UNLABELLED: A phase I study of chemotherapy was planned with S-1 and nedaplatin to find the optimal dose for patients with recurrent head and neck cancer. MATERIALS AND METHODS: Oral administration of S-1 (days 1-14) and intravenous nedaplatin (day 8) were tested for patients with recurrent head and neck cancer in a phase-I setting. The dose of S-1 was fixed and the dose of nedaplatin was escalated from 80 mg/m2, with an increase of 10 mg/m2 per step, to find the maximum tolerated dose. RESULTS: Nine patients were recruited in this trial. The maximum tolerated dose (MTD) of nedaplatin was 90 mg/m2. At this dose level, dose-limiting toxicity (DLT) was observed in two out of three patients. One experienced grade 4 thrombocytopenia and febrile grade 3 neutropenia, while the other suffered myelosuppression causing more than a two-week delay of the second chemotherapy cycle. Myelosuppression was the DLT of this regimen. CONCLUSION: The recommended phase II dose of nedaplatin combined with oral S-1 was identified as 80 mg/m2.
UNLABELLED: A phase I study of chemotherapy was planned with S-1 and nedaplatin to find the optimal dose for patients with recurrent head and neck cancer. MATERIALS AND METHODS: Oral administration of S-1 (days 1-14) and intravenous nedaplatin (day 8) were tested for patients with recurrent head and neck cancer in a phase-I setting. The dose of S-1 was fixed and the dose of nedaplatin was escalated from 80 mg/m2, with an increase of 10 mg/m2 per step, to find the maximum tolerated dose. RESULTS: Nine patients were recruited in this trial. The maximum tolerated dose (MTD) of nedaplatin was 90 mg/m2. At this dose level, dose-limiting toxicity (DLT) was observed in two out of three patients. One experienced grade 4 thrombocytopenia and febrile grade 3 neutropenia, while the other suffered myelosuppression causing more than a two-week delay of the second chemotherapy cycle. Myelosuppression was the DLT of this regimen. CONCLUSION: The recommended phase II dose of nedaplatin combined with oral S-1 was identified as 80 mg/m2.