5-Year outcome of a randomized prospective study comparing bacillus Calmette-Guérin with epirubicin and interferon-α2b in patients with T1 bladder cancer.
OBJECTIVE
In a multicenter, prospectively randomized study we evaluated the 5-year outcomes of bacillus Calmette-Guérin alone compared to a combination of epirubicin and interferon-α2b in the treatment of patients with T1 bladder cancer.


METHODS
Transurethral resection was followed by a second resection and bladder mapping. Stratification was for grade and carcinoma in situ. Followup entailed regular cystoscopy and cytology during the first 5 years. The end points assessed in this analysis were recurrence-free survival, time to treatment failure and progression, cancer specific survival and prognostic factors.


RESULTS
The study recruited 250 eligible patients. The 5-year recurrence-free survival rate was 38% in the combination arm and 59% in the bacillus Calmette-Guérin arm (p = 0.001). The corresponding rates for the other end points were not significantly different, as free of progression 78% and 77%, treatment failure 75% and 75%, and cancer specific survival 90% and 92%, respectively. The type of treatment, tumor size and tumor status at second resection were independent variables associated with recurrence. Concomitant carcinoma in situ was not predictive of failure of bacillus Calmette-Guérin therapy. An independent factor for treatment failure was remaining T1 stage at second resection.


CONCLUSIONS
Bacillus Calmette-Guérin was more effective than the tested combination therapy. The currently recommended management with second resection and 3-week maintenance bacillus Calmette-Guérin entails a low risk of cancer specific death. More aggressive treatment in patients with infiltrative tumors at second resection might improve these results. In particular, concomitant carcinoma in situ was not a predictive factor for poor outcome after bacillus Calmette-Guérin therapy.
Departments of Urology and Surgical Sciences, University Hospital Uppsala, Uppsala, Sweden. Electronic address: tammer.hemdan@surgsci.uu.se.
Tammer
T
Hemdan
Oncological Center, Umeå University Hospital, Umeå, Sweden.
Robert
R
Johansson
Department of Urology, University Hospital Linköping, Linköping, Sweden.
Staffan
S
Jahnson
Department of Urology, University Central Hospital, Oulu, Finland.
Pekka
P
Hellström
Department of Urology, Central Hospital of Rogaland, Stavanger, Norway.
Ilker
I
Tasdemir
Departments of Urology and Surgical Sciences, University Hospital Uppsala, Uppsala, Sweden.
Per-Uno
PU
Malmström
D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000627:therapeutic use*; D001500:BCG Vaccine / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D015251:Epirubicin / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D009367:Neoplasm Staging; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology
D000276:Adjuvants, Immunologic; D000903:Antibiotics, Antineoplastic; D001500:BCG Vaccine; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D015251:Epirubicin
adjuvant; chemotherapy; urinary bladder neoplasms