Abstract
Objective: To evaluate the safety, tolerability and efficacy of adjuvant intravesical gemcitabine versus bacillus Calmette-Guérin (BCG) in the treatment of high-risk superficial bladder cancer. Method: 64 patients with high-risk superficial bladder cancer (pT1 and/or G3 and/or CIS) were assigned to interventions (gemcitabine or BCG) in a randomised controlled trial. All the patients were evaluated for recurrence and progression rates (primary endpoint) and safety and tolerability (secondary endpoint). Results: The two groups were comparable in terms of baseline characteristics. Tolerability was better for gemcitabine, whereas the BCG group experienced the need for delayed treatment or withdrawal in 12.5% of cases. At a mean follow-up of 44 months, the recurrence rate in patients treated with BCG was 28.1%; the recurrence rate in patients who received gemcitabine was 53.1% (p = 0.037). Time to recurrence was shorter in patients treated with BCG (25.6 vs. 39.4 months, p = 0.042). No patients developed disease progression. Conclusions: Gemcitabine is significantly inferior to BCG, but given its favourable toxicity profile, it may be useful for patients intolerant to or otherwise unable to receive BCG.
| Original language | English |
|---|---|
| Pages (from-to) | 23-27 |
| Number of pages | 5 |
| Journal | Urologia Internationalis |
| Volume | 84 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - Feb 2010 |
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Keywords
- Bacillus Calmette-Guérin
- Gemcitabine
- Superficial bladder cancer, therapy
ASJC Scopus subject areas
- Urology
Cite this
Bacillus calmette-guérin versus gemcitabine for intravesical therapy in high-risk superficial bladder cancer : A randomised prospective study. / Porena, Massimo; Del Zingaro, Michele; Lazzeri, Massimo; Mearini, Luigi; Giannantoni, Antonella; Bini, Vittorio; Costantini, Elisabetta.
In: Urologia Internationalis, Vol. 84, No. 1, 02.2010, p. 23-27.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Bacillus calmette-guérin versus gemcitabine for intravesical therapy in high-risk superficial bladder cancer
T2 - A randomised prospective study
AU - Porena, Massimo
AU - Del Zingaro, Michele
AU - Lazzeri, Massimo
AU - Mearini, Luigi
AU - Giannantoni, Antonella
AU - Bini, Vittorio
AU - Costantini, Elisabetta
PY - 2010/2
Y1 - 2010/2
N2 - Objective: To evaluate the safety, tolerability and efficacy of adjuvant intravesical gemcitabine versus bacillus Calmette-Guérin (BCG) in the treatment of high-risk superficial bladder cancer. Method: 64 patients with high-risk superficial bladder cancer (pT1 and/or G3 and/or CIS) were assigned to interventions (gemcitabine or BCG) in a randomised controlled trial. All the patients were evaluated for recurrence and progression rates (primary endpoint) and safety and tolerability (secondary endpoint). Results: The two groups were comparable in terms of baseline characteristics. Tolerability was better for gemcitabine, whereas the BCG group experienced the need for delayed treatment or withdrawal in 12.5% of cases. At a mean follow-up of 44 months, the recurrence rate in patients treated with BCG was 28.1%; the recurrence rate in patients who received gemcitabine was 53.1% (p = 0.037). Time to recurrence was shorter in patients treated with BCG (25.6 vs. 39.4 months, p = 0.042). No patients developed disease progression. Conclusions: Gemcitabine is significantly inferior to BCG, but given its favourable toxicity profile, it may be useful for patients intolerant to or otherwise unable to receive BCG.
AB - Objective: To evaluate the safety, tolerability and efficacy of adjuvant intravesical gemcitabine versus bacillus Calmette-Guérin (BCG) in the treatment of high-risk superficial bladder cancer. Method: 64 patients with high-risk superficial bladder cancer (pT1 and/or G3 and/or CIS) were assigned to interventions (gemcitabine or BCG) in a randomised controlled trial. All the patients were evaluated for recurrence and progression rates (primary endpoint) and safety and tolerability (secondary endpoint). Results: The two groups were comparable in terms of baseline characteristics. Tolerability was better for gemcitabine, whereas the BCG group experienced the need for delayed treatment or withdrawal in 12.5% of cases. At a mean follow-up of 44 months, the recurrence rate in patients treated with BCG was 28.1%; the recurrence rate in patients who received gemcitabine was 53.1% (p = 0.037). Time to recurrence was shorter in patients treated with BCG (25.6 vs. 39.4 months, p = 0.042). No patients developed disease progression. Conclusions: Gemcitabine is significantly inferior to BCG, but given its favourable toxicity profile, it may be useful for patients intolerant to or otherwise unable to receive BCG.
KW - Bacillus Calmette-Guérin
KW - Gemcitabine
KW - Superficial bladder cancer, therapy
UR - http://www.scopus.com/inward/record.url?scp=77649131471&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=77649131471&partnerID=8YFLogxK
U2 - 10.1159/000273461
DO - 10.1159/000273461
M3 - Article
C2 - 20173364
AN - SCOPUS:77649131471
VL - 84
SP - 23
EP - 27
JO - Urologia Internationalis
JF - Urologia Internationalis
SN - 0042-1138
IS - 1
ER -