Prospective evaluation of p53 as a prognostic marker in T1 transitional cell carcinoma of the bladder.

OBJECTIVE: To prospectively evaluate p53 overexpression as a predictor of survival in patients with a first diagnosis of T1 transitional cell carcinoma (TCC) of the bladder, as several reports implicate p53 as an important prognostic marker for progression and survival, but all previous studies were retrospective, giving conflicting and irreproducible results, rendering inappropriate any attempt at integrating p53 into clinical decision-making. PATIENTS AND METHODS: Patients with a first diagnosis of T1 TCC of the bladder were enrolled; p53 overexpression was assessed by immunohistochemistry (IHC) using both monoclonal antibody 1801 and DO7. The pathological stage and IHC score were assigned by one pathologist, and the markers were scored categorically.
RESULTS: Of the 89 patients who were evaluable, 53 had p53-positive tumours. The median follow-up for the survivors was 52 months. Eighty-two patients had high-grade tumours, using the World Health Organisation/International Society of Urological Pathology 1998 grading system. Fifty-eight patients had unifocal tumours and 34 had associated carcinoma in situ. The 3 year and 5 year overall survival rates were 81% (95% Cl: 73%, 90%) and 68% (95% Cl: 56%, 80%) respectively. The 3 year and 5 year disease specific survival rates were 87% (95% Cl: 79%, 94%) and 79% (95% Cl: 70%, 89%) respectively. There was no difference in disease-specific survival between patients with and without p53 over expression (p=0.56) [corrected]
CONCLUSIONS: p53 tissue typing by IHC in a prospective cohort of patients with T1 bladder cancer was not clinically useful as a prognostic marker in a contemporary series of T1 tumours.