ORATOR Trial: Radiotherapy and Transoral Robotic Surgery Show Similar Outcomes in Oropharyngeal Cancer
Key Insights
The phase II ORATOR trial compared radiotherapy (search) and transoral robotic surgery (search) for oropharyngeal squamous cell carcinoma (search), revealing similar oncologic outcomes at 5 years.
While overall survival and progression-free survival were comparable, the study identified differing toxicity and quality of life profiles between the two treatment approaches.
Radiotherapy (search) was associated with higher rates of neutropenia (search) and dry mouth, whereas transoral robotic surgery (search) led to more dysphagia (search) and pain.
Final results from the phase II ORATOR trial indicate that both radiotherapy (search) and transoral robotic surgery (search) (TORS) yield similar and excellent oncologic outcomes for patients with oropharyngeal squamous cell carcinoma (search). However, the study, published in the Journal of Clinical Oncology, highlights differences in toxicity and quality of life between the two approaches, suggesting treatment decisions should be made collaboratively between patients and their healthcare providers.
Study Design and Key Findings
The ORATOR trial, conducted across sites in Canada and Australia, randomized 68 patients with T1-2N0-2 oropharyngeal squamous cell carcinoma (search) to either radiotherapy (search) (70 Gy in 35 fractions, with chemotherapy if node-positive) or TORS plus neck dissection (with or without adjuvant radiotherapy plus chemoradiation based on pathologic findings). The primary outcome was swallowing quality of life, assessed using the MD Anderson Dysphagia (search) Inventory (MDADI). The analysis presents findings at 5 years post-enrollment completion.
After a median follow-up of 5.1 years, MDADI total scores converged, showing no significant difference between the two groups (P = .11). Progression-free survival at 5 years was 84.0% for the radiotherapy (search) group and 82.2% for the TORS group (HR = 1.14, P = .83). Overall survival at 5 years was 84.0% and 85.1%, respectively (HR = 0.94, P = .92).
Toxicity and Quality of Life
Grade 2 to 5 adverse event rates were similar between the radiotherapy (search) and TORS groups (91% vs. 97%, P = .61). However, specific toxicities differed significantly. Neutropenia (search) and hearing loss were more common in the radiotherapy group, while dysphagia (search) and pain were more prevalent in the TORS group (all P < .05). Assessments using the EORTC QLQ-C30 and H&N35 instruments revealed that radiotherapy was associated with worse dry mouth (P = .032), and TORS with worse pain (P = .002).
Implications for Clinical Practice
According to the investigators, "Toxicity and quality of life profiles differ in some domains between radiotherapy (search) and transoral robotic surgery (search), but oncologic outcomes were excellent in both arms. Choice of treatment should remain a shared decision between the patient and their providers."