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

Research output: Contribution to journalArticle

1 Citation (Scopus)

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

Fingerprint

Non-Small Cell Lung Carcinoma
Radiotherapy
Thorax
Stomatitis
Pneumonia
Survival
Infection

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pharmacology
  • Pharmacology (medical)

Cite this

A phase i study of S-1 with concurrent radiotherapy in elderly patients with locally advanced non-small cell lung cancer. / Hasegawa, Yoshikazu; Okamoto, Isamu; Takezawa, Ken; Miyazaki, Masaaki; Tsurutani, Junji; Yonesaka, Kimio; Morinaga, Ryotaroh; Tsuya, Asuka; Terashima, Masaaki; Kudoh, Toshihiro; Azuma, Koichi; Kurata, Takayasu; Nishikawa, Tatsuyuki; Fukuoka, Masahiro; Nishimura, Yasumasa; Nakagawa, Kazuhiko.

In: Investigational New Drugs, Vol. 31, No. 3, 01.06.2013, p. 599-604.

Research output: Contribution to journalArticle

Hasegawa, Y, Okamoto, I, Takezawa, K, Miyazaki, M, Tsurutani, J, Yonesaka, K, Morinaga, R, Tsuya, A, Terashima, M, Kudoh, T, Azuma, K, Kurata, T, Nishikawa, T, Fukuoka, M, Nishimura, Y & Nakagawa, K 2013, 'A phase i study of S-1 with concurrent radiotherapy in elderly patients with locally advanced non-small cell lung cancer', Investigational New Drugs, vol. 31, no. 3, pp. 599-604. https://doi.org/10.1007/s10637-012-9833-7
Hasegawa, Yoshikazu ; Okamoto, Isamu ; Takezawa, Ken ; Miyazaki, Masaaki ; Tsurutani, Junji ; Yonesaka, Kimio ; Morinaga, Ryotaroh ; Tsuya, Asuka ; Terashima, Masaaki ; Kudoh, Toshihiro ; Azuma, Koichi ; Kurata, Takayasu ; Nishikawa, Tatsuyuki ; Fukuoka, Masahiro ; Nishimura, Yasumasa ; Nakagawa, Kazuhiko. / A phase i study of S-1 with concurrent radiotherapy in elderly patients with locally advanced non-small cell lung cancer. In: Investigational New Drugs. 2013 ; Vol. 31, No. 3. pp. 599-604.
@article{e001c93546b7450892f2d28d982bd17a,
title = "A phase i study of S-1 with concurrent radiotherapy in elderly patients with locally advanced non-small cell lung cancer",
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.",
author = "Yoshikazu Hasegawa and Isamu Okamoto and Ken Takezawa and Masaaki Miyazaki and Junji Tsurutani and Kimio Yonesaka and Ryotaroh Morinaga and Asuka Tsuya and Masaaki Terashima and Toshihiro Kudoh and Koichi Azuma and Takayasu Kurata and Tatsuyuki Nishikawa and Masahiro Fukuoka and Yasumasa Nishimura and Kazuhiko Nakagawa",
year = "2013",
month = "6",
day = "1",
doi = "10.1007/s10637-012-9833-7",
language = "English",
volume = "31",
pages = "599--604",
journal = "Investigational New Drugs",
issn = "0167-6997",
publisher = "Kluwer Academic Publishers",
number = "3",

}

TY - JOUR

T1 - A phase i study of S-1 with concurrent radiotherapy in elderly patients with locally advanced non-small cell lung cancer

AU - Hasegawa, Yoshikazu

AU - Okamoto, Isamu

AU - Takezawa, Ken

AU - Miyazaki, Masaaki

AU - Tsurutani, Junji

AU - Yonesaka, Kimio

AU - Morinaga, Ryotaroh

AU - Tsuya, Asuka

AU - Terashima, Masaaki

AU - Kudoh, Toshihiro

AU - Azuma, Koichi

AU - Kurata, Takayasu

AU - Nishikawa, Tatsuyuki

AU - Fukuoka, Masahiro

AU - Nishimura, Yasumasa

AU - Nakagawa, Kazuhiko

PY - 2013/6/1

Y1 - 2013/6/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84879104597&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84879104597&partnerID=8YFLogxK

U2 - 10.1007/s10637-012-9833-7

DO - 10.1007/s10637-012-9833-7

M3 - Article

C2 - 22623066

AN - SCOPUS:84879104597

VL - 31

SP - 599

EP - 604

JO - Investigational New Drugs

JF - Investigational New Drugs

SN - 0167-6997

IS - 3

ER -