A controlled prospective trial on 99 eligible patients evaluated the e
fficacy of intravesical epirubicin administration as prophylaxis again
st tumor recurrences after complete endoscopic resection of superficia
l bladder cancer. The treatment schedule consisting of an initial 6- o
r 8-week course of instillations, followed by single maintenance doses
(to the responders) at follow-up examinations, was modified in those
of the initial responders who were at high risk for recurrence and who
received an additional separate 4-week course of therapy. Sixty perce
nt of the epirubicin-treated patients and 41 % of the controls (who un
derwent resection alone) remained free of recurrences for a mean follo
w-up of 32.1 months, but the difference was not significant. However,
in terms of relative risk for recurrences (recurrence rate per 100 pat
ient-months and disease-free interval), comparisons between the two gr
oups of patients revealed a significant benefit of epirubicin, overall
as well as for those with a history of previous tumor recurrences, mu
ltifocal disease, and stage Ta and grade 2 neoplasms. Drug-induced tox
icity was acceptable.