Thirty-five patients (33 males, median age 58) with stage Talpha (21 p
atients) or T1, grade 1 (17 patients) or grade 2 superficial bladder c
arcinoma, were treated with transurethral resection (TUR) followed by
intravesical prophylactic therapy with 10 mg mitoxantrone administered
weekly for 6 weeks and then monthly for 10 months. Twenty-five patien
ts were newly diagnosed and 10 had relapsed after previous therapy. Di
agnosis was confirmed with cytology and biopsy. The aim of the study w
as to evaluate the prophylactic effect (relapse rate, disease free int
erval) and toxicity of intravesical mitoxantrone in superficial bladde
r carcinoma. Relapses were established with biopsy. After a mean perio
d of 12 months follow-up (median 8.3 months), 63% of patients in the w
hole group, 72% in the newly diagnosed group and 40% in the group of p
reviously relapsed patients remained relapse free. These rates compare
very favorably with the most effective prophylactic agents available.
At the end of the follow-up period the median disease-free survival f
or the whole group was not reached. Therapy was well tolerated with no
systemic toxicity and 14 patients reporting grade 1-2 local toxicity.
In no patient was treatment discontinued due to toxicity. Mitoxantron
e is an effective and safe agent for the post-TUR adjuvant intravesica
l therapy.