Prospective Randomized Clinical Trial of Chemohyperthermia with Mitomycin C Prior to Transurethral Resection of the Bladder and its Relationship with the Rate of Early Recurrence in Non-Muscle Invasive Bladder Cancer: Intermediate Analysis

Garcia Alvarez

Carlos

Urology

Complejo Hospitalario Universitario de Canarias

San Cristobal de La Laguna

SC Tenerife

Spain

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Plata Bello

Ana Cristina

Urology

Complejo Hospitalario Universitario de Canarias

San Cristobal de La Laguna

SC Tenerife

Spain

Tamayo Jover

Marco Antonio

Urology

Complejo Hospitalario Universitario de Canarias

San Cristobal de La Laguna

SC Tenerife

Spain

Plata Bello

Julio

Neurosurgery

Complejo Hospitalario Universitario de Canarias

San Cristobal de La Laguna

SC Tenerife

Spain

Secaduras Arbelo

Tania Miriam

Intensive Care

Complejo Hospitalario Nuestra Señora de la Candelaria

SC Tenerife

Spain

Concepcion Masip

Tomas

Urology

Complejo Hospitalario Universitario de Canarias

Samn Cristobal de La Laguna

SC Tenerife

Spain

Tabs

Abstract

Introduction: The recurrence rate for non-muscle invasive bladder cancer (NMIBC) varies from 50- 70%, with single immediate postoperative instillation (IPOP) of mitomycin-C (MMC) having been shown to be effective in preventing recurrence. Some 30% of patients are not suitable candidates for IPOP due to macroscopic hematuria or bladder perforation. In these circumstances the use of chemohyperthermia (CH- HIVEC) immediately prior to TURBT is a safe and effective alternative to IPOP delivered normothermically, with improved penetration of MMC through the urothelium.

Objective: To evaluate the early recurrence rate of low to intermediate risk NMIBC with the CH (HIVEC) instillation of MMC prior to TURBT (compared to single immediate IPOP MMC) at 12, 18 and 24 months. Safety and tolerability of the experimental treatment for these patients will also be evaluated.

Methods: Single center prospective randomized control clinical trial.
- Inclusion Criteria: Low to intermediate risk NMIBC, single t tumor <30mm or multiple <8 lesions and <30mm. Patients with a history of bladder TURBT <1 year were excluded.

- Primary analysis: Safety and tolerability of pre-operative instillation of MMC in 152 patients: 76 in the control arm (CA: postoperative MMC normothermic), 76 in the experimental arm (EA: Hyperthermic pre-operative MMC). Follow up with cystoscopy, cytology and ultrasound.
Assessment tools for tolerability of the instillation procedure (pain scale analogue – visual) and global satisfaction.

Results:

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Conclusions:

Chemohyperthemia treatment (HIVEC) with mitomycin-c pre-TURBT is a safe and well tolerated alternative.
After a follow-up period of 12 months, the recurrence rate in both arms are equivalent.

Speciality:

Urology

Keywords:

high-risk non-muscle invasive bladder cancer, chemohyperthermia