Long-Term Results of a Phase 2 Clinical Trial of Radiation Volume and Dose Deintensification Following Transoral Robotic Surgery and Neck Dissection for Human Papillomavirus-Associated Oropharyngeal Squamous Cell Carcinoma
Abstract
Purpose: We conducted a phase 2 clinical trial reducing both dose and volume of adjuvant radiation in patients with human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma (OPSCC). We also examined whether postoperative circulating tumor DNA (ctDNA) was prognostic for outcomes.
Methods and materials: Eligible patients had pT0 to pT3 pN0 to pN1 HPV-associated OPSCC (American Joint Committee on Cancer 8th edition) treated with primary transoral robotic surgery and neck dissection. Adjuvant radiation therapy (RT) was delivered in 25 fractions over 5 weeks. We reduced RT volumes in 2 ways: the primary oropharyngeal resection bed was omitted in select patients (pT1-T2 tumors with negative margins and no lymphovascular invasion or perineural invasion), and the contralateral neck targets were reduced to mirror the pathologically involved ipsilateral nodal levels. We also reduced RT doses: 50 Gy was given to primary resection beds requiring treatment and to ipsilateral neck levels with pathologically positive nodes; 45 Gy was delivered to other at-risk ipsilateral nodal regions and the contralateral neck. Concurrent chemotherapy was prescribed for positive margins and extranodal extension, although optionally omitted when extranodal extension was ≤1 mm. Baseline HPV ctDNA was collected after surgery and measured at 3 subsequent timepoints.
Results: We enrolled 150 patients between October 2018 and June 2022. One patient withdrew, leaving 149 patients treated per…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 150 participants or records.
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