This is an observational study involving a retrospective review of medical records of adult patients who have been treated with intravesical valrubicin for bladder carcinoma in situ (CIS) since October 2009.
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.
Study Type
OBSERVATIONAL
Enrollment
113
Vanderbilt University
Nashville, Tennessee, United States
Event-free survival
Event-free survival defined as recurrence, progression or death from any cause
Time frame: 12 months
Worsening-free Survival
Worsening-free survival defined as recurrence, progression, cystectomy, change of anti-bladder cancer therapy or death from any cause
Time frame: 12 months
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