BSD Medical Corporation (NASDAQ:BSDM) (the "Company" or "BSD") announced publication in Internal Medicine News Digital Network of new data from the ESHO/EORTC Soft Tissue and Bone Sarcoma Group (STBSG) Phase III clinical study of hyperthermia. (Freeman, S. [10/5/2010]. Regional Hyperthermia Plus Chemo Helps High-Risk, Nonextremity, Soft Tissue Sarcomas. Internal Medicine News Digital Network. Retrieved from http://www.internalmedicinenews.com). The new data were presented by Dr. R. D. Issels, Klinikum Grosshadern at the Ludwig-Maximilians University of Munich, at the biennial meeting of the European Society for Therapeutic Radiology and Oncology (ESTRO), which was held in Barcelona, Spain on September 12-16, 2010. The data demonstrated that the addition of hyperthermia to chemotherapy significantly increases progression-free and disease-free survival rates in patients with high-risk nonextremity sarcomas who have macroscopically complete surgical resection.
The Phase III STBSG trial involved 341 patients who were treated at leading research centers in Europe and the United States and used the BSD-2000 Hyperthermia System to deliver hyperthermia combined with chemotherapy for the treatment of high-risk, soft-tissue sarcoma cancer patients. The main findings of the sarcoma trial were recently published in The Lancet Oncology. (Issels RD, et al. Neo-adjuvant chemotherapy alone or with regional hyperthermia for localised high-risk soft tissue sarcoma: a randomised phase 3 multicentre study. 2010;11:561-570. doi:10.1016/S1470-2045(10)70071-1). The data demonstrated improved overall survival if regional hyperthermia (HT) was added to chemotherapy (etoposide, ifosfamide, and doxorubicin [EIA]) treatment, for patients who received the complete treatment. The study also demonstrated that regional hyperthermia combined with chemotherapy (CT) improved tumor reduction, disease-free survival, and time to disease progression.
The article in Internal Medicine News Digital Network reported on new data from the STBSG trial that involved 149 patients with high-risk nonextremity sarcomas. Adding hyperthermia to chemotherapy produced significantly higher progression-free and disease-free survival rates in these patients, according to a subgroup analysis presented by Dr. Issels. The primary end point was local progression-free survival, which remained significantly improved by the addition of hyperthermia to EIA chemotherapy.
In an interview with Ms. Freeman, Dr. Issels stated, "The rationale for using regional hyperthermia is to make tumors more sensitive to chemotherapeutic agents and radiotherapy. Besides sensitization to other treatment modalities, hyperthermia also kills tumors in a temperature range between 40° and 43° C [104°-109.4° F], and we know from preclinical and early clinical data that it seems to activate the immune system by delivering stress or danger signals."
Dr. Issels reported in the interview with Ms. Freeman that the knowledge gained from the study would be transferred to a new study on advanced pancreatic cancer that is being conducted at Klinikum Grosshadern at the Ludwig-Maximilians University of Munich.
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