Premium
Maintenance therapy with bacillus Calmette‐Guérin Connaught strain clearly prolongs recurrence‐free survival following transurethral resection of bladder tumour for non‐muscle‐invasive bladder cancer
Author(s) -
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
Publication year - 2011
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/j.1464-410x.2010.09891.x
Subject(s) - epirubicin , medicine , maintenance therapy , bladder cancer , urology , clinical endpoint , surgery , population , randomized controlled trial , cancer , chemotherapy , environmental health , cyclophosphamide
Study Type – Therapy (RCT) Level of Evidence 1b OBJECTIVE• To confirm the recurrence‐preventing efficacy and safety of 18‐month bacillus Calmette‐Guérin (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.