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Intravesical chemotherapy with epirubicin: a dose response study.
J R Masters1, R J Popert, P M Thompson
1Institute of Urology and Nephrology, University College and Department of Urology, King's College Hospital, London, United Kingdom.
The Journal of Urology
|April 21, 1999
Summary
High-dose intravesical epirubicin did not improve outcomes for superficial bladder cancer compared to standard doses. This randomized trial found no significant difference in tumor response or recurrence rates, suggesting standard dosing is sufficient.
Area of Science:
- Oncology
- Urology
- Cancer Research
Background:
- Superficial bladder cancer (pTa/pT1) requires effective intravesical chemotherapy.
- Intravesical epirubicin is a treatment option, but optimal dosing is debated.
Purpose of the Study:
- To compare the efficacy of high-dose versus standard-dose intravesical epirubicin for superficial bladder cancer.
- To evaluate differences in marker tumor response, time to first recurrence, and recurrence rates.
Main Methods:
- A randomized trial involving 122 patients with superficial bladder cancer.
- Patients received either standard (1 mg./ml.) or high-dose (2 mg./ml.) intravesical epirubicin for 1 hour.
- Outcomes assessed included marker tumor response at 3 months and recurrence over 2 years.
Main Results:
- No significant difference in marker tumor response rates between standard and high-dose epirubicin (p = 0.67).
- Higher dose epirubicin did not show superiority in time to first recurrence (hazard ratio 1.46, p = 0.14).
- The study reliably excluded a greater than 4% absolute difference in time to first recurrence in favor of the higher dose.
Conclusions:
- Doubling the standard dose of intravesical epirubicin does not improve marker tumor response or recurrence outcomes in superficial bladder cancer.
- Standard-dose intravesical epirubicin appears to be as effective as high-dose therapy for this patient population.