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Twelve‐year follow up of a randomized prospective trial comparing bacillus Calmette‐Guerin and epirubicin as adjuvant therapy in superficial bladder cancer
Author(s) -
CHENG CHI WAI,
CHAN SIU FOON PETER,
CHAN LUNG WAI,
CHAN CHI KWOK,
NG CHI FAI,
CHEUNG HO YUEN,
CHAN SHU YIN EDDIE,
WONG WAI SANG,
LAI FERNAND MACMOUNE,
TO KA FAI,
LI MIU LING
Publication year - 2005
Publication title -
international journal of urology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.172
H-Index - 67
eISSN - 1442-2042
pISSN - 0919-8172
DOI - 10.1111/j.1442-2042.2005.01064.x
Subject(s) - medicine , epirubicin , adjuvant , carcinoma in situ , grading (engineering) , randomized controlled trial , tumor progression , stage (stratigraphy) , surgery , urology , carcinoma , oncology , gastroenterology , chemotherapy , cancer , cyclophosphamide , paleontology , civil engineering , engineering , biology
Aim: To compare bacillus Calmette‐Guerin (BCG) with epirubicin in adjuvant therapy of superficial bladder transitional cell carcinoma, with respect to recurrence, progression and survival. Prognostic factors are also evaluated. Methods: Between October 1991 and September 1999, all patients harboring superficial bladder cancers (Ta or T1) with any of the relevant criteria (stage > a, grade > 1, size > 1 cm, multiple or recurrent tumors), after complete transurethral resection were randomized to receive either 81 mg Connaught strain BCG or 50 mg epirubicin. Patients with recurrences were eligible to crossover, even repeatedly, until progression. Recurrence, progression and survival were analyzed in relation to initial treatment, patient characteristics and tumor characteristics. Results: There were 209 patients included in the study, 149 men and 60 women. The mean age was 69.9 years (range, 24–92). The BCG group consisted of 102 patients and the epirubicin group contained 107 patients. Final analysis was made at a median follow up of 23, 47 and 61 months for recurrence, progression and survival, respectively. The 10‐year Kaplan‐Meier estimates for recurrence‐free, progression‐free and disease‐specific survival were 61%, 78% and 80%, respectively, for the BCG group. The corresponding figures were 32%, 74% and 92%, respectively, for the epirubicin group. Time to recurrence differed significantly between two treatment groups ( P = 0.0004). Multiplicity increased the risk of recurrence, while grading influenced recurrence, progression and disease specific survival. Conclusions: Bacillus Calmette‐Guerin prolonged time to recurrence when compared with epirubicin. Grading was shown to be a universal prognostic factor for recurrence, progression and disease specific survival.