J Alfred Witjes1, Guido Dalbagni2, Robert J Karnes3, Shahrokh Shariat4, Steven Joniau5, Joan Palou6, Vincenzo Serretta7, Stéphane Larré8, Savino di Stasi9, Renzo Colombo10, Marek Babjuk11, Per-Uno Malmström12, Nuria Malats13, Jacques Irani14, Jack Baniel15, Tommaso Cai16, Eugene Cha17, Peter Ardelt18, John Varkarakis19, Riccardo Bartoletti20, Martin Spahn21, Francesca Pisano22, Paolo Gontero22, Richard Sylvester23. 1. Department of Urology, RadboudUMC, Nijmegen, The Netherlands. Electronic address: fred.witjes@radboudumc.nl. 2. Urology Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, NY. 3. Department of Urology, Mayo Clinic, Rochester, MN. 4. Department of Urology, Comprehensive Cancer Center Medical University Vienna, Vienna, Austria. 5. Oncologic and Reconstructive Urology, Department of Urology, University Hospitals Leuven, Leuven, Belgium. 6. Department of Urology, Fundacio Puigvert, University of Barcelona, Barcelona, Spain. 7. Department of Urology, Paolo Giaccone General Hospital, Palermo, Italy. 8. Department of Surgical Science, John Radcliffe Hospital, University of Oxford, Oxford, UK. 9. Policlinico Tor Vergata, University of Rome, Rome, Italy. 10. Dipartimento di Urologia, Universita` Vita-Salute, Ospedale S. Raffaele, Milan, Italy. 11. Department of Urology, Motol Hospital, 2nd Faculty of Medicine, Charles, University of Prague, Prague, Czech Republic. 12. Department of Surgical Sciences, Uppsala University, Uppsala, Sweden. 13. Department of Urology, Spanish National Cancer Research Centre-Madrid, Madrid, Spain. 14. Department of Urology, Centre Hospitalier Universitaire La Milétrie, University of Poitiers, Poitiers, France. 15. Institute of Urology, Rabin Medical Center, Petach Tikva and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. 16. Department of Urology, Santa Chiara Hospital, Trento, Italy. 17. Department of Urology, Weill Medical College of Cornell University, New York, NY; Urology Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, NY. 18. Facharzt fur Urologie, Abteilung fur Urologie, Chirurgische Universitatsklinik, Freiburg, Germany. 19. Department of Urology, Sismanoglio Hospital, University of Athens, Athens, Greece. 20. Urology Unit, S. Maria Annunziata Hospital, University of Florence, Florence, Italy. 21. Department of Urology, University Hospital of Wuerzburg, Wuertzburg, Germany. 22. Department of Surgical Sciences, Molinette Hospital, University of Studies of Turin, Turin, Italy. 23. Formerly Department of Biostatistics, EORTC Headquarters, Brussels, Belgium.
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<0.001). With maintenance, TICE was more effective than Connaught for the time to first recurrence (HR = 0.66; 95% CI: 0.47-0.93; P = 0.019) with a trend for cancer specific survival (HR = 0.36; 95% CI: 0.14-0.92; P = 0.033). For time to progression and overall survival, Connaught and TICE had a similar efficacy. Compared to no maintenance therapy, maintenance BCG significantly reduced the risk of recurrence, progression and death, both overall, and disease specific, for TICE, but not for Connaught. CONCLUSIONS: We found that BCG Connaught results in a lower recurrence rate as compared with BCG TICE when no maintenance is used. However, the opposite is true when maintenance is given. PATIENT SUMMARY: As there is currently a BCG shortage, information on the efficacy of different BCG strains is important. In this nonrandomized retrospective comparison in over 2,000 patients, we found that BCG Connaught reduces the recurrence rate compared to BCG TICE when no maintenance is used, but the opposite is true when maintenance is given.
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 cancerpatients. 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<0.001). With maintenance, TICE was more effective than Connaught for the time to first recurrence (HR = 0.66; 95% CI: 0.47-0.93; P = 0.019) with a trend for cancer specific survival (HR = 0.36; 95% CI: 0.14-0.92; P = 0.033). For time to progression and overall survival, Connaught and TICE had a similar efficacy. Compared to no maintenance therapy, maintenance BCG significantly reduced the risk of recurrence, progression and death, both overall, and disease specific, for TICE, but not for Connaught. CONCLUSIONS: We found that BCG Connaught results in a lower recurrence rate as compared with BCG TICE when no maintenance is used. However, the opposite is true when maintenance is given. PATIENT SUMMARY: As there is currently a BCG shortage, information on the efficacy of different BCG strains is important. In this nonrandomized retrospective comparison in over 2,000 patients, we found that BCG Connaught reduces the recurrence rate compared to BCG TICE when no maintenance is used, but the opposite is true when maintenance is given.
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