Intravesicle gemcitabine in management of BCG refractory superficial TCC of urinary bladder-our experience.
BACKGROUND
The incidence of bladder malignancy is increasing worldwide and the projected rise is 28% by 2010 for both sexes (according to the WHO). Though intravesical adjuvant therapy with bacillus Calmette-Guérin (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 develop BCG failure. Hence, there is a need for an alternative intravesical agent for treatment of BCG failure. Our aim is 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 9 females between 20 and 72 years of age were instilled 2000 mg of gemcitabine in 50 ml of normal saline intravesically 2 weeks post-tumor resection, for 6 consecutive weeks. Mean follow-up for 18 months with cystoscopy was done.


RESULTS
Twenty-one patients (60%) showed no recurrences, 11 patients (31.4%) had superficial recurrences, while 3 patients (8.75%) 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 fulfills all requirements as an alternative agent in treating BCG failure patients with low adverse events, well tolerated, and highly effective in reducing tumor recurrences.
Mohanty
Nayan Kumar
NK
Department of Urology, V.M. Medical College and Safdarjang Hospital, New Delhi, India. nayankm@yahoo.co.in
Nayak
Rajiba L
RL
Vasudeva
Pawan
P
Arora
Rajender P
RP
D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage*; D001500:BCG Vaccine / Q000008:administration & dosage*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy*; D000093542:Gemcitabine
D000964:Antimetabolites, Antineoplastic; D001500:BCG Vaccine; D003841:Deoxycytidine; D000093542:Gemcitabine