Intravesical instillation of OK-432 plus pirarubicin in the prophylaxis of local recurrence after resection of superficial bladder cancer

Abstract

Objectives To evaluate the efficacy and safety of intravesical in stillation of OK-432 plus pirarubicin in the prophylaxis of recurrence after resection of bladder cancer.Methods 128 cases of superficial bladder cancer patients were randomly divided into three groups.OK-432 group: 5KE OK-432 was instilled into bladder and retained for 2 hours one week after operation.The instillation was performed once a week for 6 weeks,and then once a month for 8 months.The Pirarubicin group:30mg Pirarubicin was perfused with the same method as in Group OK-432.The group of OK-432 plus pirarubicin was instilled into bladder of alternating perfusion with the same dose,once a week for 6 weeks,each drug amounts to 6,then once a month for 8 months,each drug was perfusion for 8months.Results The patients were followed up for 3 ～ 18 months,The recurrence rate of primary disease were 12.5％,13.16％,5％ in OK-432 Group,Pirarubicin Group,OK-432 plus pirarubicin Group respectively,which had statistical significance(P ＜ 0.05).In patients with the recurrent disease,two groups lowered the recurrence rate but had no statistical significance.multiple,large,sessile and high grade tumors had high recurrence rate.In OK-432 group,patients had good compliance and no side effects,the appearance of the symptoms such as frequent micturition,urgency,urination pain or hematuriaof after bladder irritation were 3,4,4,which had no statistical significance.Conclusions Intravesical instillation of OK-432 plus pirarubicin is safe and effective in preventing local recurrence of superficial bladder cancer and is better than single injection drug.It is worth wide clinical application with good compliance and fewer side effects. Key words: Bladder Neoplasms ; Neoplasm Recurrence, Local; Picibanil; Doxorubicin