A phase I dose-escalation study of S-1 plus carboplatin in patients with advanced non-small-cell lung cancer.

Abstract:

:We conducted a phase I study to determine the maximum tolerated dose, the recommended dose and the safety profile of S-1 and carboplatin combination regimen in the treatment of patients with advanced non-small-cell lung cancer. Chemotherapy-naive patients with advanced non-small-cell lung cancer were treated with S-1 and carboplatin. S-1 was administered orally twice daily for 14 days and carboplatin on day 1 of each cycle, and this was repeated every 4 weeks. Doses of each drug were planned as follows: level 1, 5/65; level 2, 5/80; level 3, 6/80 [carboplatin (area under the curve, mg/ml/min)/S-1 (mg/m/day)]. The dose-limiting toxicity of the regimen was assessed during the first chemotherapy cycle. Twelve patients were enrolled in this study. The main grade 3 or grade 4 toxicities observed during the first cycle were neutropenia (41%), thrombocytopenia (41%) and transaminase elevation. Two of three patients in level 2 had dose-limiting toxicity and this level was considered the maximum tolerated dose. Level 1 was selected as the recommended dose. Objective responses were seen in four patients (response rate 33%). The combination of S-1 plus carboplatin is a feasible and well-tolerated regimen for the treatment of patients with advanced non-small-cell lung cancer.

journal_name

Anticancer Drugs

journal_title

Anti-cancer drugs

authors

Kaira K,Sunaga N,Yanagitani N,Imai H,Utsugi M,Shimizu Y,Iijima H,Tomizawa Y,Hisada T,Ishizuka T,Saito R,Mori M

doi

10.1097/CAD.0b013e32801265eb

subject

Has Abstract

pub_date

2007-04-01 00:00:00

pages

471-6

issue

4

eissn

0959-4973

issn

1473-5741

pii

00001813-200704000-00013

journal_volume

18

pub_type

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