:
已结题
起止时间:
1997-07-01 至 1999-12-31
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
中文摘要
来自斯堪的纳维亚三个临床试验的最新报告
他莫昔芬在乳腺癌患者中的治疗引起了关注
他莫昔芬治疗可能会增加随后发生
结直肠癌。我们建议检验这个假设
在乳腺癌患者中使用他莫昔芬与
第二次原发结直肠癌的风险增加
以人口为基础的研究。
该研究是一项嵌套式病例对照研究。
既往曾患过结肠癌和直肠癌的女性中的原发性结肠癌
乳腺癌的诊断。被诊断为I、II或III期的女性
1978年1月1日至1992年12月31日期间的乳腺癌将
从以人群为基础的癌症监测中确定
华盛顿州西部的系统(Css)。这项研究中的所有女性
随后被诊断为新的原发结肠或
二次原发癌症至少6个月以上
单方诊断后至1994年12月31日前
将作为研究案例(总计,n=161)。对于每一种情况,我们将确定
至少有两名来自研究队列的对照与
单方案件发生时的下列特点
诊断:历年、年龄(5岁年龄组)、
疾病(I、II或III)(n=361)。
他莫昔芬治疗和其他研究信息,将获得
通过提取病例和对照的医院病历并
通过向医生发送的自填式问卷
都参与了每一位患者的护理。将进行分析
比较结直肠癌的相对风险与
他莫昔芬的使用时间和近期情况。
他莫昔芬作为乳腺癌治疗的成功,加上
最小的短期影响,已经引起了人们使用的兴趣
三苯氧胺预防乳腺癌的一级预防。
有理由预计,长期的不利影响将是
被大多数乳腺癌患者接受和耐受,因为
他莫昔芬已经证明了这种潜在的疗效。
危及生命的疾病。这样的影响可能是不可接受的
健康女性,包括那些患病风险高于平均水平的女性
乳腺癌。重要的是记录所有有益的和
与他莫昔芬治疗相关的不良健康影响
可以在知情的情况下做出关于预防措施的决定
药物的使用。
英文摘要
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.
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海外基金