Original Article18F-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
Section snippets
Materials and methods
This phase 2, open-label, randomised, investigator-initiated clinical trial was part of the European ARTFORCE consortium, and conducted at seven sites in five countries. The trial protocol, with all in- and exclusion criteria, is provided in Appendix A.
In summary, inclusion criteria were age ≥ 18 years, inoperable stage II-III pathologically confirmed NSCLC, a primary tumour ≥ 4 cm in diameter with no satellite lesions and a SUVmax ≥ 5 on the pre-treatment 18F-FDG-PET scan (to allow targeting
Results
Hundred-fifty patients were enrolled between April 23, 2010 and September 15, 2017 from five European institutions (Fig. 2, Appendix Table B.2). As a result of slower accrual than anticipated, the trial management group decided to close the trial early. Of 150 patients included, 107 were eligible for dose escalation and were subsequently randomised: 54 to receive escalated-dose to the whole tumour, and 53 to the PET-subvolume. Here we publish analysis of data reported as of April 29, 2021. The
Discussion
Local control is an important outcome associated with survival after radiotherapy for LA-NSCLC.[18], [19] In addition to homogeneously increasing radiation dose, it was hypothesised that increasing the radiation dose to areas at high risk of local relapse defined by 18F-FDG-PET subvolumes could improve the cure rate. We investigated the efficacy and safety of a personalised, integrated escalation of radiotherapy dose delivered either to the primary tumour as a whole or to the PET-subvolume. In
Role of the funder/sponsor
The EC and KWF had no role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Declaration of Competing Interest
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
Acknowledgments
We are grateful for funding by the European Commission’s Seventh Framework Programme (ARTFORCE, grant agreement no 257144) and the Dutch Cancer Society (KWF) (project no 2010-4675).
The content of this report is the sole responsibility of the authors and does not necessarily reflect the official views of the EC or KWF.
Professor Sonke is supported by a grant from Elekta AB.
Professor Faivre-Finn is supported by a grant from the NIHR Manchester Biomedical Research Centre.
We thank the patients and
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