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Recombinant tumor necrosis factor for superficial bladder tumors
C N Sternberg1, M G Arena, V Pansadoro
1Regina Elena Cancer Institute, Rome, Italy.
Abstract:
Twenty patients with histologically documented superficial bladder cancer (Ta, T1, Tis) were treated with intravesical administration of TNF 400-1800 micrograms. Of 18 patients with a marker lesion, 2 obtained a complete response for 8+ and 18 months. Two had a partial response and were given other intravesical therapies after 5 and 7 months. No or minimal systemic absorption of TNF was observed and documented in 4 of 20 patients by pharmacokinetic studies, and no patients developed antibodies to intravesically administered TNF. TNF was well tolerated in doses up to 1800 micrograms. No systemic or local side effects were observed. Modest activity was attained with intravesical TNF, even in pretreated patients.
Insights
Intravesical tumor necrosis factor (TNF) showed modest activity in superficial bladder cancer patients. The treatment was well-tolerated with minimal systemic absorption and no antibody formation, suggesting potential for this immunotherapy.
Area of Science:
- Oncology
- Immunology
- Urology
Background:
- Superficial bladder cancer (Ta, T1, Tis) requires effective intravesical therapies.
- Tumor necrosis factor (TNF) is a cytokine with potential anti-cancer properties.
Purpose of the Study:
- To evaluate the safety and efficacy of intravesical TNF in patients with superficial bladder cancer.
- To assess systemic absorption and immunogenicity of intravesical TNF.
Main Methods:
- Twenty patients with superficial bladder cancer received intravesical TNF (400-1800 micrograms).
- Pharmacokinetic studies monitored systemic absorption.
- Marker lesions were assessed for response.
- Antibody formation was evaluated.
Main Results:
- Two of 18 patients with marker lesions achieved a complete response (8+ and 18 months).
- Two patients had partial responses, subsequently receiving other therapies.
- Minimal systemic TNF absorption occurred in 4/20 patients.
- No patients developed antibodies to intravesical TNF.
- TNF was well-tolerated up to 1800 micrograms with no significant side effects.
Conclusions:
- Intravesical TNF demonstrates modest activity in superficial bladder cancer, including pretreated patients.
- The treatment is safe and well-tolerated with limited systemic exposure and no observed immunogenicity.
- Further investigation into intravesical TNF for bladder cancer is warranted.