Local immunotherapy of superficial bladder cancer by intravesical instillation of recombinant interleukin-2
Tubaro, A.; Stoppacciaro, A.; Velotti, F.; Bossola, P.C.; Cusumano, G.; Vicentini, C.; De Carli, P.; Ruco, L.; Santoni, A.; Cancrini, A.
European Urology 28(4): 297-303
1995
ISSN/ISBN: 0302-2838 PMID: 8575496 Document Number: 441378
Local immunotherapy of superficial bladder cancer by endovesical administration of recombinant interleukin-2 (rIL-2) was investigated in a phase I-II study. Twenty-five patients with Ta-T1, N0, M0, G1-G2 transitional cell carcinoma of the bladder received an induction course of rIL-2 (10 daily instillations) with the tumor in place using an interpatient dose escalation scheme from 3 to 18 times 10-6 IU/day. Seven to fourteen days after the end of the induction course, the objective clinical response was evaluated and transurethral resection of the bladder tumor was carried out. Four maintenance courses (10 daily instillations) were started 1 month after surgery and carried out every 4 months at a dose of 6 times 10-6 IU/day in all patients. Follow-up visits were scheduled bimonthly during treatment and then every 6 months. No evidence of laboratory, local or systemic toxicity was observed even at the highest rIL-2 dosages. Induction of a local inflammatory response could be demonstrated at the tumor site after intravesical rIL-2 treatment. The significant reduction in tumor diameters observed in some patients may be interpreted as a sign of the biological activity of this rIL-2 regimen. Further exploratory work is required to evaluate the clinical efficacy of this immunotherapeutic approach.