Evaluation of principles in intravesical chemo- and immunotherapy for superficial bladder cancer.

There is still much controversy about the diagnostics and therapy of carcinoma in situ (TIS/CIS) of the bladder. Reliance on cytological possibilities in the primary diagnosis and grading varies in separate centres. Hence, the small series published hitherto are often incomparable due to different start points and end points of trials. We regard cytology as the key examination in TIS. Complete response (CR) and progressive disease (PD) are end points which can be defined by histology/cytology and the timer factor. Our philosophy concerning the evaluation of therapy-principles in superficial bladder cancer is mainly based on our own experience. The efficacy of MMC and of BCG was equally modest in the Finnbladder I study: the CRs 38% and 40%; the PDs 8% and 20%, respectively. The interim of the ongoing Finnbladder II study are more promising after 6 months follow-up: the CR with MMC 67% and with alternating therapy with MMC and BCG 80%; there were no progressions so far. The primary grade of TIS has been a significant prognostic factor for instillation therapy in our earlier series of 62 pts since 1976. There were no progressions of grade I but 19% of grade II and 13% of grade III. A wide consensus of concepts dominates as to the superficial bladder cancer (Ta-T1). The recurrence rate (RR) and the recurrence index (RI/m) as the end points of prophylactic trials are capable of indicating the recurrence-preventive efficacy of different instillations, allow the use of a patient as his own control, and are suitable for statistical evaluation (table I).(ABSTRACT TRUNCATED AT 250 WORDS)