Prophylactic chemotherapy for primary and recurrent superficial bladder cancer: preliminary results. The Hokkaido University Bladder Cancer Collaborating Group.

A multicenter trial for postoperative prophylaxis of the recurrence of superficial Ta-T1, G1-G2 bladder cancer was performed. Eligible patients with primary or recurrent superficial bladder cancer were randomized into four groups. For the primary cases, intravesical instillation of drugs [group A, 20 mg Adriamycin (ADM) + 200 mg cytosine arabinoside (CA) in 30 ml physiological saline; group B, 10 mg peplomycin (PEP) + 200 mg CA in 30 ml physiological saline; group C, 2 mg neocarzinostatin (NCS) + 200 mg CA in 30 ml physiological saline; and group D, control] was carried out once a week for 2 weeks, once every 2 weeks for 14 weeks, once monthly for 8 months, and, finally, once every 3 months for 1 year. For the recurrent cases, intravesical instillation of 20 mg ADM + 200 mg CA in 30 ml physiological saline as described above and daily oral administration of another drug [group E, 300 mg/day UFT; group F, 200 mg 5-fluorouracil (5-FU)/day; group G, 30 mg ubenimex/day; and group H, no oral drug] was performed. The postoperative follow-up period was 3-36 months. A total of 193 primary cases and 121 recurrent cases of superficial bladder cancer were evaluated. The cumulative 12-month nonrecurrence rates for the primary cases were 86.2% in group A, 78.1% in group B, 82.1% in group C, and 68.4% in group D. The cumulative nonrecurrence rate obtained using ADM+CA (group A) was significantly higher than the control value. On the other hand, no significant difference was found in the cumulative nonrecurrence rates calculated for the recurrent cases, regardless of the oral drug given. Intravesical instillation of ADM+CA for primary superficial bladder cancer was considered to be useful, but the long-term effect of intravesical instillation remains to be elucidated. Further refinement of this regimen is necessary for effective prophylaxis of the recurrence of superficial bladder cancer.

RCT Entities:   Population Interventions Outcomes