Hyperthermia Plus Chemotherapy Nearly Doubles Disease-Free Survival
BSD Medical announced that the results of a 340 patient randomized Phase III clinical trial testing the benefit of adding hyperthermia therapy to chemotherapy.
According to the results of this clinical study, which was conducted at nine major European cancer treatment institutions and at Duke University Medical Center in the USA, 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 (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 therapy. The patient characteristics were well balanced between these two groups. Their treatments were administered in 4 cycles every 3 weeks before and after surgery and radiation therapy. 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=0.004), a 95% increase. The median local progression free survival rate was estimated at 45.3 months for patients who received chemotherapy plus hyperthermia therapy, compared to 23.7 months for patients who received chemotherapy alone (p=0.01), a 91% increase.
The study was conducted under the direction of the European Society of Hyperthermic Oncology (ESHO RHT-95) and the European Organization for Research and Treatment of Cancer (EORTC 62961). Rolf Issels, MD PhD of the Munich University Medical School in Germany, was the principal investigator.
All hyperthermia treatments performed in the study were conducted using BSD-2000 hyperthermia systems developed and produced by BSD Medical Corp. The BSD-2000 hyperthermia therapy system non-invasively delivers precision focused hyperthermia therapy to cancerous tumors, including tumors located deep in the body. The BSD-2000 is a recipient of the Frost and Sullivan Technology Innovation of the Year Award for cancer therapy devices.