Risk of diagnosis of ovarian cancer after raised serum CA 125 concentration: a prospective cohort study

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Abstract
Objective: To determine the risk of invasive epithelial ovarian cancer and fallopian tube cancer associated with a raised concentration of the tumour marker CA 125 in asymptomatic postmenopausal women. Design: Serum CA 125 concentration was measured annually in study participants for one to four years. Participants with a concentration >/=30 U/ml were recalled for abdominal ultrasonography. Follow up was by annual postal questionnaire. Setting: General practice, occupational health departments, ovarian cancer screening unit in a teaching hospital. Subjects: 22 000 volunteers, all postmenopausal women >/=45 years of age; recruited between 1 June 1986 and 1 May 1990. Intervention: Surgical investigation if the ultrasound examination was abnormal. Main outcome measures: Cumulative and relative risk of developing an index cancer (invasive epithelial cancer of the ovary or fallopian tube) after a specified CA 125 result. Results: 49 index cancers developed in the study population during a mean follow up of 6.76 years. The overall cumulative risk of developing an index cancer was 0.0022 for the entire study population and was lower for women with a serum CA 125 concentration /=30 U/ml (0.030) and >100 U/ml (0.149). Compared with the entire study population the relative risk of developing an index cancer within one year and five years was increased 35.9-fold (95% confidence interval 18.3 to 70.4) and 14.3-fold (8.5 to 24.3) respectively after a serum CA 125 concentration >/=30 U/ml and 204.8-fold (79.0 to 530.7) and 74.5-fold (31.1 to 178.3) respectively after a concentration >/=100 U/ml. Conclusion: CA 125 is a powerful index of risk of ovarian and fallopian tube cancer in asymptomatic postmenopausal women. This study shows that raised serum CA 125 concentration is a powerful index of risk of ovarian cancer in asymptomatic postmenopausal women The risk in the year after a serum CA 125 concentration >/=100 U/ml is similar to the lifetime risk to women in high risk families The importance of a raised serum CA 125 concentration in relation to risk of other cancers is not yet known The role of CA 125 as a component of a screening strategy for ovarian cancer is under investigation, but the impact on mortality is not known