BSD Medical Announces Presentation At ASCO Of Duke University Clinical Study Using Hyperthermia With Chemotherapy To Treat Bladder Cancer

Main Category: Urology / Nephrology
Also Included In: Cancer / Oncology;  Radiology / Nuclear Medicine
Article Date: 18 Jul 2010 - 0:00 PDT

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BSD Medical Corporation ("BSD" or "Company") (NASDAQ: BSDM) reported presentation of a clinical study being conducted at Duke University on the use of hyperthermia, delivered using the BSD-2000 Hyperthermia System, combined with chemotherapy to treat bladder cancer patients who have failed standard therapy. The clinical study abstract, titled "Pilot Study of External Hyperthermia and Intravesical Mitomycin-C to Treat Recurrent Bladder Cancer after Resection and Standard Adjuvant Therapy," was presented by Zeljko Vujaskovic, MD, PhD, Duke University Medical Center (Duke), at the annual American Society of Clinical Oncology (ASCO) meeting, held in Chicago, Illinois, on June 4 to June 8, 2010.

Duke's clinical study involves the use of hyperthermia combined with intravesical chemotherapy (mitomycin-C [MMC]) to treat patients who have recurrent bladder cancer following first-line therapy or who are not expected to respond to first-line therapy. The clinical study will evaluate the safety, tolerability, and clinical benefit of administering hyperthermia and MMC as second-line treatment. There is a significant need to develop better treatment strategies for the significant number of patients who fail first-line therapy. There are 61,240 new cases of bladder cancer each year, and up to 85% of these patients will have a recurrence of their disease.

Dr. Vujaskovic had previously reported the initial results of this study at the annual Society for Thermal Medicine (STM) meeting, held in Clearwater, Florida, on April 23 to April 26, 2010. Dr. Vujaskovic reported that the initial results showed promise for these patients. Duke has enrolled 11 patients. Seven of the nine patients who have been evaluated four weeks post-treatment had no evidence of disease following treatment. Seven patients have completed maintenance therapy, and six of these seven patients had no evidence of disease. The treatment has been well tolerated with no significant toxicity. The researchers stated at STM that "BSD 2000 heating system with Sigma Ellipse applicator is an effective and safe method of delivering local bladder hyperthermia to heat intravesical mitomycin-C within therapeutic temperature range of 40°C to 43°C." Information regarding the Duke Study can be found at the clinical study registry website of the National Institutes of Health: see here.

Previous studies conducted on bladder cancer have demonstrated an 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. (M. Wittlinger, et al. "Quadrimodal treatment of high-risk T1 and T2 bladder cancer: Transurethral tumor resection followed by concurrent radiochemotherapy and regional deep hyperthermia." Radiotherapy and Oncology, 93, 2009, 358.)

On December 11, 2009, the German Society of Radiation Oncology (DEGRO) issued a press release that stated that the addition of hyperthermia to standard radiation therapy (multi-modal therapy) is effective for patients with aggressive bladder cancer who want to avoid removal of their bladder. The press release stated that the addition of hyperthermia to standard radiotherapy and chemotherapy (radiochemotherapy) increases the number of patients who can be effectively treated without removal of the bladder.

Source:
Duke Comprehensive Cancer Center
American Society of Clinical Oncology (ASCO)
BSD Medical Corporation

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