Dr. Mehanna on the Design of the De-ESCALaTE Trial in HPV+ Head and Neck Cancer

Hisham Mehanna, PhD, BMedSc, MBChB, FRCS, chair, Head and Neck Surgery, director, Institute of Head and Neck Studies and Education at the Institute of Cancer and Genomic Sciences, University of Birmingham, discusses the design of the De-ESCALaTE trial in patients with HPV-positive head and neck cancer.

For the randomized phase III De-ESCALaTE trial, investigators compared the use of chemoradiotherapy plus cetuximab to chemoradiotherapy plus cisplatin in patients with low-risk HPV oropharyngeal cancer. Although chemoradiotherapy is the standard of care for these patients, the addition of cisplatin doubles the rate of acute toxicity and heightens any long-term toxicities, says Mehanna. Younger patients tend to have a positive prognosis and can live for many years. Therefore, the trial was designed to see if supplanting cisplatin with cetuximab could lower the rate of unnecessary toxicity.

One strategy that has been put forward as a way to spare patients from unnecessary toxicity is the use of cetuximab, says Mehanna. Cetuximab is currently approved by the FDA as well as the EMA. The initial registration study showed that the addition of cetuximab resulted in a comparable safety profile to that of radiotherapy alone. Moreover, some studies have suggested that patients with HPV-positive head and neck cancer do better overall with the use of cetuximab.