Safety and tolerance of intravesical gemcitabinedocetaxel as salvage therapy for bladder cancer: Our institutional experience.

Abstract

Introduction and objectives: Nonsurgical therapeutic options for patients with BCG-refractory nonmuscle invasive bladder cancer (NMIBC) are limited. However, sequential administration of intravesical gemcitabine-docetaxel is shown to have had a 49% 1-year high-grade recurrence free survival in patients with BCG-refractory NMIBC. We describe our initial experience with the administration of intravesical gemcitabine-docetaxel therapy at our institution. Method(s): Two patients who were treated with intravesical gemcitabinedocetaxel under the emergency therapeutic protocol at our institution were prospectively followed up. Patients were treated with 6 weekly induction instillations of gemcitabine (1g), followed immediately by docetaxel (37.5mg) and toxicity, quality of life and IPSS questionnaires were assessed before, during and after intravesical therapy. Result(s): Patient 1 was an 81-year-old man with BCG refractory NMIBC. He had persistent high-grade T1 and carcinoma in situ (CIS) despite 2 courses of induction BCG. Due to his significant medical co-morbidities of ischaemic heart disease, hypertension, type 2 diabetes and obstructive sleep apnoea, he was deemed to be highrisk for a radical cystectomy. Therefore, he was treated with an induction course of intravesical gemcitabine-docetaxel. Patient 2 was a 71-year old female with severe chronic obstructive pulmonary disease (COPD) on home oxygen who recently presented with haematuria. She had previously received immunotherapy for metastatic bladder cancer and had been in remission since achieving complete response for the last 5 years. At transurethral resection of bladder tumour (TURBT), she had a tumour at the dome at the bladder, which was difficult to fully resect. Her histology demonstrated high-grade Ta urothelial carcinoma and CIS and had no evidence of metastatic disease. Given her high-risk for surgery and previously having failed BCG, she was treated with an induction course of intravesical gemcitabine-docetaxel. Both patients tolerated the intravesical gemcitabine-docetaxel and completed the induction courses of therapy without significant toxicity or adverse events. Both patients experienced mild urinary frequency and urgency. Patient 2 had ongoing haematuria prior to the therapy, which immediately settled at the end of therapy but developed dysuria, fevers and bladder spasms for two weeks during the treatment course, which resolved. At baseline, patient 1 had an IPSS score of 10 and quality of life score of 4 while patient 2 had scores of 4 and 1 respectively. There were no changes in patients' quality of life score and IPSS before, during and after intravesical therapy. Conclusion(s): Our initial experience with sequential intravesical gemcitabine and docetaxel demonstrates that it appears to be safe and well tolerated in patients with refractory NMIBC at our institution.