The inclusion of hyperthermia and chemotherapy for high-risk sarcoma cancer patients was based on data from a Phase III, randomized, multi-center, clinical trial (EORTC-62961) involving the use of regional hyperthermia and chemotherapy with EIA (etoposide, ifosfamide and adriamycin), as compared to EIA alone.

BSD Medical said the study involved 341 patients with locally advanced soft tissue sarcomas who were treated at medical centers in Europe and in the US using the BSD-2000 Hyperthermia System.

The NCCN guidelines include a discussion of the interim results of this Phase III study and note 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 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.