Phase I pharmacokinetic study of S-1 granules and nedaplatin for advanced head and neck cancer.

Abstract:

AIM:We performed a pharmacokinetic phase I trial of the combination of S-1 granules and nedaplatin for head and neck squamous cell carcinoma (HNSCC). PATIENTS AND METHODS:Patients were treated with both nedaplatin on day 1 at a dose starting at 80 mg/m(2) (level 1) escalating up to 90 mg/m(2) (level 2), and S-1 granules at a daily dose of 80 mg/m(2) on days 1 to 14 every three weeks. The primary end-point was determination of the recommended dose. RESULTS:Twenty patients were enrolled. Dose-limiting toxicities occurred in one out of six patients at dose level 1 (neutropenia) and in all three patients at level 2 (neutropenia and thrombocytopenia). The recommended dose was determined as level 1. Pharmacokinetic parameters of S-1 granule did not differ from the capsula formulation. The response rate was 42.1%. CONCLUSION:This combination was well-tolerated and manifested a promising activity against HNSCC.

journal_name

Anticancer Res

journal_title

Anticancer research

authors

Hayashi H,Okamoto I,Ueda S,Tanaka K,Okamoto K,Kawakami H,Nishina S,Takeda M,Fujisaka Y,Satoh T,Terao K,Nishimura Y,Doi K,Nakagawa K

subject

Has Abstract

pub_date

2013-12-01 00:00:00

pages

5699-705

issue

12

eissn

0250-7005

issn

1791-7530

pii

33/12/5699

journal_volume

33

pub_type

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