Warerfiltered infrared-A-hyperthermia combined with radiotherapy for advanced and recurrent tumors. First results of a multicenter phase I-II study

A prospective multicenter phase I-II study was conducted to evaluate toxicity and efficacy of IR/A-HT combined with external beam radiotherapy (RT). From December 1991 to June 1994, a total of 53 patients with 58 malignant lesions were entered in the study. There were 14 primary, 36 recurrent and 8 metastatic tumors which were located in the head and neck region (14), chestwall (31), abdominal wall (2) and the extremities (11). IR/A-HT was applied 1 to 2 times per week with up to 3 IR/A-HT-radiators directly before or after external RT for 1 hour at 40.5 to 44 C. IR/A-HT was well tolerated: In 31 (53%) lesions acute (pain, puls- oder blood pressure changes, increased skin reaction etc.) and in 25 (43%) chronic side-effects (atrophy, teleangiectasia, fibrosis etc.) were noted; usually the toxicity was minor and temporary. At 3 months FU, 32 (55%) lesions achieved a local CR and 19 (33%) a PR; at 12 months FU, 25 (43%) had persistent CR; 16 patients (18 lesions) were deceased and 3 (4 lesions) not yet in FU. In univariate analysis the following prognostic factors for CR at 3 or 12 months FU were found: Karnofsky, metastatic status, tumor size, total RT-dose, thermal parameters Tmin(av) and Tmean. For acute toxicity maximum temperature Tmax(av) was prognostically decisive. Significant differences were also found when considering the 'quality of the HT-application'. The microwave technique was superior to the infrared-A-HT-technique with regard to the penetration depth of energy deposition. (orig./MG)