A Retrospective Analysis to Evaluate the Effectiveness, Safety and Tolerability of Intravesical Valrubicin for the Treatment of Bladder Carcinoma in Situ in Clinical Practice
Initial treatment for bladder CIS is TURBT followed by intravesical immunotherapy with BCG.
Valrubicin is approved by the FDA for the treatment of BCG-refractory bladder CIS in
patients for whom immediate cystectomy would be associated with unacceptable morbidity or
mortality. The recommended course of therapy is 6 doses of 800 mg each administered
intravesically once a week. While the benefit risk profile of valrubicin has been
established in several clinical trials, current data on effectiveness and tolerability when
used in clinical practice are lacking. This protocol outlines a retrospective study to
evaluate the effectiveness, safety and tolerability of intravesical valrubicin in the
treatment of NMIBC in a clinical practice setting.
Observational Model: Case-Only, Time Perspective: Retrospective
Event-free survival defined as recurrence, progression or death from any cause
Michael Cookson, MD
United States: Institutional Review Board
|Vanderbilt University||Nashville, Tennessee 37232-6305|