Radiotherapy plus cisplatin or cetuximab in low-risk human papillomavirus-positive oropharyngeal cancer (De-ESCALaTE HPV) : an open-label randomised controlled phase 3 trial
- Mehanna, Hisham
- Robinson, Max
- Hartley, Andrew
- Kong, Anthony
- Foran, Bernadette
- Fulton-Lieuw, Tessa
- Dalby, Matthew
- Mistry, Pankaj
- Sen, Mehmet
- O'Toole, Lorcan
- Al Booz, Hoda
- Dyker, Karen
- Moleron, Rafael
- Whitaker, Stephen
- Brennan, Sinead
- Cook, Audrey
- Griffin, Matthew
- Aynsley, Eleanor
- Rolles, Martin
- De Winton, Emma
- Chan, Andrew
- Srinivasan, Devraj
- Nixon, Ioanna
- Grumett, Joanne
- Leemans, René
- Buter, Jan
- Henderson, Julia
- Harrington, Kevin
- McConkey, Christopher
- Gray, Alastair
- Dunn, Janet
- De-ESCALaTE HPV Trial Group
DOIAbstract
Background The incidence of human papillomavirus (HPV)-positive oropharyngeal cancer, a disease affecting younger patients, is rapidly increasing. Cetuximab, an epidermal growth factor receptor inhibitor, has been proposed for treatment de-escalation in this setting to reduce the toxicity of standard cisplatin treatment, but no randomised evidence exists for the efficacy of this strategy. Methods We did an open-label randomised controlled phase 3 trial at 32 head and neck treatment centres in Ireland, the Netherlands, and the UK, in patients aged 18 years or older with HPV-positive low-risk oropharyngeal cancer (non-smokers or lifetime smokers with a smoking history of <10 pack-years). Eligible patients were randomly assigned (1:1) to recei...
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