MAINTENANCE BACILLUS CALMETTE-GUERIN IMMUNOTHERAPY FOR RECURRENT TA, T1 AND CARCINOMA IN SITU TRANSITIONAL CELL CARCINOMA OF THE BLADDER: A RANDOMIZED SOUTHWEST ONCOLOGY GROUP STUDY

No AccessJournal of UrologyCLINICAL UROLOGY: Original Articles1 Apr 2000MAINTENANCE BACILLUS CALMETTE-GUERIN IMMUNOTHERAPY FOR RECURRENT TA, T1 AND CARCINOMA IN SITU TRANSITIONAL CELL CARCINOMA OF THE BLADDER: A RANDOMIZED SOUTHWEST ONCOLOGY GROUP STUDY DONALD L. LAMM, BRENT A. BLUMENSTEIN, JOHN D. CRISSMAN, JAMES E. MONTIE, JAMES E. GOTTESMAN, BRUCE A. LOWE, MICHAEL F. SAROSDY, ROBERT D. BOHL, H. BARTON GROSSMAN, THOMAS M. BECK, JOSEPH T. LEIMERT, and E. DAVID CRAWFORD DONALD L. LAMMDONALD L. LAMM , BRENT A. BLUMENSTEINBRENT A. BLUMENSTEIN , JOHN D. CRISSMANJOHN D. CRISSMAN , JAMES E. MONTIEJAMES E. MONTIE , JAMES E. GOTTESMANJAMES E. GOTTESMAN , BRUCE A. LOWEBRUCE A. LOWE , MICHAEL F. SAROSDYMICHAEL F. SAROSDY , ROBERT D. BOHLROBERT D. BOHL , H. BARTON GROSSMANH. BARTON GROSSMAN , THOMAS M. BECKTHOMAS M. BECK , JOSEPH T. LEIMERTJOSEPH T. LEIMERT , and E. DAVID CRAWFORDE. DAVID CRAWFORD View All Author Informationhttps://doi.org/10.1016/S0022-5347(05)67707-5AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: Bacillus Calmette-Guerin (BCG) immunotherapy has been widely accepted as the optimal treatment for carcinoma in situ and high grade superficial transitional cell carcinoma. However, controversy remains regarding the role of maintenance therapy, and its long-term effect on recurrence and progression. Materials and Methods: All patients in the study had transitional cell carcinoma of the bladder with carcinoma in situ or an increased risk of recurrence. The criteria for increased risk were 2 or more episodes of tumor within the most recent year, or 3 or more tumors within 6 months. At least 1 week following biopsy of carcinoma in situ and resection of any stage Ta or T1 transitional cell tumors 660 patients were started on a 6-week induction course of intravesical and percutaneous Connaught BCG. Three months following initiation of BCG induction therapy 550 consenting patients were stratified by purified protein derivative skin test and the presence of carcinoma in situ, and then randomized by central computer to receive BCG maintenance therapy (maintenance arm) or no BCG maintenance therapy (no maintenance arm). Maintenance therapy consisted of intravesical and percutaneous BCG each week for 3 weeks given 3, 6, 12, 18, 24, 30 and 36 months from initiation of induction therapy. The 384 eligible patients who were disease-free at randomization constitute the primary intent to treat analytic group because they could be followed for disease recurrence. All patients were followed for adverse effects of treatment, recurrence, disease worsening and survival. Results: No toxicities above grade 3 were noted in the 243 maintenance arm patients. The policy of withholding maintenance BCG from patients with increased side effects may have diminished the opportunity to observe severe toxicity. Estimated median recurrence-free survival was 35.7 months (95% confidence interval 25.1 to 56.8) in the no maintenance and 76.8 months (64.3 to 93.2) in the maintenance arm (log rank p <0.0001). Estimated median time for worsening-free survival, defined as no evidence of progression including pathological stage T2 disease or greater, or the use of cystectomy, systemic chemotherapy or radiation therapy, was 111.5 months in the no maintenance and not estimable in the maintenance arm (log rank p = 0.04). Overall 5-year survival was 78% in the no maintenance compared to 83% in the maintenance arm. 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Volume 163Issue 4April 2000Page: 1124-1129 Advertisement Copyright & Permissions© 2000 by American Urological Association, Inc.Keywordscarcinoma, transitional cellbladder neoplasmsbladdercarcinoma in situ, immunotherapyMetricsAuthor Information DONALD L. LAMM More articles by this author BRENT A. BLUMENSTEIN More articles by this author JOHN D. CRISSMAN More articles by this author JAMES E. MONTIE More articles by this author JAMES E. GOTTESMAN More articles by this author BRUCE A. LOWE More articles by this author MICHAEL F. SAROSDY More articles by this author ROBERT D. BOHL More articles by this author H. BARTON GROSSMAN More articles by this author THOMAS M. BECK More articles by this author JOSEPH T. LEIMERT More articles by this author E. DAVID CRAWFORD More articles by this author Expand All Advertisement PDF downloadLoading ...