BACKGROUND: To evaluate the efficacy of intravesical Gemcitabine as a second line treatment in patients with high risk transitional cell carcinoma of the bladder (Tis, TaG3, T1G2-3) who have failed both intravesical BCG and/ or BCG/ Interferon alpha.
METHODS: A total of 20 patients were analyzed. Nine patients presented with Cis, two with T1G3/Cis, two with TaG3/Cis, three with T1G2 and four patients with T1G3 disease. Gemcitabine (1000mg in 50ml sterile water) was instilled into the bladder and retained for 2 hours. Treatments were administered weekly with 6-8 treatments in total (one patient tolerated only 4 treatments). Cystoscopy with biopsy/ resection and bladder wash was performed 4 weeks post-treatment and at three month intervals thereafter. Following their induction course patients received monthly maintenance instillations.
RESULTS: The efficacy of gemcitabine exposure was defined as time to recurrence or progression necessitating definitive therapy. The median follow-up for all patients was 7.4 months (range, 1 to 25.7 months). Complete response rate was 60% (12/20 pt.). Eleven patients experienced high risk recurrences with subsequent need for definitive treatment. One patient remains disease free at 7 month. Median time to recurrence was 17.5 month (range 7.8 to 25.7 month). Of patients that recurred five have so far undergone radical cystectomy with locally confined disease. Eight patients showed no response to Gemcitabine treatment of which seven underwent radical cystectomy with locally confined disease on final pathology..
CONCLUSIONS: Gemcitabine appears to be an acceptable step to delay or avoid to cystectomy following failure after BCG and or BCG/ Interferon alpha treatment. Even though all responders but one eventually failed delay of cystectomy has not been associated with distant disease.