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Bacillus Calmette-G...
Bacillus Calmette-Guerin Is Superior to a Combination of Epirubicin and Interferon-alpha 2b in the Intravesical Treatment of Patients with Stage T1 Urinary Bladder Cancer. A Prospective, Randomized, Nordic Study
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- Duchek, Milos (author)
- Umeå universitet,Urologi och andrologi,Umea Univ, Dept Surg and Perioperat Sci Urol and Androl, Umea, Sweden
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- Johansson, Robert (author)
- Umeå universitet,Onkologi,Umea Univ Hosp, Ctr Oncol, S-90185 Umea, Sweden
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- Jahnson, Staffan (author)
- Östergötlands Läns Landsting,Linköpings universitet,Kirurgi,Hälsouniversitetet,Urologiska kliniken i Östergötland
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- Mestad, Oddvar (author)
- Stavanger Univ Hosp, Surg Clin, Dept Urol, Stavanger, Norway
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- Hellström, Pekka (author)
- Univ Cent Hosp, Dept Urol, Oulu, Finland
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- Hellsten, Sverker (author)
- Lund University,Lunds universitet,Institutionen för kliniska vetenskaper, Malmö,Medicinska fakulteten,Department of Clinical Sciences, Malmö,Faculty of Medicine,Univ Hosp, Dept Urol, Malmo, Sweden
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- Malmström, Per-Uno (author)
- Uppsala universitet,Urologkirurgi,Univ Uppsala Hosp, Dept Urol, S-75185 Uppsala, Sweden
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(creator_code:org_t)
- Elsevier BV, 2010
- 2010
- English.
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In: European Urology. - : Elsevier BV. - 0302-2838 .- 1873-7560. ; 57:1, s. 25-31
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Abstract
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- Background: Bacillus Calmette-Guerin (BCG) instillation is regarded as the most effective bladder-sparing treatment for patients with high-grade T1 tumours and carcinoma in situ (CIS). The major problem with this therapy is the side-effects, making maintenance therapy difficult, even impossible, in a proportion of patients. Thus, alternative schedules and drugs have been proposed. Objective: To compare BCG to the combination of epirubicin and interferon-alpha 2b as adjuvant therapy of T1 tumours. Design, setting, and participants: This is a Nordic multicenter, prospective, randomised trial in patients with primary T1 G2-G3 bladder cancer. Initial transurethral resection (TUR) was followed by a second-look resection. Patients were randomised to receive either regimen, given as induction for 6 wk followed by maintenance therapy for 2 yr. Measurements: The drugs were compared with respect to time to recurrence and progression. Also, side-effects were documented. Results and limitations: A total of 250 patients were randomised. At the primary end point, 62% were disease free in the combination arm as opposed to 73% in the BCG arm (p = 0.065). At 24 mo, there was a significant difference in favour of the BCG-treated patients (p = 0.012) regarding recurrence, although there was no difference regarding progression. The subgroup analysis showed that the superiority of BCG was mainly in those with concomitant CIS. In a multivariate analysis of association with recurrence/progression status, significant variables for outcome were type of drug, tumour size, multiplicity, status at second-look resection, and grade. A corresponding analysis was performed separately in the two treatment arms. Tumour size was the only significant variable for BCG-treated patients, while multiplicity, status at second-look resection, and grade were significant for patients treated with the combination. Conclusions: For prophylaxis of recurrence, BCG was more effective than the combination. There were no differences regarding progression and adverse events between the two treatments.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Urologi och njurmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Urology and Nephrology (hsv//eng)
Keyword
- Bladder cancer
- Prospective randomized trial
- Endovesical adjuvant therapy
- MEDICINE
- MEDICIN
- Endovesical adjuvant
- Bladder cancer
- Prospective randomized trial
- therapy
Publication and Content Type
- ref (subject category)
- art (subject category)
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