ABSTRACT
PURPOSE: We wanted to determine the safety and efficacy 1 year after intravesical keyhole-limpet hemocyanin (KLH) therapy for the patients suffering with superficial transitional cell carcinoma. MATERIALS AND METHODS: A total of 60 patients with bladder cancer who had undergone transurethral resection were treated with a one-year protocol (once a week for 6 weeks and 12 further treatments every 4 weeks) of KLH 20mg. The local and systemic safety and efficacy were evaluated. RESULTS: In terms of the safety of KLH, 4 patients (6.7%) reported dizziness and slight fever, and 2 (3.3%) experienced urgency. The remaining 54 patients (90.0%) did not report any local side effects during the treatment period. In terms of efficacy, recurrence developed in 32 patients (53.3%) at a mean of 4.5 months after transurethral resection; 28 patients (46.7%) were disease free after 14 months. The univariate analysis showed a greater level of efficacy in the patients suffering with bacille Calmette-Gu rin (BCG)-refractory disease (p=0.0150). No significant differences were found between the low, the intermediate-risk and the high-risk patients in terms of efficacy. CONCLUSIONS: The results of this study have confirmed the good tolerability of intravesical KLH and better efficacy in the BCG-refractory patients. However, in terms of overall efficacy, intravesical KLH therapy had no superiority over that of other intravesical treatments in terms of the overall efficacy.