Bacillus Calmette-Guerin Versus Doxorubicin Versus Thiotepa: A Randomized Prospective Study in 202 Patients with Superficial Bladder Cancer

No AccessJournal of Urology1 Mar 1990Bacillus Calmette-Guerin Versus Doxorubicin Versus Thiotepa: A Randomized Prospective Study in 202 Patients with Superficial Bladder Cancer Jose A. Martínez Piñeiro, Julio Jimenéz León, Luis Martínez Piñeiro, Luis Fiter, José A. Mosteiro, Javier Navarro, María J. García Matres, and Paloma Cárcamo Jose A. Martínez PiñeiroJose A. Martínez Piñeiro More articles by this author , Julio Jimenéz LeónJulio Jimenéz León More articles by this author , Luis Martínez PiñeiroLuis Martínez Piñeiro More articles by this author , Luis FiterLuis Fiter More articles by this author , José A. MosteiroJosé A. Mosteiro More articles by this author , Javier NavarroJavier Navarro More articles by this author , María J. García MatresMaría J. García Matres More articles by this author , and Paloma CárcamoPaloma Cárcamo More articles by this author View All Author Informationhttps://doi.org/10.1016/S0022-5347(17)40002-4AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail We report the second interim analysis of data from a randomized prospective trial comparing the prophylactic effect of 15 courses of 50mg. doxorubicin, 50mg. thiotepa or 150mg. bacillus Calmette-Guerin instilled intravesically against recurrences and progression of superficial transitional cell bladder cancer. Of 202 enrolled patients 176 currently are evaluable with a mean followup of 3 years (range 3 to 97 months). The number of patients with recurrences was significantly lower in the bacillus Calmette-Guerin arm (9 of 67) compared to the doxorubicin (23 of 53, p equals 0.002) and thiotepa (20 of 56, p equals003) arms. The over-all recurrence index per 100 patient-months also was lower for the bacillus Calmette-Guerin versus the thiotepa and doxorubicin groups (0.53 versus 1.55 and 1.7, respectively). Bacillus Calmette-Guerin also was superior in preventing recurrences and progression of high risk tumors, that is stage Tl, grade 3 or multiple growths, associated or not with carcinoma in situ. In the stage Tl category 19 of 32 (60%) tumors recurred under treatment with doxorubicin, 11 of 33 (33%) with thiotepa and 6 of 49 (12%) with bacillus Calmette-Guerin. Toxicity to intravesical bacillus Calmette-Guerin was higher compared to the other drugs but it was not limiting: bladder irritability and malaise occurred in 42% of the patients, granulomatous cystitis in 16.4% and bladder contraction in 1.4% (1 of 64). The latter complication occurred in a patient whose stage Tim grade 2 tumors had recurred 3 times, who underwent 3 transurethral bladder resections within 15 months and who had received thiotepa for 4 months after having been removed from the study 11 months after entry. Three patients in the doxorubicin group (5.6%) underwent radical cystectomy for local urothelial progression. One patient (1.8%) in the same group died of distant progression. Our preliminary results suggest that at the dose, periodicity and duration used in the study bacillus Calmette-Guerin is significantly superior to the chemotherapeutic agents doxorubicin and thiotepa for the prophylaxis of recurrence and retardation of progression in superficial transitional cell bladder tumors. © 1990 by The American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 143Issue 3March 1990Page: 502-506 Advertisement Copyright & Permissions© 1990 by The American Urological Association Education and Research, Inc.MetricsAuthor Information Jose A. Martínez Piñeiro More articles by this author Julio Jimenéz León More articles by this author Luis Martínez Piñeiro More articles by this author Luis Fiter More articles by this author José A. Mosteiro More articles by this author Javier Navarro More articles by this author María J. García Matres More articles by this author Paloma Cárcamo More articles by this author Expand All Advertisement Loading ...