CHEMORESECTION IN TA-T1 BLADDER-CANCER

Objectives: The authors present the results of two parallel phase II t rials, insti tuted by the EORTC Genito-Urinary Group in 1986, whose ai ms were to assess the tolerability and ablative capacity of mitomycin C (study 30864) and epirubicin (study 30869) in patients with multiple primary or recurrent Ta-T1 bladder cancer. Methods: A well-defined tu mour (marker lesion) was left in the bladder after transurethral resec tion (TUR). All patients received 8 weekly instillations, after which cystoscopy with bladder biopsies +/- TUR was performed, Responses were rated as follows: (1) complete - no visible or microscopic bladder ca ncer; (2)no change - persistence of the marker lesion; (3) progression - increased marker lesion size, new tumour(s) or presence of muscle-i nvasive disease at any site, Results: Ninety-six evaluable patients we re treated with mitomycin and 36 with epirubicin. The overall bladder response in the former group was complete in 50%, no change in 30% and progression in 20% of patients, while the marker lesion response was complete in 57%, no change in 39% and progression in 4%. In the epirub icin group, 56% of the patients achieved a complete overall response, while there was no change in 22% and progression in 22%. The marker le sion response in this group was complete in 67%, no change in 31% and progression in 3%. Only 2 cases of progression were due to the presenc e of muscle-invasive disease. Both of these were in the mitomycin grou p; 1 was at the marker lesion site, and 1 was at a remote site. Conclu sions: The present studies confirm the feasibility and safety of the m arker lesion model for the objective evaluation of the antitumoural ac tivity of intravesically administered drugs.