We have recently heard a few stories from doctors who have purchased Oncotherm systems. When asked why they did not choose the industry standard, Pyrexar Medical, for their hyperthermic cancer treatment center, their answers revealed some sly misinformation. The statements below are hearsay, and we presume that the anecdotal information was represented to physicians during the equipment sales process. We have provided statement ratings to help you separate fact from fiction.
Statement: Google "Oncothermia" and you will see plenty of published data that it works.
This is very misleading. In the medical field, published data refers to peer reviewed studies published in reputable medical journals. So we did our own research and typed "oncothermia" into the search bar of the journals listed below. The results compare the number of articles referencing "hyperthermia" vs number of articles referencing "oncothermia". The data spoke.
|Peer Reviewed Medical Journal||"hyperthermia"||"oncothermia"|
|International Journal of Hyperthermia||1985||1|
|European Journal of Cancer||960||1|
|International Journal of Cancer||367||0|
|British Journal of Cancer||343||0|
|Journal of Clinical Oncology||227||0|
|International Journal of Oncology||153||1|
|The Journal of the American Medical Association||80||0|
|European Society of Radiotherapy and Oncology||79||0|
|Cancer Immunology, Immunotherapy||52||0|
|International Journal of Medical Science||37||0|
|CA: A Cancer Journal for Clinicians||33||0|
|Journal of the National Cancer Institute||32||0|
|Japanese Journal of Clinical Oncology||30||0|
|Prostate Cancer and Prostatic Diseases||10||0|
|Journal of Clinical Investigation||8||0|
|Society for Endocrinology||7||0|
|Cancer Epidemiology, Biomarkers & Prevention||3||0|
If you go to the American Cancer Society website and type “oncothermia”... Sorry, no matches were found... But it gets worse, type "oncothermia" into Google and among the findings, you get an NIH abstract "Current Status of Oncothermia Therapy for Lung Cancer" by Andras Szasz,PhD . The paper uses HT studies as the foundation that hyperthermia works, but then introduces oncothermia as a false equivalent. Under the Clinical Evidence section it states that no clinical results can be provided, instead just observations through case studies. Szasz is the founder of Oncotherm and is the author of the majority of the claims found on the internet.
Statement: Pyrexar is only FDA approved for Cervical cancer and superficial tumors of Melanoma and Sarcoma.
In fact the BSD-500 Superficial/Interstitial system is approved for most indications. It has well documented success in superficial lesions like recurrent chest wall tumors, soft tissue sarcoma and melanoma. The BSD-500 Hyperthermia System is indicated for use alone or in conjunction with radiation therapy in the palliative management of certain solid surface and subsurface malignant tumors (i.e., melanoma, squamous- or basal-cell carcinoma, adencarcinoma, or sarcoma) that are progressive or recurrent despite conventional therapy. Because its interstitial capabilities are designed for brachytherapy, it has the ability to treat along side any brachytherapy treatment. This makes the BSD-500 is a very effective system. In the U.S. the BSD-2000 is FDA HDE approved for Cervical cancer, but that restriction is changing.
Statement: Pyrexar Systems requires a temperature probe to be inserted into the tumor under imaging guidance.
That is very old data. Although a physician could choose to place a temperature probe directly into the tumor, it would be an extremely rare case, not a common practice, aside from Brachytherapy where a catheter is already inserted into the tumor for radiation. We use that existing path for both temperature probes and rf antenna placement. Pyrexar equipment can track up to 8 temperature probes with a temperature resolution of ± .2˚C (per ESHO guidelines), and are commonly taped to the surface for superficial tumors or placed near deep tumors through the natural orifices using closed tip catheters. Physicians can easily place probes using their knowledge of physiology without the need for image guidance.
Statement: With Oncothermia you don’t need to use temperature probes.
This is absolutely true, but for the wrong reason. Oncotherm claims that the heat component is not the therapeutic effect on the tumor, even though they continually reference hyperthermia (heat) clinical studies. The Oncotherm system is generally not capable of elevating tumor tissues to therapeutic temperature where probes would provide necessary data and system control. Instead they promote an unsubstantiated belief that frequency waves effect the tumor at the cellular level. This is alarming as there is no clinical evidence of this “effect”. Doubly alarming is that Oncotherm is convincing physicians to use this equipment on their patients with cancer.
Statement: FDA approval is not that important unless you sell in the US.
FDA approval is the gold standard around the world. It is very difficult to get because it requires claims to be based on supporting factual evidence. Even though not required for sales outside the US (there are no Oncotherm systems operating legally in the US) the global medical community acknowledges this labeling and the gravity of its certification. In addition to being Made in America, Pyrexar also has CE, TUV, ISO 13485, RoHs and KFDA approvals. (CFDA and TFDA re-certification pending due to our address change)
Statement: The recent Amsterdam study shows the radiative heating method (used by Pyrexar) was superior in heating versus all capacitive heating systems, but is not user friendly.
The study showed the radiated source heating was superior (read previous post) in the Pyrexar Superficial system but that has nothing to do with user friendly. Pyrexar systems now come standard with a 24” monitor, a new improved applicator support arm, simple temperature thermal well sensor calibration and a redesigned user friendly touch screen interface, plus many other time saving and simplification features. The features that are most accessed by the RT are icon driven and right up front. All of the more advanced controls and treatment simulators are still active and can be easily pulled up on the screen for more advanced user adjustments. The software tracks input from the temperature probes and continuously makes power adjustments to hold the tumor at target temperatures.
So don't fall for it. 17 Phase III studies show its about Heat, not Hype.