ABSTRACT
The neutron therapy program at King Faisal Specialist Hospital and Research Center conducted a phase II study to evaluate the toxicity and efficacy of neutrons against conventional external megavoltage irradiation in patients with locally advanced head and neck malignancy. One hundred and nineteen patients were allocated to receive either photons (46/119) or neutrons (73/119). Radiation effects were scored according to the EORTC/RTOG criteria; data was collected weekly during treatment, once a month for the first year and at 6-month intervals subsequently. While acute effects were scored in all patients, only 59 were evaluable for late effects and locoregional control. A composite of the average reaction results were obtained using this information, to compare them in time, for acute and late effects in both arms of the study. The maximum acute reactions in the two groups were similar. In the majority of the patients (80%) acute skin and mucosal reactions occurred during the last week of treatment. The changes in the subcutaneous tissues and salivary glands became clinically apparent at 3 months or later. Salivary gland toxicity was more severe in the photon arm and the difference was statistically significant at 3 months (P = 0.04) but this was lost at 12 months. Late effects for skin and subcutaneous tissues were significantly more severe in the neutron arm with P values of 0.04 and 0.01 respectively. Three patients in the neutron arm died of grade 4 radiation complications. The local control and survival were similar in both groups.
