The efficacy of BCG TICE and BCG Connaught in a cohort of 2,099 patients with T1G3 non muscle-invasive bladder cancer
Por:
Witjes, JA, Dalbagni, G, Karnes, RJ, Shariat, S, Joniau, S, Palou, J, Serretta, V, Larre, S, di Stasi, S, Colombo, R, Babjuk, M, Malmstrom, PU, Malats, N, Irani, J, Baniel, J, Cai, T, Cha, EGN, Ardelt, P, Varkarakis, J, Bartoletti, R, Spahn, M, Pisano, F, Gontero, P, Sylvester, R
Publicada:
1 nov 2016
Resumen:
Background: Potential differences in efficacy of different bacillus Calmette-Guerin (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. (C) 2016 Elsevier Inc. All rights reserved.
Filiaciones:
Witjes, JA:
Radboudumc, Dept Urol, Nijmegen, Netherlands
Dalbagni, G:
Mem Sloan Kettering Canc Ctr, Dept Surg, Urol Serv, New York, NY 10021 USA
Karnes, RJ:
Mayo Clin, Dept Urol, Rochester, MN USA
Shariat, S:
Med Univ Vienna, Ctr Comprehens Canc, Dept Urol, Vienna, Austria
Joniau, S:
Univ Hosp Leuven, Dept Urol, Oncol & Reconstruct Urol, Leuven, Belgium
Palou, J:
Univ Barcelona, Fundacio Puigvert, Dept Urol, Barcelona, Spain
Serretta, V:
Paolo Giaccone Gen Hosp, Dept Urol, Palermo, Italy
Larre, S:
Univ Oxford, John Radcliffe Hosp, Dept Surg Sci, Oxford, England
di Stasi, S:
Univ Rome, Policlin Tor Vergata, Rome, Italy
Colombo, R:
Univ Vita Salute, Dipartimento Urol, Osped S Raffaele, Milan, Italy
Babjuk, M:
Univ Prague, Fac Med 2, Motol Hosp, Dept Urol, Prague, Czech Republic
Malmstrom, PU:
Uppsala Univ, Dept Surg Sci, Uppsala, Sweden
Malats, N:
Spanish Natl Canc Res Ctr Madrid, Dept Urol, Madrid, Spain
Irani, J:
Univ Poitiers, CHU La Miletrie, Dept Urol, Poitiers, France
Baniel, J:
Rabin Med Ctr, Inst Urol, Petah Tiqwa, Israel
Tel Aviv Univ, Sackler Fac Med, Tel Aviv, Israel
Cai, T:
Santa Chiara Hosp, Dept Urol, Trento, Italy
Cha, EGN:
Mem Sloan Kettering Canc Ctr, Dept Surg, Urol Serv, New York, NY 10021 USA
Cornell Univ, Weill Med Coll, Dept Urol, New York, NY USA
Ardelt, P:
Chirurg Univ Klin, Urol Abt, Facharzt Urol, Freiburg, Germany
Varkarakis, J:
Univ Athens, Sismanoglio Hosp, Dept Urol, Athens, Greece
Bartoletti, R:
Univ Florence, S Maria Annunziata Hosp, Urol Unit, Florence, Italy
Spahn, M:
Univ Hosp Wuerzburg, Dept Urol, Wuertzburg, Germany
Pisano, F:
Univ Studies Turin, Molinette Hosp, Dept Surg Sci, Turin, Italy
Gontero, P:
Univ Studies Turin, Molinette Hosp, Dept Surg Sci, Turin, Italy
Sylvester, R:
EORTC Headquarters, Dept Biostat, Brussels, Belgium
Green Accepted, Green Published
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