Impact of radiotherapy protocol adherence in NSCLC patients treated with concurrent chemoradiation: RTQA results of the PET-Plan trial.

Autor: Gkika E; Department of Radiation Oncology, Medical Center, University of Freiburg, Germany; German Cancer Consortium (DKTK) Partner Site Freiburg, German Cancer Research Center (DKFZ), Heidelberg, Germany; Faculty of Medicine, University of Freiburg, Germany. Electronic address: eleni.gkika@uniklinik-freiburg.de., Schimek-Jasch T; Department of Radiation Oncology, Medical Center, University of Freiburg, Germany; German Cancer Consortium (DKTK) Partner Site Freiburg, German Cancer Research Center (DKFZ), Heidelberg, Germany., Kremp S; Department of Radiotherapy and Radiation Oncology, Saarland University Medical Center and Faculty of Medicine, Homburg/Saar, Germany., Lenz S; Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, Germany., Stockinger M; Department of Radiation Oncology, University Hospital Mainz, Germany., Schaefer-Schuler A; Department of Nuclear Medicine, Saarland University Medical Center and Faculty of Medicine, Homburg/Saar, Germany., Mix M; Faculty of Medicine, University of Freiburg, Germany; Department of Nuclear Medicine, Medical Center, University of Freiburg, Germany., Küsters A; Department of Radiation Oncology, Kliniken Maria Hilf, Mönchengladbach, Germany., Tosch M; Department of Nuclear Medicine, Helios University Hospital Wuppertal, Germany; Department of Medicine, Faculty of Health, University of Witten/Herdecke, Witten, Germany., Hehr T; Department of Radiation Oncology, Marienhospital, Stuttgart, Germany., Eschmann SM; Department of Nuclear Medicine, Marienhospital, Stuttgart, Germany., Bultel YP; Department of Radiation Oncology, Klinikum Mutterhaus der Boromäerinnen, Trier, Germany., Hass P; Department of Radiation Oncology, University Hospital Magdeburg, Germany., Fleckenstein J; Department of Radiotherapy and Radiation Oncology, Saarland University Medical Center and Faculty of Medicine, Homburg/Saar, Germany., Thieme AH; Department of Radiation Oncology, Charité - Universitätsmedizin Berlin, Germany., Dieckmann K; Department of Radiotherapy, Vienna General Hospital, Medical University of Vienna, Austria., Miederer M; Department of Nuclear Medicine, University Hospital Mainz, Germany., Holl G; Department of Nuclear Medicine, Helios Kliniken Schwerin, Germany., Rischke HC; Department of Radiation Oncology, Medical Center, University of Freiburg, Germany; Faculty of Medicine, University of Freiburg, Germany; Department of Nuclear Medicine, Saarland University Medical Center and Faculty of Medicine, Homburg/Saar, Germany., Adebahr S; Department of Radiation Oncology, Medical Center, University of Freiburg, Germany; German Cancer Consortium (DKTK) Partner Site Freiburg, German Cancer Research Center (DKFZ), Heidelberg, Germany., König J; Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Hospital of Mainz, Germany., Binder H; Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, Germany., Grosu AL; Department of Radiation Oncology, Medical Center, University of Freiburg, Germany; German Cancer Consortium (DKTK) Partner Site Freiburg, German Cancer Research Center (DKFZ), Heidelberg, Germany; Faculty of Medicine, University of Freiburg, Germany., Nestle U; Department of Radiation Oncology, Medical Center, University of Freiburg, Germany; German Cancer Consortium (DKTK) Partner Site Freiburg, German Cancer Research Center (DKFZ), Heidelberg, Germany; Faculty of Medicine, University of Freiburg, Germany; Department of Nuclear Medicine, Medical Center, University of Freiburg, Germany.
Jazyk: angličtina
Zdroj: Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology [Radiother Oncol] 2021 Oct; Vol. 163, pp. 32-38. Date of Electronic Publication: 2021 Jul 24.
DOI: 10.1016/j.radonc.2021.07.017
Abstrakt: Introduction: The success of intensification and personalisation of the curative treatment of non-small cell lung cancer (NSCLC) is strongly associated with the precision in radiotherapy. Here, we evaluate the impact of radiotherapy protocol adherence in a prospective multicentre trial.
Methods: In the open-label, randomised, controlled PET-Plan trial, patients with inoperable NSCLC were randomized at a 1:1 ratio regarding the target volume delineation informed by 1 F-FDG PET and CT plus elective nodal irradiation (arm A) or target volumes informed by PET alone (arm B) and received iso-toxically dose-escalated concurrent chemoradiation. The prospectively organised quality assurance program (RTQA) included individual case review by predefined criteria. For evaluation, protocol adherence was scored as per protocol (pP), with minor (miD), intermediate (inD) and major (maD) deviations. In order to exclude biases through patients who discontinued treatment, patients who received ≥60 Gy were additionally analysed.
Results: Between 05/2009-11/2016, 205 patients were randomized, 204 patients started treatment according to protocol of which 31 (15%) patients had maD. Patients with maD had an inferior overall survival (OS) (HR 2.9, 95% CI 1.8-4.4, p < 0.0001) and a higher risk of loco-regional progression (HR 5.7, 95% CI 2.7-11.1, p < 0.0001). These results were significant also in the subgroup of patients receiving ≥ 60 Gy. Patients with maD concerning normal tissue delineation and/or dose constraints had a worse OS (p = 0.006) although no higher incidence of grade ≥ 3 toxicities.
Conclusions: Non-adherence to the radiotherapy protocol was associated with an inferior OS and loco-regional control. These results underline the importance of RTQA.
(Copyright © 2021. Published by Elsevier B.V.)
Databáze: MEDLINE
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