BSD Medical (Salt Lake City) reported 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.

"We're one of the few companies in the United States that really is devoting major efforts and resources to develop hyperthermia cancer systems," Dennis Gauger, the company's CFO, told Medical Device Daily.

The multi-institutional study, "Quadrimodal treatment of high-risk T1 and T2 bladder cancer: Transurethral tumor resection followed by concurrent radiochemotherapy and regional deep hyperthermia," demonstrated an 80% three-year overall survival for these high-risk patients who were treated with hyperthermia, BSD said. 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 five years) as well as local tumor control rate (81% vs. 63% at three years). The researchers reported a significant correlation between the number of hyperthermia treatments and overall survival probability for these patients.

M. Wittlinger, et al., from the Department of Radiation Oncology of Erlangen University Medical School (Erlangen, Germany), published the study in Radiotherapy and Oncology, the official publication of the European Society for Therapeutic Radiology and Oncology (Brussels).

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.

Dixie Sells, VP of regulatory affairs for BSD, told MDD that the study was independently conducted, not sponsored by the company. While this study only enrolled 45 patients, Sells said the researchers did a couple of earlier studies and they plan to do additional studies with more patients.

"It's a small group [of patients] but it did produce very promising results," Sells said.

The authors conducted the research at three medical centers in Germany, including: the University of Erlangen (Germany); the University of Frankfurt/Main (Germany); and the Hospital Martha-Maria (Munich, Germany).

BSD said its product line includes systems that have been designed to offer a range of thermal treatment systems. The BSD-2000 is restricted to investigational use in the U.S. The company also has an ongoing investigational device exemption study in the U.S. for the system.

Gauger said the device has received regulatory approval in other parts of the world, including some parts of Europe and in China. He said the company is currently in the process of an FDA review seeking a Humanitarian Device Exemption (HDE) for the BSD 2000.

BSD has an FDA-approved hypothermia device designed to treat surface and subsurface tumors, Sells said, but the BSD 2000 is designed to treat deep tumors, such as bladder and cervical tumors.

In September the company reported that the FDA was continuing to review its HDE marketing submission for the BSD 2000, which it said is designed for use in conjunction with radiation therapy for the treatment of cervical carcinoma patients who are ineligible for chemotherapy (Medical Device Daily, Sept. 24, 2009).

BSD noted another study that was published in 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 (41 patients) or combined with hyperthermia (42 patients), following bladder conserving surgery. The percentage of patients who had a tumor recurrence at two 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). Another study of 101 bladder cancer patients, reported in The Lancet in 2000, demonstrated that 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), the company said.

Sells said the reason researchers are trying to treat patients with high-risk bladder cancer with so many different treatments is to try to improve bladder preservation.

According to the study results, the bladder-preserving rate was 96%, or 43 of the 45 patients, at three years. The authors noted that 80%, or 24 of 30 patients, were at least mostly satisfied with their bladder function. "The quadrimodal treatment was feasible and well tolerated. Local control and bladder-preserving rates were encouraging," they wrote.

The study of hyperthermia is not new, Sells said. She told MDD that modern research on the therapy started in about 1976.

"The promise of hyperthermia is it enhances other treatments ... but doesn't appear to increase toxicity," Sells said. For example, she said that with radiation therapy there are some cell divisions that radiation therapy doesn't treat, but hyperthermia does.

The researchers said that for a conclusive appraisal of the result more patients and longer follow-up are necessary. The median follow-up in this study was 34 months.

Amanda Pedersen, 229-471-4212;

amanda.pedersen@ahcmedia.com