Phase I study of nedaplatin prior to S-1 in patients with locally advanced head and neck squamous cell carcinoma.

Abstract

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.

PATIENTS AND 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.

• Authors: Dai Sato, Yasunao Kogashiwa, Kiyoaki Tsukahara, Koichi Yamauchi, Naoyuki Kohno
• Journal: Chemotherapy (Chemotherapy) Vol. 59 Issue 4 Pg. 314-8 ( 2013) ISSN: 1421-9794 [Electronic] Switzerland
• PMID: 24480865 (Publication Type: Clinical Trial, Phase I, Journal Article)
• Copyright: © 2014 S. Karger AG, Basel.

Chemical References

• Antineoplastic Agents
• Drug Combinations
• Organoplatinum Compounds
• S 1 (combination)
• Tegafur
• Oxonic Acid
• nedaplatin

Topics

• Administration, Oral
• Aged
• Antineoplastic Agents (adverse effects, therapeutic use)
• Carcinoma, Squamous Cell (drug therapy)
• Drug Administration Schedule
• Drug Combinations
• Drug Therapy, Combination
• Female
• Head and Neck Neoplasms (drug therapy)
• Humans
• Male
• Maximum Tolerated Dose
• Middle Aged
• Neutropenia (etiology)
• Organoplatinum Compounds (adverse effects, therapeutic use)
• Oxonic Acid (adverse effects, therapeutic use)
• Tegafur (adverse effects, therapeutic use)
• Thrombocytopenia (etiology)
• Treatment Outcome