Results of intensifying radiation treatment in advanced laryngeal, hypopharyngeal (LH) and oropharyngeal cancers (OPC) using metabolic dose escalation strategies: (INTELHOPE).
rct · Level II
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- Record sourced from PubMed, PMID 42435815.
- Also identified by DOI 10.1016/j.radonc.2026.111698.
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Abstract
Concurrent cisplatin and radiation for high-risk laryngopharyngeal cancers have high failure rates. This Phase II randomized study compares standard radiation dosing with FDG-PET guided escalated dosing in p16-negative oropharyngeal (OP) and locally advanced laryngopharyngeal (LP) cancers. Our randomized clinical trial included patients with locally advanced p16-negative OP and LP cancers. 18FDG PET guided escalated arm 73.5 Gy/30 fractions patients were treated with a 5 mm isotropic margin on the SUV40%max (BTV-PET) whilst the standard arm patients received 66 Gy/30 fractions to the high-risk CTV. Both arms were planned to receive concurrent cisplatin chemotherapy (40 mg/m<sup>2</sup> weekly). The study was designed as a hybrid/seamless Phase 2 study to first exclude excess grade 4 toxicities, followed by an efficacy comparison. Efficacy outcomes included 2-year locoregional recurrence, disease-free survival (DFS), and overall survival (OS). From 2016 to 2021, 102 patients were treated (42 LP, 60 OP), with 51 in each treatment arm. Median age was 59, with 72.5% having T3/4 primaries and 58.8% N2-3 nodal stage. Both arms received a median of 5 cisplatin cycles. Safety assessment showed only a single patient with Grade 4 toxicity, and the trial was allowed to complete accrual. Acute grade 3 toxicities showed no significant differences between the two arms, with mucositis (35.3% in both arms), dermatitis, dysphagia, and feeding tube requirement being similar. With a median follow-up of 40 months, the 2-year locoregional control rate was 85.4%, with no significant difference between the arms (88.6% standard vs 82.2% escalated, p = 0.57). The 2-year DFS and OS rates also showed no significant differences (59.7%, 64.7%, 54.8% for DFS, 67.3%, 68.2%, 66.6% for OS, p = 0.65 and p = 0.99, respectively). While feasible, FDG-PET-based dose escalation did not improve local control, DFS, or OS in our patient population.