Phase II study to investigate the ablative efficacy of intravesical administration of gemcitabine in intermediate-risk superficial bladder cancer (SBC).
OBJECTIVE
Phase I studies have so far demonstrated that intravesical Gemcitabine up to a 40 mg/ml concentration is well tolerated and has a substantial ablative activity on high-risk BCG refractory SBC. New treatment options are needed for intermediate-risk SBC recurring after conventional intravesical treatments. The purpose of the present study was to investigate the ablative efficacy of intravesical Gemcitabine on intermediate-risk SBC.


METHODS
The study was designed as a two-stage phase II trial, with a sample size of 39 patients. The efficacy of intravesical Gemcitabine at a concentration of 40 mg/ml (2000 mg in 50 ml saline solution) administered weekly for 6 weeks was assessed on a single marker tumour left in the bladder after a complete TUR of all other lesions. Patients underwent TUR or biopsy at the site of the marker lesion 2 weeks after completion of the treatment.


RESULTS
Complete response was observed in 22 out of 39 patients (56%). No progression was observed among the 17 non-responders. Neither systemic nor local side effects generally exceeded grade I toxicity.


CONCLUSIONS
The ablative effect of Gemcitabine produced a higher number of responses than the minimum required by the protocol to indicate a significant probability of drug efficacy. It is worth testing the drug in phase III trials to assess for durability of response.
Department of Medical Sciences, Urology Clinic, University of Piemonte Orientale, Via Solaroli, 17, 28100 Novara, Italy. paolo.gontero@med.unipmn.it
Paolo
P
Gontero
Giovanni
G
Casetta
Gloria
G
Maso
Filippo
F
Sogni
Giuliano
G
Pretti
Andrea
A
Zitella
Bruno
B
Frea
Alessandro
A
Tizzani
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; D006801:Humans; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy*; D000093542:Gemcitabine
D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine