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ARTICLE | Clinical News

BSD-2000 Hyperthermia System: Phase III data

May 10, 2010 7:00 AM UTC

Data from an international Phase III trial in 341 patients with localized, high-risk STS showed that the BSD-2000 Hyperthermia System plus neoadjuvant chemotherapy with etoposide, ifosfamide and doxorubicin significantly reduced local tumor progression at 2 years vs. chemotherapy alone (19% vs. 30%, p=0.003). BSD-2000 plus chemotherapy also led to significantly greater median disease-free survival (>120 vs. 75 months, p=0.011) and a significantly increased treatment response rate (28.8% vs. 12.7%, p=0.002) vs. chemotherapy alone.

In a pre-specified per protocol (PP) analysis of patients who completed therapy, OS was significantly higher for BSD-2000 plus chemotherapy vs. chemotherapy alone (p=0.038). Grade 3/4 leukopenia was significantly more frequent in the BSD-2000 plus chemotherapy group vs. chemotherapy alone (p=0.005). Data were published in The Lancet Oncology. ...