“…In the thiotepa study [8,9], there was no reduction in the percentage of patients who had recurrence, 41.9% versus 37.5%; however, this trial has been criticized because of the low drug concentration used, 30 mg/50 ml. In the mitomycin C (MMC) trial [10,11], based on updated summary data, there was a reduction in the percentage with recurrence from 48.3% to 36.3% overall (p = 0.04) and from 70% to 50% in patients with multiple tumors (p = 0.09). However, in both of these studies, patients who recurred at 3 mo prior to starting their additional instillations were already counted as having their first recurrence, potentially diluting the size of any treatment effect.…”