Prospective Trial of Stereotactic Body Radiation Therapy for Both Operable and Inoperable T1N0M0 Non-Small Cell Lung Cancer: Japan Clinical Oncology Group Study JCOG0403

详细信息    查看全文

• 作者：Yasushi Nagata ; MD^&lowast ; ; ^{nagat@hiroshima-u.ac.jp" class="auth_mail" title="E-mail the corresponding author} ; Masahiro Hiraoka ; MD^&dagger ; ; Taro Shibata ; MSc^&Dagger ; ; Hiroshi Onishi ; MD^§ ; ; Masaki Kokubo ; MD^‖ ; Katsuyuki Karasawa ; MD^¶ ; ; Yoshiyuki Shioyama ; MD^# ; Rikiya Onimaru ; MD^&lowast ; &lowast ; ; Takuyo Kozuka ; MD^&dagger ; &dagger ; ; Etsuo Kunieda ; MD^&Dagger ; &Dagger ; ; Tsutomu Saito ; MD^§ ; § ; ; Keiichi Nakagawa ; MD^‖‖ ; Masato Hareyama ; MD^¶ ; ¶ ; ; Yoshihiro Takai ; MD^## ; Kazushige Hayakawa ; MD^&lowast ; &lowast ; &lowast ; ; Norio Mitsuhashi ; MD^&dagger ; &dagger ; &dagger ; ; Satoshi Ishikura ; MD^&Dagger ; &Dagger ; &Dagger ;
• 刊名：International Journal of Radiation Oncology*Biology*Physics
• 出版年：2015
• 出版时间：1 December 2015
• 年：2015
• 卷：93
• 期：5
• 页码：989-996
• 全文大小：735 K

文摘

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.