Phase I study of nedaplatin prior to S-1 in patients with locally advanced head and neck squamous cell carcinoma.
BACKGROUND
We previously reported on the regimen of S-1 plus nedaplatin (NDP), with S-1 was administered orally for 14 days and NDP intravenously on day 8. The maximum tolerated dose (MTD) of NDP was determined to be 90 mg/m². The main toxicities were neutropenia and thrombocytopenia. This result was tolerated, but we believe there is a more effective and tolerable regimen. Thus, we investigated the S-1 regimen administered orally for 14 days, and NDP intravenously on day 1 in patients with locally advanced head and neck squamous cell carcinoma.


METHODS
Oral administration of S-1 (days 1-14) and intravenous NDP (day 1) were tested for patients with advance head and neck cancer in a phase I setting. The dose of S-1 was fixed and the dose of NDP was escalated from 70 mg/m², with an increase of 10 mg/m² per step, to find the MTD.


RESULTS
A total of 15 patients were registered. The MTD of NDP was determined to be 100 mg/m². The main toxicities were neutropenia and thrombocytopenia. The response rate (RR) was 57.1%.


CONCLUSIONS
The recommended dose of NDP for a phase II study was determined to be 100 mg/m². We concluded that our regimen was well tolerated and that the RR was acceptable.
Department of Otolaryngology, Head and Neck Surgery, Kyorin University School of Medicine, Tokyo, Japan.
Dai
D
Sato
Yasunao
Y
Kogashiwa
Kiyoaki
K
Tsukahara
Koichi
K
Yamauchi
Naoyuki
N
Kohno
D000284:Administration, Oral; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy*; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009503:Neutropenia / Q000209:etiology; D009944:Organoplatinum Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D010094:Oxonic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D005641:Tegafur / Q000009:adverse effects / Q000627:therapeutic use*; D013921:Thrombocytopenia / Q000209:etiology; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D004338:Drug Combinations; D009944:Organoplatinum Compounds; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; C053989:nedaplatin