PROSPECTIVE-STUDY OF SERUM CA-125 LEVELS AS MARKERS OF OVARIAN-CANCER

PROSPECTIVE-STUDY OF SERUM CA-125 LEVELS AS MARKERS OF OVARIAN-CANCER
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DOI:
10.1001/jama.269.9.1123
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发表时间:
1993-03-03
影响因子:
120.7
通讯作者:
COMSTOCK, GW
COMSTOCK, GW
中科院分区:
医学1区
文献类型:
--
作者:
HELZLSOUER, KJ;BUSH, TL;COMSTOCK, GW

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客观。-前瞻性评价血清CA-125水平检测卵巢癌的敏感性和特异性。病例对照研究嵌套在一个队列的妇女谁献血的社区为基础的血清库成立于1974年。美国马里兰州华盛顿县.人口. -病例包括1975年至1989年发生卵巢癌的37名妇女。对照组由73名女性组成,年龄和自上次月经以来的时间相匹配,并且在病例诊断之前没有癌症。血清CA-125水平。结果测量。组织学证实卵巢癌。结果。在病例确诊前12年内,每3年,病例的血清CA-1 25水平均高于对照组。在随访的前3年内诊断的病例的中位水平为35.4 U/mL,而对照组为9.0 U/mL(P= 0.002)。前3年内血清CA-1 25水平大于35 U/mL的敏感性为57%(95%置信区间,20%至88%),特异性为100%(95%置信区间下限,73%)。敏感性和特异性随着诊断时间的增加而下降。血清CA-125水平的测量,特别是在35 U/mL的参考值下,不足以灵敏地单独用作检测卵巢癌的筛选试验。较低的CA-125参考值可以识别出患卵巢癌风险较高的女性,但CA-125测量不能推荐用于此目的,因为很高比例的女性会被错误地归类为患卵巢癌的高风险。
Objective.-To evaluate prospectively the sensitivity and specificity of serum CA-125 levels for the detection of ovarian cancer.Design.-Case-control study nested within a cohort of women who donated blood to a community-based serum bank established in 1974.Setting.-Washington County, Maryland.Population.-Cases consisted of 37 women who developed ovarian cancer from 1975 through 1989. Controls consisted of 73 women, matched on age and time since last menstrual period, and free of cancer until the cases' diagnoses.Study Variable.-Serum CA-125 levels.Outcome Measure.-Histologically confirmed ovarian cancer.Results.-Levels of serum CA-1 25 among cases were higher than among controls for each 3-year interval up to 12 years prior to the time of the cases' diagnoses. The median level for cases diagnosed within the first 3 years of follow-up was 35.4 U/mL compared with 9.0 U/mL for controls (P=.002). The sensitivity of a serum CA-1 25 level greater than 35 U/mL within the first 3 years was 57% (95% confidence interval, 20% to 88%) and the specificity was 100% (95% confidence interval lower limit, 73%). Sensitivity and specificity decreased with increasing time to diagnosis.Conclusions.-Measurement of serum CA-125 levels, particularly at a reference value of 35 U/mL, is not sufficiently sensitive to be used alone as a screening test for the detection of ovarian cancer. Lower CA-125 reference values could identify women at higher risk of developing ovarian cancer, but CA-125 measurement cannot be recommended for this purpose because of the high proportion of women who would be falsely classified as being at high risk for developing ovarian cancer.