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The aim of this research was to detect new valid prognostic indicators that allow us to choose the best therapy and follow-up for patients with a poor prognosis. One hundred and twenty-nine patients with invasive squamous carcinoma of the vulva treated at the Gynecology Clinic of the University of Padua between January 1, 1975 and December 31, 1999 have been evaluated: Protein p53 and ki-67 were studied by immunohistochemical investigations and their prognostic significance was evaluated. The relation with the classic clinico-pathological prognostic factors was also studied. The results showed a close association between tissue overexpression of the two proteins and clinico-pathological characteristics of the aggressivity of the neoplasm. Moreover, the group of positive p53 patients with a diffuse distribution pattern of ki-67 resulted in having a somewhat shorter survival with respect to the groups with negative p53 and/or a focal pattern. Such negative prognostic significance was confirmed by the results of the multivariate analysis performed with the Cox model which shows that patients with p53 positive values and a diffuse pattern have a higher relative risk of death compared to patients with p53 negative values and focal pattern (p=0.0001). The statistical significance of the prognostic value of the association of p53 and ki-67 thus seems to give these two factors greater weight with respect to the others we investigated.

A proliferating cell nuclear antigen (Ki-67) expression was investigated in 73 cases of invasive vulvar cancer, to detect new diagnostic and prognostic factors. We individualized, like Hendriks (1994), two general patterns of reactivity: 1) diffused positivity in all tumoral tissue with a bad prognosis; 2) focal positivity, localized at the edge of tumoral aggregates. Moreover, within focal patterns, one group with positivity to MIB-l of 0.2-6% and another group of 7-9% with different prognoses (better in the first group). Histotype, lymph-nodal status, FIGO stage are strictly correlated with distribution of Ki-67; on the contrary, no correlation was found with grading and number of mitoses.