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 lymph nodes in patients with head and neck cancer represents a therapeutic challenge. Clinical results using conventional radiation therapy are disappointing; on the other hand, the evaluation of recent innovative radiotherapeutic methods is still pending. The end points of this analysis were focused on 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 combined with local hyperthermia in fixed and inoperable metastatic neck lymph nodes. 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 external hyperthermia (18/21 evaluable nodes), were re-evaluated. RESULTS The statistically significant difference observed in "early" response (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 statistically significant difference in survival at 5 years (p = 0.02). With respect to side effects, no clearly enhanced acute or late toxicity has been found; as severe late effects, two patients with bone necroses possibly related to the combined treatment have been observed. Thermal analysis failed to show a significant correlation between heating parameters and the end points of the study. CONCLUSION This report with 5-year follow-up confirms the efficacy and the absence of severe toxicity of the combination of radical radiation and hyperthermia in the treatment of metastatic lymph nodes in Stage IV squamous cell carcinoma of the head and neck.