[The protein of fibrocystic breast disease--methods of measurement and clinical implications].

The gross cystic disease of the breast has been reported to be associated with a two to fourfold increased breast cancer risk. The cyst fluid contains several hormones and proteins among whom we have isolated and characterized one of these proteins with an estimated molecular weight at 17.4 kilodaltons (Gross Cystic Disease Fluid Protein-17 kDa or GCDFP-17). A specific antiserum against GCDFP-17 was produced and an enzyme-linked immunosorbent assay (ELISA) was perfected to obtain a simple and sensitive method for the study of the GCDFP-17. This protein is also stimulated by androgens in vitro like in vivo and is a potential marker of an androgens' excess. Subsequently, we were able to study 33 ovarian micropolycystic syndromes (OPCS) with a biological hyperandrogenism (Hyperandrogenic Group or GH) compared with 32 control women (GT). The body mass index (BMI) of GH was significantly greater than that of G.T. (29.8 +/- 9.3 vs 21.3 +/- 2.7 kgs/m2--p. < 0.01). The mean plasma value of testosterone (T), delta 4-androstenedione (delta 4-A), dehydroepiandrosterone sulfate (SHDA) and the ratio of T. on sex binding protein (SBP) or free testosterone index (ITL) were significantly greater in GH than in GT (p < 0.01). Despite the circulating excess of androgens in GH, there were no significant differences for GCDFP-17 between the 2 groups (G.H. = 222 +/- 74 vs G.T. = 230 +/- 84 ng/ml) and any correlation between plasma androgens and GCDFP-17 (p < 0.05). Nevertheless, the androgens' excess in G.H. was clearly smaller than that which was seen with the doses of potent androgens used in the treatment of metastatic breast cancer.