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 Tanimoto & 1 others Katsuyuki Kiura

Research output: Contribution to journalArticle

12 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 - 2014

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Non-Small Cell Lung Carcinoma
Lung Neoplasms
Radiotherapy
Thorax
Drug Therapy
Febrile Neutropenia
Survival
Esophagitis
Fluorouracil
Disease-Free Survival
Pneumonia
Histology
Therapeutics
Confidence Intervals
Radiation
Neoplasms

Keywords

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

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

Cite this

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

In: European Journal of Cancer, Vol. 50, No. 16, 2014, p. 2783-2790.

Research output: Contribution to journalArticle

Aoe, Keisuke ; Takigawa, Nagio ; Hotta, Katsuyuki ; Maeda, Tadashi ; Kishino, Daizo ; Nogami, Naoyuki ; Tabata, Masahiro ; Harita, Shingo ; Okada, Toshiaki ; Kubo, Toshio ; Hosokawa, Shinobu ; Fujiwara, Keiichi ; Gemba, Kenichi ; Yasugi, Masayuki ; Kozuki, Toshiyuki ; Kato, Yuka ; Katsui, Kuniaki ; Kanazawa, Susumu ; Ueoka, Hiroshi ; Tanimoto, Mitsune ; Kiura, Katsuyuki. / 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. In: European Journal of Cancer. 2014 ; Vol. 50, No. 16. pp. 2783-2790.
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title = "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",
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.",
keywords = "Keywords Elderly patients, Non-small-cell lung cancer, S-1 Radiation",
author = "Keisuke Aoe and Nagio Takigawa and Katsuyuki Hotta and Tadashi Maeda and Daizo Kishino and Naoyuki Nogami and Masahiro Tabata and Shingo Harita and Toshiaki Okada and Toshio Kubo and Shinobu Hosokawa and Keiichi Fujiwara and Kenichi Gemba and Masayuki Yasugi and Toshiyuki Kozuki and Yuka Kato and Kuniaki Katsui and Susumu Kanazawa and Hiroshi Ueoka and Mitsune Tanimoto and Katsuyuki Kiura",
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TY - JOUR

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

T2 - The Okayama Lung Cancer Study Group Trial 0801

AU - Aoe, Keisuke

AU - Takigawa, Nagio

AU - Hotta, Katsuyuki

AU - Maeda, Tadashi

AU - Kishino, Daizo

AU - Nogami, Naoyuki

AU - Tabata, Masahiro

AU - Harita, Shingo

AU - Okada, Toshiaki

AU - Kubo, Toshio

AU - Hosokawa, Shinobu

AU - Fujiwara, Keiichi

AU - Gemba, Kenichi

AU - Yasugi, Masayuki

AU - Kozuki, Toshiyuki

AU - Kato, Yuka

AU - Katsui, Kuniaki

AU - Kanazawa, Susumu

AU - Ueoka, Hiroshi

AU - Tanimoto, Mitsune

AU - Kiura, Katsuyuki

PY - 2014

Y1 - 2014

N2 - 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.

AB - 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.

KW - Keywords Elderly patients

KW - Non-small-cell lung cancer

KW - S-1 Radiation

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