Primary transoral surgery (TOS) followed by reduced-dose radiotherapy (RT) led to “outstanding” outcomes in patients with intermediate-risk, HPV-positive, locally advanced oropharyngeal cancer, according to researchers.
The team reported these results, from the phase 2 E3311 trial, in the Journal of Clinical Oncology.
For this trial (ClinicalTrials.gov Identifier: NCT01898494), researchers evaluated primary TOS and reduced-dose postoperative RT as a de-intensification strategy.
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The study included 359 patients who were categorized based on pathology findings as low risk, intermediate risk, or high risk. The patients’ median age was 58 years (range, 37-80 years), and most were men (88.9%). The most common primary disease sites were the tonsillar fossa (66.3%) and base of the tongue (30.6%).
After undergoing TOS, patients were assigned to 1 of 4 treatment arms. Low-risk patients were placed under observation (38 patients). Intermediate-risk patients were randomly assigned to receive RT at 50 Gy (100 patients) or 60 Gy (108 patients). High-risk patients received RT at 66 Gy with concurrent weekly cisplatin at 40 mg/m2 (113 patients).
The median follow-up was 35.2 months for patients who had not progressed and 35.4 months for patients who were still alive.
The estimated 2-year progression-free survival rates were 96.9% for the observation arm, 94.9% for the 50 Gy arm, 96.0% for the 60 Gy arm, and 90.7% for the 66 Gy-cisplatin arm.
The estimated 2-year overall survival rates were 100% for the observation arm, 99.0% for the 50 Gy arm, 98.1% for the 60 Gy arm, and 96.3% for the 66 Gy-cisplatin arm.
During surgery, the most common grade 3 adverse events (AEs) were dysphagia (6%) and oral hemorrhage (3%). During RT, the most common grade 3 AEs were dysphagia and oral mucositis. Dysphagia was observed in 3% of patients in the 50 Gy arm, 5% in the 60 Gy arm, and 16% in the 66 Gy-cisplatin arm. Oral mucositis occurred in 5%, 11%, and 19%, respectively.
There was a “consistent decline” in quality of life and swallowing scores during treatment, the researchers noted. Scores recovered to baseline in the observation arm, the 50 Gy arm, and the 60 Gy arm, but scores remained slightly lower for patients in the 66 Gy-cisplatin arm.
“This novel, randomized phase 2 clinical trial reports the first prospective, multicenter data for TOS in head and neck cancer,” the researchers wrote. “For the 70% of patients who underwent de-intensified postoperative adjuvant therapy, outstanding progression-free survival supports the safety and efficacy of treatment de-intensification (elimination of chemotherapy and 10 Gy less radiation).”
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Reference
Ferris RL, Flamand Y, Weinstein GS, et al. Phase II randomized trial of transoral surgery and low-dose intensity-modulated radiation therapy in resectable p16+ locally advanced oropharynx cancer: An ECOG-ACRIN Cancer Research Group Trial (E3311). J Clin Oncol. Published online October 26, 2021. doi:10.1200/JCO.21.01752
