Intravesical hyperthermia and mitomycin-C for carcinoma in situ of the urinary bladder: experience of the European Synergo® working party

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Abstract

Objectives

To study the results of chemotherapy combined with intravesical hyperthermia in patients with mainly BCG-failing carcinoma in situ (CIS).

Methods

Patients with histologically confirmed CIS were included retrospectively. Outpatient thermochemotherapy treatment was done with mitomycin-C (MMC) and the Synergo ^® system SB-TS 101 (temperature range between 41 and 44°C), weekly for 6–8 weeks, followed by 4–6 sessions every 6–8 weeks.

Results

Fifty-one patients were treated between 1997 and 2005 from 15 European centers. Thirty-four were pre-treated with BCG. Mean age was 69.9 years. Twenty-four patients had concomitant papillary tumors. The mean number of hyperthermia/MMC treatments per patient was 10.0. Of the 49 evaluable patients 45 had a biopsy and cytology proven complete response. In two patients CIS disappeared, but they had persistent papillary tumors. Follow-up of 45 complete responders showed 22 recurrences after a mean of 27 months (median 22): T2 (4), T1 (4), T1/CIS (1), CIS (5), Ta/CIS (2), Ta (5) and Tx (1). Side effects (bladder complaints) were generally mild and transient.

Conclusions

In patients with primary or BCG-failing CIS, treatment with intravesical hyperthermia and MMC appears a safe and effective treatment. The initial complete response rate is 92%, which remains approximately 50% after 2 years.

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Most cited references 29

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Guideline for the management of nonmuscle invasive bladder cancer (stages Ta, T1, and Tis): 2007 update.

M Craig Hall, Sam S Chang, Guido Dalbagni … (2007)

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Management of BCG failures in superficial bladder cancer: a review.

Julia J. Witjes (2006)

Review management of bacillus Calmette-Guérin (BCG) failures in superficial bladder cancer. Search of published literature and meeting abstracts. Patients in whom BCG fails are not a uniform group. Failure cannot be predicted but high-risk patients can be identified. In case of failure and progression the outcome is bad. Conservative but investigative alternatives are BCG/interferon-alpha, intravesical hyperthermia/chemotherapy, or photodynamic therapy. Standard treatment in failing patients remains cystoprostatectomy. BCG failures need careful and individualized therapy in experienced hands.

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Sequential BCG and electromotive mitomycin versus BCG alone for high-risk superficial bladder cancer: a randomised controlled trial.

Andrea De Martino, Antonella Giannantoni, Shannon Stasi … (2005)

The rationale for combining anticancer drugs has not been applied consistently to use of intravesical agents for treatment of superficial bladder cancer, for which immunotherapeutic BCG and chemotherapeutic mitomycin seem to be a potentially effective combination. We aimed to do a prospective, randomised comparison of BCG alone with that of sequential BCG and electromotive mitomycin in patients with stage pT1 bladder cancer. After transurethral resection and multiple biopsies, 212 patients with stage pT1 bladder cancer were randomly assigned to: 81 mg BCG infused over 120 min once a week for 6 weeks (n=105); or to 81 mg BCG infused over 120 min once a week for 2 weeks, followed by 40 mg electromotive mitomycin (intravesical electric current 20 mA for 30 min) once a week as one cycle for three cycles (n=107). Complete responders underwent maintenance treatment: those assigned BCG alone had one infusion of 81 mg BCG once a month for 10 months, and those assigned BCG and mitomycin had 40 mg electromotive mitomycin once a month for 2 months, followed by 81 mg BCG once a month as one cycle for three cycles. The primary endpoint was disease-free interval; secondary endpoints were time to progression; overall survival; and disease-specific survival. Analyses were done by intention to treat. This trial has been submitted for registration at the US National Cancer Institute website . Median follow-up was 88 months (IQR 63-110). Patients assigned sequential BCG and electromotive mitomycin had higher disease-free interval than did those assigned BCG alone (69 months [95% CI 55-86] vs 21 months [15-54]; difference between groups 48 months [42-54], log-rank p=0.0012). Patients assigned sequential BCG and electromotive mitomycin also had lower recurrence (41.9% [32.7-51.5] vs 57.9% [48.7-67.5]; difference between groups 16.0% [2.7-29.3], log-rank p=0.0012); progression (9.3% [3.8-14.8] vs 21.9% [17.9-25.9]; difference between groups 12.6% [3.0-22.2], log-rank p=0.004); overall mortality (21.5% [13.5-29.5] vs 32.4% [23.4-41.4], difference between groups 10.9% [0.6-21.2], log-rank p=0.045); and disease-specific mortality (5.6% [1.2-10.0] vs 16.2% [6.1-23.3], difference between groups 10.6% [2.5-18.7], log-rank p=0.01). Side-effects were mainly localised to the bladder. BCG-induced inflammation might increase the permeability of the bladder mucosa such that mitomycin can reach the target tissue more easily and exert its anticancer effect.

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Author and article information

Contributors

: 31-24-3616712 , 31-24-3541031 , f.witjes@uro.umcn.nl

Journal

Journal ID (nlm-ta): World J Urol

Title: World Journal of Urology

Publisher: Springer-Verlag (Berlin/Heidelberg )

ISSN (Print): 0724-4983

ISSN (Electronic): 1433-8726

Publication date (Electronic): 22 February 2009

Publication date (Print): June 2009

Volume: 27

Issue: 3

Pages: 319-324

Affiliations

[1 ]Department of Urology, Radboud University Nijmegen Medical Centre, PO Box 9101, 6500 HB Nijmegen, The Netherlands

[2 ]Department of Urology, Hadassah University Hospital, Jerusalem, Israel

[3 ]Department of Urology, Ospedale Consorziale di Treviglio e Caravaggio, Treviglio, Italy

[4 ]Department of Urology, Bnay-Zion Medical Center, Haifa, Israel

Article

Publisher ID: 384

DOI: 10.1007/s00345-009-0384-2

PMC ID: 2694311

PubMed ID: 19234857

SO-VID: 572e9208-8560-4ad8-8493-9820122cddfe

History

Date received : 16 January 2009

Date accepted : 26 January 2009

Custom metadata

ScienceOpen disciplines: Urology

Keywords: hyperthermia,thermochemotherapy,mitomycin-c,bladder cancer,cis

Data availability:

ScienceOpen disciplines: Urology

Keywords: hyperthermia, thermochemotherapy, mitomycin-c, bladder cancer, cis

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