In a long-term longitudinal analysis of the phase II ORATOR trial reported in the Journal of Clinical Oncology, Anthony Nichols, MD, and colleagues found that a statistically significant improvement in swallowing quality of life persisted through 3 years after treatment with radiotherapy vs transoral robotic surgery and neck dissection for oropharyngeal squamous cell carcinoma. However, differences did not achieve a clinical meaningful change at any time point.
Study Details
In the trial, 68 patients with T1–2, N0–2 (≤ 4 cm) disease from sites in Canada and Australia were randomly assigned between August 2012 and June 2017 to receive radiotherapy, with chemotherapy in patients with N1–2 disease (n = 34) or transoral robotic surgery plus neck dissection with or without adjuvant therapy (n = 34). The radiotherapy group received intensity-modulated radiotherapy at 70 Gy in 35 fractions over 7 weeks to areas of gross disease and 56 Gy to low-risk nodal areas.
Concurrent chemotherapy was recommended for patients with node-positive disease, with cisplatin at 100 mg/m2 on days 1, 22, and 43 of radiotherapy being preferred. In the surgery group, adjuvant radiotherapy at 60 Gy in 30 fractions was recommended for patients with intermediate-risk pathologic features, and adjuvant chemoradiation was given to patients with high-risk features.
The primary endpoint was swallowing quality of life at 1 year using the MD Anderson Dysphagia Inventory (MDADI); the scale ranges from 20 to 100, with higher scores indicating better swallowing quality of life. Analysis was performed in the intention-to-treat population.
On longitudinal analysis, the swallowing quality of life difference between primary radiotherapy and transoral robotic surgery plus neck dissection approaches persists but decreases over time. Patients with oropharyngeal squamous cell carcinoma should be informed about the pros and cons of both treatment options.— Anthony Nichols, MD, and colleagues
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Key Findings
Of 32 evaluable patients in the radiotherapy group, 9 (28%) received radiotherapy alone and 23 (72%) received concurrent chemotherapy. Among 34 evaluable patients in the surgery group, 10 (29%) received surgery alone, 16 (47%) received adjuvant radiotherapy, and 8 (24%) received adjuvant chemoradiation.
As previously reported, mean (standard deviation [SD]) MDADI total scores at 1 year were 86.9 (1.4) in the radiotherapy group vs 80.1 (13.0) in the surgery group (P = .042), with the difference not meeting the clinically meaningful change threshold of 10 points.
Median follow-up was 45 months. MDADI total scores were 86.0 (13.5) vs 84.8 (12.5) at 2 years (P = .74) and 88.9 (11.3) vs 83.3 (13.9) at 3 years (P = .12). For the entire period, scores were significantly better in the radiotherapy group (P = .049), but differences decreased after 1 year and did not meet criteria for clinically meaningful change at any time point.
An increase in pain and dental concerns observed in the surgery group at 1 year resolved at 2 and 3 years. Patients in the surgery group more commonly used nutritional supplements at 3 years (P = .015), and dry mouth scores were higher in the radiotherapy group over time (P = .041).
No differences in 3-year overall or progression-free survival were observed between the two groups. Overall survival rates were 87.2% (95% confidence interval [CI] = 69.4%–95.0% vs 88.2% (95% CI = 71.6%–95.4%), and progression-free survival rates were 87.3% (95% CI = 69.5%–95.0%) vs 85.3% (95% CI = 68.2%–93.6%).
The investigators concluded, “On longitudinal analysis, the swallowing quality of life difference between primary radiotherapy and transoral robotic surgery plus neck dissection approaches persists but decreases over time. Patients with oropharyngeal squamous cell carcinoma should be informed about the pros and cons of both treatment options.”
Dr. Nichols, of the London Health Sciences Centre, London, Ontario, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by a Canadian Cancer Society Research Institute Quality of Life Grant and others. For full disclosures of the study authors, visit ascopubs.org.
