ESHO 2-85. Hyperthermia as an adjuvant to radiation therapy in the treatment of advanced neck nodes: A randomized multicenter study by the European Society for Hyperthermic Oncology.

Abstract

Background and purpose: European Society for Hyperthermic Oncology (ESHO) 2-85 is a multicenter randomized trial investigating hyperthermia (HT) as an adjuvant to radiotherapy (RT) in treatment of locally advanced neck nodes. The trial never fulfilled recruitment and was stopped prematurely, and has not previously been published.

Patients and methods: Between January 1987 and February 1993, 64 evaluable neck nodes in 54 patients were included. Tumors were stratified according to institution and nodal size and randomly assigned to receive RT alone (2 Gy/fx, 5 fx/wk) to a total dose of 60-70 Gy, including boost, or the same RT followed once weekly by HT (aimed for 43°C for 60 min). The primary endpoint was persistent complete response (local control).

Results and interpretation: Sixty-four tumors in 54 patients were evaluable, with a median observation of 17 months. Thirty-four tumors were randomized to RT alone and 30 to RT+HT. Compliance with RT was good. HT was associated with moderate to severe pain and discomfort in 38% of the treatments. In 57% of the heated patients at least one treatment achieved the target temperature. HT did not significantly increase radiation morbidity. The complete response rate was 53% in the RT versus 80% in the RT+HT group, and 3-year persistent local control rate was 32% for RT alone versus 53% for RT+HT; HR: 0.48 [0.23-0.98]. The ESHO 2-85 study demonstrated that addition of a weekly HT treatment to RT of advanced neck nodes significantly enhanced the persistent tumor control. The results substantiate the potential clinical benefit of hyperthermic oncology.