In patients with multiple tumours, each tumour was given a number prior to randomization. The same radiation dose was given to both lesions and if the first was randomized to radiation, the second would be given combined treatment or vice versa. Patients with 3 tumours were considered as patients with 2 plus 1 tumour, etc.
Radiation was applied with either electrons or high-voltage photons through one or multiple portals. Hyperthermia was applied with microwave or radiofrequency equipment. There was no limitations to the equipment used except that it should be likely to provide a tumour temperature of 43.0C. Active skin cooling was allowed. The heat treatment should be applied after each of the radiation fractions and should be started within 30 minutes.
Over-all the treatment yielded a high response rate and resulted in a significant palliative effect in most patients, irrespectively of the treatment arm. One hundred and three (80%) of the tumours obtained a complete or partial response which in most patients was persistent. Only 16 tumours response time of 10 months. The combined heat and radiation treatment had, however, a significantly higher complete response rate than tumours treated with radiation alone. The response rate was also significantly better in patients given 27Gy compared to 24Gy. Although small tumours had a 54% complete response rate versus 38% in tumours >4cm.
The overall 5-year survival rate of the patients was 19%. 38% of the patients have a 5-year survival probability if all known disease was controlled (independent of the treatment given), compared to 8% in the patients with persistent active disease (the last patient in this group died after 63 months). Also sex was of prognostic importance with a 5-year survival of 30% in women compared to 8% in men. Similarly, patients with single tumours survived significantly longer than patients with multiple lesions (5-year survival of 24% versus 13%).
Over-all the treatment yielded a high response rate and resulted in a significant palliative effect in most patients, irrespective of the treatment schedules. Univariate and multivariate analysis both showed that adjuvant hyperthermia significantly improved local tumour control when applied in association with few large radiation fractions in the treatment of malignant melanoma. Also tumour size and dose of radiation were found to be of significant prognostic importance. The effect of adjuvant hyperthermia was related to the extent of heating achieved.
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Scientific article publishing date 4/3/1995
Immucura identifier BSC21_035EN