Control group and maintenance treatment with bacillus Calmette-Guerin for carcinoma in situ and/or high grade bladder tumors.
OBJECTIVE
Intravesical instillations of bacillus Calmette-Guerin have demonstrated satisfactory results in the treatment of vesical carcinoma in situ and high grade superficial bladder tumors. We designed a protocol to evaluate the decrease in tumor recurrence with maintenance therapy.


METHODS
Between June 1989 and May 1995 an initial course of 6 intravesical instillations of Connaught strain bacillus Calmette-Guerin was administered in patients with carcinoma in situ and/or high grade superficial bladder tumors. Six months later 131 disease-free patients were randomly assigned to a control group or a maintenance therapy group that received 6 instillations every 6 months (6 x 6) for a 2-year period.


RESULTS
Of the 126 evaluable patients at a mean followup of 79 months there were no significant differences in recurrence nor progression. A total of 16 patients (26.2%) in the control and 10 (15.1%) in the maintenance group had superficial relapse at a mean of 24 and 20 months, respectively (p = 0.07). Eight patients underwent radical cystectomy due to bladder contraction in 1, high grade superficial recurrence in 4 and disease progression in 3. Of the 65 patients on maintenance therapy 22 (33.85%) completed the planned 2-year treatment.


CONCLUSIONS
Six-month maintenance therapy in patients treated initially for carcinoma in situ and/or high grade superficial bladder tumors who are disease-free at 6 months did not significantly decrease recurrence or progression.
Palou
J
J
Department of Urology, Fundació Puigvert, Universitat Autónoma de Barcelona, Barcelona, Spain.
Laguna
P
P
Millán-Rodríguez
F
F
Hall
R R
RR
Salvador-Bayarri
J
J
Vicente-Rodríguez
J
J
D000328:Adult; D000368:Aged; D001500:BCG Vaccine / Q000627:therapeutic use*; D002278:Carcinoma in Situ / Q000628:therapy*; D002295:Carcinoma, Transitional Cell / Q000628:therapy*; D015653:Cystectomy; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007167:Immunotherapy; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D001749:Urinary Bladder Neoplasms / Q000628:therapy*
D001500:BCG Vaccine