The efficacy of BCG TICE and BCG Connaught in a cohort of 2,099 patients with T1G3 non–muscle-invasive bladder cancer

• Published in: Urologic oncology 2016-11, Vol.34 (11), p.484.e19-484.e25
• Main Authors: Witjes, J. Alfred, M.D., Ph.D, Dalbagni, Guido, M.D, Karnes, Robert J., M.D, Shariat, Shahrokh, M.D, Joniau, Steven, M.D., Ph.D, Palou, Joan, M.D., Ph.D, Serretta, Vincenzo, Ph.D, Larré, Stéphane, M.D, di Stasi, Savino, M.D., Ph.D, Colombo, Renzo, M.D., Ph.D, Babjuk, Marek, M.D., C.Sc, Malmström, Per-Uno, M.D, Malats, Nuria, M.D, Irani, Jacques, Ph.D, Baniel, Jack, Ph.D, Cai, Tommaso, M.D, Cha, Eugene, M.D, Ardelt, Peter, M.D, Varkarakis, John, Ph.D, Bartoletti, Riccardo, M.D, Spahn, Martin, M.D., Ph.D, Pisano, Francesca, M.D, Gontero, Paolo, M.D, Sylvester, Richard, M.D
• Format: Article
• Language: English
• Subjects: Adjuvants, Immunologic - therapeutic use; Administration, Intravesical; Aged; Aged, 80 and over; BCG Connaught; BCG Tice; BCG vaccine; BCG Vaccine - therapeutic use; bladder cancer; Carcinoma, Transitional Cell - pathology; Carcinoma, Transitional Cell - therapy; Drug Evaluation; Female; Follow-Up Studies; high grade; Humans; Immunotherapy; Immunotherapy, Active; Intravesical drug administration; Kaplan-Meier Estimate; Maintenance Chemotherapy; Male; Middle Aged; Neoplasm Grading; Neoplasm Invasiveness; Neoplasm Staging; progression; Proportional Hazards Models; Recurrence; Retrospective Studies; T1G3; Treatment Outcome; Urinary Bladder Neoplasms - pathology; Urinary Bladder Neoplasms - therapy; Urology
• ISSN: 1078-1439; 1873-2496; 1873-2496
• DOI: 10.1016/j.urolonc.2016.05.033

Abstract Background Potential differences in efficacy of different bacillus Calmette-Guérin (BCG) strains are of importance for daily practice, especially in the era of BCG shortage. Objective To retrospectively compare the outcome with BCG Connaught and BCG TICE in a large study cohort of pT1 high-grade non–muscle-invasive bladder cancer patients. Design, setting, and participants Individual patient data were collected for 2,451 patients with primary T1G3 tumors from 23 centers who were treated with BCG for the first time between 1990 and 2011. Outcome measurements and statistical analysis Using Cox multivariable regression and adjusting for the most important prognostic factors in this nonrandomized comparison, BCG Connaught and TICE were compared for time to recurrence, progression, and the duration of cancer specific survival and overall survival. Results and limitations Information on the BCG strain was available for 2,099 patients: 957 on Connaught and 1,142 on TICE. Overall, 765 (36%) patients received some form of maintenance BCG, 560 (59%) on Connaught and 205 (18%) on TICE. Without maintenance, Connaught was more effective than TICE only for the time to first recurrence (hazard ratio [HR] = 1.48; 95% CI: 1.20–1.82; P