Phase I study of S-1 and nedaplatin for patients with recurrence of head and neck cancer.
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.


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.


CONCLUSIONS
The recommended phase II dose of nedaplatin combined with oral S-1 was identified as 80 mg/m2.
Kodaira
Takeshi
T
Department of Therapeutic Radiation Oncology, Aichi Cancer Center Hospital, 464-8681 Nagoya, Aichi, Japan. 109103@aichi-cc.jp
Fuwa
Nobukazu
N
Tachibana
Hiroyuki
H
Hidano
Satoshi
S
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects
D004338:Drug Combinations; D009944:Organoplatinum Compounds; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; C053989:nedaplatin