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 language | English |
|---|---|
| Pages (from-to) | 989-996 |
| Number of pages | 8 |
| Journal | International Journal of Radiation Oncology Biology Physics |
| Volume | 93 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - Dec 1 2015 |
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All Science Journal Classification (ASJC) codes
- Radiation
- Oncology
- Radiology Nuclear Medicine and imaging
- Cancer Research
Cite this
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 journal › Article
}
TY - JOUR
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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UR - http://www.scopus.com/inward/citedby.url?scp=84946752940&partnerID=8YFLogxK
U2 - 10.1016/j.ijrobp.2015.07.2278
DO - 10.1016/j.ijrobp.2015.07.2278
M3 - Article
C2 - 26581137
AN - SCOPUS:84946752940
VL - 93
SP - 989
EP - 996
JO - International Journal of Radiation Oncology Biology Physics
JF - International Journal of Radiation Oncology Biology Physics
SN - 0360-3016
IS - 5
ER -