SALT LAKE CITY--(BUSINESS WIRE)-- BSD Medical Corporation (BSD) (NASDAQ:BSDM) announced today that The Lancet Oncology, the premier worldwide journal for original oncology research, has issued a press release regarding the publication of the results of a Phase III clinical study of hyperthermia using the BSD-2000 Hyperthermia System, combined with chemotherapy for the treatment of high-risk soft-tissue sarcoma cancer (STS) patients, “Neo-adjuvant chemotherapy alone or with regional hyperthermia for localised high-risk soft-tissue sarcoma: a randomised phase 3 multicentre study”. (The Lancet Oncology, Early Online Publication, 29 April 2010, doi:10.1016/S1470-2045(10)70071-1 .) The complete text of The Lancet Oncology press release has been included below.
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.”
Prof Rolf Issels, Klinikum der Universität München-Campus Grosshadern, Munich, Germany. T) +49-89-7095-4768 E) [email protected]
About The Lancet Oncology
The Lancet is the world's longest running medical journal and one of the world's best-known, oldest and most respected medical journals. The Lancet is an authoritative voice in global medicine and publishes high-quality clinical trials that will alter medical practice. The Lancet Oncology publishes original research relevant to clinical cancer specialists worldwide. Between the first online publication in 1996 and today, 1.8 million users have registered at thelancet.com.
About BSD Medical Corporation (www.BSDMedical.com)
BSD Medical Corporation develops, manufactures, markets and services systems to treat cancer and benign diseases using heat therapy delivered using focused radio frequency (RF) and microwave energy. BSD’s product lines include both hyperthermia and ablation treatment systems. BSD’s hyperthermia cancer treatment systems, which have been in use for several years in the United States, Europe and Asia, are used to treat certain tumors with heat (hyperthermia) while increasing the effectiveness of other therapies such as radiation therapy. BSD’s microwave ablation system, which the Company will introduce to the market this year, has been developed as a stand-alone therapy to employ precision-guided microwave energy to ablate (destroy) soft tissue. The Company has extensive intellectual property, multiple products in the market, and well established distribution in the United States, Europe and Asia. Certain of the Company’s products have received regulatory approvals in the United States, Europe and China. The BSD-2000 is restricted to investigational use in the United States. 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 defined in the Private Securities Litigation Reform Act of 1995. All forward-looking statements are subject to risks and uncertainties detailed in the Company's filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date on which such statements are made, and the Company undertakes no obligation to update such statements to reflect events or circumstances arising after such date.
BSD Medical Corporation, Salt Lake City
Dennis Gauger, 801-972-5555
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