BSD Medical Corporation (NASDAQ:BSDM) reports that significant and “medical practice changing” clinical study results were the subject of a news briefing at Europe’s largest cancer congress, ECCO15 – ESMO34, which is being held September 20 to 24, 2009, in Berlin, Germany. A Phase III study, which utilized the BSD-2000 Hyperthermia System, demonstrated that patients with high risk soft-tissue sarcomas were 30% more likely to be alive and cancer free almost three years after starting treatment if targeted heat therapy (hyperthermia) was added to their chemotherapy treatment.
The press information stated that, “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.” The press release also stated that the results increase the case for intensifying the exploration of this type of treatment of other types of cancer. “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 at the ECCO-ESMO congress.
“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.”
The Phase III study involved 341 patients who were treated at medical centers in Europe and in the United States. All patients had locally advanced soft tissue sarcomas and were at high risk of recurrence and spread. All patients were given chemotherapy before and after surgery and radiotherapy. Half of the patients were randomly given hyperthermia along with chemotherapy.
“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%.”