Anthony Nichols, MD
In the phase II ORATOR trial reported in The Lancet Oncology, Anthony Nichols, MD, and colleagues found a statistical but not clinically meaningful improvement in swallowing-related quality of life outcomes 1 year after treatment with radiotherapy vs transoral robotic surgery and neck dissection in patients with oropharyngeal squamous cell carcinoma.
The investigator-initiated open-label trial included 68 patients with T1–T2, N0–2 (≤ 4 cm) oropharyngeal squamous cell carcinoma from six sites in Canada and Australia. Patients were randomly assigned between August 2012 and June 2017 to receive radiotherapy (70 Gy, with chemotherapy if N1–2; n = 34) or transoral robotic surgery plus neck dissection (with or without adjuvant chemoradiotherapy based on pathology; n = 34). Randomization was stratified by p16 status.
The primary endpoint was swallowing-related quality of life at 1 year according to MD Anderson Dysphagia Inventory (MDADI) score (20–100, with higher score indicating better quality of life). The study was powered to detect a 10-point improvement—defined as a clinically meaningful change—in the transoral robotic surgery plus neck dissection group on intent-to-treat analysis.
Median follow-up was 25 months in the radiotherapy group and 29 months in the transoral robotic surgery plus neck dissection group. Mean MDADI total scores at 1 year were 86.9 in the radiotherapy group vs 80.1 in the transoral robotic surgery plus neck dissection group (P = .042), with the difference not meeting the criterion for clinically important difference. MDADI scores favored radiotherapy overall across all patient visits and for most subscales, but average differences between groups did not meet the threshold for clinically meaningful change.
No differences in progression-free or overall survival were observed between groups.
The radiotherapy group had a higher incidence of any grade neutropenia (18% vs 0%), hearing loss (38% vs 15%), and tinnitus (35% vs 6%), whereas the transoral robotic surgery plus neck dissection group had a higher incidence of trismus (26% vs 3%). The most common grade 3 adverse events were dysphagia (18%), hearing loss (18%), and mucositis (12%) in the radiotherapy group and dysphagia (26%) in the transoral robotic surgery plus neck dissection group. One patient died due to bleeding after transoral robotic surgery.
The investigators concluded, “Patients treated with radiotherapy showed superior swallowing-related quality of life scores 1 year after treatment, although the difference did not represent a clinically meaningful change. Toxicity patterns differed between the groups. Patients with oropharyngeal squamous cell carcinoma should be informed about both treatment options.” ■