ORATOR2 study methodology
The primary endpoint of the trial was OS, compared with historical controls, with secondary endpoints of PFS, quality of life, and toxicity.
A total of 30 patients were randomized to receive RT, and 31 to receive TOS and neck dissection, with adjuvant reduced-dose RT depending on pathologic findings.
At a median follow-up of 17 months, there were 3 deaths in the surgery arm, including the 2 previously mentioned patients who died from treatment-related causes at 0.7 and 4.3 months after randomization, and 1 patient who died from myocardial infarction at 8.5 months. As noted before, OS and PFS data were not mature at the time of study termination.
Quality of life and functional outcomes were generally similar between the trial arms, except for worse scores among patients randomized to TOS and neck dissection in subdomains of coughing and weight loss on the European Organisation for Research and Treatment of Cancer H&N35 scale.
The trial was supported by an Ontario Institute for Cancer Research clinician-scientist operating grant and Wolfe Surgical Research Professorship in the Biology of Head and Neck Cancers Fund. Dr. Nichols reported grants from Novartis Canada outside the submitted work. Dr. Gross reported grants and personal fees from Regeneron, personal fees from Sanofi-Genzyme, Intuitive Surgical, and DragonFly Therapeutics, as well as advisory board service for PDS Biotechnology, Shattuck Labs, and Sanofi-Genzyme outside the submitted work.