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A randomized comparative dose‐ranging study of interferon‐α and mitomycin‐C as an internal control in primary or recurrent superficial transitional cell carcinoma of the bladder
Author(s) -
Malmström P.U.
Publication year - 2002
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1046/j.1464-410x.2002.02734.x
Subject(s) - medicine , mitomycin c , cystoscopy , adverse effect , toxicity , interferon , urology , gastroenterology , transitional cell carcinoma , carcinoma , lesion , surgery , bladder cancer , cancer , immunology , urinary system
Objective To compare, in a phase II study, the activity and toxicity of three dose levels of interferon‐α, and of mitomycin‐C given intravesically (as an internal control to validate the results), the primary objective being to investigate the percentage of complete responses (complete disappearance of a marker lesion) induced by the three interferon‐α dose levels on a marker lesion; a secondary objective was to compare the interferon‐α doses for toxicity. Patients and methods In all, 115 patients were enrolled, with the inclusion criteria being multiple grade 1 or 2, stage Ta or T1, primary or recurrent transitional cell carcinoma of the bladder. Interferon‐α (30, 50 and 80 MU) and mitomycin‐C (40 mg) intravesical treatments were given as follows. Patients randomized to one of three interferon‐α dose levels were treated weekly for 12 weeks. However, in week 9 (first cystoscopy after baseline) interferon‐α treatment was stopped if there was a complete response or disease progression. Patients randomized to mitomycin‐C were treated weekly for 8 weeks only and in week 9 underwent follow‐up cystoscopy. Results Interferon‐α at doses of 30, 50 and 80 MU gave response rates at 13 weeks of 19%, 33% and 41%, respectively. Although the response rates were higher for 50 and 80 MU than for 30 MU, the differences were not statistically significant. All three interferon‐α groups had significantly lower response rates than the internal control, mitomycin‐C (72%). The safety analysis showed that most of the adverse events were of mild to moderate severity. Adverse events were experienced by 37%, 37% and 48% of patients receiving 30, 50 and 80 MU interferon‐α, respectively, and by 55% of patients receiving mitomycin‐C. The corresponding rates for severe adverse events related to treatment were 9% for interferon‐α and 10% for mitomycin‐C. Conclusion Ablative therapy with interferon‐α was less effective than mitomycin‐C in patients with superficial bladder cancer. Both drugs were well tolerated, although interferon‐α appeared to have a slightly better overall safety profile.