The incidence of oropharyngeal squamous cell carcinoma (OPSCC) has increased, mainly related to a rise in human papillomavirus infection. Radiation therapy (RT) has historically been the standard treatment. However, trans-oral robotic surgery (TORS), a new surgical approach, has surpassed radiation therapy as the most common U.S. method due to the potential for fewer adverse events (AEs). A study presented at the 2019 ASCO Annual Meeting compared these treatment options and found that they had similar outcomes.
The randomized, open-label, phase II ORATOR trial enrolled 68 patients with T1-T2 N0-2 (≤4 cm) OPSCC amenable to TORS between 2012 and 2017. Patients were stratified by p16 mutation status to receive radiation therapy consisting of 70 Gy/35 fractions with chemotherapy if disease was N1-2 (n=34) or TORS with or without adjuvant chemoradiation therapy based on pathology (n=34). The primary endpoint was a definitive comparison of swallowing quality of life at one-year based on the MD Anderson Dysphagia Inventory (MDADI). Patients were enrolled from Canada and Australia. The median age was 59 years, and 87% were male. Primary tumor sites were palatine tonsil (74%) and base of the tongue (26%). The treatment groups had similar baseline characteristics, and 88% of both patient cohorts had p16 mutation.
The median follow-up was 27 months. At one year, the radiation therapy cohort had statistically superior MDADI scores compared with the TORS group (mean, 86.9±11.4 vs. 80.1±13.0; P=0.042). However, this was not a clinically meaningful change. Other quality of life (QOL) metrics were also similar at one year. Feeding tube rates at one year were 3% (n=1) in the radiation therapy group and 0% in the TORS group. Rates of treatment-related grade ≥2 AEs were also similar (91% vs. 100%, respectively; P=0.24). Neutropenia, constipation, and tinnitus occurred more often in the radiation therapy arm, while trismus occurred more often in the TORS arm (P<0.05 for all).
One bleeding-related death occurred in the TORS arm. The treatment cohorts had similar overall survival and progression-free survival.
“This study provides the first level one evidence to inform patients of the QOL impact of both approaches,” the researchers concluded.
Nichols AC, Theurer J, Prisman E, et al. A phase II randomized trial for early-stage squamous cell carcinoma of the oropharynx: Radiotherapy versus trans-oral robotic surgery (ORATOR). Abstract #6006. Presented at the 2019 ASCO Annual Meeting, Chicago, IL, May 31, 2019.