Intravesical gemcitabine for high risk, nonmuscle invasive bladder cancer after bacillus Calmette-Guérin treatment failure

Abstract

Purpose: We report our experience with intravesical gemcitabine for bladder cancer after failed bacillus Calmette-Guérin treatment.

Materials and methods: We retrospectively reviewed the records of patients at our cancer center treated with intravesical gemcitabine after bacillus Calmette-Guérin failure. We estimated progression-free, recurrence-free and cancer specific survival using the cumulative incidence function, considering death from another cause as a competing risk. Comparisons were made using the Gray test. Overall survival was estimated using the Kaplan-Meier method and differences were compared with the log rank test.

Results: Of 69 patients treated with intravesical gemcitabine 37 had bacillus Calmette-Guérin refractory disease. Median followup in progression-free patients was 3.3 years. Progression-free and cancer specific survival were similar in patients with refractory disease and those with other types of bacillus Calmette-Guérin failure. Overall survival was lower in patients with refractory disease (58% vs 71%) but this was not statistically significant (p=0.096). Of the patients 27 patients experienced a complete response. Progression-free, cancer specific and overall survival did not differ significantly between patients with and without a complete response. Cystectomy was subsequently performed in 20 patients. Those with a complete response had a delayed time to cystectomy and no muscle invasive bladder cancer at cystectomy. There were no serious adverse events and only a minority of patients discontinued treatment due to adverse events.

Conclusions: In our experience intravesical gemcitabine should be considered after bacillus Calmette-Guérin failure in patients with bladder cancer who refuse radical cystectomy or who are not candidates for major surgery.

Keywords: BCG; BCG vaccine; CIS; CR; CSS; MIBC; NMIBC; NR; OS; PFS; PR; RFS; bacillus Calmette-Guérin; cancer specific survival; carcinoma in situ; complete response; gemcitabine; muscle invasive bladder cancer; no response; nonMIBC; overall survival; partial response; progression-free survival; recurrence-free survival; treatment failure; urinary bladder; urinary bladder neoplasms.