A phase II trial of stereotactic body radiation therapy for operable T1N0M0 non-small cell lung cancer: Japan Clinical Oncology Group (JCOG0403)—Long term follow-up results.

Authors

null

Yasushi Nagata

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

Organizations

Hiroshima Univ Hosp, Hiroshima, Japan, Japan Red Cross Wakayama Medical Center, Wakayama, Japan, Japan Clinical Oncology Group Data Center, National Cancer Center, Tokyo, Japan, University of Yamanashi, Chuo-Shi, Japan, Kobe City Medical Center General Hospital, Kobe, Japan, Department of Radiation Oncology, Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital, Tokyo, Japan, Ion Beam Therapy Center, SAGA HIMAT Foundation, Tosu, Japan, Department of Radiology, Hokkaido University Graduate School of Medicine, Sapporo, Japan, Tokai University, Kanagawa, Japan, Nagoya City University, Nagoya, Japan

Research Funding

Other

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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Abstract Details

Meeting

2018 ASCO Annual Meeting

Session Type

Poster Discussion Session

Session Title

Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Track

Lung Cancer

Sub Track

Local-Regional Non–Small Cell Lung Cancer

Clinical Trial Registration Number

NCT00238875

Citation

J Clin Oncol 36, 2018 (suppl; abstr 8512)

DOI

10.1200/JCO.2018.36.15_suppl.8512

Abstract #

8512

Poster Bd #

118

Abstract Disclosures