Prevention of recurrence with epirubicin and lactobacillus casei after transurethral resection of bladder cancer.
OBJECTIVE
A prospective, randomized, controlled trial was done to evaluate whether oral administration of a preparation of the probiotic agent Lactobacillus casei (Yakult Honsha, Tokyo, Japan) could enhance the prevention of recurrence by intravesical instillation of epirubicin after transurethral resection for superficial bladder cancer.


METHODS
Between August 1999 and December 2002, 207 patients clinically diagnosed with superficial bladder cancer were included as study candidates and underwent transurethral resection, followed by intravesical instillation of 30 mg epirubicin/30 ml saline twice during 1 week. After histological confirmation of superficial bladder cancer they were again included as study participants with 102 randomized to receive treatment with 6 additional intravesical instillations of epirubicin during the 3-month period after transurethral resection (epirubicin group) and 100 randomized to intravesical chemotherapy on the same schedule as the epirubicin group plus oral administration of 3 gm Lactobacillus casei preparation per day for 1 year (epirubicin plus Lactobacillus casei group). Patients were evaluated for intravesical recurrence, disease progression, prognosis and adverse drug reactions.


RESULTS
The 3-year recurrence-free survival rate was significantly higher in the epirubicin plus Lactobacillus casei group than in the epirubicin group (74.6% vs 59.9%, p = 0.0234), although neither progression-free nor overall survival differed between the groups. The incidence of adverse drug reactions did not significantly differ between the groups and there were no serious adverse drug reactions.


CONCLUSIONS
Intravesical instillation of epirubicin plus oral administration of Lactobacillus casei preparation is a novel, promising treatment for preventing recurrence after transurethral resection for superficial bladder cancer.
Naito
Seiji
S
Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Koga
Hirofumi
H
Yamaguchi
Akito
A
Fujimoto
Naohiro
N
Hasui
Yoshihiro
Y
Kuramoto
Hiroshi
H
Iguchi
Atsushi
A
Kinukawa
Naoko
N
D000283:Administration, Intravesical; D000284:Administration, Oral; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage*; D015331:Cohort Studies; D003131:Combined Modality Therapy; D003558:Cystoscopy; D018572:Disease-Free Survival; D015251:Epirubicin / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007780:Lacticaseibacillus casei; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control*; D019936:Probiotics / Q000008:administration & dosage*; D001749:Urinary Bladder Neoplasms / Q000473:pathology / Q000628:therapy*
D000903:Antibiotics, Antineoplastic; D015251:Epirubicin