A phase II study of S-1 monotherapy as second-line treatment for advanced non-small cell lung cancer

Yoshitaka Totani, Yuji Saito, Masamichi Hayashi, Toshihiko Tada, Yasuo Kohashi, Yuki Mieno, Atsushi Kato, Hiromi Imizu, Yukiko Yoneda, Tami Hoshino, Yasuhiro Uchiyama, Yasuo Takeuchi, Mitsushi Okazawa, Hiroki Sakakibara

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34 Citations (Scopus)


Purpose: To assess the efficacy and toxicity of an oral anticancer fluoropyrimidine derivative, S-1, for previously treated patients with advanced non-small cell lung cancer (NSCLC). Patients and methods: Patients with advanced (clinical stage IIIB-IV) NSCLC who had previously received one platinum-based chemotherapy were enrolled. S-1 was administered orally at the dosage decided by using the nomogram based on patient BSA b.i.d. for 28 consecutive days, repeated every 6 weeks. Results: Between August 2005 and July 2007, 50 patients were entered into this study. Six patients achieved partial response (PR), and the overall response rate of eligible patients was 12.5% (6/48) (95% confidence interval (95%CI), 3.1-21.9%). Disease control rate was 39.6% (19/48) (95%CI, 25.7-53.4%). Median progression-free survival was 2.5 months. Median survival time was 8.2 months, and 1-year survival rate was 29.6%. No grade 4 toxicities were encountered. Grade 3 hematological toxicities comprised neutropenia in one patient (2.1%) and anemia in one patient (2.1%). Grade 3 non-hematological toxicities were observed in only five patients (10.4%). Treatment-related death did not occur. Conclusion: S-1 is an active and well-tolerated monotherapy for second-line treatment of advanced NSCLC.

Original languageEnglish
Pages (from-to)1181-1185
Number of pages5
JournalCancer Chemotherapy and Pharmacology
Issue number6
Publication statusPublished - 11-2009

All Science Journal Classification (ASJC) codes

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)


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