Delayed high-dose intravesical epirubicin therapy of superficial bladder cancer. A way to reduce the side effects and increase the efficacy--a phase 2 trial.
BACKGROUND
Intravesical epirubicin is a widely used agent for the treatment of superficial bladder cancer. A direct relationship between dose and activity has been reported: unfortunately the dose increase also increased the frequency and the intensity of treatment-related side effects.


METHODS
A phase 2 trial was designed to evaluate the toxicity and the activity of a delayed (biweekly) high-dose (80 mg) epirubicin therapy of superficial bladder cancer. Thirty patients with intermediate risk superficial bladder cancer (stage mTa, G2) have been treated with transurethral resection and epirubicin intravesical therapy: the patients were given 80 mg epirubicin in 50 ml sterile saline every 2 weeks for 6 times (delayed regimen). The follow-up ranged from 3 to 26 months. Eleven of 30 (37%) patients experienced a local adverse reaction to intravesical epirubicin requiring specific medication (grade > or = 2 according to NCI-CTC v.2.0, 1999). No systemic toxicity related to the treatment was observed.


RESULTS
Out of the 29 evaluable patients, 22 (76%) were free of disease after the induction course, 6 (21%) had superficial bladder cancer recurrences and 1 (3%) experienced tumor progression.


CONCLUSIONS
A delayed (biweekly instillation) high-dose (80 mg) intravesical epirubicin regimen was acceptable in terms of side effects and showed a worthwhile therapeutical impact in patients with intermediate risk superficial bladder cancer.
Bassi
PierFrancesco
P
Department of Urology, University of Padova Medical School, Padova, Italy. bassipf@unipd.it
Spinadin
Renato
R
Longo
Fabrizio
F
Saraeb
Salim
S
Pappagallo
Giovanni Luigi
GL
Zattoni
Filiberto
F
Pagano
Francesco
F
D000283:Administration, Intravesical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D015251:Epirubicin / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy*
D000903:Antibiotics, Antineoplastic; D003692:Delayed-Action Preparations; D015251:Epirubicin