BSD Medical Corp announced that the results of a 340-patient randomized phase III clinical trial testing the benefit of adding hyperthermia therapy to chemotherapy were presented at the recent annual American Society of Clinical Oncology (ASCO) conference in Chicago. According to the results of this clinical study, which was conducted at nine major European cancer treatment institutions and at Duke University Medical Center, both disease-free survival time and local progression-free survival time for patients with locally advanced, high-grade soft-tissue sarcomas nearly doubled when hyperthermia therapy was added to chemotherapy, as compared to patients who received chemotherapy alone.

The patients enrolled in this clinical study were very ill, with high-grade (stage II/III) soft-tissue sarcomas and were at significant risk of local failure and metastasis. The patients were randomly assigned to receive either chemotherapy alone or chemotherapy combined with hyperthermia. Patient characteristics were well balanced between the two groups. Their treatments were administered in four cycles every 3 weeks before and after surgery and radiation therapy.

Survival Significantly Improved

For patients who received both hyperthermia therapy and chemotherapy, the median disease-free survival was 31.7 months, compared to 16.2 months for those who received chemotherapy alone (P = .004)—a 95% increase. The median local progression-free survival rate was estimated at 45.3 months for patients who received chemotherapy plus hyperthermia, compared to 23.7 months for patients who received chemotherapy alone (P = .01)—a 91% increase.

The study was conducted under the direction of the European Society of Hyperthermic Oncology (ESHO RHT-95) and the European Organisation for Research and Treatment of Cancer (EORTC 62961). Rolf Issels, md, phd, of the Munich University Medical School in Germany, was the principal investigator.