CLINICAL-SIGNIFICANCE OF NEGATIVE AND EQUIVOCAL URINARY-BLADDER CYTOLOGY ALONE AND IN COMBINATION WITH DNA IMAGE-ANALYSIS AND CYSTOSCOPY

BACKGROUND. We evaluated the individual and combined ability of cytolo gy (CYT), image analysis (IA), and cystoscopy (CYSTO) to predict the p resence of transitional cell carcinoma (TCC) at 6 months of follow-up in patients with or without a prior history of urothelial carcinoma an d negative (NEG) or equivocal (atypical or suspicious) urinary CYT. ME THODS. Fifty-one patients (43 with prior TCC) provided 57 urinary samp les that were evaluated by CYT and DNA IA. Forty-nine patients were ev aluated by CYSTO. Disease status was reassessed at 6 months by a combi nation of clinical, CYSTO, CYT, and histologic follow-up. RESULTS. At 6 months' follow-up, the incidence of recurrence for patients with dip loid, broad diploid, or aneuploid DNA histograms was 38%, 73%, and 100 %, respectively. In the same group of patients, 43% of patients with N EG and ''atypicaI'' CYT recurred compared with 83.3% of patients with ''suspicious'' CYT. The predictive value (PV) of a positive (+) CYSTO evaluation was 100%; however. a NEG CYSTO examination was correct in o nly 73% of cases. Sensitivities of CYT, IA, and CYSTO to predict recur rence were 54%, 59%, and 62.5%, respectively, whereas the combined sen sitivity of all three modalities was 72%. The +PV of combined CYT and IA in patients with prior TCC was 90% with aneuploidy 100% specific fo r malignancy; the NEG PV of combined CYT, IA, and CYSTO was 70%. CYT, IA, and CYSTO were highly significant in predicting recurrence (P = 0. 0017, P = 0.0026, and P = 0.0002, respectively) whereas tumor grade an d degree of invasiveness as assessed on initial biopsy were not signif icant. However, 11% of patients recurred between 6 months to 1 year wh o had NEG CYT, NEG CYSTO, and NEG IA. CONCLUSIONS, Diagnostic accuracy increases in patients with NEG or equivocal CYT if supplemented by DN A I4 and CYSTO. In patients with no history of TCC, equivocal urine CY T and/or abnormal DNA IA can occur after chemotherapy, radiation thera py, or viral infection. In these patients, the combined approach toget her with accurate history is essential for correct diagnosis. For the small subpopulation of patients who recur but demonstrate no abnormali ties on combined testing, more sensitive diagnostic tests, such as chr omosomal abnormalities by in situ hybridization, need to be developed. (C) 1997 American Cancer Society.