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Investigational New Drugs

, Volume 31, Issue 3, pp 599–604 | Cite as

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

  • Yoshikazu Hasegawa
  • Isamu Okamoto
  • Ken Takezawa
  • Masaaki Miyazaki
  • Junji Tsurutani
  • Kimio Yonesaka
  • Ryotaroh Morinaga
  • Asuka Tsuya
  • Masaaki Terashima
  • Toshihiro Kudoh
  • Koichi Azuma
  • Takayasu Kurata
  • Tatsuyuki Nishikawa
  • Masahiro Fukuoka
  • Yasumasa Nishimura
  • Kazuhiko Nakagawa
PHASE I STUDIES

Summary

Background A phase I study was performed to evaluate dose-limiting toxicity and the recommended dose for the oral fluoropyrimidine S-1 administered concurrently with thoracic radiotherapy (TRT) in elderly (≥70 years of age) patients with locally advanced non-small cell lung cancer. Methods S-1 was administered on days 1 to 14 and 22 to 35 at oral doses of 65 or 80 mg m−2 day−1. TRT was administered in 2-Gy fractions five times weekly for a total dose of 60 Gy. Twelve previously untreated patients were treated with S-1 at 65 (n = 6) or 80 (n = 6) mg m−2 day−1. Results All patients completed the planned 60 Gy of TRT. Dose-limiting toxicity included pneumonitis (n = 2), infection (n = 1), and stomatitis (n = 1), each of grade 3, but each event was reversible. The recommended dose for S-1 was determined to be 80 mg m−2 day−1. No patient experienced toxicity of grade 4. The dose intensity of S-1 was well maintained and the combination of S-1 plus TRT was well tolerated overall. The overall response rate was 83.3 %, with a median survival time of 34.0 months. Conclusions Administration of S-1 at 80 mg m−2 day−1 on days 1 to 14 and 22 to 35 can be safely combined with concurrent TRT in elderly patients with locally advanced non-small cell lung cancer.

Keywords

Locally advanced Non-small cell lung cancer Elderly Chemoradiation S-1 

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Copyright information

© Springer Science+Business Media, LLC 2012

Authors and Affiliations

  • Yoshikazu Hasegawa
    • 2
  • Isamu Okamoto
    • 1
  • Ken Takezawa
    • 1
  • Masaaki Miyazaki
    • 1
  • Junji Tsurutani
    • 1
  • Kimio Yonesaka
    • 1
  • Ryotaroh Morinaga
    • 1
  • Asuka Tsuya
    • 1
  • Masaaki Terashima
    • 1
  • Toshihiro Kudoh
    • 1
  • Koichi Azuma
    • 1
  • Takayasu Kurata
    • 1
  • Tatsuyuki Nishikawa
    • 3
  • Masahiro Fukuoka
    • 1
  • Yasumasa Nishimura
    • 3
  • Kazuhiko Nakagawa
    • 1
  1. 1.Department of Medical OncologyKinki University Faculty of MedicineOsakaJapan
  2. 2.Department of Medical OncologyKishiwada City HospitalOsakaJapan
  3. 3.Department of Radiation OncologyKinki University Faculty of MedicineOsakaJapan

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