Phase I/II study of S-1 plus carboplatin in patients with advanced non-small cell lung cancer

Kenji Tamura, Isamu Okamoto, Tomohiro Ozaki, Tatsuhiko Kashii, Koji Takeda, Masashi Kobayashi, Kaoru Matsui, Takashi Shibata, Takayasu Kurata, Kazuhiko Nakagawa, Masahiro Fukuoka

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16 Citations (Scopus)


The objective of this phase I/II study was to determine the recommended dose (RD) of S-1 and carboplatin (CBDCA), and to evaluate the efficacy and safety of this combination in the treatment of patients with advanced non-small cell lung cancer (NSCLC). Chemotherapy-naïve patients were treated with S-1 given orally on days 1-14, and CBDCA infused intravenously on day 1, repeated every 3 weeks. RD was AUC5 of CBDCA and 80 mg/m2 of S-1. Nineteen patients were treated at the RD. The overall response was 30.8% (95% confidence interval: 17.1-58.3%). The response rate in the RD was 36.8% (95% CI: 16.3-61.6%). The median overall survival time was 11.1 months (95% CI: 8.1-15.3 months) and the median progression-free survival time was 5.0 months (95% CI: 3.6-6.0 months). Major grades 3-4 toxicities were thrombocytopaenia (47%), anaemia (26%) and infection (16%). This is the first report to show promising activity of this combination in phase II, including survival data and manageable toxicity, especially in outpatients receiving treatment for advanced NSCLC.

Original languageEnglish
Pages (from-to)2132-2137
Number of pages6
JournalEuropean Journal of Cancer
Issue number12
Publication statusPublished - Aug 2009
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research


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