中高リスク筋層非浸潤性膀胱癌に対する抗癌剤術後即時単回膀胱内注入療法の再発予防効果

Abstract

We retrospectively evaluated the efficacy of immediate single instillation (SI) of pirarubicine hydrochloride (THP) in the chemoprevention of intermediate and high risk patients with non-muscle-invasive bladder cancer (NMIBC). The study population consisted of 256 intermediate and high risk patients with NMIBC who underwent Bacillus Calmette-Guerin (BCG) induction therapy or delayed intravesical chemotherapy between 1999 and 2014. We introduced SI of 30 mg THP in 30 ml normal saline for all cases in 2010, and thus earlier cases could be considered as historical controls. As BCG induction therapy, patients received 80 mg of BCG Tokyo strain 2 weeks after transurethral resection of bladder tumor (TURBT), and the instillations were repeated weekly for 8 weeks. On the other hand, as delayed intravesical chemotherapy, patients received 30 mg THP in 30 ml normal saline over a period of 6 months starting 2 weeks after TURBT. The instillation schedule was once a week for 1 month, every other week for 1 month and once a month for 4 months. The patients were followed with cystoscopy and urine cytology every 3 months for the first 2 years and every 6 months thereafter. The 3-, and 5-year non-recurrence rates were 80. 3 and 80.3%, respectively, in the single immediate instillation group and 69.7 and 64.5%, respectively, in the control group. Univariate analysis revealed a significant difference between the SI group and the control group (P=0. 025). Multivariate analysis showed that there was an independent and significant recurrence risk factor in selecting chemotherapy instead of BCG in additional intravesical instillation therapy and not to perform SI. Limitations of our study are its retrospective and nonrandomized nature with a limited number of patients.