Treatment of Superficial Bladder Tumors with Intravesical Recombinant Interferon Alpha-2a

Abstract

In a prospective study, the toxicity and efficacy of an instillation therapy with recombinant interferon alpha-2a (rIFN-α-2a) were evaluated in 12 patients with superficial bladder tumors. Treatment consisted of 8 weekly instillations of 54 × 10⁶ IU rIFN-α-2a in 50 ml saline. Two weeks after completion of the instillation therapy, the tumor status was assessed with cystoscopy, biopsy and bladder wash-out cytology. Two partial responses, 1 no change and 2 progressive disease were seen in the 5 patients with TA tumors. In the 4 patients with carcinoma in situ, 1 complete response, 1 partial response and 2 no change were observed. Three patients suffered from carcinoma in situ and superficial papillary tumors, 1 showed complete response of the carcinoma in situ but no change of the TA tumor, the other 2 patients showed progressive disease. Three patients with partial response received a follow-up combination therapy with interferon intravesically and etretinate orally (25 mg/day). These patients presented progressive disease or no change 10 weeks after starting the follow-up combination therapy. During the treatment period, no side effects of interferon or changes of the serum interferon levels were observed. The treatment results are considered unsatisfactory; nevertheless, some activity after intravesical administration of interferon (mainly in patients with carcinoma in situ) could be demonstrated. Since the cytotoxic and antiproliferative effects seem to be dose-dependent, further studies might be done using higher interferon dosages and shorter treatment intervals.

Intralesional Alpha Interferon Therapy in Papillary Superficial Transitional Cell Carcinoma of the Bladder A Pilot Study

“…Data on the involvement of the immune system in bladder tumours treated with IFNs are mostly fragmentary and difficult to interpret. The few well documented trials (Ackermann et al, 1988;Williams, 1988;Niijima et aE., 1989;Micali et al, 1990) on the intravesical instillation of rIFNs recorded no modifications in either serum IFN or the host immune system. In the present study, the intralesional administration of rIFNcr-2 was accompanied by a slight rise in serum rIFNol and the flu-like syndrome characteristic of systemic rIFNcr administration, but was not associated with activation of either the local or systemic immune system.…”

“…Promising results of IFN therapy in superficial TCC of the bladder have been reported at many meetings held since 1978. Few clinical trials have published more detailed reports (Ackermann et al, 1988;Torti et al, 1988;Niijima et al, 1989;Glashan, 1990). Moreover, the different types of IFN and varying treatment schedules allow no reliable conclusions to be drawn from these reports.…”

“…In some pilot studies, particularly those on CIS, intravesical instillation of IFN has proved to be as efficacious as single intravesical instillation of cytotoxic drugs or BCG, but with less or no toxicity. Ackermann et al (1988) andTorti et al (1988) carried out phase I1 trials with weekly intravesical instillations of rIFNcr-2 at doses of 50 to 1OOOx lo6 IU given over 8 weeks to a total of 47 patients with CIS and/or papillary superficial TCC of the bladder. There were 6 complete responses (29%) and no partial responses in the 21 patients with papillary superficial TCC, 7 complete responses (30%) in the 20 CIS patients and 4 complete responses on CIS only in the 6 patients with both lesions.…”