Intravesical gemcitabine therapy for superficial transitional cell carcinoma: results of a Phase II prospective multicenter study.
OBJECTIVE
To determine the tolerability and efficacy after 1 year of weekly intravesical gemcitabine therapy in patients with intermediate-risk and high-risk superficial transitional cell carcinoma.


METHODS
A total of 116 patients with intermediate-risk and high-risk bladder cancer who had undergone transurethral resection were treated with one cycle (once a week for 6 weeks) of gemcitabine 2000 mg. Local and systemic tolerability and efficacy were evaluated.


RESULTS
In terms of the tolerability of gemcitabine, 14 patients (12.0%) reported urgency, 6 (5.1%) dizziness and slight fever (less than 38 degrees C), 1 (0.8%) severe abdominal pain, with ulcerative lesions of the bladder mucosa at cystoscopy, and 1 (0.8%) parosmia. The remaining 94 patients (81.3%) did not report any local side effects during the treatment period. In terms of efficacy, recurrence developed in 29 patients (25.4%) a mean of 7 months after transurethral resection; 85 patients (74.6%) were disease free after 12 months. The univariate analysis showed a greater level of efficacy in patients with a first occurrence (P = 0.0408), patients who had had no previous treatment (P = 0.0368), and patients with Stage pTa superficial transitional cell carcinoma (P = 0.0018). The multivariate analysis did not reveal any significant data. No significant differences were found between the intermediate-risk and high-risk patients in tolerability or efficacy. No recurrence developed in 18 (75%) of 24 intermediate-risk bacille Calmette-Guérin-refractory or 7 (43.7%) of 16 high-risk bacille Calmette-Guérin-refractory patients.


CONCLUSIONS
The results of our study have confirmed the good tolerability and 1 year efficacy of intravesical gemcitabine. The treatment schedule proposed resulted in high patient compliance, and the results can be compared with the results of studies using other intravesical treatments.
Bartoletti
Riccardo
R
Department of Urology, University of Florence, Florence, Italy. bartoletti@unifi.it
Cai
Tommaso
T
Gacci
Mauro
M
Giubilei
Gianluca
G
Viggiani
Fabrizio
F
Santelli
Giorgio
G
Repetti
Fabio
F
Nerozzi
Stefano
S
Ghezzi
Paolo
P
Sisani
Michele
M
D000283:Administration, Intravesical; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012307:Risk Factors; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy*; D000093542:Gemcitabine
D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine