REPORT OF LONG-TERM FOLLOW-UP IN A RANDOMIZED TRIAL COMPARING RADIATION-THERAPY AND RADIATION-THERAPY PLUS HYPERTHERMIA TO METASTATIC LYMPH-NODES IN STAGE-IV HEAD AND NECK PATIENTS

Purpose: The treatment of inoperable metastatic lymphnodes in patients with head and neck cancer represents a therapeutic challenge. Clinica l results using conventional radiation therapy are disappointing; on t he other hand, the evaluation of recent innovative radiotherapeutic me thods is still pending. The end points of this analysis were focused o n long-term local control, on its potential influence on survival, and on late toxicity of a previously reported randomized Phase III study comparing conventionally fractionated radical irradiation alone or com bined with local hyperthermia in fixed and inoperable metastatic neck lymphnodes. Methods and Materials: The medical records of 41 patients (44 nodes) with advanced locoregional Stage IV squamous cell cancer of the head and neck and randomized to treatment in the period 1985-1986 with irradiation alone (22/23 evaluable nodes) or combined with exter nal hyperthermia (18/21 evaluable nodes), were re-evaluated. Results: The statistically significant difference observed in ''early'' respons e (p = 0.0164) in favor of the combined treatment results in improved 5-year actuarial nodal control (p = 0.015). Clinical improvement noted in tumor control positively affects survival, leading to a statistica lly significant difference in survival at 5 years (p = 0.02). With res pect to side effects, no clearly enhanced acute or late toxicity has b een found; as severe late effects, two patients with bone necroses pos sibly related to the combined treatment have been observed. Thermal an alysis failed to show a significant correlation between heating parame ters and the end points of the study. Conclusion: This report with 5-y ear follow-up confirms the efficacy and the absence of severe toxicity of the combination of radical radiation and hyperthermia in the treat ment of metastatic lymphnodes in Stage IV squamous cell carcinoma of t he head and neck.