The objective was to conduct a US multicenter, retrospective medical record study examining the effectiveness, safety, and patterns of use of
valrubicin for treatment of nonmuscle-invasive
bladder cancer (
NMIBC) by clinicians since the 2009 reintroduction of
valrubicin.
METHODS: Patients ≥ 18 years with
NMIBC who received had one or more instillations of
valrubicin (October 2009- September 2011) were eligible. The primary endpoint was event-free survival (EFS). Safety and tolerability were also assessed.
RESULTS: The medical records of 113 patients met the inclusion criteria; 100 patients (88.5%) completed
valrubicin treatment. The median age was 75 years (range 42-95 years). The median
NMIBC duration was 31 months since diagnosis: 51.3% (58/113) had
carcinoma in situ (CIS) alone, and 31.9% (36/113) had unspecified
NMIBC. Most patients, 94.7% (107/113), had more than three
valrubicin instillations and 70.8% (80/113) completed a full course. The EFS rate (95% confidence interval) was 51.6% (40.9-61.3%), 30.4% (20.4-41.1%), and 16.4% (7.9-27.5%) at 3, 6, and 12 months, respectively. Median time to an event was 3.5 (2.5-4.0) months after the first
valrubicin instillation. Local adverse reactions (LARs) were experienced by 49.6% (56/113) of patients; most LARs were mild (93.6%). The most frequent LARs were
hematuria, pollakiuria, micturition urgency, bladder
spasm, and
dysuria. In total, 4.4% (5/113) of patients discontinued
valrubicin because of adverse events or LARs.
CONCLUSIONS: Data from the present retrospective study are consistent with previous prospective clinical trials that demonstrated
valrubicin effectiveness and tolerability for select patients with CIS, before considering
cystectomy. Additional prospective studies are warranted to evaluate
valrubicin safety and efficacy in the broader patient population with
NMIBC.