BSD Medical Corporation (NASDAQ:BSDM) (Company or BSD) (
), a leading provider of medical systems utilizing heat therapy to treat cancer, announced today that published study results demonstrate improved rates of complete pathological tumor response (no evidence of viable tumor in primary tumor and lymph nodes) in advanced rectal cancer patients from the addition of hyperthermia, delivered using the BSD-2000 Hyperthermia System. The researchers also reported that hyperthermia may provide enough reduction in tumor size (downstaging) to allow an increased rate of sphincter preservation surgery (which can allow patients to maintain normal rectal function) in a subgroup of patients with rectal tumors located lower in the gastrointestinal tract. Hyperthermia was added to standard preoperative radiochemotherapy (combined radiotherapy and chemotherapy) for 61 patients, and results were retrospectively compared to 45 patients with locally advanced rectal cancer who were treated with standard preoperative radiochemotherapy alone.
The rate of complete pathological tumor response (pCR) was significantly higher in the patients receiving at least four hyperthermia treatments (22.5%), as compared to a rate of only 6.7% for patients receiving radiochemotherapy alone, and a rate of 4.7% for patients treated with radiochemotherapy and only one to three hyperthermia treatments (
=0.043). The researchers also noted that the pCR rate of 22.5% achieved from the addition of hyperthermia is higher than the pCR rate reported in most published presurgical radiochemotherapy studies, including studies utilizing multiple chemotherapy agents. Hyperthermia significantly increased the number of patients with tumors located within 8 cm of the anal verge who were able to have sphincter-sparing surgery: 57% in the hyperthermia group compared to only 35% in the group that did not receive hyperthermia (p=0.077). Sphincter-sparing surgery is expected to provide a dramatic improvement in quality of life for rectal cancer patients.
The study, “Pathological Complete Response and Sphincter-Sparing Surgery after Neoadjuvant Radiochemotherapy with Regional Hyperthermia for Locally Advanced Rectal Cancer Compared with Radiochemotherapy Alone,” was published in The International Journal of Hyperthermia by C. Schroeder, et al., from the Department of Radiation Oncology of the University of Tübingen (Tübingen), in Germany. Tübingen is one of Europe’s oldest and most prestigious universities and an international leader in medical research.