Stereotactic body radiotherapy for centrally located inoperable early-stage NSCLC: EORTC 22113-08113 LungTech Phase II trial results
Authors
Levy, A.Adebahr, S.
Hurkmans, C.
Ahmed, M.
Ahmad, S.
Guckenberger, M.
Geets, X.
Lievens, Y.
Lambrecht, M.
Pourel, N.
Lewitzki, V.
Konopa, K.
Franks, K.
Dziadziuszko, R.
McDonald, F.
Fortpied, C.
Clementel, E.
Fournier, B.
Rizzo, S.
Fink, C.
Riesterer, O.
Peulen, H.
Andratschke, N.
McWilliam, Alan
Gkika, E.
Schimek-Jasch, T.
Grosu, A. L.
Le Pechoux, C.
Faivre-Finn, Corinne
Nestle, U.
Affiliation
Division of Cancer Sciences, The Christie NHS Foundation Trust, University of Manchester, Manchester, United Kingdom.Issue Date
2024
Metadata
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INTRODUCTION: The international phase II single-arm LungTech trial 22113-08113 of the European Organization for Research and Treatment of Cancer assessed the safety and efficacy of stereotactic body radiotherapy (SBRT) in patients with centrally located early-stage NSCLC. METHODS: Patients with inoperable non-metastatic central NSCLC (T1-T3 N0 M0, ≤7cm) were included. After prospective central imaging review and radiation therapy quality assurance for any eligible patient, SBRT (8 × 7.5 Gy) was delivered. The primary endpoint was freedom from local progression probability three years after the start of SBRT. RESULTS: The trial was closed early due to poor accrual related to repeated safety-related pauses in recruitment. Between August 2015 and December 2017, 39 patients from six European countries were included and 31 were treated per protocol and analyzed. Patients were mainly male (58%) with a median age of 75 years. Baseline comorbidities were mainly respiratory (68%) and cardiac (48%). Median tumor size was 2.6 cm (range 1.2-5.5) and most cancers were T1 (51.6%) or T2a (38.7%) N0 M0 and of squamous cell origin (48.4%). Six patients (19.4%) had an ultracentral tumor location. The median follow-up was 3.6 years. The rates of 3-year freedom from local progression and overall survival were 81.5% (90% confidence interval [CI]: 62.7%-91.4%) and 61.1% (90% CI: 44.1%-74.4%), respectively. Cumulative incidence rates of local, regional, and distant progression at three years were 6.7% (90% CI: 1.6%-17.1%), 3.3% (90% CI: 0.4%-12.4%), and 29.8% (90% CI: 16.8%-44.1%), respectively. SBRT-related acute adverse events and late adverse events ≥ G3 were reported in 6.5% (n = 2, including one G5 pneumonitis in a patient with prior interstitial lung disease) and 19.4% (n = 6, including one lethal hemoptysis after a lung biopsy in a patient receiving anticoagulants), respectively. CONCLUSIONS: The LungTech trial suggests that SBRT with 8 × 7.5Gy for central lung tumors in inoperable patients is associated with acceptable local control rates. However, late severe adverse events may occur after completion of treatment. This SBRT regimen is a viable treatment option after a thorough risk-benefit discussion with patients. To minimize potentially fatal toxicity, careful management of dose constraints, and post-SBRT interventions is crucial.Citation
Levy A, Adebahr S, Hurkmans C, Ahmed M, Ahmad S, Guckenberger M, et al. Stereotactic Body Radiotherapy for Centrally Located Inoperable Early-Stage NSCLC: EORTC 22113-08113 LungTech Phase II Trial Results. Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer. 2024 May 22. PubMed PMID: 38788924. Epub 2024/05/25. eng.Journal
Journal of Thoracic OncologyDOI
10.1016/j.jtho.2024.05.366PubMed ID
38788924Additional Links
https://dx.doi.org/10.1016/j.jtho.2024.05.366Type
ArticleLanguage
enae974a485f413a2113503eed53cd6c53
10.1016/j.jtho.2024.05.366
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