9 mei 2011 toegevoegd: Lees aub de waarschuwing voor dr. Robert Gorter en het Medisch Centrum Keulen. Dr. Robert Gorter is in opspraak geraakt in Duitsland en Egypte en ook wij distantiëren ons van dr. Robert Gorter. Klik hier of onder vragen voor uitvoerige uitleg waarom wij dr. Robert Gorter geen betrouwbare arts meer vinden.

5 mei 2010: Bron The Lancet - Oncology

Adfgelopen week kwam ook The Lancet oncology met een artikel over de gerandomiseerde studie van dr. Issels waarbij hyperthermie bij sarcoma's een hoog significant langere ziektevrije tijd en significant meer overall overlevingen geeft. Onderstaand hebben we al uitgebreid deze studie besproken en ook voor u vertaald maar we beginnen met het artikel uit The Lancet van afgelopen week: Scroll verder voor meer details over deze studie.

THE LANCET ONCOLOGY: Press Release

Thursday 29 April 2010

Regional Hyperthermia Combined With Chemotherapy Could Improve Survival In Sarcoma Patients

Treating high-risk sarcoma with hyperthermia, by applying regional heat, alongside chemotherapy could improve the chances of survival, concludes an Article published Online First in The Lancet Oncology.

There are just over 10,000 new cases of soft-tissue sarcomas in the USA every year, and half of these people will eventually die of the disease. Yet the best way to treat this cancer is unclear. Hyperthermia in addition to chemotherapy has already shown promise in early trials. The theory is that the heat boosts the activity of the drugs by helping to kill the cancer cells directly.

Rolf Issels at the Klinikum der Universität, and the Helmholtz Zentrum, München, Germany, and colleagues undertook a phase-3 study of 341 patients to investigate whether this combination treatment could improve survival in patients with high-risk sarcomas. All patients were assigned to pre-operative and post-operative chemotherapy with etoposide, ifosfamide, and doxorubicin. 169 of these (selected at random) were given additional treatment with regional hyperthermia concentrated on the sarcoma. The team’s aim was to measure local progression-free and disease-free survival—ie, how many people survived without local tumour progression or any evidence of disease.

Patients who were given hyperthermia in addition to chemotherapy were 42% more likely to survive with local control, and 30% more likely to survive free of disease than those given chemotherapy alone.

Hyperthermia had “moderate” toxicity, say the team. Patients who were given regional hyperthermia were more likely to develop leucopenia (reduced white-blood cells), probably because of the heating field covering part of the bone marrow, especially in patients with large abdominal or pelvic tumours, say the researchers.

“Whether a similar benefit will be seen in lower risk patients, and whether the safety profile will be the same, and hence the trade off between benefit and harm worthwhile, remains to be established,” they add. Based on these results, their current routine clinical practice consists of pre-operative and post-operative first-line chemotherapy combined with regional hyperthermia – in addition to preoperative radiotherapy – where possible.

The authors say: “This randomised trial provides the first evidence that regional hyperthermia added to preoperative and postoperative chemotherapy is clinically more effective than chemotherapy alone in a specific population of patients with high-risk STS. This therapeutic strategy offers a new treatment option, and can be integrated in the multimodal treatment approach for these patients.”

 

24 september 2009: Bron: Nieuwsbrief van ECCO en ESMO

We hebben aan de informatie uit 2007 en 2008, zie hieronder de volgende informatie toegevoegd. Het gaat in principe om dezelfde studie maar werd gepresenteerd op een medisch congres in Berlijn 22 september 2009 van de ECCO - European Cancer Organisation  en ESMO - European Society for Medical Oncology in Berlijn. Voor alle duidelijkheid hier is een hyperthermie techniek gebruikt die wel verbrandingen geeft maar ook wel goed te controleren is, aldus de onderzoekers:

Een Nederlandse samenvatting van onderstaand artikel:

Dr. Issels beschrijft hierin hoe hyperthermie naast chemo significant het leven verlengt van mensen met soft sarcoma's.  Let wel dat alle patienten eerder al operaties en bestrlaing achter de rug hadden. Alle patienten waren wel op moment van starten vrij van aanwijsbare tumoren. Het ging er dus om om een recidief te voorkomen of de ziektevrije tijd zo lang mogeljik te verlengen met chemo en hyperthermie of met chemo alleen. 

Na een mediane follow-up van 34 maanden, waren van de 341 deelnemende patienten er 153 patiënten (44,9%) in totaal gestorven. Uit een analyse van de 269 patienten die een volledige behandeling van of 4 cycli van alleen chemotherapie of 4 cylci van chemo plus 8 behandelingen met hyperthermie kregen bleek  dat degenen die de hyperthermie als aanvulling erbij kregen zij 44% minder kans hadden om te sterven tijdens de follow-up periode dan degenen die alleen chemotherapie hadden gekregen.
 
"De patiënten uit de combinatiegroep van chemo plus hyperthermie scoorden op alle metingen van deze studie beter, aldus Prof Issels. "Bijna drie jaar na aanvang van de behandeling, hadden de patienten uit deze groep 42% minder kans op een herhaling van hun kanker op dezelfde plaats of te sterven dan degenen die alleen chemotherapie kregen. De mediande overlevingstijd lag geschat op 120 maanden voordat de plaatselijke progressie van hun ziekte zich weer voordeed, in vergelijking met geschat 75 maanden voor alleen de chemogroep. Ook de mediane ziektevrije tijd van de patiënten was 32 maanden in de groep die beide behandelingen kreeg, in vergelijking met 18 maanden in de groep die alleen chemotherapie - een verbetering van 30%. " 
Na twee jaar was 76 procent van de patiënten in de hyperthermiegroep nog in leven zonder lokale progressie van de kanker, vergeleken met 61 procent in de chemotherapie groep. Het aantal patiënten die tumorregressie bewerkstelligden steeg van 12,7% in de chemotherapie alleen groep naar 28,8% in de hyperthermiegroep, terwijl het aandeel van de patiënten die hun tumor zagen groeien 6,8% bleek in de hyperthermiegroep, vergeleken met 20% in de chemotherapie alleen groep.
 
De meest frequente bijwerking van de hyperthermiegroep was een milde tot matige pijn, gemeld bij 45% van de patiënten. De meest ernstige bijwerking is ernstige brandwonden, gezien bij een patiënt (0,6%). Brandblaren traden op bij 17,8% van de patienten.

 

Impact of regional hyperthermia (RHT) on response to neo-adjuvant chemotherapy and survival of patients with high-risk soft-tissue sarcoma (HR-STS): Results of the randomized EORTC-ESHO intergroup trial (NCI-00003052) 1LBA
 
R.D. Issels, L.H. Lindner, C.M. Wendtner, P. Hohenberger, P. Reichardt, S. Daugaard, U. Mansmann, W. Hiddemann, J.Y. Blay, J. Verweij
 
Targeted heat therapy offers new standard treatment option for soft tissue sarcoma
 
Berlin, Germany: Patients with soft-tissue sarcomas at high risk of spreading were 30% more likely to be alive and cancer free almost three years after starting treatment if their tumours were heated at the time they received chemotherapy, according to new research. The finding bolsters the case for intensifying exploration of the strategy in other types of cancer.
 
The study, which found that the addition of the innovative heat technique more than doubled the proportion of patients whose tumours responded to chemotherapy without increasing toxicity, is also the first to show that any treatment other than surgery followed by radiation can prolong survival of this type of patient.
 
“These findings provide a new standard treatment option and we believe they are likely to change the way many specialists treat these tumours,” said the study’s leader, Professor Rolf Issels, a professor of medical oncology at Klinikum Grosshadern Medical Center at the University of Munich in Germany, who presented the results today (Tuesday 22 September) in Berlin at Europe’s largest cancer congress, ECCO 15 – ESMO 34 [1].
 
“But the implications of these findings are more far-reaching,” Prof Issels said. “This is also the first clear evidence that targeted heat therapy adds to chemotherapy. We expect our findings will encourage other researchers to test the approach in other locally advanced cancers. Targeted heat therapy has already shown promise in recurrent breast and locally advanced cervical cancer in combination with radiation and studies combining it with chemotherapy in other localised tumours such as those in the pancreas and rectum are ongoing.”
 
Soft tissue sarcomas involve cancer that starts in the soft, supporting tissues of the body, such as muscle, fat, blood vessels, nerves, tendons, tissue around the joints and deep layers of the skin. They are relatively rare, accounting for about three percent of all cancers, but are more common in children and young adults. Surgery is the primary treatment, but sometimes these tumours are difficult to remove completely, so they are often also treated with radiotherapy and sometimes chemotherapy. However, in cases where the disease is localised, the benefits of chemotherapy have been shown to be limited. In high-risk patients, any relapse usually occurs within two or three years. Survival varies widely depending on the location and severity of the tumour, with abdominal sarcomas being the most deadly.
 
The phase III study involved 341 patients being treated at several centres in Europe and the United States between July 1997 and November 2006 for locally advanced soft tissue sarcomas that were at high risk of recurrence and spread. More than half of the tumours were located in the abdomen, while the rest were in the arms and legs. All patients were given chemotherapy before and after surgery and radiotherapy.
 
Half were randomly given targeted heat treatment along with the chemotherapy. The technique, known as regional hyperthermia, uses focused electromagnetic energy to warm the tissue in and around the tumour to between 40 and 43 degrees Celsius (104 – 109.4 degrees Fahrenheit). The heat not only kills cancer cells, but it also seems to make chemotherapy work better by making cancer cells more sensitive. It also improves blood flow, which allows chemotherapy to be more effective.
 
After an average follow-up of 34 months, only 153 patients (44.9%) in total had died. The improvement in overall survival was not statistically meaningful when all patients were analysed, but an analysis of the 269 who completed the full treatment of either four cycles of initial chemotherapy alone or four chemotherapy cycles and eight heat treatments found that those who got the heat therapy were 44% less likely to die during the follow-up period than those who got chemotherapy alone.
 
“The patients receiving the targeted heat therapy fared better on all outcome measurements,” Prof Issels said. “Almost three years after starting treatment, they were 42% less likely to experience a recurrence of their cancer at the same site or to die than those who were getting chemotherapy alone, surviving an estimated 120 months before local progression of their disease, compared with an estimated 75 months. Similarly, the average length of time that patients remained disease free was 32 months in the group that got both treatments, compared with 18 months in the group that got chemotherapy alone – an improvement of 30%.”
At two years, 76 percent of the patients in the heat therapy group were still alive without local progression of their cancer, compared with 61 percent in the chemotherapy alone group. The proportion of patients who experienced tumour shrinkage rose from 12.7% in the chemotherapy alone group to 28.8%, while the proportion of patients who saw their tumour grow was 6.8% in the heat therapy group, compared with 20% in the chemotherapy alone group.
 
The most frequent side effect of the heat therapy was mild to moderate discomfort, reported in 45% of patients. The most serious side effect was severe burns, seen in one patient (0.6%). Blisters occurred in 17.8%.
 
“This strategy has been in development for about 20 years, with about 150 leading groups studying it, but the clear results of this trial show that the field has now matured to the point where we must step up efforts to explore its potential to offer an entirely new way of treating locally advanced disease in several major cancers,” Prof Issels said. “That will take investment from public funders to underwrite trials that investigate, for instance, whether it will be possible to reduce the dose of chemotherapy drugs by boosting their effectiveness with targeted heat therapy and whether the technique can enhance the effectiveness of newer targeted drugs.”
 
Other questions remaining include whether targeted heat therapy can play a role in stimulating the immune system to more effectively attack cancer, Prof Issels said, adding that studies of heat shock protein therapy indicate that they may activate the immune system against the disease.
 
The study was funded by the German cancer foundation Deutsche Krebshilfe and the Helmholtz Assocation, Germany’s largest scientific organisation.
 

16 september 2008: Bron: Oncology

We publiceerden al eerder een studie van regionale hyperthermie bij soft sarcoma's (kanker in de weke delen) , zie hieronder, maar deze week publiceerde Oncology een artikel waarin regionale hyperthermie wordt aanbevolen voor soft sarcoma's.  Er zit veel verschil tussen de hyperthermie zoals die in Nederland wordt toegepast o.a. in de Erasmus en AMC en ook dus gebruikt bij deze patienten bij sarcoma's waarbij de verbrandingskans wel groot is, maar controleerbaar en de electro hyperthermie zoals die bijna overal in de wereld wordt toegepast en ook bij o.a.. dr. Robert Gorter en in Bochum. Deze vorm van electro hyperthermie is ongevaarljik en de kans op verbranden is bijna nihil. Maar geeft hetzelfde effect. Hoe dat in zijn werk gaat zie o.a. videofilmpjes van patienten die o.a. hyperthermie ondergingen/ondergaan onder patientenervaringen en dan onder video's. . Of videovoorlichtingsfilmpjes van het SNFK en klik daar op video.

 

 

5 juni 2007: Bron: BSD Medical Corp

Hyperthermie als aanvulling op chemo bij patienten met soft sarcoma's graad II en III en in slechte conditie verdubbelt ziektevrije overlevingstijd t.o. alleen chemo. Een hoog significante verbetering met 95%. Dit blijkt uit een gerandomiseerde fase III studie bij 340 patienten. Hier zo goed als letterlijk vertaalt het persbericht over deze studie.

De patienten met soft sarcoma's graad II en III in deze studie waren bij aanvang ernstig ziek met ernstige klachten en een zeer hoog risico op uitzaaiingen. De patienten werden gerandomiseerd verdeeld over twee groepen. De ene groep kreeg alleen chemotherapie, de andere groep chemotherapie plus hyperthermie. De karakteristieken van de patienten (ernst van de ziekte en klachten enz. ) werden evenwichtig verdeeld over beide groepen. Hun behandelingen werden toegediend in vier cycli elkke drie weken voor en na operatie en bestraling. Voor de patienten die de gecombineerde behandeling kregen bleek de ziektevrije overlevingstijd mediaan 31,7 maanden, voor de patienten die alleen chemotherapie kregen bleek de mediane ziektevrije overlevingstijd 16,2 maanden. Derhalve een hoog significante verbetering van de ziektevrije overlevingstijd met 95% (p=0.004). De mediane lokale ziektevrije tijd (dus de plaatsen waar al tumoren zaten en deze waren behandeld, (soft sarcoma's "verplaatsen" zich vaak door het hele lichaam) was vastgesteld op 45.3 maanden voor die patienten die de gecombineerde behandeling van chemo en hyperthermie kregen tegenover 23.7 maanden voor patienten die chemotherapie alleen kregen (p=0.01), een verbetering met 91%.

Hier het persbericht dat wij kregen toegestuurd.

Hyperthermia Plus Chemotherapy Nearly Doubles Disease-Free Survival Compared to Chemotherapy Alone for Sarcoma Cancer Patients SALT LAKE CITY—June 4, 2007— BSD Medical Corp. (AMX:BSM) announced today that the results of a 340 patient randomized Phase III clinical trial testing the benefit of adding hyperthermia therapy to chemotherapy were presented at the annual American Society of Clinical Oncology (ASCO) conference underway in Chicago, Illinois. According to the results of this clinical study, which was conducted at nine major European cancer treatment institutions and at Duke University Medical Center in the USA, both disease-free survival time and local progression free survival time for patients with locally advanced, high-grade soft tissue sarcomas nearly doubled when hyperthermia therapy was added to chemotherapy, as compared to patients who received chemotherapy alone.

The patients enrolled in this clinical study were very ill, with high-grade (II/III) soft tissue sarcomas and were at significant risk of local failure and metastasis. The patients were randomly assigned to receive either chemotherapy alone or chemotherapy combined with hyperthermia therapy. The patient characteristics were well balanced between these two groups. Their treatments were administered in 4 cycles every 3 weeks before and after surgery and radiation therapy. For patients who received both hyperthermia therapy and chemotherapy the median disease free survival was 31.7 months, compared to 16.2 months for those who received chemotherapy alone (p=0.004), a 95% increase. The median local progression free survival rate was estimated at 45.3 months for patients who received chemotherapy plus hyperthermia therapy, compared to 23.7 months for patients who received chemotherapy alone (p=0.01), a 91% increase.

The study was conducted under the direction of the European Society of Hyperthermic Oncology (ESHO RHT-95) and the European Organization for Research and Treatment of Cancer (EORTC 62961). Rolf Issels, MD PhD of the Munich University Medical School in Germany, was the principal investigator. Duke University was a participant in the international study listed on the National Cancer Institute’s website at http://www.cancer.gov/clinicaltrials/EORTC-62961 under the NCI number

NCT00003052. 7 december 2006: Bron: BSD Medical Corporal.

Een fase III studie met 340 hoog risico patienten bewijst dat wanneer bij patienten met soft sarcoma's een combinatiebehandeling wordt gegeven van chemo en hyperthermie de overlevingstijd bijna wordt verdubbeld. De studie zal voorjaar 2007 worden gepresenteerd.

SALT LAKE CITY, December 6, 2006—BSD Medical Corp. (AMEX:BSM) today announced the conclusion of a Phase III clinical study involving 340 high-risk soft tissue sarcoma patients that evaluates the results of treatments delivered by the company’s BSD-2000 cancer therapy systems. The purpose of this multi-center, randomized, international clinical study was to compare the results for patients who received a combination of chemotherapy and hyperthermia therapy (through BSD-2000 systems) to those who received chemotherapy alone.

The study has been conducted under the direction of the European Society of Hyperthermic Oncology (ESHO RHT-95) and the European Organization for Research and Treatment of Cancer (EORTC 62961). Rolf Issels, MD PhD of the Munich University Medical School in Germany is the principal investigator. Duke University Medical Center has been a participant as one of the research centers in this international clinical trial, which is listed on the National Cancer Institute’s website at http://www.cancer.gov/clinicaltrials/EORTC-62961 under the NCI number NCT00003052.

Soft tissue sarcomas are cancerous tumors located in muscle, fat or lymphatic tissue mostly situated in the lower pelvis and/or the upper part of the extremities. This form of cancer affects both adults and children, and represents a formidable therapeutic challenge. Normally 50% of patients with high-grade sarcoma tumors die from the cancer. This high-risk soft tissue sarcoma trial has consequently been followed with interest by the medical community.

The BSD-2000 was used in this clinical trial because of its ability to deliver precision-focused deep hyperthermia therapy. An article in the September 2006 issue of CANCER (see vol. 107, Issue 6, pp. 1373-1382), the official journal of the American Cancer Society, also evaluated BSD Medical’s BSD-2000/3D/MR for its application in monitoring regional hyperthermia treatments in patients with soft tissue sarcomas of the lower extremities and pelvis. The BSD-2000/3D/MR has the desirable capability of imaging treatments in progress through magnetic resonance imaging (MRI) by means of a process called “thermography.” The report concluded that “Noninvasive MR thermography of soft tissue sarcoma was feasible and suitable for validating the quality of heating during RHT (Regional Hyperthermia).” The report cited is copyrighted by the American Cancer Society.

This multi-center, randomized, Phase III trial was concluded December 4, 2006. The results of the trial will be reported when they are released.

BSD Medical is the leading developer of precision-guided RF and microwave systems used to treat cancer with heat both to kill cancer cells directly and boost the effectiveness of companion treatments with radiation. Research such as the current study involving high-risk soft tissue sarcomas is also being conducted on the use of hyperthermia therapy in combination with chemotherapy, or with combined radiation and chemotherapy. For its advanced design the BSD-2000, including its high-featured version, the BSD-2000/3D/MR, BSD Medical received the 2005 Technology Innovation of the Year Award for cancer therapy devices from Frost and Sullivan. For further information visit BSD Medical’s website at www.BSDMedical.com.

Statements contained in this press release that are not historical facts are forward-looking statements, as that item is defined in the Private Securities Litigation Reform Act of 1995. All forward-looking statements and projections or expectations of future events, including the success of results from clinical trials mentioned involving the Company’s cancer therapy systems, are subject to risks and uncertainties detailed in the Company’s filings with the Securities and Exchange Commission.

 

16 september aangevuld met dit persbericht in Oncology:

1: Curr Opin Oncol. 2008 Jul;20(4):438-43. Links
 

Regional hyperthermia in high-risk soft tissue sarcomas.

Issels RD.

University Hospital Medical Center Grosshadern, Medical Clinic III and Helmholtz Zentrum münchen - German Research Center for Environmetal Health, Munich, Germany. rolf.issels@med.uni-muenchen.de

PURPOSE OF REVIEW: On the basis of the definition of high-risk soft tissue sarcomas and prognostic factors, the most recent developments of preoperative treatment strategies with special emphasis on regional hyperthermia combined chemotherapy are reviewed. RECENT FINDINGS: The most important prognostic factors (e.g. size, grade, depth and resection margins) for localized soft tissue sarcomas have been defined to predict the probability of sarcoma-specific death providing a useful tool for patient stratification and clinical trial eligibility determination that are also relevant in the outcome of paediatric patients with adult type soft tissue sarcomas. Clinical research on innovative preoperative treatment strategies has essentially focused on the combination of preoperative radiochemotherapy or chemotherapy alone, but unfortunately the reported results are based upon retrospective analysis or nonrandomized phase II studies with small sample size. For the use of regional hyperthermia (RHT) therapy, phase II studies have advocated a possible benefit of the use of regional hyperthermia in combination with chemotherapy targeting the heating field to the region of tumour burden. The preliminary results of a completed European Organization for Research and Treatment of Cancer-European Society of Hyperthermic Oncology intergroup randomized phase III trial for the most common types of adult high-risk soft tissue sarcomas demonstrate a significant benefit in the clinical outcome of patients receiving regional hyperthermia therapy.

SUMMARY: Regional hyperthermia combined with preoperative and postoperative chemotherapy offers a new appropriate treatment option for high-risk soft tissue sarcomas.

PMID: 18525341 [PubMed - indexed for MEDLINE]

 

 

1: Curr Opin Oncol. 2008 Jul;20(4):438-43. Links
 

Regional hyperthermia in high-risk soft tissue sarcomas.

Issels RD.

University Hospital Medical Center Grosshadern, Medical Clinic III and Helmholtz Zentrum münchen - German Research Center for Environmetal Health, Munich, Germany. rolf.issels@med.uni-muenchen.de

PURPOSE OF REVIEW: On the basis of the definition of high-risk soft tissue sarcomas and prognostic factors, the most recent developments of preoperative treatment strategies with special emphasis on regional hyperthermia combined chemotherapy are reviewed. RECENT

FINDINGS: The most important prognostic factors (e.g. size, grade, depth and resection margins) for localized soft tissue sarcomas have been defined to predict the probability of sarcoma-specific death providing a useful tool for patient stratification and clinical trial eligibility determination that are also relevant in the outcome of paediatric patients with adult type soft tissue sarcomas. Clinical research on innovative preoperative treatment strategies has essentially focused on the combination of preoperative radiochemotherapy or chemotherapy alone, but unfortunately the reported results are based upon retrospective analysis or nonrandomized phase II studies with small sample size. For the use of regional hyperthermia (RHT) therapy, phase II studies have advocated a possible benefit of the use of regional hyperthermia in combination with chemotherapy targeting the heating field to the region of tumour burden. The preliminary results of a completed European Organization for Research and Treatment of Cancer-European Society of Hyperthermic Oncology intergroup randomized phase III trial for the most common types of adult high-risk soft tissue sarcomas demonstrate a significant benefit in the clinical outcome of patients receiving regional hyperthermia therapy.

SUMMARY: Regional hyperthermia combined with preoperative and postoperative chemotherapy offers a new appropriate treatment option for high-risk soft tissue sarcomas.

PMID: 18525341 [PubMed - indexed for MEDLINE]

hyperthermie, soft sarcoma


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