Prospective trial of stereotactic body radiation therapy for both operable and inoperable T1N0M0 non-small cell lung cancer: Japan Clinical Oncology Group Study JCOG0403

Yasushi Nagata, Masahiro Hiraoka, Taro Shibata, Hiroshi Onishi, Masaki Kokubo, Katsuyuki Karasawa, Yoshiyuki Shioyama, Rikiya Onimaru, Takuyo Kozuka, Etsuo Kunieda, Tsutomu Saito, Keiichi Nakagawa, Masato Hareyama, Yoshihiro Takai, Kazushige Hayakawa, Norio Mitsuhashi, Satoshi Ishikura

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Abstract

Purpose To evaluate, in Japan Clinical Oncology Group study 0403, the safety and efficacy of stereotactic body radiation therapy (SBRT) in patients with T1N0M0 non-small cell lung cancer (NSCLC). Methods and Materials Eligibility criteria included histologically or cytologically proven NSCLC, clinical T1N0M0. Prescribed dose was 48 Gy at the isocenter in 4 fractions. The primary endpoint was the percent (%) 3-year overall survival. The threshold % 3-year survival to be rejected was set at 35% for inoperable patients, whereas the expected % 3-year survival was 80% for operable patients. Results Between July 2004 and November 2008, 169 patients from 15 institutions were registered. One hundred inoperable and 64 operable patients (total 164) were eligible. Patients' characteristics were 122 male, 47 female; median age 78 years (range, 50-91 years); adenocarcinomas, 90; squamous cell carcinomas, 61; others, 18. Of the 100 inoperable patients, the % 3-year OS was 59.9% (95% confidence interval 49.6%-68.8%). Grade 3 and 4 toxicities were observed in 10 and 2 patients, respectively. No grade 5 toxicity was observed. Of the 64 operable patients, the % 3-year OS was 76.5% (95% confidence interval 64.0%-85.1%). Grade 3 toxicities were observed in 5 patients. No grade 4 and 5 toxicities were observed. Conclusions Stereotactic body radiation therapy for stage I NSCLC is effective, with low incidences of severe toxicity. This treatment can be considered a standard treatment for inoperable stage I NSCLC. This treatment is promising as an alternative to surgery for operable stage I NSCLC.

Original languageEnglish
Pages (from-to)989-996
Number of pages8
JournalInternational Journal of Radiation Oncology Biology Physics
Volume93
Issue number5
DOIs
Publication statusPublished - Dec 1 2015

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Medical Oncology
Non-Small Cell Lung Carcinoma
lungs
radiation therapy
Japan
Radiotherapy
cancer
toxicity
grade
Survival
confidence
Confidence Intervals
intervals
surgery
Squamous Cell Carcinoma
safety
Adenocarcinoma
Therapeutics
incidence
Safety

All Science Journal Classification (ASJC) codes

  • Radiation
  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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Prospective trial of stereotactic body radiation therapy for both operable and inoperable T1N0M0 non-small cell lung cancer : Japan Clinical Oncology Group Study JCOG0403. / Nagata, Yasushi; Hiraoka, Masahiro; Shibata, Taro; Onishi, Hiroshi; Kokubo, Masaki; Karasawa, Katsuyuki; Shioyama, Yoshiyuki; Onimaru, Rikiya; Kozuka, Takuyo; Kunieda, Etsuo; Saito, Tsutomu; Nakagawa, Keiichi; Hareyama, Masato; Takai, Yoshihiro; Hayakawa, Kazushige; Mitsuhashi, Norio; Ishikura, Satoshi.

In: International Journal of Radiation Oncology Biology Physics, Vol. 93, No. 5, 01.12.2015, p. 989-996.

Research output: Contribution to journalArticle

Nagata, Y, Hiraoka, M, Shibata, T, Onishi, H, Kokubo, M, Karasawa, K, Shioyama, Y, Onimaru, R, Kozuka, T, Kunieda, E, Saito, T, Nakagawa, K, Hareyama, M, Takai, Y, Hayakawa, K, Mitsuhashi, N & Ishikura, S 2015, 'Prospective trial of stereotactic body radiation therapy for both operable and inoperable T1N0M0 non-small cell lung cancer: Japan Clinical Oncology Group Study JCOG0403', International Journal of Radiation Oncology Biology Physics, vol. 93, no. 5, pp. 989-996. https://doi.org/10.1016/j.ijrobp.2015.07.2278
Nagata, Yasushi ; Hiraoka, Masahiro ; Shibata, Taro ; Onishi, Hiroshi ; Kokubo, Masaki ; Karasawa, Katsuyuki ; Shioyama, Yoshiyuki ; Onimaru, Rikiya ; Kozuka, Takuyo ; Kunieda, Etsuo ; Saito, Tsutomu ; Nakagawa, Keiichi ; Hareyama, Masato ; Takai, Yoshihiro ; Hayakawa, Kazushige ; Mitsuhashi, Norio ; Ishikura, Satoshi. / Prospective trial of stereotactic body radiation therapy for both operable and inoperable T1N0M0 non-small cell lung cancer : Japan Clinical Oncology Group Study JCOG0403. In: International Journal of Radiation Oncology Biology Physics. 2015 ; Vol. 93, No. 5. pp. 989-996.
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abstract = "Purpose To evaluate, in Japan Clinical Oncology Group study 0403, the safety and efficacy of stereotactic body radiation therapy (SBRT) in patients with T1N0M0 non-small cell lung cancer (NSCLC). Methods and Materials Eligibility criteria included histologically or cytologically proven NSCLC, clinical T1N0M0. Prescribed dose was 48 Gy at the isocenter in 4 fractions. The primary endpoint was the percent ({\%}) 3-year overall survival. The threshold {\%} 3-year survival to be rejected was set at 35{\%} for inoperable patients, whereas the expected {\%} 3-year survival was 80{\%} for operable patients. Results Between July 2004 and November 2008, 169 patients from 15 institutions were registered. One hundred inoperable and 64 operable patients (total 164) were eligible. Patients' characteristics were 122 male, 47 female; median age 78 years (range, 50-91 years); adenocarcinomas, 90; squamous cell carcinomas, 61; others, 18. Of the 100 inoperable patients, the {\%} 3-year OS was 59.9{\%} (95{\%} confidence interval 49.6{\%}-68.8{\%}). Grade 3 and 4 toxicities were observed in 10 and 2 patients, respectively. No grade 5 toxicity was observed. Of the 64 operable patients, the {\%} 3-year OS was 76.5{\%} (95{\%} confidence interval 64.0{\%}-85.1{\%}). Grade 3 toxicities were observed in 5 patients. No grade 4 and 5 toxicities were observed. Conclusions Stereotactic body radiation therapy for stage I NSCLC is effective, with low incidences of severe toxicity. This treatment can be considered a standard treatment for inoperable stage I NSCLC. This treatment is promising as an alternative to surgery for operable stage I NSCLC.",
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T1 - Prospective trial of stereotactic body radiation therapy for both operable and inoperable T1N0M0 non-small cell lung cancer

T2 - Japan Clinical Oncology Group Study JCOG0403

AU - Nagata, Yasushi

AU - Hiraoka, Masahiro

AU - Shibata, Taro

AU - Onishi, Hiroshi

AU - Kokubo, Masaki

AU - Karasawa, Katsuyuki

AU - Shioyama, Yoshiyuki

AU - Onimaru, Rikiya

AU - Kozuka, Takuyo

AU - Kunieda, Etsuo

AU - Saito, Tsutomu

AU - Nakagawa, Keiichi

AU - Hareyama, Masato

AU - Takai, Yoshihiro

AU - Hayakawa, Kazushige

AU - Mitsuhashi, Norio

AU - Ishikura, Satoshi

PY - 2015/12/1

Y1 - 2015/12/1

N2 - Purpose To evaluate, in Japan Clinical Oncology Group study 0403, the safety and efficacy of stereotactic body radiation therapy (SBRT) in patients with T1N0M0 non-small cell lung cancer (NSCLC). Methods and Materials Eligibility criteria included histologically or cytologically proven NSCLC, clinical T1N0M0. Prescribed dose was 48 Gy at the isocenter in 4 fractions. The primary endpoint was the percent (%) 3-year overall survival. The threshold % 3-year survival to be rejected was set at 35% for inoperable patients, whereas the expected % 3-year survival was 80% for operable patients. Results Between July 2004 and November 2008, 169 patients from 15 institutions were registered. One hundred inoperable and 64 operable patients (total 164) were eligible. Patients' characteristics were 122 male, 47 female; median age 78 years (range, 50-91 years); adenocarcinomas, 90; squamous cell carcinomas, 61; others, 18. Of the 100 inoperable patients, the % 3-year OS was 59.9% (95% confidence interval 49.6%-68.8%). Grade 3 and 4 toxicities were observed in 10 and 2 patients, respectively. No grade 5 toxicity was observed. Of the 64 operable patients, the % 3-year OS was 76.5% (95% confidence interval 64.0%-85.1%). Grade 3 toxicities were observed in 5 patients. No grade 4 and 5 toxicities were observed. Conclusions Stereotactic body radiation therapy for stage I NSCLC is effective, with low incidences of severe toxicity. This treatment can be considered a standard treatment for inoperable stage I NSCLC. This treatment is promising as an alternative to surgery for operable stage I NSCLC.

AB - Purpose To evaluate, in Japan Clinical Oncology Group study 0403, the safety and efficacy of stereotactic body radiation therapy (SBRT) in patients with T1N0M0 non-small cell lung cancer (NSCLC). Methods and Materials Eligibility criteria included histologically or cytologically proven NSCLC, clinical T1N0M0. Prescribed dose was 48 Gy at the isocenter in 4 fractions. The primary endpoint was the percent (%) 3-year overall survival. The threshold % 3-year survival to be rejected was set at 35% for inoperable patients, whereas the expected % 3-year survival was 80% for operable patients. Results Between July 2004 and November 2008, 169 patients from 15 institutions were registered. One hundred inoperable and 64 operable patients (total 164) were eligible. Patients' characteristics were 122 male, 47 female; median age 78 years (range, 50-91 years); adenocarcinomas, 90; squamous cell carcinomas, 61; others, 18. Of the 100 inoperable patients, the % 3-year OS was 59.9% (95% confidence interval 49.6%-68.8%). Grade 3 and 4 toxicities were observed in 10 and 2 patients, respectively. No grade 5 toxicity was observed. Of the 64 operable patients, the % 3-year OS was 76.5% (95% confidence interval 64.0%-85.1%). Grade 3 toxicities were observed in 5 patients. No grade 4 and 5 toxicities were observed. Conclusions Stereotactic body radiation therapy for stage I NSCLC is effective, with low incidences of severe toxicity. This treatment can be considered a standard treatment for inoperable stage I NSCLC. This treatment is promising as an alternative to surgery for operable stage I NSCLC.

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