MC1675, a Phase III Evaluation of De-Escalated Adjuvant Radiation Therapy (DART) vs. Standard Adjuvant Treatment for Human Papillomavirus Associated Oropharyngeal Squamous Cell Carcinoma
التفاصيل البيبلوغرافية
العنوان:
MC1675, a Phase III Evaluation of De-Escalated Adjuvant Radiation Therapy (DART) vs. Standard Adjuvant Treatment for Human Papillomavirus Associated Oropharyngeal Squamous Cell Carcinoma
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/m2 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/m2). Stratification was by risk group (intermediate risk vs ENE+) and smoking status ( 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 4 LN). For ENE+/pN0-1 pts, (DART vs SOC) 2 yr PFS was 89.6% vs 95.8%; LRC 95.8% vs 100.0%; DMFS 96.4% vs 95.8%. For ENE+/pN2 (DART vs SOC) PFS was 42.9% vs 100%; LRC 77.0% vs 100%; DMFS 59.4% vs 100%. Conclusion DART demonstrated less toxicity, improved swallowing function and QOL when compared to SOC. DART also had excellent LRC, PFS, and OS rates, particularly in the ENE negative cohort. Caution is advised for de-escalating ENE+ pts with pN2 disease.
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