Sarah Deschuymer1, Daan Nevens2, Frederic Duprez3, Jean-François Daisne4, Rüveyda Dok5, Annouschka Laenen6, Mia Voordeckers7, Wilfried De Neve3, Sandra Nuyts8. 1. Department of Radiation Oncology, KU Leuven - University of Leuven, University Hospitals Leuven, Belgium. 2. Department of Radiation Oncology, Iridium Kanker Netwerk, University of Antwerp, Faculty of Medicine and Health Sciences, Belgium. 3. Department of Radiotherapy-Oncology, Ghent University Hospital, Belgium. 4. Department of Radiation Oncology, Université Catholique de Louvain, CHU-UCL-Namur, Site Ste-Elisabeth, Belgium. 5. Laboratory of Experimental Radiotherapy, Department of Oncology, KU Leuven - University of Leuven, Belgium. 6. Leuven Biostatistics and Statistical Bioinformatics Center, University of Leuven, Belgium. 7. Department of Radiation Oncology, UZ Brussel, Vrije Universiteit Brussel, Belgium. 8. Department of Radiation Oncology, KU Leuven - University of Leuven, University Hospitals Leuven, Belgium; Laboratory of Experimental Radiotherapy, Department of Oncology, KU Leuven - University of Leuven, Belgium. Electronic address: Sandra.nuyts@uzleuven.be.
Abstract
BACKGROUND AND PURPOSE: A multicenter prospective randomized controlled trial was performed to investigate whether dose reduction to the elective nodal volume (PTVelect) in head and neck carcinoma reduces radiation-induced dysphagia, primary endpoint, without compromising tumor control, secondary endpoint. Here, we report on the long-term follow-up of the secondary endpoint (NCT01812486). MATERIALS AND METHODS: Two hundred patients treated with primary (chemo)radiotherapy (RT) were randomized (1:1) between the standard arm, irradiation to PTVelect up to an equivalent dose (EQD2) of 50 Gy and the experimental arm, irradiation to PTVelect up to EQD2 of 40 Gy. The primary tumor and involved nodes were treated according to the standard of care, EQD2 70 Gy (PTVhigh). Regional recurrences (RR) were projected on the initial RT planning-CT to identify the recurrence localization. RESULTS: The 5-year (5Y) RR was 14.0% (CI95% 7.9; 21.8) in the 40 Gy arm versus 7.5% (CI95% 3.3; 14.0) in the 50 Gy arm (p = 0.10). Majority of RR in the 40 Gy arm (9/13) were projected in PTVhigh and 2 RR were seen outside the treated RT volume. Only 2 RR occurred in PTVelect irradiated up to 40 Gy which was the same number as RR occurring in the 50 Gy PTVelect. The 5Y-overall survival (OS) was 56.5% (CI95% 45.7; 65.9) in the 40 Gy arm versus 49.6% (CI95% 39.0; 59.2) in the 50 Gy arm (p = 0.56). CONCLUSION: At 5-years, no statistically significant differences regarding OS, local recurrence, RR nor distant metastases were observed between both treatment arms. This study is underpowered to undoubtedly demonstrate non-inferiority. However, since in both arms only two RR in the PTVelect were observed, reducing the dose to PTVelect appears safe and should be further investigated.
RCT Entities:
BACKGROUND AND PURPOSE: A multicenter prospective randomized controlled trial was performed to investigate whether dose reduction to the elective nodal volume (PTVelect) in head and neck carcinoma reduces radiation-induced dysphagia, primary endpoint, without compromising tumor control, secondary endpoint. Here, we report on the long-term follow-up of the secondary endpoint (NCT01812486). MATERIALS AND METHODS: Two hundred patients treated with primary (chemo)radiotherapy (RT) were randomized (1:1) between the standard arm, irradiation to PTVelect up to an equivalent dose (EQD2) of 50 Gy and the experimental arm, irradiation to PTVelect up to EQD2 of 40 Gy. The primary tumor and involved nodes were treated according to the standard of care, EQD2 70 Gy (PTVhigh). Regional recurrences (RR) were projected on the initial RT planning-CT to identify the recurrence localization. RESULTS: The 5-year (5Y) RR was 14.0% (CI95% 7.9; 21.8) in the 40 Gy arm versus 7.5% (CI95% 3.3; 14.0) in the 50 Gy arm (p = 0.10). Majority of RR in the 40 Gy arm (9/13) were projected in PTVhigh and 2 RR were seen outside the treated RT volume. Only 2 RR occurred in PTVelect irradiated up to 40 Gy which was the same number as RR occurring in the 50 Gy PTVelect. The 5Y-overall survival (OS) was 56.5% (CI95% 45.7; 65.9) in the 40 Gy arm versus 49.6% (CI95% 39.0; 59.2) in the 50 Gy arm (p = 0.56). CONCLUSION: At 5-years, no statistically significant differences regarding OS, local recurrence, RR nor distant metastases were observed between both treatment arms. This study is underpowered to undoubtedly demonstrate non-inferiority. However, since in both arms only two RR in the PTVelect were observed, reducing the dose to PTVelect appears safe and should be further investigated.
Authors: Jenny Bertholet; Paul-Henry Mackeprang; Silvan Mueller; Gian Guyer; Hannes A Loebner; Yanick Wyss; Daniel Frei; Werner Volken; Olgun Elicin; Daniel M Aebersold; Michael K Fix; Peter Manser Journal: Radiat Oncol Date: 2022-07-15 Impact factor: 4.309
Authors: Floris C J Reinders; Tristan C F van Heijst; Joel Mases; Chris H J Terhaard; Patricia A H Doornaert; Marielle E P Philippens; Cornelis P J Raaijmakers Journal: Phys Imaging Radiat Oncol Date: 2021-11-10