Phase I/II study of S-1 combined with carboplatin in recurrent and/or metastatic head and neck cancer as outpatient chemotherapy.
BACKGROUND
The aims of this study were to determine the recommended dose (RD) in combination chemotherapy of S-1 and carboplatin in recurrent and/or metastatic head and neck cancer (phase I) and to examine response rate and toxicities at RD (phase II).


METHODS
S-1 was given orally at a fixed dose of 40, 50, or 60 mg twice daily based on the patient's body surface area for 21 days followed by a 14-day rest. In phase I, carboplatin was given intravenously to a cohort of three patients on day 8 at a dose of 2.5, 3.0, 3.5, or 4.0 area under the curve (AUC) values, depending on the dose-limiting toxicities (DLTs).


RESULTS
In phase I, the RD was estimated as 2.5 AUC. In phase II, thrombocytopenia and leukopenia were most commonly found as hematologic DLTs, which were manageable without hospitalization. The response rate was 40.9%.


CONCLUSIONS
This regimen is considered to be active against recurrent and/or metastatic head and neck cancer in an outpatient setting.