In a Dutch trial (UPGRADE-RT) reported in the Journal of Clinical Oncology, van den Bosch et al found that definitive radiotherapy with reduced-dose elective neck irradiation was safe and effective compared with standard-dose elective neck irradiation in patients with head and neck squamous cell carcinoma.
Study Details
In the study, 295 evaluable patients with newly diagnosed cT2-4N0-2M0 disease, enrolled at five sites in the Netherlands between 2016 and 2022, received definitive accelerated radiotherapy at 68 Gy in 34 fractions over 5.5 weeks. Patients receiving concurrent chemotherapy were not eligible. Patients were randomly assigned 2:1 to receive reduced-dose (43 Gy; n = 196) or standard-dose (50 Gy; n = 99) elective neck irradiation. The primary outcome measure was normalcy of diet score at 1 year. The secondary outcome measure was recurrence in electively irradiated nodes at 2 years in the dose-reduction group; the prespecified boundary for acceptability was an upper-bound one-sided 95% confidence interval [CI] of 9%.
Key Findings
The mean normalcy of diet score at 1 year was 91.6 (95% CI = 88.5–94.7) in the dose-reduction group vs 92.6 (95% CI = 88.2–97.1) in the control group (mean difference = –1.1, 95% CI = –6.5 to 4.4).
The 2-year recurrence rate in electively irradiated nodes in the dose-reduction group was 4.9% (upper-bound one-sided 95% CI = 7.5%); the upper-bound value did not exceed the prespecified boundary for acceptability, confirming safety of use of the reduced dose. The 2-year rate in the control group was 4.3% (upper-bound one-sided 95% CI, 7.7%).
On exploratory analyses, the dose-reduction group exhibited reduced risk of grade ≥ 3 acute dysphagia (requiring tube feeding: 10.7% vs 19.2%, relative risk = 0.56, 95% CI = 0.32–0.98, P = .046) and improved xerostomia-related quality of life (difference at 3 months = –10.73 (95% CI = –18.43 to –3.02, P = .006) compared with the control group.
The study supports the results of a Belgian trial by Deschuymer et al. The investigators concluded: “This is the second randomized controlled trial demonstrating that reduced elective dose is safe in definitive [radiotherapy] for [head and neck cancer].”
Sven van den Bosch, MD, PhD, Radboud University Medical Center, Department of Radiation Oncology, Nijmegen, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by the Dutch Cancer Society. For full disclosures of all study authors, visit ascopubs.org.
