A phase II study of S-1 chemotherapy with concurrent thoracic radiotherapy in elderly patients with locally advanced non-small-cell lung cancer: The Okayama Lung Cancer Study Group Trial 0801

Keisuke Aoe, Nagio Takigawa, Katsuyuki Hotta, Tadashi Maeda, Daizo Kishino, Naoyuki Nogami, Masahiro Tabata, Shingo Harita, Toshiaki Okada, Toshio Kubo, Shinobu Hosokawa, Keiichi Fujiwara, Kenichi Gemba, Masayuki Yasugi, Toshiyuki Kozuki, Yuka Kato, Kuniaki Katsui, Susumu Kanazawa, Hiroshi Ueoka, Mitsune TanimotoKatsuyuki Kiura

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

Background Although thoracic irradiation (TRT) is a standard treatment for elderly patients with locally advanced non-small-cell lung cancer (LA-NSCLC), treatment outcomes are poor. We previously reported a phase I trial combining S-1, an oral 5-fluorouracil derivative, and thoracic radiation, which yielded safe and effective outcomes. Methods In this phase II trial, 30 patients aged 76 years or older with LA-NSCLC received S-1 (80 mg/m2 on days 1-14 and 29-42) and TRT (60 Gy). The primary end-point was the response rate. Results The median age and pre-treatment Charlson score were 79 years and 1, respectively. The mean proportions of the actual doses of S-1 and TRT delivered relative to the planned doses were 95% and 98%, respectively. Partial responses were observed in 19 patients (63%; 95% confidence interval: 45-82%), which did not attain the end-point. At a median follow-up time of 23.7 months, the median progression-free survival and median survival times were 13.0 months and 27.9 months, respectively. No difference in efficacy was observed upon stratification by tumour histology. Toxicities were generally mild, except for grade 3 or greater febrile neutropenia and pneumonitis in 7% and 10% of patients, respectively. No patient developed severe oesophagitis. Conclusions Although the primary end-point was not met, concurrent S-1 chemotherapy and radiotherapy yielded favourable survival data. Also, the combined treatment was well-tolerated in elderly patients with LA-NSCLC.

Original languageEnglish
Pages (from-to)2783-2790
Number of pages8
JournalEuropean Journal of Cancer
Volume50
Issue number16
DOIs
Publication statusPublished - Nov 2014

Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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