Docetaxel and cisplatin in locally advanced or metastatic squamous-cell carcinoma of the head and neck: A phase II study of the Southern Italy Cooperative Oncology Group (SICOG)

Background: Docetaxel is one of the most promising new drugs against squamo us-cell carcinoma of the head and neck (SCCHN), while cisplatin is one of t he most active single agents. A phase I study has shown the feasibility of the combination of the two drugs, and activity in SCCHN has been seen. Patients and methods: Patients with locally advanced, inoperable, or metast atic SCCHN, never pretreated with radiotherapy or chemotherapy, received th ree courses of docetaxel 75 mg/m(2) and cisplatin 100 mg/m(2), every three weeks. Thereafter, responsive metastatic patients received additional chemo therapy, while patients with locally advanced disease underwent radiation t herapy. Results: Forty-six patients (forty-five with locally advanced, one with met astatic disease) were entered into the study. Ten patients did not complete three courses of chemotherapy because of early death; one patient disconti nued treatment after one course. Twenty-one objective responses were observ ed (46%, 95% confidence interval (CI): 31%-60%), including five complete re sponses (11%) and sixteen partial responses (35%). Following induction chem otherapy plus radiation therapy, 9 of 21 evaluable patients were rendered d isease free, while 8 additional patients had a partial response. After a me dian follow-up of 18 months, the median duration of response was 12 months, (range 3-25+), and the median overall survival was 11 months. Six early de aths were considered possibly treatment-related (sepsis following grade 4 n eutropenia in two cases, hypovolemic shock following severe diarrhea in fou r cases). Neutropenia was the most severe toxicity (grade 3-4 in 28 patient s, median duration 4 days); diarrhea and vomiting were the most troublesome non-haematologic toxicities (grade 4 in 4 and 3 patients, respectively). Conclusions: The combination of docetaxel and cisplatin is active in SCCHN, but toxicity is substantial. This schedule does not appear to offer any ad vantage compared with conventional regimens.