Trial Information

Clinical Study of Intravesical Epirubicin Plus BCG to Prevent the Recurrence of Transitional Cell Carcinoma of Bladder After Surgical Management

Methods From July 1996 to November 2003, a total of 138 cases of bladder cancer underwent
TURBT or partial cystectomy were entered the trail. They were divided into 3 groups
randomly: 1, EPI plus BCG; 2, use BCG alone; and 3, use EPI alone. All the patients have
been followed up for 28-40 months after surgery (average time was 36 months), and the
frequency of bacterial, chemical cystitis and other local side effects were also
observed.Results After a median follow up of 36 months, the number of recurrences in group
1 was significantly reduced than group 2 and 3 (p<0.05 vs group 2 and 3, x2-test). The
frequency of bacterial, chemical cystitis and other local side effects was similar in group
1 and 2, whereas significant severe side effect was found in group 3 (p<0.05 vs group 2 and
1, x2-test). Allergic reactions, including skin rash, were more frequent in group 3, and
other systemic effects were more frequent in group 1. Conclusion Biochemotherapy by single
dose EPI plus sequential BCG intravesical is markedly effect in preventing the recurrence of
bladder cancer after surgical management. Its side effects are low. This method is of high
clinical value.