Gemcitabine versus bacille Calmette-Guérin after initial bacille Calmette-Guérin failure in non-muscle-invasive bladder cancer: A multicenter prospective randomized trial

Giuseppe Di Lorenzo, Sisto Perdonà, Rocco Damiano, Adriana Faiella, Francesco Cantiello, Sandro Pignata, Paolo Ascierto, Ester Simeone, Marco De Sio, Riccardo Autorino

Research output: Contribution to journalArticle

Abstract

BACKGROUND: The efficacy of intravesical gemcitabine was evaluated compared with repeated administration of bacille Calmette-Guérin (BCG) after BCG failure in high-risk, non-muscle-invasive bladder cancer (BC). METHODS: In this multicenter, prospective, randomized, phase 2 trial, eligible patients were those with high-risk non-muscle-invasive BC, failing 1 course of BCG therapy. All patients were randomly allocated to Group A, receiving intravesical gemcitabine (at a dose of 2000 mg/50 mL) twice weekly for 6 consecutive weeks and then weekly for 3 consecutive weeks at 3, 6, and 12 months, or Group B, receiving intravesical BCG (Connaught strain, 81 mg/50 mL) over a 6-week induction course and each week for 3 weeks at 3, 6, and 12 months. Outcome measures were recurrence rate, time to first recurrence, and progression rate. Treatment-related complications were also evaluated. RESULTS: Eighty participants were enrolled, 40 for each group 52.5% in Group A developed disease recurrence versus 87.5% of those in Group B (P = .002). There was no statistically significant difference in mean time to the first recurrence (Group A, 3.9 months; Group B, 3.1 months; P = .09). Kaplan-Meier analysis of 2-year recurrence-free survival showed significant differences between Group A and B (19% and 3%, respectively, P <.008). Seven of 21 (33%) patients in Group A and 13 of 35 (37.5%) patients in Group B had disease progression and underwent radical cystectomy (P = .12). Both intravesical administrations were generally well tolerated. CONCLUSIONS: Gemcitabine might represent a second-line treatment option after BCG failure in high-risk non-muscle-invasive BC patients.

Original languageEnglish
Pages (from-to)1893-1900
Number of pages8
JournalCancer
Volume116
Issue number8
DOIs
Publication statusPublished - Apr 15 2010

Fingerprint

gemcitabine
Urinary Bladder Neoplasms
Recurrence
Intravesical Administration
Cystectomy
Kaplan-Meier Estimate
Disease Progression
Therapeutics
Outcome Assessment (Health Care)
Survival

Keywords

  • Bacille Calmette-Guérin
  • Failure
  • Gemcitabine
  • Superficial bladder cancer

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Gemcitabine versus bacille Calmette-Guérin after initial bacille Calmette-Guérin failure in non-muscle-invasive bladder cancer : A multicenter prospective randomized trial. / Di Lorenzo, Giuseppe; Perdonà, Sisto; Damiano, Rocco; Faiella, Adriana; Cantiello, Francesco; Pignata, Sandro; Ascierto, Paolo; Simeone, Ester; De Sio, Marco; Autorino, Riccardo.

In: Cancer, Vol. 116, No. 8, 15.04.2010, p. 1893-1900.

Research output: Contribution to journalArticle

@article{6d91022f7a3c424fb0bba680682e4ef0,
title = "Gemcitabine versus bacille Calmette-Gu{\'e}rin after initial bacille Calmette-Gu{\'e}rin failure in non-muscle-invasive bladder cancer: A multicenter prospective randomized trial",
abstract = "BACKGROUND: The efficacy of intravesical gemcitabine was evaluated compared with repeated administration of bacille Calmette-Gu{\'e}rin (BCG) after BCG failure in high-risk, non-muscle-invasive bladder cancer (BC). METHODS: In this multicenter, prospective, randomized, phase 2 trial, eligible patients were those with high-risk non-muscle-invasive BC, failing 1 course of BCG therapy. All patients were randomly allocated to Group A, receiving intravesical gemcitabine (at a dose of 2000 mg/50 mL) twice weekly for 6 consecutive weeks and then weekly for 3 consecutive weeks at 3, 6, and 12 months, or Group B, receiving intravesical BCG (Connaught strain, 81 mg/50 mL) over a 6-week induction course and each week for 3 weeks at 3, 6, and 12 months. Outcome measures were recurrence rate, time to first recurrence, and progression rate. Treatment-related complications were also evaluated. RESULTS: Eighty participants were enrolled, 40 for each group 52.5{\%} in Group A developed disease recurrence versus 87.5{\%} of those in Group B (P = .002). There was no statistically significant difference in mean time to the first recurrence (Group A, 3.9 months; Group B, 3.1 months; P = .09). Kaplan-Meier analysis of 2-year recurrence-free survival showed significant differences between Group A and B (19{\%} and 3{\%}, respectively, P <.008). Seven of 21 (33{\%}) patients in Group A and 13 of 35 (37.5{\%}) patients in Group B had disease progression and underwent radical cystectomy (P = .12). Both intravesical administrations were generally well tolerated. CONCLUSIONS: Gemcitabine might represent a second-line treatment option after BCG failure in high-risk non-muscle-invasive BC patients.",
keywords = "Bacille Calmette-Gu{\'e}rin, Failure, Gemcitabine, Superficial bladder cancer",
author = "{Di Lorenzo}, Giuseppe and Sisto Perdon{\`a} and Rocco Damiano and Adriana Faiella and Francesco Cantiello and Sandro Pignata and Paolo Ascierto and Ester Simeone and {De Sio}, Marco and Riccardo Autorino",
year = "2010",
month = "4",
day = "15",
doi = "10.1002/cncr.24914",
language = "English",
volume = "116",
pages = "1893--1900",
journal = "Cancer",
issn = "0008-543X",
publisher = "John Wiley and Sons Inc.",
number = "8",

}

TY - JOUR

T1 - Gemcitabine versus bacille Calmette-Guérin after initial bacille Calmette-Guérin failure in non-muscle-invasive bladder cancer

T2 - A multicenter prospective randomized trial

AU - Di Lorenzo, Giuseppe

AU - Perdonà, Sisto

AU - Damiano, Rocco

AU - Faiella, Adriana

AU - Cantiello, Francesco

AU - Pignata, Sandro

AU - Ascierto, Paolo

AU - Simeone, Ester

AU - De Sio, Marco

AU - Autorino, Riccardo

PY - 2010/4/15

Y1 - 2010/4/15

N2 - BACKGROUND: The efficacy of intravesical gemcitabine was evaluated compared with repeated administration of bacille Calmette-Guérin (BCG) after BCG failure in high-risk, non-muscle-invasive bladder cancer (BC). METHODS: In this multicenter, prospective, randomized, phase 2 trial, eligible patients were those with high-risk non-muscle-invasive BC, failing 1 course of BCG therapy. All patients were randomly allocated to Group A, receiving intravesical gemcitabine (at a dose of 2000 mg/50 mL) twice weekly for 6 consecutive weeks and then weekly for 3 consecutive weeks at 3, 6, and 12 months, or Group B, receiving intravesical BCG (Connaught strain, 81 mg/50 mL) over a 6-week induction course and each week for 3 weeks at 3, 6, and 12 months. Outcome measures were recurrence rate, time to first recurrence, and progression rate. Treatment-related complications were also evaluated. RESULTS: Eighty participants were enrolled, 40 for each group 52.5% in Group A developed disease recurrence versus 87.5% of those in Group B (P = .002). There was no statistically significant difference in mean time to the first recurrence (Group A, 3.9 months; Group B, 3.1 months; P = .09). Kaplan-Meier analysis of 2-year recurrence-free survival showed significant differences between Group A and B (19% and 3%, respectively, P <.008). Seven of 21 (33%) patients in Group A and 13 of 35 (37.5%) patients in Group B had disease progression and underwent radical cystectomy (P = .12). Both intravesical administrations were generally well tolerated. CONCLUSIONS: Gemcitabine might represent a second-line treatment option after BCG failure in high-risk non-muscle-invasive BC patients.

AB - BACKGROUND: The efficacy of intravesical gemcitabine was evaluated compared with repeated administration of bacille Calmette-Guérin (BCG) after BCG failure in high-risk, non-muscle-invasive bladder cancer (BC). METHODS: In this multicenter, prospective, randomized, phase 2 trial, eligible patients were those with high-risk non-muscle-invasive BC, failing 1 course of BCG therapy. All patients were randomly allocated to Group A, receiving intravesical gemcitabine (at a dose of 2000 mg/50 mL) twice weekly for 6 consecutive weeks and then weekly for 3 consecutive weeks at 3, 6, and 12 months, or Group B, receiving intravesical BCG (Connaught strain, 81 mg/50 mL) over a 6-week induction course and each week for 3 weeks at 3, 6, and 12 months. Outcome measures were recurrence rate, time to first recurrence, and progression rate. Treatment-related complications were also evaluated. RESULTS: Eighty participants were enrolled, 40 for each group 52.5% in Group A developed disease recurrence versus 87.5% of those in Group B (P = .002). There was no statistically significant difference in mean time to the first recurrence (Group A, 3.9 months; Group B, 3.1 months; P = .09). Kaplan-Meier analysis of 2-year recurrence-free survival showed significant differences between Group A and B (19% and 3%, respectively, P <.008). Seven of 21 (33%) patients in Group A and 13 of 35 (37.5%) patients in Group B had disease progression and underwent radical cystectomy (P = .12). Both intravesical administrations were generally well tolerated. CONCLUSIONS: Gemcitabine might represent a second-line treatment option after BCG failure in high-risk non-muscle-invasive BC patients.

KW - Bacille Calmette-Guérin

KW - Failure

KW - Gemcitabine

KW - Superficial bladder cancer

UR - http://www.scopus.com/inward/record.url?scp=77950986756&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=77950986756&partnerID=8YFLogxK

U2 - 10.1002/cncr.24914

DO - 10.1002/cncr.24914

M3 - Article

C2 - 20162706

AN - SCOPUS:77950986756

VL - 116

SP - 1893

EP - 1900

JO - Cancer

JF - Cancer

SN - 0008-543X

IS - 8

ER -