Abstract | OBJECTIVE: To determine the role, if any, of one and five installations of intravesical thiotepa in the treatment of newly diagnosed superficial bladder cancer. PATIENTS AND METHODS: A multicentre randomized clinical trial was carried out involving 417 patients with newly diagnosed superficial bladder cancer. After transurethral resection the patients were randomized into one of three treatment arms: no thiotepa; one instillation of thiotepa at the time of resection; one instillation at time of resection and then at 3-monthly intervals for one year (giving a total of five instillations). In all treatment arms the dosage was 30 mg thiotepa in 50 ml saline. The main outcome measures were time to first superficial recurrence, recurrence rate (defined as the number of possible cystoscopies per annum) and failure-free interval rate (where failure was defined as the development of invasive disease, metastatic disease or death from bladder cancer). RESULTS: After a median follow-up of 8 years and 9 months analysis showed no evidence of a difference between the three groups with respect to time to first recurrence, recurrence rates or the failure-free interval rate. CONCLUSIONS: This analysis confirms that the thiotepa regimens tested cannot be recommended for use outside clinical trials for patients with newly diagnosed superficial bladder cancer.
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Authors | |
Journal | British journal of urology
(Br J Urol)
Vol. 73
Issue 6
Pg. 632-8
(Jun 1994)
ISSN: 0007-1331 [Print] England |
PMID | 8032829
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
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Topics |
- Administration, Intravesical
- Carcinoma, Transitional Cell
(drug therapy, mortality, surgery)
- Chemotherapy, Adjuvant
- Cystoscopy
- Drug Administration Schedule
- Follow-Up Studies
- Humans
- Neoplasm Recurrence, Local
(prevention & control)
- Prognosis
- Thiotepa
(administration & dosage)
- Urinary Bladder Neoplasms
(drug therapy, mortality, surgery)
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