title: Management of BCG non-responders with fixed dose intravesical gemcitabine in superficial transitional cell carcinoma of urinary bladder.
abstract: OBJECTIVE
  The incidence of bladder malignancy is increasing worldwide and the projected rise is 28% by 2010 for both sexes (WHO). Though intravesical adjuvant therapy with BCG is superior to any other immunotherapeutic/chemotherapeutic agent in reducing tumor recurrences and disease progression, its real efficacy remains controversial as one-third of the patients will soon become BCG failure. Hence there is a need for an alternative intravesical agent for treatment of BCG failure. Our aim was to study the efficacy, tolerability and safety of intravesical Gemcitabine in managing BCG-refractory superficial bladder malignancy.
  
  
  METHODS
  Thirty-five BCG failure patients, 26 males and nine females between 20-72 years of age were instilled with 2000 mg of Gemcitabine in 50 ml of normal saline intravesically two weeks post tumor resection, for six consecutive weeks. Mean follow-up was for 18 months with cystoscopies.
  
  
  RESULTS
  Twenty-one patients (60%) showed no recurrences, 11 patients (31.4%) had superficial recurrences while three patients (8.6%) progressed to muscle invasiveness. Average time to first recurrence was 12 months and to disease progression was 16 months. Adverse event was low and mild. Therapy was well tolerated.
  
  
  CONCLUSIONS
  Gemcitabine fulfils all requirements as an alternative agent, in treating BCG failure patients with low adverse events, is well tolerated and highly effective in reducing tumor recurrences.
authors.affiliation: Department of Urology, VM Medical College and Safdarjung Hospital, New Delhi, India.
authors.forename: N K
authors.initials: NK
authors.lastname: Mohanty
authors.forename: Rajiba L
authors.initials: RL
authors.lastname: Nayak
authors.forename: Pawan
authors.initials: P
authors.lastname: Vasudeva
authors.forename: R P
authors.initials: RP
authors.lastname: Arora