The researches find that the Transoral robotic surgery (TORS) with concurrent neck dissection has supplanted radiotherapy in the USA as the most common treatment for oropharyngeal squamous cell carcinoma (OPSCC), yet no randomised trials have compared these modalities. Therefore We aimed to evaluate differences in quality of life (QOL) 1 year after treatment. The ORATOR trial was an investigator-initiated, multicentre, international, open-label, parallel-group, phase 2, randomised study.
Patients are enrol at six hospitals in Canada and Australia. We randomly assigned (1:1) patients aged 18 years or older, with Eastern Cooperative Oncology Group scores of 0–2; and with T1–T2, N0–2 (≤4 cm) OPSCC tumour types to radiotherapy (70 Gy, with chemotherapy if N1–2) or TORS plus neck dissection; (with or without adjuvant chemoradiotherapy, based on pathology). But Following stratification by p16 status, patients are randomly assign using a computer-generated randomisation list with permuted blocks of four.
The primary endpoint was swallowing-related QOL at 1 year as established using the MD Anderson Dysphagia Inventory (MDADI) score, powered to detect a 10-point improvement (a clinically meaningful change); in the TORS plus neck dissection group. Because All analyses were done by intention to treat 68 patients were randomly assigned (34 per group) between Aug 10, 2012, and June 9, 2017. Because Median follow-up was 25 months (IQR 20–33) for the radiotherapy group and 29 months ;(23–43) for the TORS plus neck dissection group. MDADI total scores at 1 year were mean 86·9 (SD 11·4) in the radiotherapy group versus 80·1 (13·0) in the TORS plus neck dissection group (p=0·042).
Plus neck dissection group
There were more cases of neutropenia (six [18%] of 34 patients vs none of 34); hearing loss (13 [38%] vs five [15%]), and tinnitus (12 [35%] vs two [6%]) reported in the radiotherapy group than in the TORS plus neck dissection group; and more cases of trismus in the TORS plus neck dissection group (nine [26%] vs one [3%]). The most common adverse events in the radiotherapy group were dysphagia (n=6), hearing loss (n=6); and mucositis (n=4), all grade 3, and in the TORS plus neck dissection group, dysphagia (n=9, all grade 3); and there is one death cause by bleeding after TORS.
Patients treated with radiotherapy showed superior swallowing-related QOL scores 1 year after treatment, although the difference did not represent a clinically meaningful change. Therefore Toxicity patterns differed between the groups. Because Patients with OPSCC should be inform about both treatment options. But Canadian Cancer Society Research Institute Grant (#701842); Ontario Institute for Cancer Research Clinician-Scientist research grant, and the Wolfe Surgical Research Professorship in the Biology of Head and Neck Cancers grant.