CISPLATIN, HYPERTHERMIA, AND RADIATION (TRIMODAL THERAPY) IN PATIENTSWITH LOCALLY ADVANCED HEAD AND NECK TUMORS - A PHASE-I-II STUDY

Purpose: Hyperthermia is now being widely used to treat clinical malig nancies especially combined with radiotherapy and more rarely with che motherapy. The combination of heat, radiation, and chemotherapy (trimo dality) can lead to potent interaction. The present Phase I-II study w as conducted to evaluate the feasibility and acute toxicity of a combi nation of cisplatin, hyperthermia, and irradiation in the treatment of superficial cervical nodal metastases from head and neck cancer. Meth ods and Materials: Eighteen patients with measurable neck metastases f rom previously untreated squamous cell head and neck tumors were enter ed into the trial. Therapy consisted of a conventional irradiation (to tal dose 70 Gy, 2 Gy five times a week) combined with a weekly adminis tration of 20 mg/m2 iv of cisplatin and a total of two sessions of loc al external microwave hyperthermia (desired temperature of 42.5-degree s-C for 30 min). Results: Feasibility of the treatment was demonstrate d. Acute local toxicity was mild; no thermal blisters or ulcerations w ere reported and only two patients experienced local pain during hyper thermia. Cutaneous toxicity appeared greater than in our previous stud ies with irradiation plus hyperthermia and irradiation plus cisplatin. Systemic toxicity was moderate with major toxic effects observed in t hree patients (World Health Organization (WHO) grade 3 anaemia). Even though it was not an aim of the study to evaluate the nodal response, we observed a complete response rate of 72.2% (95% confidence interval 51-93.4%), 16.6% of partial response and 11.1% of no change. Conclusi on: The study confirms the feasibility of the combination of cisplatin , heat, and radiation with an acceptable toxicity profile. The trimoda l therapy deserves further evaluation as a way to enhance the efficacy of irradiation in the treatment of nodal metastases from head and nec k tumors.