Phase I study of S-1 and nedaplatin for patients with recurrence of head and neck cancer
Kodaira, T.; Fuwa, N.; Tachibana, H.; Hidano, S.
Anticancer Research 26(3b): 2265-2268
2006
ISSN/ISBN: 0250-7005 PMID: 16821599 Document Number: 602672
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/m(2), with an increase of 10 mg/m(2) 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/m(2). 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.