A phase I study of S-1 with concurrent thoracic radiotherapy in elderly patients with localized advanced non-small cell lung cancer

Nagio Takigawa, Katsuyuki Kiura, Katsuyuki Hotta, Shinobu Hosokawa, Naoyuki Nogami, Keisuke Aoe, Kenichi Gemba, Keiichi Fujiwara, Shingo Harita, Mitsuhiro Takemoto, Kengo Himei, Tetsu Shinkai, Yoshirou Fujiwara, Saburo Takata, Masahiro Tabata, Susumu Kanazawa, Mitsune Tanimoto

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7 Citations (Scopus)


S-1, an oral 5-fluorouracil derivative, is effective against advanced non-small cell lung cancer (NSCLC) with mild toxicity and synergistic effects with radiation in preclinical trials. In this phase I study, we evaluated the dose-limiting toxicity and recommended dose of S-1 for a future phase II study when administered concurrently with thoracic radiation (total dose of 60Gy at 2Gy per daily fraction) in elderly patients (>75 years old) with localized advanced NSCLC. S-1 was administered on days 1-14 and 29-42 at the following dosages: 60, 70, and 80mg/m2/day. Twenty-two previously untreated patients were enrolled in this study. Dose-limiting toxicity included febrile neutropenia, thrombocytopenia, stomatitis, and pneumonitis. One patient had grade 5 radiation pneumonitis. No other patient experienced radiation pneumonitis or esophagitis exceeding grade 2. The recommended dose for S-1 was determined to be 80mg/m2/day, which produced an overall response rate of 75% (n=12). The median progression-free survival time was 11.5 months (95% confidence interval: 7.1-15.8 months) with a median follow-up time of 27.9 months. These results indicate that concurrent treatment with S-1 and thoracic radiation is a feasible option for NSCLC in the elderly. A phase II study is currently under way.

Original languageEnglish
Pages (from-to)60-64
Number of pages5
JournalLung Cancer
Issue number1
Publication statusPublished - Jan 2011



  • Elderly
  • Non-small cell lung cancer
  • Radiation
  • S-1

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

Cite this

Takigawa, N., Kiura, K., Hotta, K., Hosokawa, S., Nogami, N., Aoe, K., Gemba, K., Fujiwara, K., Harita, S., Takemoto, M., Himei, K., Shinkai, T., Fujiwara, Y., Takata, S., Tabata, M., Kanazawa, S., & Tanimoto, M. (2011). A phase I study of S-1 with concurrent thoracic radiotherapy in elderly patients with localized advanced non-small cell lung cancer. Lung Cancer, 71(1), 60-64. https://doi.org/10.1016/j.lungcan.2010.04.012