LONG-TERM RESULTS AND RISK FACTORS OF TUMOR RECURRENCE IN PATIENTS WITH SUPERFICIAL BLADDER CANCER WHO WERE TREATED BY INTRAVESICAL BACILLUS CALMETTE-GUERIN (BCG) INSTILLATION

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  • 表在性膀胱癌に対するBCG膀胱内注入療法の平均観察期間5年における再発予防効果

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An evaluation was made of the long-term results and risk factors of tumor recurrence in patients with superficial bladder cancer who were treated with intravesical bacillus Calmette-Guerin (BCG) and who had a mean follow-up period of 57 months.<br>Eligible for the study were a total of 102 patients who were treated by transurethral resection of tumors and were considered to be free from tumor from 1984 to 1989. A suspension containing 80mg Tokyo 172 strain BCG in 50ml normal saline was given intravesically to 50 patients once a week for six weeks without further maintenance instillation. To the other 52 patients was additionally given monthly intravesical BCG instillation for 12 months.<br>The actuarial nonrecurrent rates according to sex, different BCG treatment protocol, tumor grade, tumor status including primary or recurrent tumors, and solitary or multiple tumors were estimated by Kaplan-Meier method. The estimated three-, five- and seven-year actuarial nonrecurrent rates in all 102 cases were 77.3%, 68.5% and 60.6%, respectively. When nonrecurrent rates were compared to tumor characteristics, no statistically significant differences were observed between primary and recurrent tumors or between solitary and multiple tumors estimated by generalized Wilcoxon method. On the other hand, when nonrecurrent rates were compared with tumor grades, grade 3 tumor showed a 40.0% three-year nonrecurrent rate. The differences between grade 3 and grade 1 and between grade 3 and grade 2 were statistically significant (p<0.05).<br>When the efficacies of BCG therapies incorporating different BCG treatment protocols were compared, the 50 cases of the weekly instillation group presented 58.4% five-year nonrecurrent rate compared to 74.4% for the 52 cases treated by maintenance instillation. However, the difference was not statistically significant. The mean tumor-free periods compared between the weekly treatment group and the maintenance group revealed 41.7±18.7 months and 53.1±21.3 months, respectively, with the difference being significant (p<0.01).<br>Multivariate analysis using Cox's proportional hazards model was performed to identify the most significant factors for tumor recurrence. The single most important factor for tumor recurrence was found to be tumor grade (risk ratio 9.694, p<0.05). No other factor was chosen as a statistically significant factor for tumor recurrence.<br>These results indicate that efficacy of intravesical BCG instillation for high-grade bladder cancer is not sufficiently satisfactory, and that maintenance instillation probably contributes to a tumor-free period and to delayed tumor recurrence.

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