BACKGROUND: Results with docetaxel as single drug in squamous-cell head and neck cancer have been encouraging. The purpose of the present phase II study is to evaluate the antitumour efficacy and toxicity of the combination of docetaxel and cisplatin in patients with recurrent or disseminated squamous-cell carcinoma of the head and neck (SCCHN) for whom no curative therapy is available. PATIENTS AND METHODS: Eligibility criteria included: written informed consent; WHO performance status < or = 2; age 18-70 years; adequate bone marrow, liver, and renal function; measurable or evaluable disease; no previous systemic chemotherapy (prior radiotherapy and/or surgery were allowed), no other previous or concurrent malignancy; no peripheral neuropathy. Treatment consisted of docetaxel 75 mg/m2 in a one-hour infusion after pre-treatment with prednisolone, followed by cisplatin 75 mg/m2 in a half-hour infusion preceded and followed by hydration. Treatment was repeated every three weeks for a maximum of eight cycles. RESULTS: Twenty-five patients (median age 52 years, range 33-66) entered the trial, all were evaluable for survival, twenty-four for response and toxicity. Twenty-four patients had undergone prior radiotherapy and seventeen had also had surgery. Nineteen had local-regional recurrence only, three had local-regional disease and distant metastases, and three had distant metastases only. Patients received a median of 5 treatment cycles (range 2-8). Overall response rate was 33% (8 of 24) of patients; complete response rate was 8% (2 of 24) of patients, lasting 2.2 and 17.1 months, respectively; partial response rate was 25% (6 of 24) of patients, lasting for a median of 4.9 months (range 1.7-11.6 months). Median survival was 11 months. Toxicity was relatively well tolerated. However, one patient died of probable toxicity (neutropenia and infection) and three patients discontinued treatment because of toxicity (massive oedema, myocardial infarction, persistent thrombocytopenia). The most frequent moderate-to-severe toxicity (75% of patients) was grade 3-4 neutropenia, transient in all but one patient. Grade 3 neuropathy occurred in one patient, none had grade 4. Grade 3 oral mucositis occurred in three patients, none had grade 4. Grade 2-3 hypomagnesaemia occurred in 10 patients requiring magnesium infusion. CONCLUSIONS: Docetaxel and cisplatin is an active combination in patients with recurrent or disseminated SCCHN. Remissions are however fairly short. Toxicity is significant, but generally manageable
Udgivelsesdato: 2000/7