Objective: To report long-term follow-up results of a phase II trial of salvage intravesical nanoparticle albumin-bound (nab)-paclitaxel for patients with recurrent non-muscle-invasive bladder cancer after previous intravesical bacillus Calmette-Guérin (BCG) therapy.
Methods: This was a phase II trial investigating the use of intravesical nab-paclitaxel in patients with recurrent Tis, Ta, and T1 urothelial carcinoma who failed at least 1 prior induction course of intravesical BCG. Patients received 500 mg/100 mL of nab-paclitaxel in 6 weekly intravesical instillations. Complete responders were offered full-dose maintenance for 6 months. Overall survival, recurrence-free survival, cystectomy-free survival, and cancer-specific survival were assessed via Kaplan-Meier analysis.
Results: A total of 28 patients were enrolled with a median follow-up of 41 months (range 5-76). There were 22 men and 6 women with a median age of 79 (range 36-93), and the median number of prior intravesical therapies was 2. Twenty-one of the 28 patients (75%) were BCG refractory. Ten of the 28 patients (36%) achieved complete response. Six of the 28 patients remain cancer free, with a recurrence-free survival rate of 18%. Five-year overall and cancer-specific survival rates were 56% and 91%, respectively. Radical cystectomy occurred in 11 of the 28 patients (39%), of whom 2 out of 11 (18%) had pT2 or greater disease.
Conclusion: With a median follow-up of 41 months, 18% of this cohort treated with nab-paclitaxel was disease free. Cystectomy-free survival was 61% and bladder cancer-specific mortality was 9%. Nab-paclitaxel is a reasonable treatment option in this high-risk population.
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