Stefan Welz1, David Mönnich2, Christina Pfannenberg3, Konstantin Nikolaou3, Mathias Reimold4, Christian La Fougère4, Gerald Reischl5, Paul-Stefan Mauz6, Frank Paulsen1, Markus Alber7, Claus Belka8, Daniel Zips9, Daniela Thorwarth10. 1. Department of Radiation Oncology, University of Tübingen, Germany. 2. Section for Biomedical Physics, Department of Radiation Oncology, University of Tübingen, Germany. 3. Department of Radiology, Diagnostic and Interventional Radiology, University of Tübingen, Germany. 4. Department of Nuclear Medicine, University of Tübingen, Germany. 5. Department of Preclinical Imaging and Radiopharmacy, University of Tübingen, Germany. 6. Department of Otorhinolaryngology, University of Tübingen, Germany. 7. Section for Biomedical Physics, Department of Radiation Oncology, University of Tübingen, Germany; Department of Radiation Oncology, University of Heidelberg, Germany. 8. Department of Radiation Oncology, University of Tübingen, Germany; Department of Radiation Oncology, LMU Munich, Germany. 9. Department of Radiation Oncology, University of Tübingen, Germany; German Cancer Consortium (DKTK), partner site Tübingen; and German Cancer Research Center (DKFZ), Heidelberg, Germany. 10. Section for Biomedical Physics, Department of Radiation Oncology, University of Tübingen, Germany; German Cancer Consortium (DKTK), partner site Tübingen; and German Cancer Research Center (DKFZ), Heidelberg, Germany. Electronic address: daniela.thorwarth@med.uni-tuebingen.de.
Abstract
BACKGROUND AND PURPOSE: To prospectively assess the prognostic value of tumour hypoxia determined by dynamic [18F]Fluoromisonidazole (dynFMISO) PET/CT, and to evaluate both feasibility and toxicity in patients with locally advanced squamous cell carcinomas of the head and neck (LASCCHN) treated withdynFMISO image-guided dose escalation (DE) using dose-painting by contours. PATIENTS AND METHODS: We present a planned interim analysis of a randomized phase II trial. N=25 patients withLASCCHN received baseline dynFMISO PET/CT to derive hypoxic volumes (HV). Patients with tumour hypoxia were randomized into standard radiochemotherapy (stdRT) (70Gy/35 fractions) or DE (77Gy/35 fractions) to the HV. Patients with non-hypoxic tumours were treated with stdRT. Loco-regional control (LRC) in hypoxic patients randomized to stdRT was compared to non-hypoxic patients. Feasibility and toxicity were analysed for patients in the DE arm and compared to stdRT. RESULTS: With a mean follow-up of 27months, LRC in hypoxic patients receiving stdRT (n=10) was significantly worse compared to the non-hypoxic group (n=5) (2y-LRC 44.4% versus 100%, p=0.048). The respective LRC for the DE group (n=10) was 70.0%. Treatment compliance as well as acute and late toxicity did not show significant differences between the DE and the standard dose arms. CONCLUSION:Tumour hypoxia determined by baseline dynFMISO PET/CT is associated with a high risk of local failure in patients with LASCCHN. First data suggest that DE to HV is feasible without excess toxicity.
RCT Entities:
BACKGROUND AND PURPOSE: To prospectively assess the prognostic value of tumour hypoxia determined by dynamic [18F]Fluoromisonidazole (dynFMISO) PET/CT, and to evaluate both feasibility and toxicity in patients with locally advanced squamous cell carcinomas of the head and neck (LASCCHN) treated with dynFMISO image-guided dose escalation (DE) using dose-painting by contours. PATIENTS AND METHODS: We present a planned interim analysis of a randomized phase II trial. N=25 patients with LASCCHN received baseline dynFMISO PET/CT to derive hypoxic volumes (HV). Patients with tumour hypoxia were randomized into standard radiochemotherapy (stdRT) (70Gy/35 fractions) or DE (77Gy/35 fractions) to the HV. Patients with non-hypoxic tumours were treated with stdRT. Loco-regional control (LRC) in hypoxicpatients randomized to stdRT was compared to non-hypoxicpatients. Feasibility and toxicity were analysed for patients in the DE arm and compared to stdRT. RESULTS: With a mean follow-up of 27months, LRC in hypoxicpatients receiving stdRT (n=10) was significantly worse compared to the non-hypoxic group (n=5) (2y-LRC 44.4% versus 100%, p=0.048). The respective LRC for the DE group (n=10) was 70.0%. Treatment compliance as well as acute and late toxicity did not show significant differences between the DE and the standard dose arms. CONCLUSION:Tumour hypoxia determined by baseline dynFMISO PET/CT is associated with a high risk of local failure in patients with LASCCHN. First data suggest that DE to HV is feasible without excess toxicity.
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Authors: Daniela Thorwarth; Stefan Welz; David Mönnich; Christina Pfannenberg; Konstantin Nikolaou; Matthias Reimold; Christian La Fougère; Gerald Reischl; Paul-Stefan Mauz; Frank Paulsen; Markus Alber; Claus Belka; Daniel Zips Journal: J Nucl Med Date: 2019-05-10 Impact factor: 10.057
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