Hiroshima Univ Hosp, Hiroshima, Japan
Yasushi Nagata , Masahiro Hiraoka , Taro Shibata , Hiroshi Onishi , Masaki Kokubo , Katsuyuki Karasawa , Yoshiyuki Shioyama , Rikiya Onimaru , Etsuo Kunieda , Satoshi Ishikura
Background: The purpose was to evaluate the safety and efficacy of stereotactic body radiation therapy (SBRT) in patients (pts) with both operable and inoperable T1N0M0 non-small cell lung cancer (NSCLC) (UICC 6th ed., 2002). The 3 and 5 year follow-up results were published in 2015. This is the updated report with a 10-year follow-up for the operable population. Methods: The eligibility criteria included NSCLC, clinical T1N0M0, operable pts assessed by thoracic surgeons. Operability was recategorized by the study coordinator after registration and before the primary analysis. The prescription was 48 Gy at the isocenter in 4 fractions over 4-8 days. The primary endpoint was the 3-year overall survival (OS) and the secondary endpoints included progression-free survival (PFS), local-progression free survival (LPFS), event-free survival (EFS) and toxicity. Results: Between July 2004 and May 2007, 65 operable pts were registered and 64 eligible pts were included in efficacy analysis. The pts characteristics were: male 45, female 20; median age 79 (range 50-91). All pts completed the protocol treatment. At the last follow-up in February 2017 (median follow-up is 5.2 years), 20 died with disease, 24 died with other disease, 1 with treatment-related death, 2 died with unknown reason and 17 alive. The median survival was 5.6 year (95% CI: 4.1 – 7.1 year).The 3, 5, 10-year survival were 76.5% (95% CI: 64.0% - 85.1%), 54.0% (95% CI: 41.0% - 65.4%) and 23.8% (95% CI: 13.7% - 35.5%). The 10-year PFS, LPFS, and EFS were 19.1% (95% CI: 9.8% - 30.7%), 20.9% (95% CI: 11.1% - 32.8%), 13.7% (95% CI: 6.0% - 24.6%). A total of 27 failures were observed including 9 with local failure, 11 with regional nodal failure and 11 with distant metastases. Grade 3 toxicity occurred in 6 pts: chest pain 1 (1.5%), dyspnea 4 (6.2%), hypoxia 1 (1.5%), and pneumonitis 2 (3.1%). No grade 4 or 5 toxicity occurred. Conclusions: Long term results confirmed the efficacy and safety of the previous result. SBRT has a potential to be an alternative to surgery and deserves a further evaluation. To further improve the tumor control, a randomized phase III study investigating higher dose is underway (JCOG1408). Clinical trial information: NCT00238875
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