The ORATOR Trials Have Spoken—Where Do We Go From Here?
Mené au Canada et en Australie sur 61 patients atteints d'un carcinome épidermoïde oropharyngé de stade T1-T2N0-2 et lié au papillomavirus humain (durée médiane de suivi : 17 mois ; 86,4 % d'hommes), cet essai randomisé multicentrique de phase II évalue l'efficacité, du point de vue de la survie globale, et la toxicité d'un traitement par radiothérapie par rapport à une approche chirurgicale transorale
In this issue of JAMA Oncology, Palma et al present ORATOR2, a prospective randomized clinical trial designed to test the best of nonsurgical and surgical deintensification strategies in low-risk human papillomavirus (HPV)–positive oropharynx squamous cell cancer (OPSCC). The results were published after deaths in the surgical arm led to early closure of the trial.ORATOR2 follows ORATOR, to our knowledge the first randomized comparison of radiation therapy (RT) and surgery for OPSCC. Starting in 2012, Nichols et al randomized 68 patients with T1-2, N0-2 (American Joint Committee on Cancer 7th edition) OPSCC to treatment with 70 Gy of RT (with or without chemotherapy) vs transoral surgery and neck dissection (with or without adjuvant RT/chemoradiation therapy). The primary end point was swallowing quality of life using the MD Anderson Dysphagia Inventory. The RT cohort having better baseline scores demonstrated statistically superior MD Anderson Dysphagia Inventory scores at 1 year, although this did not meet the predetermined threshold to qualify as a clinically meaningful change. The differences have decreased over time.
JAMA Oncology , éditorial, 2021