The Holy Grail for those treating cancer patients is to be able to successfully eliminate tumors with radiotherapy without impacting vital organs that surround the growths. The problem has always been that the affected areas often move or shift due to a variety of different reasons. While the movement might be less than a millimeter, that shift can throw off therapy and cause some unwanted side affects.
Essentially, clinicians have been operating blind and have been forced to take measures such as increasing treatment margins around the tumor and using a slightly lower dose of radio frequency to effectively deal with the cancerous growths.
But a device that has been called the "GPS for the Body" by patients, clinicians, and its developer has been proven to reduce the side affects and complications in patients who suffered from prostate cancer and give physicians a proven roadmap of the tumor inside the body, according to a recently published clinical study.
In the study, Calypso Medical's (Seattle) tumor tracking system – and how the device could reduce patient-reported acute morbidity in prostate cancer patients who were treated with radiotherapy – was evaluated.
The study, titled, "Assessing the Impact of Margin Reaction (AIM)," was published in the online publication Urology. It comes nearly four years after the Calypso System was given FDA approval (Medical Device Daily, Aug. 9, 2006).
"No question this is the most important study for us," Eric Meier, Calypso's president/CEO told Medical Device Daily. "We were founded on a premise that if you can track the movement of cancer in real time, and alert the technician if the targeted tissue moves beyond predetermined parameters, then you can significantly reduce acute morbidity and other side effects. With this data we now have proof positive that our device works."
Researchers in the study compared 64 patients to 153 patients in a comparator study that was published in the New England Journal of Medicine.
"What we wanted to demonstrate was that a reduction of treatment margins would result in a meaningful reduction in side affects [from therapy]," Constantine Mantz , MD, radiation oncologist at 21st Century Oncology (Cape Coral, Florida) and lead investigator of the study, told MDD.
To do this, researchers implanted Beacon electromagnetic transponders, which are the size of a grain of rice and emit signals in the patients. This allowed researchers to track the location of the prostate with sub-millimeter accuracy.
Whenever the tumor or the prostate moved, the beacons, which is part of the Calypso System, gave an audio and visual warning letting clinicians know of the change.
This level of precision allowed researchers to reduce the PTV margin while at the same time increase the radiation dose to 81 Gray (Gy) to more effectively treat the cancer. Comparator patients were treated using standard institutional processes and larger PTV margins.
In both groups, patient-reported quality of life was assessed before and after the completion of radiation therapy using a clinically validated questionnaire, the Expanded Prostate Cancer Index Composite (EPIC) that measures several different domains of the patient's health.
Changes in scores were compared between the AIM study and comparator groups while accounting for important patient and cancer characteristics.
The AIM study group experienced significantly fewer side effects associated with bowel urgency and frequency, fecal incontinence and urinary irritation than the comparator group. AIM patients not receiving hormonal therapy also experienced smaller, yet statistically significant advantages over the comparator group in terms of sexual function.
"In the group of patients that were treated with Calypso, the quality of life was much better than the other group following the treatment," Mantz told MDD.
To date there are close to 100 Calypso Systems installed in the U.S. and the company has what it calls a "toehold" in Europe. The Calypso System has only been approved by the FDA for prostate cancer treatment.
"I think it's safe to say that we hope to have strong clinical data on states outside of the prostate cancer," Meier said when he was asked what the device's progress would be in a year.
He said that the company was looking toward getting a designation for the device to treat pancreas and lung cancers as well.
What also bolsters the news of the study is a recent funding round that yielded the company $50 million. Calypso reported completion of the $50 million funding round of venture capital financings, led by Skyline Ventures and Frazier Healthcare Ventures last fall (MDD, Sept. 18, 2009).
Also participating in this financing round were existing investors Versant Ventures, BB Biotech, Arnerich Massena & Associates, Apothecary Capital, RiverVest Ventures, Merlin Nexus, Early Bird Ventures, Glenview Capital Management, Integra Ventures, AEOW, Kaiser Permanente Ventures, Mosaix Ventures, SB Life Science Ventures, Mitsui & Co. Venture Partners and Rockport Ventures.
With such strong clinical data present, the device has become a game changer in treating cancers according to Mantz.
"It certainly has become a [game changer] in my practice," he said. "I think as time goes on and as [clinicians'] experience increases with Calypso, we'll see a greater adoption rate of this device."
Omar Ford, 404-262-5546;