CLINICAL-PHASE-II EVALUATION OF PACLITAXEL IN COMBINATION WITH CISPLATIN IN METASTATIC OR RECURRENT SQUAMOUS-CELL CARCINOMA OF THE HEAD ANDNECK

Background. Paclitaxel as single agent has shown marked activity in se veral malignancies. The aim of the present phase II trial was to deter mine the activity of paclitaxel/cisplatin in patients with metastatic or recurrent squamous cell carcinoma of the head and neck. Patients an d methods: 200 mg/m(2) paclitaxel was administered over three hours fo llowed by cisplatin (100 mg/m(2)), repeated every 22 days. Twenty-eigh t patients were entered and received a total of 99 cycles (median 2, r ange 1-6). All patients were evaluable for toxicity and 25 for respons e. Results. Hematologic toxicities included leukopenia CTC grade 3 in 13 patients, and grade 4 in five patients, neutropenia grade 3 in nine patients, and grade 4 in eigth patients: grade 3 anemia and grade 2 t hrombocytopenia in one patient each. Non-hematologic toxicities includ ed hypotension grade 2 (six patients), grade 3 (four patients), and gr ade 4 (two patients). A decline in renal function was observed in 15 c ourses and 10 patients, leading to a median delay of 2.5 days. Neurose nsory and neuromotor toxicity grade 1 were observed in 13 patients (gr ade 2. 12 patients; grade 3. one patient), myalgia grade 3 in one pati ent, asthenia grade 3 in two and grade 4 in one patient. Partial respo nses were observed in 12 patients for an overall response rate of 48% (95% CI: 28%-68%) with a median response duration of 6.5 months (range 1-10 months). Stable disease was observed in seven patients, of who t wo also had clinical benefit.Conclusions. Paclitaxel 200 mg/m(2) admin istered over three hours combined with cisplatin 100 mg/m(2) is an act ive regimen warranting further evaluation.