Top Line: At ASTRO 2021 we got an ORATOR-2 teaser demonstrating there’s no detriment to (perfect) survival and (perfect) disease control with de-escalated definitive radiation to 60 Gy when compared to transoral robotic surgery (TORS) for T1-T2N0-1 HPV+ oropharyngeal cancer.
The Study: We now have the full publication with more details on secondary outcomes. Across 61 enrollees, over two-thirds received bimodality therapy: 21/31 (68%) in the surgery arm received adjuvant radiation (none with concurrent chemo), and 21/30 (72%) in the radiation arm received concurrent chemo. At a median follow-up of only 17 months, the primary outcome of survival data is still immature, but we'll remind you here that it was closed early to accrual due to two treatment-related deaths in the TORS arm from hemorrhage and cervical osteomyelitis. There has also been another death due to myocardial infarction and one local recurrence in the surgery arm. The radiation arm, on the other hand, continues to bat a thousand for both overall and progression-free survival. The secondary outcome of grade 2+ toxicity occurred in 20/30 (67%) after radiation and 22/31 (71%) after TORS. Sure, arguments can be made that ORATOR2 was a small trial stopped early with a much higher death rate than the much larger ECOG 3311 trial (0.2%). But at the end of the day, disease and functional outcomes are as good if not better with radiation, and radiation techniques are much more widely scalable than complex surgical techniques.TBL: Prospective randomized data adds growing support for the use of de-escalated definitive radiation for T1-2N0-1 HPV+ oropharyngeal cancer, both when compared to standard 70 Gy as well as the popular surgical alternative TORS. | Palma, JAMA Oncol 2022