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

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Abstract

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.

Original languageEnglish
Pages (from-to)599-604
Number of pages6
JournalInvestigational New Drugs
Volume31
Issue number3
DOIs
Publication statusPublished - Jun 1 2013
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pharmacology
  • Pharmacology (medical)

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