Second-Line Intravesical Gemcitabine in High Risk Superficial Bladder Cancer: Our Experience

Purpose Intravesical instillation of Gemcitabine may represent a useful second-line chemotherapy in case of non-muscle-invasive bladder cancer. Herein, we reported our experience with intravesical Gemcitabine in a group of patients affected by high-grade transitional cell carcinoma (TCC) of the bladder. Materials and Methods We retrospectively analyzed a total of 17 patients (15 males and 2 females), affected by high-risk superficial bladder cancer, who were refractory, intolerant or not eligible to intravesical BCG immunotherapy. Each patient received 2000 mg of Gemcitabine diluted in 100 mL of 0.9% saline solution, administered twice a week for 6 weeks. At start, TCC stage and grade were: CIS in 10 patients, TaG3 in 5 and T1G3 in the remaining 2 cases. Those with no macroscopic lesion and negative cytology and histology were considered as complete responders; those with only positive cytology as partial responders, and those with positive biopsy or evidence of macroscopic lesions as non-responders. Results Patients’ mean age was 71.5 yrs (± 7.3 yrs standard deviation). Overall, median follow-up was 12 months [interquartile range (IQR) 9–15 months]. A complete remission was achieved in 10 cases (58.8%), a partial response in 2 (11.8%), while 5 patients (29.4%) were considered as non-responders. Tumor stage and/or grade progression was observed in 26.7% of the cases. Overall, the 6-month recurrence-free survival was 33.3%. Drug toxicity was relatively low: 2 patients developed a grade II dysuria (NCI-CTC criteria); fever >38° was observed in 1 case. Conclusions Although our experience and follow-up are still rather limited to formulate any conclusive assessment, our study seems to confirm that Gemcitabine could be used as a safe and efficient intravesical chemotherapy agent even in high grade TCCs, representing a promising second-line option in those cases who failed, were intolerant or not eligible to BCG therapy. (Urologia 2009; 76: 178–84)