BSD Medical Corporation (NASDAQ:BSDM) announced that published study results demonstrated improvement in overall survival, tumor response rates, and local tumor control from the addition of hyperthermia therapy, delivered using the BSD-2000 Hyperthermia System, to the standard treatment regimen for 45 patients with high-risk bladder cancer.

The multi-institutional study, titled "Quadrimodal treatment of high-risk T1 and T2 bladder cancer: Transurethral tumor resection followed by concurrent radiochemotherapy and regional deep hyperthermia," demonstrated an 80% 3-year overall survival for these high-risk patients who were treated with hyperthermia. The researchers also reported that, in comparison to the results of a previous study they had conducted on trimodal treatment alone for bladder cancer patients, the addition of hyperthermia resulted in a higher overall survival (82% vs. 67% at 5 years) as well as local tumor control rate (81% vs. 63% at 3 years). The researchers reported a significant correlation between the number of hyperthermia treatments and overall survival probability for these patients.

The study was published in Radiotherapy and Oncology by M. Wittlinger, et al., from the Department of Radiation Oncology of the prestigious Erlangen University Medical School in Germany. Radiotherapy and Oncology is the official publication of the European Society for Therapeutic Radiology and Oncology.

The primary objective for the addition of hyperthermia to trimodal therapy is to optimize survival rate while still preserving bladder function, and the study data show promise for this treatment. In addition to the current study, the authors reported that two previous clinical studies had also demonstrated improved results from the addition of hyperthermia to treat high-risk bladder cancer patients. Colombo, et al., reported in the Journal of Clinical Oncology in 2003 on a multicenter trial where 83 patients with intermediate or high-risk bladder tumors were randomized to receive Mitomycin-C alone (n = 41) or combined with hyperthermia (n = 42), following bladder conserving surgery. The percentage of patients who had a tumor recurrence at 2 years was significantly reduced by the addition of hyperthermia (17.1% tumor recurrence rate for patients treated with hyperthermia and Mitomycin-C vs. 57.5% tumor recurrence rate for those treated with Mitomycin-C alone, p = 0.002). J. van der Zee, et al., reported in The Lancet in 2000 on a study of 101 bladder cancer patients where the addition of hyperthermia to radiotherapy significantly increased the complete tumor response (disappearance of all local tumor) rate (73% for patients treated with hyperthermia and radiotherapy vs. 51% for patients treated with radiotherapy alone, p = 0.01).

The authors stated that, "Notwithstanding the limitations of historical comparisons and the small patient number of the presented hyperthermia cohort, these data suggest a further improvement in response rates, local control and overall survival by quadrimodal treatment compared to our previous data achieved with trimodality treatment."

About the Researchers

The research was conducted by eight prominent medical researchers who are at the forefront of oncology research. The authors conducted the research at three prestigious medical centers in Germany, including: the University of Erlangen, Germany, one of Germany's largest universities that provides a unique range of interdisciplinary research; the University of Frankfurt/Main, Germany, which is one of the leading research universities in Germany and is at the forefront of research in the life sciences; and the Hospital Martha-Maria, Germany, which has positioned itself as a hospital that provides a focus on quality of care for patients.

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