11 gfebruari 2018: Born ASCO GU 2018

Aanvullend op onderstaande informatie is op ASCO 2018 de resultaten van een 11 jarige studie gepresenteerd waarin wordt bevestigd dat Radiofrequency-Induced Thermochemotherapy (hyperthermie met het Synergo systeem) een betere aanpak is van niet-spier invasieve blaaskanker met hoog risico dan BCG plus cystectomy in het voorkomen van een recidief met veel betere kwaliteit van van leven omdat een volledige cystectomy niet nodig was en 80,6 procent van de patienten hun blaas konden behouden. Dezxe vorm van hyperthermie met het Synergo systeem wordt ook in Nederland toegepast o.a. in de Radboud in Nijmegen. (Zie ook dit PDF document over blaaskanker ) en mogelijke opties van behandelen. (tekst gaat verder onder plaatje van Synergo systeem)

hyperthermie synergo systeem

Er is nog geen studierapport gepubliceerd maar hier de resultaten uit een presentatie tijdens ASCO GU 2018.

Dit studierapport: Intravesical radiofrequency-induced hyperthermia combined with chemotherapy for non-muscle-invasive bladder cancer is een publicatie uit 2015 van dezelfde studie en wel volledig te lzen of downloaden.

Dit zijn de nieuwe resultaten. (onderaan artikel een abstract met referentielijst):

A total of 67 patients (4 female, 63 male) have been enrolled, 65.7% of whom harbor carcinoma in situ. Alternatively, 85% of patients were treated with primary radiofrequency-induced thermochemotherapy effect. Bacillus Calmette-Guerin failed in 15%.

In 14.9% (10 of 67 patients), the tumor persisted at week 11 after induction therapy (proven by transurethral resection of bladder tumor). This persistence led to early cystectomy in 4 of 10 patients. Mean recurrence-free survival was 3.5 years. In cases of recurrence, 10.4% progressed to non–muscle-invasive bladder cancer, including 6% of metastatic tumors.

High-risk non–muscle-invasive bladder cancer was observed in 6% of patients, and led to cystectomy. Recurrence of non–muscle-invasive bladder cancer occurred in 1.5% of cases, with organ preservation.

The mortality rate was 1 in every 67 patients. Serious adverse events of radiofrequency-induced thermochemotherapy effect led to discontinuation in 9% of cases. The bladder preservation rate was 80.6%, with 53.8% (14 of 26 patients) achieving long-term efficacy for over 5 years. 

Dr. Kilb concluded that radiofrequency-induced thermochemotherapy effect proved powerful in its ability to cure and maintain recurrence-free bladder cancer status in high-risk non–muscle-invasive bladder cancer in both the short and long term.

Risk of cystectomy was very low and risk of systemic progression leading to death from bladder cancer was minimal. Organ preservation was achieved in 80.6% of cases and lasted up to 11 years.

Radiofrequency-induced thermochemotherapy effect was shown to be an alternative to bacillus Calmette-Guerin and preferable to early cystectomy in high-risk non–muscle-invasive bladder cancer.

“After 10 years of follow-up,” Dr. Kilb noted, “we can confirm positive long-term results in terms of organ preservation and risk of progression. We hope to establish the Synergo system as an accepted therapy for high-risk non–muscle-invasive bladder cancer, included in guidelines for bladder cancer treatment. The system provides a more successful therapy for patients with high-risk non–muscle-invasive bladder cancer.”

update 12 maart 2010:

We hebben het abstract van deze studie er nu ook bijgeplaatst. Direct onder de introductietekst van 31 oktober 2009 

Update 31 oktober 2009: Bron: website van Medical Enterprise.

Op verzoek van een woordvoerder van Medical Enterprise plaatsen we onderstaande informatie. Deze informatie is voor verantwoording van Medical Enterprise en we wijzen u op onze disclaimer. Medical-enterprises biedt aan blaaskankerpatiënten, voor oppervlakkige blaaskanker een combinatiebehandeling hyperthermie en Mitomycine C na operatieve verwijdering van zoveel mogelijk tumorweefsel. En met hoogsignificant positieve resultaten. Hier een stukje introductie gekopieerd van de website van Medical Enterprise en een deepliink naar deze website waarop ook adressen staan van de ziekenhuizen in Nederland en België (heel Europa) waar deze combinatiebehandeling wordt gegeven.

Bron: website van Medical Enterprise.

De arts bepaalt het type van behandeling of de combinatie van behandelingen aan op basis van de gegevens over de tumor(en) en de toestand van de patiënt. Indien er verscheidene behandelingsopties zijn, overleggen de arts en de patiënt samen over de beslissing. Synergo® In weerwil van de courant gebruikte behandelingen is het percentage van herhalingen van de tumor of vordering van de ziekte bij patiënten met middelhoog tot hoog risico groot.

De technologie van Synergo combineert een plaatselijke verwarming van de blaaswand (hyperthermie) met het gelijktijdig spoelen van de urineblaas met een chemotherapeutisch geneesmiddel. Zowel de verwarming als het spoelen gebeuren door middel van een via de urethra in de urineblaas ingebrachte catheter De Synergo-catheter heeft drie belangrijke functies: 1. Gelijkmatige verwarming van de blaaswand door middel van een kleine antenne die radiostraling afgeeft (microgolven) 2. Controle van de temperatuur door middel van gevoelige thermokoppels, op verscheidene punten van de blaaswand. 3. Circulatie van het gekoelde chemotherapeutische geneesmiddel in en uit de blaas.

Zie website voor mooie verduidelijkende foto's. Alle gegevens worden door de Synergo-computer verwerkt en opgevolgd, zodat de blaastemperatuur tijdens de behandeling constant en stabiel blijft. De technologie van Synergo is goedgekeurd door de Europese normerende overheden ( CE normering ), terwijl de procedure voor goedkeuring door de U.S. Food and Drug Administration (FDA) loopt. De technologie is met succes toegepast in toonaangevende medische centra in diverse landen (Italië, Duitsland, Frankrijk, Oostenrijk, Israël en Nederland). Tot nu toe zijn honderden patiënten behandeld en hebben de behandelingen indrukwekkende resultaten opgeleverd. De behandeling van Synergo leidt tot een daling van de frequentie van de post-operatieve herhaling van tumoren (een vermindering van 58% naar 17% tijdens een opvolgingsperiode van twee jaar, en van 65% naar 26% in een geschatte opvolgingsperiode van vijf jaar), vergeleken met de tot nu toe courant toegepaste behandelingen.

De behandeling met Synergo omvat twee benaderingen: a. Behandeling voor de preventie van de herhaling van de tumor (profylaxe). Ze is bedoeld voor patiënten bij wie de tumor chirurgisch (TURT) of met laserstralen (TUF) is verwijderd. Deze behandeling is een alternatief voor het chemotherapeutisch spoelen van de urineblaas (zonder warmte) of de biologisch actieve (immunologische) behandelingen die vandaag courant worden gebruikt b. Behandeling voor de verwijdering van de tumor (ablatie). Ze is bedoeld voor patiënten met een sterk ontwikkelde tumor of uitgebreide kwaadaardige zones in de urineblaas (die moeilijk in één operatie te verwijderen zijn) en voor patiënten met vaak herhalende tumoren. Ze is ook bedoeld voor patiënten van wie de toestand geen verdoving mogelijk maakt. In beide gevallen wordt de patient met een serie van wekelijkse sessies van een uur ( profylactische patienten krijgen na de serie wekelijkse behandelingen nog een aantal maandelijkse behandelingen ) op de polikliniek behandeld. Na elke behandeling kan de patiënt zijn gewone dagelijkse bezigheden of werkzaamheden hervatten. De veiligheid van de technologie van Synergo is in een reeks klinische studies onderzocht en bewezen. De bijwerkingen van de behandelingen zijn meestal licht en tijdelijk (plaatselijke pijn, brandend gevoel tijdens het urineren, drang en frequentie van het urineren) en verdwijnen meestal binnen de 48-72 uren na de behandeling; ze houden geen gevaar in voor de patiënt. Opvolging van de patiënt Na de behandeling voor kanker van de urineblaas blijft men de patiënt zorgvuldig medisch opvolgen met regelmatige cystoscopieën en andere tests, afhankelijk van het geval. Dit is nodig om een eventuele terugkeer van de ziekte zo snel mogelijk op te sporen. Eerst is de frequentie van de controles hoog (om de drie maanden), later worden ze meer gespreid, volgens het oordeel van de arts. De opvolgingsbezoeken zijn erg belangrijk en de patiënten moeten hun best doen om het aanbevolen opvolgingsschema te volgen.

J Urol. 2009 Oct;182(4):1313-7. Epub 2009 Aug 14.

Combined thermo-chemotherapy for recurrent bladder cancer after bacillus Calmette-Guerin.

Nativ O, Witjes JA, Hendricksen K, Cohen M, Kedar D, Sidi A, Colombo R, Leibovitch I.

Urology Department, Bnai-Zion Medical Center, Haifa, Israel. ofer.nativ@b-zion.org.il

Comment in:

PURPOSE: Despite an initial adequate response many patients with nonmuscle invasive urothelial cell carcinoma of the bladder eventually have recurrence after intravesical bacillus Calmette-Guerin treatments. We evaluated the efficacy of combined bladder wall hyperthermia and intravesical mitomycin C instillation (thermo-chemotherapy) in cases of recurrence after bacillus Calmette-Guerin.

MATERIALS AND METHODS: A total of 111 patients with recurrent papillary nonmuscle invasive urothelial cell carcinoma of the bladder after previous bacillus Calmette-Guerin treatment underwent complete bladder tumor resection and were referred for prophylactic adjuvant treatment with thermo-chemotherapy. Treatment was received on an outpatient basis weekly for 6 weeks, followed by 6 maintenance sessions at 4 to 6-week intervals. Each treatment included 2, 30-minute cycles of 20 mg mitomycin C and bladder wall hyperthermia to 42C +/- 2C. Cystoscopy and urine cytology were performed after the completion of induction treatment and every 3 months thereafter. 

RESULTS: The Kaplan-Meier estimated disease-free survival rate was 85% and 56% after 1 and 2 years, respectively. No maintenance treatment was associated with decreased efficacy, that is the recurrence rate was 61% at 2 years vs 39% in those with maintenance treatments (p = 0.01). The progression rate was 3%.

CONCLUSIONS: Thermo-chemotherapy may be effective for papillary nonmuscle invasive urothelial cell carcinoma of the bladder that recurs after BCG treatment without increasing the risk of tumor progression. Maintenance therapy is important and improves the outcome.

PMID: 19683278 [PubMed - indexed for MEDLINE]

Meest recente publicaties van hyperthermie en chemo bij blaaskanker zijn deze, maar op website van Medical Enterprise en in Pubmed zijn veel meer studies te vinden over hyperthermie als aanvulling op chemo en blaaskanker:

1. Van der Heijden A.G, Cornelius F. J. J, Verhaegh G, O'Donnell M.A, Schalken J.A, Witjes J.A. The Effect of Hyperthermia on Mitomycin-C Induced Cytotoxicity in Four Human Bladder Cancer Cell Lines. Submitted for publication to J Urol 2004.

2. Van der Heijden A.G, Kiemeney L.A, Gofrit O.N, Nativ O, Sidi A, Leib Z, Colombo R, Naspro R, Pavone M, Baniel J, Hasner F, Witjes J.A. Preliminary European Results of Local Microwave Hyperthermia and Chemotherapy Treatment in Intermediate or High Risk Superficial Transitional Cell Carcinoma of the Bladder. Accepted for publication in Eur Urol: 2004.

3. Gofrit O.N, Shapiro A, Pode D, Sidi A, Nativ O, Leib Z, Witjes J.A, Van Der Heijden A.G, Naspro R, Colombo R. Combined Local Bladder Hyperthermia and Intravesical Chemotherapy for the Treatment of High Grade Superficial Bladder Cancer. Urol 63(3):466-471;2004.

Radiofrequency-induced thermochemotherapy effect was shown to be an alternative to bacillus Calmette-Guerin and preferable to early cystectomy in high-risk non–muscle-invasive bladder cancer.

Intravesical radiofrequency-induced hyperthermia combined with chemotherapy for non-muscle-invasive bladder cancer

Pages 351-362 | Received 13 Nov 2015, Accepted 05 Jan 2016, Published online: 24 Feb 2016

Although many treatment modalities and schedules for non-muscle-invasive bladder cancer (NMIBC) exist, all yet prove to have limitations. Therefore the search for new forms of therapy continues. One of these forms consists of combining intravesical chemotherapy, typically mitomycin C (MMC), with hyperthermia achieved by a microwave-applicator. We aimed to review the current status of intravesical radiofrequency (RF) induced chemohyperthermia (CHT) for NMIBC with regard to efficacy, adverse-events (AEs) and its future perspective. A search for RF-induced CHT in MEDLINE, Embase, Cochrane and ClinicalTrials.gov databases was performed. Relevant conference abstracts were searched for manually. If applicable, experts on the area were consulted. Papers were selected based on abstract and title. A table of newly published clinical trials since 2011 was constructed. No meta-analysis could be performed based on these new papers. Efficacy proved to be better for RF-induced CHT compared to both MMC alone and bacillus Calmette–Guérin (BCG) instillations, with the latter being based on just one abstract of a randomised controlled trial. The AE rate in CHT is higher compared to MMC instillation, but is similar compared to BCG, albeit different in the type of AE. In almost all studies no severe AEs are reported. Although heterogeneity in methodology exists, RF-induced CHT seems promising. However, alternative methods of applying hyperthermia are starting to present their first results, imposing as effective options too. Intravesical RF-induced CHT may become an alternative for BCG instillation, and possibly for cystectomy, although further level 1 evidence is required for both reliable and reproducible data on efficacy and adverse events.

Conclusion

Radiofrequency-induced chemo-hyperthermia remains a promising treatment modality which appears to be a potential alternative to BCG immunotherapy. It can also be used in patients unfit to undergo radical cystectomy, or to prolong bladder preservation time. Adverse events and safety profile seem to be acceptable in the context of the indication for RF-induced CHT. Nonetheless, a more solid scientific basis is needed to define the position of RF-induced CHT in relation to other hyperthermic treatment modalities and in relation to the newly emerged non-hyperthermia treatments.

Declaration of interest

J.A.W. is an investigator for Medical Enterprise Ltd (MEL), Amsterdam, without financial compensation and no conflict of interest, and was an adviser for MEL Amsterdam in 2014, with financial compensation and no conflict of interest. The other authors have no other interests to declare. The authors alone are responsible for the content and writing of the paper.

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