Objectives. To estimate and compare recurrence rates, index of recurre
nce, and disease-free interval in patients with superficial recurrent
bladder cancer receiving bacille Calmette-Guerin (BCG) or interferon (
IFN) for immunoprophylaxis. Methods. One hundred twenty-two patients w
ith recurrent superficial Stage pT1, grade 1 to 3 tumors were enrolled
in a randomized, prospective, multicenter trial with two treatment ar
ms of endovesical immunoprophylaxis: 150 mg of BCG versus 54 MU of rec
ombinant IFN-alpha-2a. Administration was weekly during the first mont
h, biweekly for 2 months, and monthly for 9 months. Both groups were s
imilar with regard to tumor stage, grade, size, and number. Results. S
ixty-one patients were evaluable in the BCG group and 49 in the IFN gr
oup. Tumors recurred in 34 (69.4%) of 49 patients in the IFN group (89
0 months of follow-up) and in 24 (39.3%) of 61 in the BCG group (1272
months of follow-up). The total number of recurrences (28 for BCG, 47
for IFN), disease-free interval (mean 19.3 months for BCG, 15.3 months
for IFN), and index of recurrence (2.2 for BCG, 5.5 for IFN) were sta
tistically significant (P = 0.001) in favor of BCG. Progression to inv
asive carcinoma was similar in both study arms. Neither systemic nor l
ocal side effects were seen in the IFN group. However, the previously
reported toxicity of BCG was confirmed. Conclusions. According to our
trial, BCG remains the most efficacious agent for immunoprophylaxis of
recurrent superficial bladder tumors. (C) 1997, Elsevier Science Inc.
All rights reserved.