Disease control and late toxicity in Adaptive Dose Painting by Numbers vs. non-adaptive radiotherapy for head and neck cancer: a randomized controlled phase II trial
Abstract
BACKGROUND AND PURPOSE
Local recurrence remains the main cause of death in stage III-IV non-metastatic head-and-neck cancer (HNC) with relapse-prone regions within high 18F-FDG-PET-signal gross tumor volume. We investigated if dose-escalation within this subvolume combined with a 3-phase treatment-adaptation could increase local (LC) and regional (RC) control at equal or minimized radiation-induced toxicity, by comparing adaptive 18F-FDG-PET-voxel-intensity-based dose-painting-by-numbers (A-DPBN) with non-adaptive standard intensity-modulated radiotherapy (S-IMRT).
MATERIALS AND METHODS
This two-center randomized controlled phase II trial assigned (1:1) patients to receive A-DPBN or S-IMRT (+/-chemotherapy). Eligibility: non-metastatic HNC of oral cavity, oro-/hypopharynx or larynx, needing radio(chemo)therapy; T1-4N0-3 (exception: T1-2N0 glottic); KPS≥70; ≥18 years and informed consent.
PRIMARY OUTCOMES
1-year LC and RC. The dose prescription for A-DPBN was intercurrently adapted in two steps to an absolute dose-volume limit (≤1.75cm3 can receive >84Gy and normalized isoeffective dose >96Gy) as a safety measure during the study course after 4/7 A-DPBN patients developed ≥G3 mucosal ulcers.
RESULTS
Ninety-five patients were randomized (A-DPBN: 47; S-IMRT: 48). Median follow-up amounts 31 months (IQR: 14-48 months); 29 patients died (17 of cancer progression). A-DPBN results in superior LC compared to S-IMRT with 1- and 2-year LC of 91% and 88% vs. 78% and 75%, respectively…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 29 participants or records.
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