(18)F-FDG-PET guided vs whole tumour radiotherapy dose escalation in patients with locally advanced non-small cell lung cancer (PET-Boost): results from a randomised clinical trial
AuthorsCooke, S. A.
Dirk de Ruysscher, P.
Fredberg Persson, G.
Faivre-Finn , Corinne
Dieleman, E. M. T.
van Diessen, J. N. A.
van Elmpt, W.
Damen, E. M. F.
Sonke, J. J.
Belderbos, J. S. A.
AffiliationDepartment of Radiation Oncology, Netherlands Cancer Institute (NKI-AVL), Amsterdam, The Netherlands
MetadataShow full item record
AbstractBackground and purpose: We aimed to assess if radiation dose escalation to either the whole primary tumour, or to an 18F-FDG-PET defined subvolume within the primary tumour known to be at high risk of local relapse, could improve local control in patients with locally advanced non-small-cell lung cancer. Materials and methods: Patients with inoperable, stage II-III NSCLC were randomised (1:1) to receive dose-escalated radiotherapy to the whole primary tumour or a PET-defined subvolume, in 24 fractions. The primary endpoint was freedom from local failure (FFLF), assessed by central review of CT-imaging. A phase II 'pick-the-winner' design (alpha = 0.05; beta = 0.80) was applied to detect a 15 % increase in FFLF at 1-year. Clinicaltrials: gov:NCT01024829. Results: 150 patients were enrolled. 54 patients were randomised to the whole tumour group and 53 to the PET-subvolume group. The trial was closed early due to slow accrual. Median dose/fraction to the boosted volume was 3.30 Gy in the whole tumour group, and 3.50 Gy in the PET-subvolume group. The 1-year FFLF rate was 97 % (95 %CI 91-100) in whole tumour group, and 91 % (95 %CI 82-100) in the PET-subvolume group. Acute grade ≥ 3 adverse events occurred in 23 (43 %) and 20 (38 %) patients, and late grade ≥ 3 in 12 (22 %) and 17 (32 %), respectively. Grade 5 events occurred in 19 (18 %) patients in total, of which before disease progression in 4 (7 %) in the whole tumour group, and 5 (9 %) in the PET-subvolume group. Conclusion: Both strategies met the primary objective to improve local control with 1-year rates. However, both strategies led to unexpected high rates of grade 5 toxicity. Dose differentiation, improved patient selection and better sparing of central structures are proposed to improve dose-escalation strategies.
CitationCooke SA, Dirk de Ruysscher P, Reymen B, Lambrecht M, Fredberg Persson G, Faivre-Finn Frcr C, et al. (18)F-FDG-PET guided vs whole tumour radiotherapy dose escalation in patients with locally advanced non-small cell lung cancer (PET-Boost): results from a randomised clinical trial. Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology. 2023 Jan 24:109492. PubMed PMID: 36706958. Epub 2023/01/28. eng.
JournalRadiotherapy and Oncology
- Imaging-based target volume reduction in chemoradiotherapy for locally advanced non-small-cell lung cancer (PET-Plan): a multicentre, open-label, randomised, controlled trial.
- Authors: Nestle U, Schimek-Jasch T, Kremp S, Schaefer-Schuler A, Mix M, Küsters A, Tosch M, Hehr T, Eschmann SM, Bultel YP, Hass P, Fleckenstein J, Thieme A, Stockinger M, Dieckmann K, Miederer M, Holl G, Rischke HC, Gkika E, Adebahr S, König J, Grosu AL, PET-Plan study group
- Issue date: 2020 Apr
- Effect of Midtreatment PET/CT-Adapted Radiation Therapy With Concurrent Chemotherapy in Patients With Locally Advanced Non-Small-Cell Lung Cancer: A Phase 2 Clinical Trial.
- Authors: Kong FM, Ten Haken RK, Schipper M, Frey KA, Hayman J, Gross M, Ramnath N, Hassan KA, Matuszak M, Ritter T, Bi N, Wang W, Orringer M, Cease KB, Lawrence TS, Kalemkerian GP
- Issue date: 2017 Oct 1
- An individualized radiation dose escalation trial in non-small cell lung cancer based on FDG-PET imaging.
- Authors: Wanet M, Delor A, Hanin FX, Ghaye B, Van Maanen A, Remouchamps V, Clermont C, Goossens S, Lee JA, Janssens G, Bol A, Geets X
- Issue date: 2017 Oct
- The PET-boost randomised phase II dose-escalation trial in non-small cell lung cancer.
- Authors: van Elmpt W, De Ruysscher D, van der Salm A, Lakeman A, van der Stoep J, Emans D, Damen E, Öllers M, Sonke JJ, Belderbos J
- Issue date: 2012 Jul
- Areas of high 18F-FDG uptake on preradiotherapy PET/CT identify preferential sites of local relapse after chemoradiotherapy for non-small cell lung cancer.
- Authors: Calais J, Thureau S, Dubray B, Modzelewski R, Thiberville L, Gardin I, Vera P
- Issue date: 2015 Feb