The growth fraction of 68 canine cutaneous melanomas was determined by immunostaining with MIB-1, a monoclonal antibody to a Ki-67 epitope that recognizes all proliferating cells. Fifty tumours were classified histologically as benign and 18 as malignant. The Ki-67 proliferative index (percentage of positive cells over 500 neoplastic cells) was low (< 15%) in 55 cases and high (> or = 15%) in 13 cases. High Ki-67 proliferative index and histological malignancy were both associated with significantly poorer 2-year survival (P < 0.0001). However, the predictive value of the Ki-67 proliferative index (97%) was higher than the predictive value of classical histology (91%). The evaluation of the growth fraction by the Ki-67 proliferative index is highly predictive of the biological behaviour of canine cutaneous melanoma.