Login to Access Video or Poster Abstract: MP15-13
Sources of Funding: none

Introduction

Intravesical therapy is the first line treatment for non-muscle invasive bladder cancer (NMIBC) however response rates are not durable and response rates to second-line intravesical therapy are 20 percent or less in this population. The next step in management includes radical cystectomy with urinary diversion however many patients do not undergo cystectomy due to comorbid diseases or because of patient refusal. A preclinical murine intravesical trial using gemcitabine, cisplatin and a taxane found the combination therapy to be superior to single-agents alone. Thus there is a strong rationale for a multimodal combination intravesical regimen of these agents.

Methods

Patients with BCG refractory or recurrent high-risk (high-grade Ta or high/low grade T1 or CIS with any grade) non-muscle invasive bladder cancer who refused or were ineligible for radical cystectomy were enrolled. All patients underwent a pre-treatment transurethral resection of bladder tumor and then received a 6-week regimen of multi-agent intravesical chemotherapy. All patients received the same dose of gemcitabine (2000mg) while the dose of cisplatin and cabazitaxel were escalated as shown in table 1. Toxicity was categorized according to Common Terminology Criteria for Adverse Events v4. After treatment, patient response is assessed via random biopsy and urine cytology. Complete responders (negative biopsy and cytology at six weeks after induction) are eligible for 1 year of monthly maintenance therapy at the doses they received during the trial.

Results

Median age of the 9 patients was 74 years (table 1) and the median number of prior intravesical therapies was 4 (range 2-5). All patients completed 6 weeks of induction CGC. Any local toxicity was found in 7 patients with 5 experiencing at least 1 grade 1 toxicity and 4 experiencing at least 1 grade 2 toxicity. Seven of eight patients were complete responders.

Conclusions

Cabazitaxel, gemcitabine and cisplatin appears to be a well-tolerated intravesical salvage chemotherapy regimen for the treatment of BCG-refractory non-muscle invasive bladder cancer.

Funding

none