Multi-Institution Evaluation of Sequential Intravesical Gemcitabine and Docetaxel in the Treatment of Bacillus Calmette-Guerin Naïve Patients with Non-Muscle Invasive Bladder Cancer

Abstract

<h2>Abstract</h2><h3>Introduction</h3> <b>:</b> Single agent intravesical chemotherapy regimens have historically compared unfavorably to Bacillus Calmette-Guerin (BCG) as initial treatment following resection for patients with high-risk non-muscle invasive bladder cancer (NMIBC). However, there have been few reports of multi-agent intravesical chemotherapy regimens in this setting. Our objective is to determine the efficacy of sequential intravesical gemcitabine and docetaxel (Gem/Doce) in BCG naïve patients with NMIBC. <h3>Patients and Methods</h3> <b>:</b> Collaborating institutions retrospectively identified patients with NMIBC who were treated with Gem/Doce between 6/2009 and 5/2018. An sub-cohort of patients without prior BCG and treated with Gem/Doce was identified. Treatment consisted of 6 weekly instillations of gemcitabine (1 gram/50mL) followed immediately by docetaxel (37.5 mg/50mL). Maintenance was utilized at the discretion of the treating physician. Recurrence-free survival (RFS), progression (PFS), and overall survival (OS) were assessed. Treatment tolerance and discontinuation were also evaluated. Statistical analysis was descriptive in nature. <h3>Results</h3> <b>:</b> Sixty-five patients were treated, with median age 75 years and median follow-up of 15.2 months. 77% had high-grade disease and 40% had carcinoma in-situ (CIS). RFS was 82%, 76%, and 66% at 6, 12 and 24 months respectively. Amongst patients with high-grade disease, high-grade RFS was 85%, 78%, and 66% at 6, 12, and 24 months respectively. One patient progressed to muscle-invasive bladder cancer. Limitations include the retrospective study design, small cohort size, and lack of a comparator arm. <h3>Conclusion</h3> : Intravesical Gem/Doce may be an effective treatment for BCG naïve NIMBC and warrants further investigation. <h3>MicroAbstract</h3> <b>:</b> BCG is the gold-standard adjuvant treatment following TURBT for high-risk NMIBC. Unfortunately, ongoing production shortages have diminished BCG availability. In a multi-institutional retrospective cohort of 65 patients, we f 56098[mound sequential intravesical gemcitabine and docetaxel (Gem/Doce) provided significant relief of recurrence (66% RFS at 2-years) and was well-tolerated (97% finished a full induction). Prospective evaluation of Gem/Doce is underway.