BSD Medical Corporation (NASDAQ:BSDM) (Company or BSD) (
), a leading provider of medical systems that utilize heat therapy to treat cancer, announced the publication of results from a clinical study on advanced pancreatic cancer using the BSD-2000 Hyperthermia System (BSD-2000). The study, "Gemcitabine and cisplatin combined with regional hyperthermia as second-line treatment in patients with gemcitabine-refractory advanced pancreatic cancer", (
Int J Hyperthermia.
2013;29:8-16) reported the results of a retrospective analysis of 23 patients with advanced or metastatic pancreatic cancer who had relapsed after first-line chemotherapy treatment. The researchers, Tschoep-Lechner,
., reported that hyperthermia, delivered using the BSD-2000, combined with gemcitabine and cisplatin resulted in low toxicity and high feasibility, even in these study patients who had a very negative prognosis and no standard treatment options. The researchers also reported that, despite the intrinsic limitation of a small retrospective analysis, the results suggested clinical efficacy of hyperthermia combined with gemcitabine and cisplatin whereas gemcitabine and cisplatin without hyperthermia does not seem to provide a significant benefit in patients with advanced pancreatic cancer.
In order to acquire additional data, the researchers are currently conducting a multicenter randomized Phase III study on the use of gemcitabine and cisplatin combined with hyperthermia compared to gemcitabine alone to treat postoperative pancreatic cancer. The study, which will accrue 332 patients, is led by the Department of Medical Oncology, Klinikum Grosshadern, Munich University Medical School, Munich, Germany, with Rolf D. Issels MD PhD as principal investigator. Participating centers for patient accrual include Klinik Bad Trissl, Schlossbergklinik Oberstaufen, Erlangen UMS, Tübingen UMS, Düsseldorf UMS and Charité UMS Berlin, all Germany.
Pancreatic cancer is one of the deadliest and most difficult to treat cancers and is the fourth leading cause of cancer-related death in the U.S. and throughout the world for both genders. Worldwide, there are approximately 278,684 patients per year diagnosed with pancreatic cancer. The median survival is approximately 6 months for patients with metastatic disease and 10 months for patients with locally advanced disease. Advanced pancreatic cancer patients currently have few treatment options. The risk of developing pancreatic cancer increases as people age.