Gemcitabine Single Agent for Recurrent Post Bladder Preservation Therapy and in Metastatic Transitional Cell Carcinoma of Urinary Bladder in Elderly Patients with Renal Impairment

Purpose : The objectives of the study are to evaluate efficacy (ORR, PFS, & OS) and toxicity of single-agent gemcitabine in recurrent post conservative therapy and in the metastatic transitional cell carcinoma of the urinary bladder in elderly patients with a renal impairment. Patients and Methods: Between March 2014 and September 2016 , Fourteen patients have recurrent post conservative therapy & in metastatic transitional cell cancer of the urinary bladder in elderly patients with renal impairment were included to receive single-agent gemcitabine (1,000 mg/m2) administered weekly times three on a 4-week cycle. The median age was 74.5 years. The majority of patients (57.2%) have metastatic disease at diagnosis also a majority of patients (57.2%) have a solitary metastatic disease. The median overall treatment period was 14 weeks (range: 4-24 weeks). Results: Overall response rate was 35.7% (CR 7.1% + PR 28.6%). Median-Progression Free Survival was 20 weeks (95% CI: 95% CI: 8.313- 31.687). Median Overall survival rates were 40 weeks (95% CI: 28.313-51.687). 50% of patients experienced at least one grade 1 or 2 neutropenia and 71.5% of patients developed thrombocytopenia and no patient (0%) required hospitalization during therapy for neutropenic fever or dehydration . 50% patients required treatment delayed at least one week due to treatment toxicity. Conclusion: The single agent Gemcitabine had significant improvement in response rate, progression-free survival and overall survival with good tolerance and manageable toxicity.