The first 2 authors contributed equally to this article.
Gemcitabine versus bacille Calmette-Guérin after initial bacille Calmette-Guérin failure in non-muscle-invasive bladder cancer†‡
A multicenter prospective randomized trial
Article first published online: 16 FEB 2010
Copyright © 2010 American Cancer Society
Volume 116, Issue 8, pages 1893–1900, 15 April 2010
How to Cite
Di Lorenzo, G., Perdonà, S., Damiano, R., Faiella, A., Cantiello, F., Pignata, S., Ascierto, P., Simeone, E., De Sio, M. and Autorino, R. (2010), Gemcitabine versus bacille Calmette-Guérin after initial bacille Calmette-Guérin failure in non-muscle-invasive bladder cancer. Cancer, 116: 1893–1900. doi: 10.1002/cncr.24914
We thank Boldface Editors for linguistic revision.
Contributions to the study were as follows: conception and design, Autorino, Di Lorenzo, Perdonà; acquisition of data, Autorino, Cantiello, Di Lorenzo; analysis and interpretation of data, Autorino, De Sio, Di Lorenzo, Perdonà, Pignata; drafting the manuscript, Autorino, Di Lorenzo; critical revision of the manuscript for important intellectual content, Ascierto, Damiano, De Sio, Simeone; statistical analysis, Di Lorenzo, Faiella; supervision, Perdonà; patient enrollment, Autorino, Cantiello, Faiella, Perdonà, Simeone.
- Issue published online: 6 APR 2010
- Article first published online: 16 FEB 2010
- Manuscript Accepted: 9 JUL 2009
- Manuscript Revised: 22 JUN 2009
- Manuscript Received: 15 APR 2009
- bacille Calmette-Guérin;
- superficial bladder cancer
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).
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.
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.
Gemcitabine might represent a second-line treatment option after BCG failure in high-risk non-muscle-invasive BC patients. Cancer 2010. © 2010 American Cancer Society.