Maintenance therapy with bacillus Calmette-Guerin Connaught strain clearly prolongs recurrence-free survival following transurethral resection of bladder tumour for non-muscle-invasive bladder cancer

作者：Hinotsu Shiro; Akaza Hideyuki^*; Naito Seiji; Ozono Seiichiro; Sumiyoshi Yoshiteru; Noguchi Sumio; Yamaguchi Akito; Nagamori Satoshi; Terai Akito; Nasu Yasutomo; Kume Haruki; Tomita Yoshihiko; Tanaka Yoshinori; Samma Shoji; Uemura Hirotsugu; Koga Hirofumi; Tsushima Tomoyasu

来源：BJU International, 2011, 108(2): 187-195.

DOI：10.1111/j.1464-410X.2010.09891.x

• bacillus Calmette-Guerin
• maintenance therapy
• non-muscle-invasive bladder cancer
• intravesical therapy
• transurethral resection
• prevention of recurrence

OBJECTIVE
To confirm the recurrence-preventing efficacy and safety of 18-month bacillus Calmette-Guerin (BCG) maintenance therapy for non-muscle-invasive bladder cancer.
PATIENTS AND METHODS
The enrolled patients had been diagnosed with recurrent or multiple non-muscle-invasive bladder cancer (stage Ta or T1) after complete transurethral resection of bladder tumours (TURBT).
The patients were randomized into three treatment groups: a maintenance group (BCG, 81 mg, intravesically instilled once weekly for 6 weeks as induction therapy, followed by three once-weekly instillations at 3, 6, 12 and 18 months after initiation of the induction therapy), a non-maintenance group (BCG, 81 mg, intravesically instilled once weekly for 6 weeks) and an epirubicin group (epirubicin, 40 mg, intravesically instilled nine times). The primary endpoint was recurrence-free survival (RFS).
RESULTS
Efficacy analysis was performed for 115 of the full-analysis-set population of 116 eligible patients, including 41 maintenance group patients, 42 non-maintenance group patients and 32 epirubicin group patients.
At the 2-year median point of the overall actual follow-up period, the final cumulative RFS rates in the maintenance, non-maintenance and epirubicin groups were 84.6%, 65.4% and 27.7%, respectively.
The RFS following TURBT was significantly prolonged in the maintenance group compared with the non-maintenance group (generalized Wilcoxon test, P = 0.0190).
CONCLUSION
BCG maintenance therapy significantly prolonged the post-TURBT RFS compared with BCG induction therapy alone or epirubicin intravesical therapy.

• 出版日期2011-7