BSD Medical Corporation announced the inclusion of hyperthermia and chemotherapy as a recommended cancer treatment for Stage IV (metastatic) sarcomas in the “Practice Guidelines in Oncology” (V.2.2010), which is issued by the National Comprehensive Cancer Network (NCCN). NCCN is a not-for-profit alliance of 21 of the world’s leading cancer centres, and its practice guidelines are a benchmark for clinical policy in the oncology community.
The inclusion of hyperthermia and chemotherapy for high risk sarcoma cancer patients was based on data from a phase III, randomized, multi-centre, clinical trial (EORTC-62961) involving the use of regional hyperthermia and chemotherapy with EIA (etoposide, ifosfamide and adriamycin), as compared to EIA alone.
The study involved 341 patients with locally advanced soft tissue sarcomas who were treated at medical centres in Europe and in the United States using the BSD-2000 Hyperthermia System.
The NCCN guidelines include a discussion of the interim results of this phase III study and notes that after a median follow-up of 24.9 months, disease free survival was 31.7 months for the patients treated with hyperthermia and EIA compared to 6.2 months for the patients treated with EIA alone and that local progression free survival and overall response rate were also significantly superior.
The Lancet Oncology, the premiere worldwide journal for original oncology research, published the results of this phase III clinical study of hyperthermia, “Neo-adjuvant chemotherapy alone or with regional hyperthermia for localised high-risk soft-tissue sarcoma: a randomised phase III multi-centre study”. (Lancet Oncol. 2010 Jun;11(6):561-70 .)
The published study results demonstrated that the addition of regional hyperthermia, using the BSD-2000 Hyperthermia System, to chemotherapy (EIA) resulted in a significant reduction in disease progression or death, with a median disease-free survival of greater than 120 months (i.e., the median is not yet reached) for the HT+ EIA group, as compared to 75 months in the EIA only group.
NCCN is recognized by the Centres for Medicare and Medicaid Services and private payers as a mandated reference for oncology coverage policies. Managed care, medical directors, and other healthcare professionals also reference NCCN guidelines when making treatment and reimbursement decisions.
The NCCN guidelines are distributed free of charge to clinical professionals in the United States and internationally. User-friendly patient versions of NCCN guidelines are available to patients and their families.
The BSD-2000 – developed and patented exclusively by BSD – delivers localized therapeutic heating (hyperthermia) by applying radiofrequency (RF) energy. This creates a central focusing of energy that can be electronically focused to target the 3-dimensional shape, size, and location of the tumour, thus providing dynamic control of the heating delivered to the tumour region.
The BSD-2000 is restricted to investigational use in the US, and the Company is currently conducting a clinical study to evaluate the safety and efficacy of hyperthermia using the BSD-2000 combined with radiotherapy for the treatment of patients suffering from locally advanced, persistent, or recurrent deep tumours of the pelvis; i.e., cervical, prostate, rectal, and bladder. BSD has also applied for a Humanitarian Device Exemption (HDE) approval for its BSD-2000 Hyperthermia System and this submission is still under review by the FDA.
BSD Medical Corporation develops, manufactures, markets and services systems to treat cancer and benign diseases using heat therapy delivered using focused radiofrequency (RF) and microwave energy.