Hyperthermia, well known as a radiosensitizer for cancer treatment, has found its way into South Korea’s leading cancer centers. The country, with a population over 50 million, has the third highest cancer rate among women and ranks 8th in the world overall. In addition to treating cancers of the pelvic region with the Pyrexar BSD-2000 Deep Regional Hyperthermia system, physicians have also found profound value in hyperthermia as a palliative treatment. Prescribing hyperthermia to relieve cancer-related pain and increase patient mobility is being used in convalescent centers throughout the country.

hanbeam sk 062017(left to right) James Kim, Bob DePalma, Brian Bay, Mark Falkowski

The BSD-2000 units are getting quite a workout in centers throughout South Koreas. Some facilities are reporting 8 to 10 treatments a day, every day, generating an estimated 200 patient treatments a month.

During a recent trip to Asia, Pyrexar CEO, Mark Falkowski met with Hanbeam Technologies president, Brian Bay and his team in Seoul, Korea. Hanbeam is a Pyrexar sales leader and has placed 11 BSD-2000 Deep Regional units in the country in the last 12 months. Currently Hanbeam is waiting regulatory approval from the KFDA to import the BSD-500 Superficial Hyperthermia system into the region.

Hanbeam continues to promote hyperthermia with a major presentation in Seoul this month, inviting well-known hyperthermia expert Dr. Jacoba van der Zee from Erasmus University in The Netherlands. Dr. van der zee has authored many clinical papers and several landmark hyperthermia studies. Her extensive clinical experience in treating a range of cancers using hyperthermia makes her a well-spring of knowledge in a country that is embracing the technology.

This years STM (Society of Thermal Medicine) conference was a great success.  The 3 day event was held at the beautiful CasaMagna Marriot Resort in Cancun, Mexico.  The society strives to promote new discoveries in thermal biology, physics/engineering and medicine.  Each year they come together to present their ideas in this forum.

STM 2017 Booth

Highlights

  1. Dr. Rolf Issels, Ludwig-Maximilians-University of Munich, included an update on the long term survival benefit of adding hyperthermia to chemotherapy for soft tissue sarcoma in the Phase III randomized clinical trial.  Data demonstrates a more than doubling the overall survival time. Chemotherapy averaging 6.2 years vs. 15.4 years when adding hyperthermia.  Treatments were performed using the Pyrexar BSD-2000. 

  2. Dr. Jacoba Van der Zee, Erasmus University,  gave a very good talk reviewing 55 hyperthermia randomized trials including 5,099 patients showing the significant effectiveness of HT.  Significant benefit was found in 19 of 27 trials when adding hyperthermia to radiation therapy, 9 of 11 trials when adding HT to chemotherapy, and in 7 of 10 trials by adding HT to both radiation plus chemotherapy.  Concluding, “These results indicate that hyperthermia is a universal and effective modifier of radiotherapy and/or chemotherapy in malignant tumors.”

  3. Dr. Elizabeth Repasky, Roswell Cancer Center, presented a plenary lecture describing the many ways that elevated temperature and physical stresses can stimulate immune responses.  

  4. Dr. Hana Trefna, Chalmers University of Technology, presented efforts to release in this summer a new ESHO QA guideline to support the growing interest and application of interstitially applied hyperthermia with Brachytherapy.

  5. Dr. Ruediger Wessalowski, University of Dusseldorf, reported the success in treating pediatric ovarian germ cell tumors with hyperthermia and chemotherapy using the Pyrexar BSD-2000 system.  This study included 22 patients.  The overall survival in this patient population with an unfavorable prognosis was 71% (95% CI 46-86).  This concluded: “A multi-modality therapy including regional hyperthermia according to the Hyper-PEI protocol has led to long-term remission in the majority of patients with advanced refractory or recurrent ovarian germ cell tumors.”  

  6. Dr. Niloy Datta, Kantonspital Aarau AG, presented a systemic review and meta-analysis of HT and RT in locally recurrent breast cancer which was also published in 2016.  This review report included 34 clinical studies that included 2110 patients.  The conclusion of the met-analysis is “Thermoradiotherpay (HTRT) enhances the likelihood of complete response rates in locally recurrent breast carcinomas (LRBTCs) over radiation therapy alone by 22% with minimal acute and late morbidities.  For even those previously irradiated, re-irradiation with hyperthermia provides a loco-regional control in two-thirds of the patients.  HTRT could therefore be considered as an effective and safe palliative treatment option for LRBCs.”  

  7. Dr. James Snider, University of Maryland, reported treatments for 87 patients treated with the Pyrexar BSD-500.  Of this group 3 patients were treated by a pencil beam scanning proton therapy method showing the feasibility of combining hyperthermia with proton therapy.

  8. Dr. Arpit Chabra, University of Maryland, reported on the use of the Pyrexar BSD-500 hyperthermia as an external thermal therapy (ETT) method with external beam radiotherapy (EBRT) in treating non-melanoma skin cancers on 6 patients.   The conclusion stated: “This data tends to support strong consideration of using ETT concurrently with EBRT in this setting. “

  9. Gerard Van Rhoon, Phd, Erasmus MC Cancer Institute, was presented with the 28th J. Eugene Robinson award presented annually to an investigator who has made outstanding contributions to the field of hyperthermic oncology.
     
  10. Mark W. Dewhirst, Phd, Duke University, was presented with the George M Hahn award presented every other year to an investigator whose research has contributed in a significant way to new clinical applications in thermal therapy. 

Thanks for STM president Robert Ivkov, Johns Hopkins University School of Medicine, and team for putting on an amazing event.

In the follow-up fifth installment of the ABC story, we see hyperthermia cancer treatment take a foothold in Utah.  Gamma West Cancer Services, serving the Intermountain West starts its own thermal oncology group.  We hear about their early success with the treatment and their plans to expand the service.  If you missed the previous Part 1Part 2Part 3Part 4 you can use the links.


Last year, ABC4 traveled to New Orleans to learn about hyperthermia: a cancer treatment that kills harmful cells with heat. We explored its use throughout the world, but found that hyperthermia was not being used in the Intermountain West.

But now, it is.

“Cancer's not a neat word for anybody,” says Terrance Faber.

Faber was diagnosed with stage four prostate cancer one year ago.

“You know, I have aggressive cancer...and whatever we can do to combat that. And hyperthermia apparently is one really big help,” Faber continues.

And now he has that option right here in Salt Lake City. Gamma West Cancer Services is the first facility in Utah to use hyperthermia treatment.

Dr. John Hayes,the president of Gamma West, says “We have invested space, equipment, personnel...and we would like to become a regional center of excellence for hyperthermia.”

Hayes explained that there is clinical data which shows a benefit when you add hyperthermia to an already prescribed radiation treatment, especially in recurrent cancers.

So, when Faber’s cancer came back, Dr. Hayes added hyperthermia to Faber’s treatment plan.

Dr. Hayes says it works like this: the heat causes more blood to flow into the tissue. That brings more oxygen to the tumor cells trapped inside scar tissue. This makes radiation more effective.

Mr. Faber has plenty of scar tissue from previous treatments.

Our crew was there for Faber’s first hyperthermia treatment.

“Because he's had prior treatment, we're going to give a treatment with extra power, and let's say umph, to get rid of all this cancer,” Dr. Hayes explains.

Hyperthermia treatments have been around for more than three decades. Just last year, we at Good4Utah showed you how it's being used in Europe. However, many facilities in the U.S. still aren't using it. Many of these places say there is not enough peer-reviewed research yet to prove, or disprove, its effectiveness.

But Dr. Hayes disagrees.

“With hyperthermia, we have decades old data, with 15 randomized controlled clinical trials showing a benefit.”

Dr. Hayes says it typically only takes a few days to see a tumor visibly shrink after being treated with hyperthermia.

Both Dr. Hayes and Mr. Faber are optimistic about the future.

“I'm real excited about the way things are going. I'm feeling real good,” says Faber.

 

New Study shows that Radiated Hyperthermia is superior to Capacitive Hyperthermia in the Treatment of Superficial Cancerous Tumors. Clinical data demonstrates that adding superficial hyperthermia treatment to radiation in the treatment of Recurrent Chest Wall Tumors (breast cancer) and malignant melanoma can double* the complete response (tumor eliminated) rate. Add Hyperthermia, Your chances of beating cancer DOUBLES!

The downside, not everyone who claims to offer hyperthermia can deliver this potentially life saving benefit.  It essential comes down to two heat delivery methodologies; Capacitive vs Radiated Electromagnetic Fields. In a recent comparison study at the Department of Radiation Oncology at the University of Amsterdam, researchers H.P. Kok and J. Crezee compare hyperthermia systems made by Pyrexar, ALBA, Oncotherm, Celcius 42 and Thermotron. SPOILER ALERT: Pyrexar’s BSD-500 Superficial Hyperthermia system is the only one among the systems tested to earn FDA Approval.

Feature Radiated Microwave Capacitive
Pyrexar Oncotherm Celcius 42 Thermotron
FDA Approved YES NO NO NO
Temperature Probes & Monitoring YES NO NO YES
SAR based tumor temp. YES NO YES YES
Phase III published clinical studies HT+RT YES NO NO NO
Made in the USA YES NO NO NO


Pyrexar uses radiated microwave / radio frequency to pass energy into the body and absorbed by the tissue as heat. This heat delivery can be measured and compared using a numerical value called a SAR (Specific Absorption Rate). Primary benefit of choosing a hyperthermia system using frequency radiated field is that the energy can be transmitted from the antenna to the cancer tumor without getting stuck in the fat layer.  Capacitive heating techniques used in Oncotherm, Celsius 42 and Thermotron have difficulty passing thru the fat layer.  This often results in the super-heating of the fat layer, causing patient discomfort and blocking the tumor from receiving a therapeutic dose of heat.

Capacitive systems often claim they heat, just not where it will do the patient the most good if there is superficial fat over the tumor.  More fatty tissue in the treatment area equals poor results.  Oncotherm claims they avoid over heating of the fat tissues of the surface by limiting the radio frequency power from their capacitive electrodes .  Technology speak for they don't heat, hoping to rely on their claimed non-thermal effects for the treatment. 

Conclusion from the report, “This study showed that radiative hyperthermia yields more favorable SAR and temperature distributions for superficial tumor locations, compared with capacitive heating, especially within heterogeneous tissues. With radiative heating, higher tumor temperatures can be achieved without inducing treatment limiting hot spots, which will benefit clinical outcome.”

View the entire report “A comparison of the heating characteristics of capacitive and radiative superficial hyperthermia” in the International Journal of Hyperthermia, 2017.

* statement based on published Phase III Clinical Studies