Nipple fluid carcinoembryonic antigen and prostate-specific antigen in cancer-bearing and tumor-free breasts

Purpose: Mammograms and breast examinations are established methods for ear ly breast cancer detection. Routine mammography screening reduces breast ca ncer mortality among women ages greater than or equal to 50 years, but addi tional screening methods are needed. We and others have found high levels o f carcinoembryonic antigen (CEA) and prostate-specific antigen (PSA) in nip ple aspirate fluids (NAFs), but the usefulness for these biomarkers for ear ly breast cancer detection is unknown. Patients and Method: NAFs from one or both breasts of 388 women were analyz ed for CEA, PSA, and albumin levels. The study included 44 women with newly diagnosed invasive breast cancers, 67 women with proliferative breast lesi ons (duct-al and lobular carcinoma in situ and atypical ductal hyperplasia) , and 277 controls without these breast lesions. Analyses were conducted us ing the log(10)-transformed CEA and PSA levels to normalize the distributio ns of these tumor markers. Results: Nipple fluid CEAs are significantly higher for cancerous breasts t han turner-free breasts (median 1,830 and 1,408 ng/mL, respectively; P <.01 ). However, at 90% specificity of the assay (CEA = 11,750 ng/mL), the corre sponding sensitivity for cancer detection is 32%. CEA levels are not signif icantly different for breasts with proliferative lesions compared with tumo r-free breasts. Nipple fluid PSAs do not differ by turner status. Analyses of NAF albumin-standardized CEAs and PSAs yield similar results. Nipple flu id CEA and PSA titers are correlated in the affected and unaffected breast of women with unilateral lesions. Conclusion: Nipple fluid CEAs are higher for breasts with untreated invasiv e cancers, but the test sensitivity is low. Nipple fluid PSA titers do not seem to be useful for breast cancer detection. J Clin Oncol 19:1462-1467. ( C) 2001 by American Society of Clinical Oncology.