Outcomes, safety and tolerability of intravesical gemcitabine-docetaxel as salvage therapy for non-muscle invasive bladder cancer: Our institutional experience.

Abstract

INTRODUCTION AND OBJECTIVES: Non-surgical therapeutic options for BCG-refractory non-muscle invasive bladder cancer (NMIBC) are limited. However, sequential administration of intravesical gemcitabine-docetaxel demonstrates a 49% 1-year high-grade recurrence-free survival in patients with BCG-refractory NMIBC. We describe our initial experience with intravesical gemcitabine-docetaxel therapy. METHOD(S): Two patients treated with intravesical gemcitabine-docetaxel under the emergency therapeutic protocol at our institution were prospectively reviewed. The treatment protocol was 6-weekly induction instillations of gemcitabine (1g), followed by docetaxel (37.5mg). Outcomes, toxicity, quality of life (QOL) and IPSS questionnaires were assessed. RESULT(S): Patient 1 was an 81-year-old male with BCG refractory high-grade T1 and carcinoma in situ (CIS), deemed a high-risk surgical candidate due to his significant medical co-morbidities. Following induction gemcitabinedocetaxel therapy, cystoscopy demonstrated no residual disease at 2 months post-therapy. Patient 2 was a 71-year old female with multiple medical comorbidities. She previously received immunotherapy for metastatic bladder cancer followed by remission. However, she presented with haematuria and a high-grade Ta urothelial tumour at the bladder dome (which was difficult to resect fully) but no metastatic disease. Given her high risk for surgery and previously having failed BCG, she was treated with an induction course of intravesical gemcitabine-docetaxel. While this treatment settled her haematuria, she had persistent disease in the bladder and developed a new adnexal mass with progressive lymphadenopathy. Both patients completed induction therapy without significant toxicity, experiencing only mild urinary frequency and urgency. Pre-treatment, patient 1 reported an IPSS score of 10 and QOL score of 4 while patient 2 scored 4 and 1 respectively. There were no changes in patients' QOL score and IPSS before, during, and after intravesical therapy. CONCLUSION(S): Our initial experience with intravesical gemcitabine-docetaxel demonstrates that it appears to be safe and well-tolerated in patients with refractory NMIBC. Variability in the outcomes appears to depend on the patients' pre-treatment disease stage.