De-intensification of postoperative radiotherapy in head and neck cancer irrespective of human papillomavirus status—results of a prospective multicenter phase II trial (DIREKHT Trial)

作者：Marlen Haderlein, Jens Müller von der Grün, Panagiotis Balermpas, Claus Michael Rödel, Matthias Hautmann, Felix Steger, Christopher Bohr, Thomas Hehr, Carmen Stromberger, Volker Budach, Markus Michael Schymalla, Rita Engenhart‐Cabillic, Lukas Kocik, Hans Geinitz, Ursula Nestle, Gunter Klautke, Claudia Scherl, Christine M. Gall, Benjamin Frey, Philipp Schubert, Sabine Semrau, Oliver J. Ott, Marco Rainer Kesting, Heinrich Iro, Sarina K. Mueller, Rainer J. Fietkau · 发表于：Frontiers in Oncology · 年份：2024 · DOI：10.3389/fonc.2024.1447123 · 被引用次数：16 · 研究领域：Head and Neck Cancer Studies、Esophageal Cancer Research and Treatment、Head and Neck Surgical Oncology

Background: Current standard treatment concepts in head and neck squamous cell carcinoma (HNSCC) are based on former studies using 2D and 3D treatment plans. However, modern radiation techniques allow for a more precise and individual dose application. Therefore, in a clearly defined patient population, de-intensified risk-adapted radiation is investigated. Methods: Patients with newly diagnosed HNSCC after surgery (with resection margins ≥1 mm and cM0) with the following tumor stages (TNM 7th Edition) were eligible for the study: oral cavity, oropharynx, or larynx: pT1-3, pN0-pN2b; hypopharynx: pT1-2, pN1. The patients should have either a low risk of local recurrence [≤pT2, resection margin ≥5 mm, no peritumoral lymphangiosis (L0), and no perineural invasion] or contralateral lymph node metastasis (≤3 ipsilateral lymph node metastases, in case of well-lateralized oropharyngeal or oral cavity cancer contralateral cN0, otherwise pN0). Patients were assigned to three different treatment regimes with reduction of the treated volume, radiation dose, or both, according to tumor stage and results of surgery performed. The primary objective was to show an LRR of <10% after 2 years. Findings: = 1 (0.7%), larynx. A total of 61 patients (41.0%) were stage IVA, 81 (54.0%) were stage III, and 8 (5.3%) were stage II. Median follow-up was 36 months. Cumulative incidence of 2y-LRR was 5.6% (95% CI: 1.7%-9.2%) in the whole study population and 14.1% (95% CI: 3.8%-23.2%) in patients with ora...