A pilot clinical trial of intravesical mitomycin-C and external deep pelvic hyperthermia for non-muscle-invasive bladder cancer.

Authors

Brant A Inman, Duke University Medical CenterFollow
Paul R. Stauffer, Thomas Jefferson UniversityFollow
Oana A Craciunescu, Duke University Medical CenterFollow
Paolo F Maccarini, Duke University Medical CenterFollow
Mark W Dewhirst, Duke University Medical CenterFollow
Zeljko Vujaskovic, University of MarylandFollow

Document Type

Article

Publication Date

5-2014

Comments

This article has been peer reviewed. It is the authors' final version prior to publication in International Journal of Hyperthermia, Volume 30, Issue 3, May 2014, Pages 171-175.

The published version is available at DOI: 10.3109/02656736.2014.882021. Copyright © Informa Healthcare

Abstract

PURPOSE: This paper aims to evaluate the safety and heating efficiency of external deep pelvic hyperthermia combined with intravesical mitomycin C (MMC) as a novel therapy for non-muscle-invasive bladder cancer (NMIBC).

MATERIALS AND METHODS: We enrolled subjects with bacillus Calmette-Guérin (BCG) refractory NMIBC to an early phase clinical trial of external deep pelvic hyperthermia (using a BSD-2000 device) combined with MMC. Bladders were heated to 42 °C for 1 h during intravesical MMC treatment. Treatments were given weekly for 6 weeks, then monthly for 4 months. Heating parameters, treatment toxicity, and clinical outcomes were systematically measured.

RESULTS: Fifteen patients were enrolled on the clinical trial. Median age was 66 years and 87% were male. Median European Organisation for Research and Treatment of Cancer (EORTC) recurrence and progression scores were 6 and 8, respectively. The full treatment course was attained in 73% of subjects. Effective bladder heating was possible in all but one patient who could not tolerate the supine position due to lung disease. Adverse events were all minor (grade 2 or less) and no systemic toxicity was observed. The most common adverse effects were Foley catheter pain (40%), abdominal discomfort (33%), chemical cystitis symptoms (27%), and abdominal skin swelling (27%). With a median follow-up of 3.18 years, 67% experienced another bladder cancer recurrence (none were muscle invasive) and 13% experienced an upper tract recurrence.

CONCLUSIONS: External deep pelvic hyperthermia using the BSD-2000 device is a safe and reproducible method of heating the bladder in patients undergoing intravesical MMC. The efficacy of this treatment modality should be explored further in clinical trials.

Recommended Citation

Inman, Brant A; Stauffer, Paul R.; Craciunescu, Oana A; Maccarini, Paolo F; Dewhirst, Mark W; and Vujaskovic, Zeljko, "A pilot clinical trial of intravesical mitomycin-C and external deep pelvic hyperthermia for non-muscle-invasive bladder cancer." (2014). Department of Radiation Oncology Faculty Papers. Paper 52.
https://jdc.jefferson.edu/radoncfp/52

PubMed ID

24490762