A phase I study of S1 with concurrent radiotherap

Authors: 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

Publish Date: 2012/05/24

Volume: 31, Issue: 3, Pages: 599-604

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Abstract

Background A phase I study was performed to evaluate doselimiting toxicity and the recommended dose for the oral fluoropyrimidine S1 administered concurrently with thoracic radiotherapy TRT in elderly ≥70 years of age patients with locally advanced nonsmall cell lung cancer Methods S1 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 2Gy fractions five times weekly for a total dose of 60 Gy Twelve previously untreated patients were treated with S1 at 65 n = 6 or 80 n = 6 mg m−2 day−1 Results All patients completed the planned 60 Gy of TRT Doselimiting 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 S1 was determined to be 80 mg m−2 day−1 No patient experienced toxicity of grade 4 The dose intensity of S1 was well maintained and the combination of S1 plus TRT was well tolerated overall The overall response rate was 833  with a median survival time of 340 months Conclusions Administration of S1 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 nonsmall cell lung cancer

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