摘要：
Purpose/Objective(s) We previously reported the results of a phase II clinical trial evaluating 30-36 Gy of adjuvant radiation therapy (RT) for selected patients with HPV+ OPSCC. Herein we report the two-year results of a phase III trial comparing this 30-36 Gy regimen with standard of care (SOC) adjuvant RT. Materials/Methods All patients (pts) received transoral robotic surgery (TORS) and neck dissection for a margin negative resection. Pts with pT4 disease or who required >2 attempts to clear margins were excluded. Pts with intermediate risk factors received 30 Gy/1.5 Gy b.i.d. + docetaxel 15 mg/m 2 days 1 and 8, while pts with extranodal extension (ENE) simultaneously received 36 Gy/1.8 Gy b.i.d. to ENE+ nodal levels. Pts were randomized (2:1) to DART or SOC (60 Gy ± weekly cisplatin 40 mg/m 2 ). Stratification was by risk group (intermediate risk vs ENE+) and smoking status (< vs ≥10 pack-yr). The primary endpoint was grade ≥3 AE rate ≥3 mos after RT with the study powered to have 90% power to detect a grade ≥3 AE rate reduction from 25% to 7%. Secondary endpoints were OS, LRC, PFS, and QOL. Pts received a swallow evaluation (MBSImP) before, 1 mo, and 1 yr post-RT. Pts also had QOL assessed with the FACT-HN, EORTC-HN35, and University of Michigan Xerostomia QOL Scale (XeQOLS) pre-RT and 1, 3, 12, and 24 mos post-RT. Results Accrual was from 10/16 – 8/20 (n = 194, DART: 130, SOC: 64, ENE+: 115 (59%), Non-smokers: 139 (72%), median age 59.4 yrs (37.9-81.6), male 89%. Median follow-up as of 7/21 was 25.3 mo. 1.6% DART and 27.4% SOC pts (p<0.0001) required a feeding tube. Grade ≥3 AEs at 3 months were 1.6% DART vs 7.1% SOC (p = 0.058). Swallowing function change from baseline to 1 month was superior in the DART arm (DART vs SOC, median) MBSImP: -0.3 vs -2.6 (p = 0.0155) as was baseline to 3 month QOL FACT-HN: 5.1 vs -3.2 (p = 0.0007); EORTC-HN Pain: -8.6 vs 2.5 (p = 0.0009); XeQOLS: 2.9 vs 11.7 (p = 0.0001). 2 yr statistics between DART and SOC arms were similar ex
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