Long-term Survival Outcomes With Intravesical Nanoparticle Albumin-bound Paclitaxel for Recurrent Non–muscle-invasive Bladder Cancer After Previous Bacillus Calmette-Guérin Therapy
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Elsevier Inc.
Abstract
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. © 2017 Elsevier Inc.
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Adjuvants, immunologic, Administration, intravesical, Aged, Albumins, Antineoplastic agents, Bcg vaccine, Carcinoma, transitional cell, Cystectomy, Dose-response relationship, drug, Drug monitoring, Female, Humans, Kaplan-meier estimate, Male, Nanoparticles, Neoplasm invasiveness, Neoplasm recurrence, local, Paclitaxel, Survival rate, Treatment outcome, Urinary bladder neoplasms, Albumin, Gemcitabine, Mitomycin, Nanoparticle, Valrubicin, 130-nm albumin-bound paclitaxel, Albuminoid, Antineoplastic agent, Immunological adjuvant, Adult, Article, Bcg vaccination, Cancer patient, Cancer recurrence, Cancer specific survival, Cancer survival, Clinical article, Follow up, Human, Kaplan meier method, Long term survival, Maintenance therapy, Non muscle invasive bladder cancer, Overall survival, Phase 2 clinical trial, Priority journal, Recurrence free survival, Salvage therapy, Transitional cell carcinoma, Treatment duration, Treatment response, Bladder tumor, Clinical trial, Dose response, Drug therapy, Intravesical drug administration, Pathology, Procedures, Tumor invasion, Tumor recurrence