Source: DGNews  |  Posted 4 years ago

By Shazia Qureshi

PARIS, FRANCE -- February 11, 2008 -- Regional hyperthermia added to chemotherapy reduced the risk of disease progression at 3 and 6 months in patients with high-grade soft-tissue sarcoma (STS), according to findings reported here at the 19th International Congress on Anti-Cancer Treatment (ICACT).

The benefit of hyperthermia was seen whether patients had primary disease without surgery, recurrent disease, or resection of primary or recurrent tumours, the researchers noted.

Lead investigator Rolf Issels, MD, PhD, Professor, University Hospital Medical Centre Grosshadern, Ludwig Maximilian University, Munich, Germany, presented the results here on February 7. The findings were from a further analysis of a previous randomised phase 3 trial, Dr. Issels noted.

The study enrolled 341 patients with STSs were larger than 5 cm, grade II/III, deep, and extracompartmental. Patients were randomised to systemic chemotherapy alone (n = 172) or in combination with regional hyperthermia deep treatment (n = 169).

Regional deep hyperthermia therapy consisted of warming the area of the body within which the tumour was located up to a temperature of 40°C to 44°C. In previous phase 3 research, Dr. Issels's team showed that high temperatures can kill tumour cells and shrink tumours with minimal injury to normal tissues.

Chemotherapy consisted of etoposide 250 mg/m², ifosfamide 6 g/m², and adriamycin 50 mg/m² administered for 4 cycles every 3 weeks both before and after local aggressive therapy (surgery plus radiation therapy).

The researchers defined early disease progression as local and/or distant relapse or death from any cause at both 3 and 6 months. They recorded this as local progression-free survival (LPFS) and disease-free survival, and followed patients for a median of 25.5 months.

According to the study results, LPFS at 3 months was 94.6% in patients given chemotherapy plus hyperthermia, and 86.0% in patients with chemotherapy alone (difference 8.6%, 95% confidence interval [CI] 2.3-14.9, P =.008). This difference remained significant at 6 months (91.4% vs 77.8%, 95% CI 5.9-21.3, P <.001).

Disease-free survival was significantly higher in patients on combination therapy at both 3 and 6 months. At 3 months, it was 94.0% in patients receiving chemotherapy plus hyperthermia and 83.1% in those given chemotherapy alone (95% CI 4.1-17.6, P =.002). At 6 months, the respective values were 87.7% and 73.8% (difference 13.9%, 95% CI 5.5-22.3, P =.001).

The researchers noted that the difference between treatment groups was seen whether patients had primary disease without surgery, recurrent disease, or resection of primary or recurrent tumours.

Funding for this study was provided by Deutsche Krebshilfe (German Cancer Aid) and the Helmholtz-Gemeinschaft Deutscher Forschungszentren (Helmholtz Association of German Research Centres).

[Presentation title: Pre- and Postoperative Chemotherapy Combined With Regional Hyperthermia in High Risk Soft Tissue Sarcomas (HR-STS): A New Standard Treatment Option? Abstract OR25]