KEY POINTS
- The randomized phase II INTELHOPE trial included 102 patients with poor-risk oropharyngeal cancer or locally advanced laryngeal/hypopharyngeal cancer, with 51 patients per arm. Both groups received concurrent weekly cisplatin at 40 mg/m².
- The experimental arm received 73.5 Gy in 30 fractions to an FDG-PET-defined boost target, with 63 Gy to the intermediate-risk CTV and 54 Gy electively. The control arm received 66 Gy in 30 fractions to the high-risk CTV and 54 Gy electively.
- At a median follow-up of 40 months, 2-year locoregional control was 82.2% with dose escalation versus 88.6% with standard treatment (HR 1.36, 95% CI 0.47–3.91; p=0.57).
- Two-year disease-free survival was 54.8% versus 64.7% (HR 1.13; p=0.65), while overall survival was 66.6% versus 68.2% (HR 1.00; p=0.99) for escalated and standard treatment, respectively.
- Acute grade ≥3 mucositis, dysphagia, feeding-tube use, and hospitalization were similar. However, crude late grade 4–5 toxicity without active disease was 12% versus 3.9%, with severe events concentrated mainly in laryngeal/hypopharyngeal cancers (SHR 3.09, 95% CI 0.64–14.84; p=0.158).
CLINICAL TAKEAWAY
These results do not support routine FDG-PET-guided escalation to 73.5 Gy for poor-risk oropharyngeal or advanced laryngeal/hypopharyngeal cancers. The absence of efficacy benefit, combined with a clinically concerning late-toxicity signal, is particularly relevant for laryngeal and hypopharyngeal primaries, although the trial was underpowered for smaller efficacy and toxicity differences.