Daan Nevens1, Fréderic Duprez2, Jean Francois Daisne3, Ruveyda Dok4, Ann Belmans5, Mia Voordeckers6, Danielle Van den Weyngaert7, Wilfried De Neve2, Sandra Nuyts8. 1. Department of Radiation Oncology, KU Leuven - University of Leuven, University Hospitals Leuven, Belgium. Electronic address: daan.nevens@uzleuven.be. 2. Department of Radiotherapy, Ghent University Hospital, Belgium. 3. Department of Radiation Oncology, Clinique et Maternité Sainte-Elisabeth, Namur, Belgium. 4. Laboratory of Experimental Radiotherapy, Department of Oncology, Katholieke Universiteit Leuven (KU Leuven), Belgium. 5. Leuven Biostatistics and Statistical Bioinformatics Centre, University of Leuven, Belgium. 6. Department of Radiation Oncology, UZ Brussel, Vrije Universiteit Brussel, Belgium. 7. Department of Radiation Oncology, ZNA Middelheim, Antwerp, Belgium. 8. Department of Radiation Oncology, KU Leuven - University of Leuven, University Hospitals Leuven, Belgium.
Abstract
BACKGROUND AND PURPOSE: A multi-center prospective randomized clinical trial has been performed investigating whether a reduction of the dose to the elective nodal sites in head and neck cancer delivered by intensity modulated radiotherapy (IMRT) would result in a reduction of late side effects without compromising tumor control. MATERIALS AND METHODS:Two hundred patients were included. The prescription dose to the elective nodal volumes was a normalized iso-effective dose in 2Gy fractions (NID2Gy) of 50Gy in the standard arm and of 40Gy in the experimental arm. Late toxicity was scored at 6, 12, 18 and 24months using the RTOG scoring system. RESULTS: We observed a trend toward less dysphagia at 6months in the experimental arm, however this was not confirmed after longitudinal analysis. Regarding moderate salivary gland toxicity we observed lower incidence of salivary gland toxicity ⩾grade 1, at 6 (p=0.01) and 18months (p=0.03). After two years of follow up, we did not observe significant differences in estimated local failure rate (14.1% in the 40Gy arm vs 14.4% in the 50Gy arm), estimated regional failure rate (13.0% vs 5.5% in the 40 and the 50Gy arm respectively), estimated metastatic recurrence (13.4% vs 18.5% in the 40 and the 50Gy arm respectively), estimated disease-free survival (57.9% vs 65.3% in the 40 and the 50Gy arm respectively) nor estimated overall survival (72.0% vs 73.2% in the 40 and the 50Gy arm respectively). CONCLUSIONS: In our study population there was no statistically significant difference regarding survival and estimated recurrence rates between both arms of this study. We found a trend toward less dysphagia at 6months (however not significant after longitudinal analysis) and found a significant reduction of any salivary gland toxicity at 6 and 18months in the 40Gy arm.
RCT Entities:
BACKGROUND AND PURPOSE: A multi-center prospective randomized clinical trial has been performed investigating whether a reduction of the dose to the elective nodal sites in head and neck cancer delivered by intensity modulated radiotherapy (IMRT) would result in a reduction of late side effects without compromising tumor control. MATERIALS AND METHODS: Two hundred patients were included. The prescription dose to the elective nodal volumes was a normalized iso-effective dose in 2Gy fractions (NID2Gy) of 50Gy in the standard arm and of 40Gy in the experimental arm. Late toxicity was scored at 6, 12, 18 and 24months using the RTOG scoring system. RESULTS: We observed a trend toward less dysphagia at 6months in the experimental arm, however this was not confirmed after longitudinal analysis. Regarding moderate salivary gland toxicity we observed lower incidence of salivary gland toxicity ⩾grade 1, at 6 (p=0.01) and 18months (p=0.03). After two years of follow up, we did not observe significant differences in estimated local failure rate (14.1% in the 40Gy arm vs 14.4% in the 50Gy arm), estimated regional failure rate (13.0% vs 5.5% in the 40 and the 50Gy arm respectively), estimated metastatic recurrence (13.4% vs 18.5% in the 40 and the 50Gy arm respectively), estimated disease-free survival (57.9% vs 65.3% in the 40 and the 50Gy arm respectively) nor estimated overall survival (72.0% vs 73.2% in the 40 and the 50Gy arm respectively). CONCLUSIONS: In our study population there was no statistically significant difference regarding survival and estimated recurrence rates between both arms of this study. We found a trend toward less dysphagia at 6months (however not significant after longitudinal analysis) and found a significant reduction of any salivary gland toxicity at 6 and 18months in the 40Gy arm.
Authors: Ambika Parmar; Michaelina Macluskey; Niall Mc Goldrick; David I Conway; Anne-Marie Glenny; Janet E Clarkson; Helen V Worthington; Kelvin Kw Chan Journal: Cochrane Database Syst Rev Date: 2021-12-20
Authors: Benjamin S Rosen; Peter G Hawkins; Daniel F Polan; James M Balter; Kristy K Brock; Justin D Kamp; Christina M Lockhart; Avraham Eisbruch; Michelle L Mierzwa; Randall K Ten Haken; Issam El Naqa Journal: Int J Radiat Oncol Biol Phys Date: 2018-07-10 Impact factor: 7.038
Authors: Lars Schüttrumpf; Sebastian Marschner; Katrin Scheu; Julia Hess; Sibylle Rietzler; Axel Walch; Philipp Baumeister; Thomas Kirchner; Ute Ganswindt; Horst Zitzelsberger; Claus Belka; Cornelius Maihoefer Journal: Radiat Oncol Date: 2020-01-06 Impact factor: 3.481