The frequency and the significance of apocrine differentiation in carc
inomas of the breast are uncertain, because of the lack of reliable an
d reproducible criteria for morphological diagnosis. The 15 kDa glycop
rotein of cystic breast disease (GCDFP-15) is regarded as a specific f
unctional marker of apocrine cells. Expression of the prolactin-induci
ble protein (PIP)/GCDFP-15 gene was investigated by Northern blot anal
ysis and in situ hybridization in breast cancer cell lines and in an u
nselected series (33 cases) of primary carcinomas of the breast. On th
e same cases, histological assessment of apocrine differentiation and
immunocytochemical detection of GCDFP-15 were also performed and corre
lated with follow-up data. The presence of PIP/GCDFP-15 mRNA was a fea
ture of a relatively high number of cases, but was incompletely correl
ated with histological and immunocytochemical evidences of apocrine di
fferentiation. Expression of the PIP/GCDFP-15 gene was significantly a
ssociated with relapse-free survival, and may represent a novel variab
le of functional and prognostic relevance.