A multicenter, prospective, randomized controlled study was begun in 1985 on the effect of
ethoglucid and
keyhole-limpet hemocyanin in the prevention of recurrent superficial
transitional cell carcinoma of the bladder (stages pTa to pT1, grades 1 to 3 according to the recommendation of the International Union Against
Cancer and the World Health Organization). The study was performed on a selected group of patients at high risk for further recurrences. All of these patients were pre-treated with different chemotherapeutic agents (
doxorubicin or
mitomycin C) and still had recurrent superficial
transitional cell carcinoma. All
tumors were removed by transurethral resection and all patients were presumed to be free of
tumor at initiation of the prophylactic instillations. Patients in the
ethoglucid group received 0.565 gm. (
solution of 1%)
ethoglucid weekly for 6 weeks and then monthly for 1 year. Patients in the
keyhole-limpet hemocyanin group were immunized with 1 mg.
keyhole-limpet hemocyanin intracutaneously, and then weekly
bladder instillations of 30 mg. were given for 6 weeks and then monthly for 1 year. The percentage of recurrences, recurrence rate, interval free of disease,
tumor progression and effect on downstaging were evaluated for both therapeutic arms. The percentage of recurrences (60.9% in the
ethoglucid group versus 55.3% in the
keyhole-limpet hemocyanin group) and the comparison of interval to recurrence for all patients showed no statistical significant difference (p = 0.808, Mantel-Cox test). A comparison of the interval to recurrence in patients with recurrent
tumors only showed a mean interval free of disease of 8.8 months for patients given
ethoglucid versus 5.5 months for those given
keyhole-limpet hemocyanin (p = 0.006, Wilcoxon test). Recurrence rate (4.8 versus 6.5, respectively) and
tumor progression rate (21.7 versus 21.1%, respectively) showed no statistically significant difference (p greater than 0.1).