Objective: Serum assays for CA 125 are used to monitor disease status
in patients undergoing treatment for epithelial ovarian cancer. While
a number of benign gynecologic as well as benign and malignant nongyne
cologic conditions are associated with CA 125 elevations, the establis
hed ''normal'' range describes a healthy population of women, The meta
bolism and clearance of CA 125 is not well understood, Because mild de
grees of renal impairment frequently occur in ovarian cancer patients,
we investigated the effect of impaired renal function on basal CA 125
in a population of female dialysis patients. Methods: Twenty-five wom
en on hemodialysis were selected at random. Patients ranged in age fro
m 29 to 87 years. Renal disease was secondary in most cases to diabete
s mellitus or hypertension, The creatinine clearance was less than 10
cc/min for all patients, The duration of dialysis ranged from 3 months
to 14 years, Serum levels of CA 125 were measured using monoclonal an
tibodies in an immunoradiometric assay, Results: The mean of duplicate
determinations for 23 of 25 (92%) patients fell within the normal ran
ge for otherwise healthy women (<35 U/ml). There was no apparent corre
lation between CA 125 level and age, menopausal status, BUN, serum cre
atinine, adequacy of dialysis, or primary underlying diagnosis. Of the
2 patients (8%) with CA 125 levels above the normal range, 1 was prem
enopausal and the other was postmenopausal; their CA 125 elevations we
re marginal (49.81 and 50.51). Conclusions: The results of this study
demonstrate that even marked renal insufficiency is not itself associa
ted with significant elevations of CA 125 above the normal range selec
ted for otherwise healthy women, The development of renal insufficienc
y during treatment for ovarian cancer should not alter the interpretat
ion of serum levels of CA 125. (C) 1995 Academic Press, Inc.