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

J. Alfred Witjes, Guido Dalbagni, Robert Jeffrey Karnes, Shahrokh Shariat, Steven Joniau, Joan Palou, Vincenzo Serretta, Stéphane Larré, Savino di Stasi, Renzo Colombo, Marek Babjuk, Per Uno Malmström, Nuria Malats, Jacques Irani, Jack Baniel, Tommaso Cai, Eugene Cha, Peter Ardelt, John Varkarakis, Riccardo Bartoletti & 4 others Martin Spahn, Francesca Pisano, Paolo Gontero, Richard Sylvester

Research output: Contribution to journalArticle

24 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)484.e19-484.e25
JournalUrologic Oncology: Seminars and Original Investigations
Volume34
Issue number11
DOIs
StatePublished - Nov 1 2016

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Urinary Bladder Neoplasms
Bacillus
Maintenance
Recurrence
Survival
Neoplasms
Cohort Studies

Keywords

  • BCG Connaught
  • BCG Tice
  • BCG vaccine
  • bladder cancer
  • high grade
  • Immunotherapy
  • Intravesical drug administration
  • progression
  • recurrence
  • T1G3

ASJC Scopus subject areas

  • Oncology
  • Urology

Cite this

The efficacy of BCG TICE and BCG Connaught in a cohort of 2,099 patients with T1G3 non–muscle-invasive bladder cancer. / Witjes, J. Alfred; Dalbagni, Guido; Karnes, Robert Jeffrey; Shariat, Shahrokh; Joniau, Steven; Palou, Joan; Serretta, Vincenzo; Larré, Stéphane; di Stasi, Savino; Colombo, Renzo; Babjuk, Marek; Malmström, Per Uno; Malats, Nuria; Irani, Jacques; Baniel, Jack; Cai, Tommaso; Cha, Eugene; Ardelt, Peter; Varkarakis, John; Bartoletti, Riccardo; Spahn, Martin; Pisano, Francesca; Gontero, Paolo; Sylvester, Richard.

In: Urologic Oncology: Seminars and Original Investigations, Vol. 34, No. 11, 01.11.2016, p. 484.e19-484.e25.

Research output: Contribution to journalArticle

Witjes, JA, Dalbagni, G, Karnes, RJ, Shariat, S, Joniau, S, Palou, J, Serretta, V, Larré, S, di Stasi, S, Colombo, R, Babjuk, M, Malmström, PU, Malats, N, Irani, J, Baniel, J, Cai, T, Cha, E, Ardelt, P, Varkarakis, J, Bartoletti, R, Spahn, M, Pisano, F, Gontero, P & Sylvester, R 2016, 'The efficacy of BCG TICE and BCG Connaught in a cohort of 2,099 patients with T1G3 non–muscle-invasive bladder cancer', Urologic Oncology: Seminars and Original Investigations, vol. 34, no. 11, pp. 484.e19-484.e25. https://doi.org/10.1016/j.urolonc.2016.05.033
Witjes, J. Alfred ; Dalbagni, Guido ; Karnes, Robert Jeffrey ; Shariat, Shahrokh ; Joniau, Steven ; Palou, Joan ; Serretta, Vincenzo ; Larré, Stéphane ; di Stasi, Savino ; Colombo, Renzo ; Babjuk, Marek ; Malmström, Per Uno ; Malats, Nuria ; Irani, Jacques ; Baniel, Jack ; Cai, Tommaso ; Cha, Eugene ; Ardelt, Peter ; Varkarakis, John ; Bartoletti, Riccardo ; Spahn, Martin ; Pisano, Francesca ; Gontero, Paolo ; Sylvester, Richard. / The efficacy of BCG TICE and BCG Connaught in a cohort of 2,099 patients with T1G3 non–muscle-invasive bladder cancer. In: Urologic Oncology: Seminars and Original Investigations. 2016 ; Vol. 34, No. 11. pp. 484.e19-484.e25.
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abstract = "Background Potential differences in efficacy of different bacillus Calmette-Gu{\'e}rin (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.",
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TY - JOUR

T1 - The efficacy of BCG TICE and BCG Connaught in a cohort of 2,099 patients with T1G3 non–muscle-invasive bladder cancer

AU - Witjes, J. Alfred

AU - Dalbagni, Guido

AU - Karnes, Robert Jeffrey

AU - Shariat, Shahrokh

AU - Joniau, Steven

AU - Palou, Joan

AU - Serretta, Vincenzo

AU - Larré, Stéphane

AU - di Stasi, Savino

AU - Colombo, Renzo

AU - Babjuk, Marek

AU - Malmström, Per Uno

AU - Malats, Nuria

AU - Irani, Jacques

AU - Baniel, Jack

AU - Cai, Tommaso

AU - Cha, Eugene

AU - Ardelt, Peter

AU - Varkarakis, John

AU - Bartoletti, Riccardo

AU - Spahn, Martin

AU - Pisano, Francesca

AU - Gontero, Paolo

AU - Sylvester, Richard

PY - 2016/11/1

Y1 - 2016/11/1

N2 - 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.

AB - 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.

KW - BCG Connaught

KW - BCG Tice

KW - BCG vaccine

KW - bladder cancer

KW - high grade

KW - Immunotherapy

KW - Intravesical drug administration

KW - progression

KW - recurrence

KW - T1G3

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