The expression of p53 protein was studied in formalin-fixed paraffin-e
mbedded specimens of 41 well-differentiated adenocarcinomas of the gal
l-bladder, six cases of acute cholecystitis and 23 cases of chronic ch
olecystitis, using a monoclonal p53 (PAb 1801) antibody and streptavid
in-biotin. p53 staining was divided into diffuse, focal or sporadic pa
tterns. The relationship between the p53 Labeling Index (p53 LI) and c
ellular proliferation was also investigated using monoclonal Ki-67 (MI
B1) antibody. Twenty-four of the 41 carcinomas (58.5%) had a diffuse s
taining pattern with a high p53 LI (47-93%) and 9.8% (4/41) had a foca
l staining pattern with an intermediate p53 LI (22-34%), with no relat
ion to pT stage, tumor size, histologic type or grade of cytologic aty
pia, The p53 LI was higher than the Ki-67 LI in these tumors except fo
r one. On the other hand, p53 staining was completely sporadic in the
non-neoplastic specimens with a low p53 LI (0.2-2.8%). The p53-positiv
e cells in these specimens were located only within areas of Ki-67-pos
itive cells. In conclusion, p53-protein overexpression occurs as an ea
rly event in approximately 70% of well-differentiated adenocarcinomas
of the gall-bladder, and this alteration is maintained during progress
ion from intramucosal to invasive carcinoma. p53 immunostaining can di
stinguish malignant from benign lesions of the gall-bladder.