Cancer and Oncology Research 4(4): 64-72, 2016 http://www.hrpub.org DOI: 10.13189/cor.2016.040402 Gemcitabine Single Agent for Recurrent Post Bladder Preservation Therapy and in Metastatic Transitional Cell Carcinoma of Urinary Bladder in Elderly Patients with Renal Impairment Haider Y. Shukur Middle Euphrates Cancer Center of Clinical Oncology (MECC), Faculty of Medicine, Ibn Hayyan Medical University, Iraq Copyright©2016 by authors, all rights reserved. Authors agree that this article remains permanently open access under the terms of the Creative Commons Attribution License 4.0 International License Abstract 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/m 2 ) 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. Keywords Recurrent Bladder Cancer, Transitional Cell Carcinoma, First-line Therapy, Gemcitabine, Chemotherapy, Metastasis 1. Introduction The incidence of bladder cancer is increasing. An estimated 74,000 new cases of urinary bladder cancer will be diagnosed in the United States (56,320 men and 17,680 women) in 2015. [1] Bladder cancer, the sixth most common cancer, is three times more prevalent in men than in women in the United States. During the same period, approximately 16,000 deaths (11,510 men and 4490 women) will result from bladder cancer.[2] Bladder cancers are rarely diagnosed in individuals younger than 40 years of age. Because the median age at diagnosis is 65 years, medical co-morbidities are a frequent consideration in patient management. [3] The highest incidence is observed in Egypt with 37 cases per 100,000 inhabitants. Smoking is the most implicated risk factor in western countries, followed by other factors such as polycyclic aromatic hydrocarbons and cyclophosphamide. [4] In East Africa (especially Egypt), chronic infection with Schistosoma haematobium is the most common etiology and is often associated with squamous cell carcinoma. [5] More than 90% of urothelial tumors originate in the urinary bladder, 8% originate in the renal pelvis, and the remaining 2% originate in the ureter and urethra. Urothelial (transitional cell) carcinomas, the most predominant histological type which represents more than 90% of the cases in the United States, may develop anywhere transitional epithelium is present, from the renal pelvis to the ureter, bladder, and proximal two-thirds of the urethra. [6,7] The clinical spectrum of bladder cancer can be divided into 3 categories that differ in prognosis, management, and therapeutic aims. The first category consists of non-muscle-invasive tumors (epithelium, Ta; lamina propria, T1; or carcinoma in situ, Tis) which is managed with complete transurethral resection of the bladder tumor (TURBT) with or without intravesical therapy where goal of the treatment is directed at reducing recurrences and preventing progression to a more advanced stage. [8]