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Reduced-Dose Radiation Therapy for HPV-Associated Oropharyngeal Carcinoma (NRG Oncology HN002).

Reduced-Dose Radiation Therapy for HPV-Associated Oropharyngeal Carcinoma (NRG Oncology HN002). Journal of clinical oncology : official journal of the American Society of Clinical Oncology Yom, S. S., Torres-Saavedra, P. n., Caudell, J. J., Waldron, J. N., Gillison, M. L., Xia, P. n., Truong, M. T., Kong, C. n., Jordan, R. n., Subramaniam, R. M., Yao, M. n., Chung, C. H., Geiger, J. L., Chan, J. W., O'Sullivan, B. n., Blakaj, D. M., Mell, L. K., Thorstad, W. L., Jones, C. U., Banerjee, R. N., Lominska, C. n., Le, Q. T. 2021: JCO2003128

Abstract

Reducing radiation treatment dose could improve the quality of life (QOL) of patients with good-risk human papillomavirus-associated oropharyngeal squamous cell carcinoma (OPSCC). Whether reduced-dose radiation produces disease control and QOL equivalent to standard chemoradiation is not proven.In this randomized, phase II trial, patients with p16-positive, T1-T2 N1-N2b M0, or T3 N0-N2b M0 OPSCC (7th edition staging) with = 10 pack-years of smoking received 60 Gy of intensity-modulated radiation therapy (IMRT) over 6 weeks with concurrent weekly cisplatin (C) or 60 Gy IMRT over 5 weeks. To be considered for a phase III study, an arm had to achieve a 2-year progression-free survival (PFS) rate superior to a historical control rate of 85% and a 1-year mean composite score = 60 on the MD Anderson Dysphagia Inventory (MDADI).Three hundred six patients were randomly assigned and eligible. Two-year PFS for IMRT + C was 90.5% rejecting the null hypothesis of 2-year PFS = 85% (P = .04). For IMRT, 2-year PFS was 87.6% (P = .23). One-year MDADI mean scores were 85.30 and 81.76 for IMRT + C and IMRT, respectively. Two-year overall survival rates were 96.7% for IMRT + C and 97.3% for IMRT. Acute adverse events (AEs) were defined as those occurring within 180 days from the end of treatment. There were more grade 3-4 acute AEs for IMRT + C (79.6% v 52.4%; P < .001). Rates of grade 3-4 late AEs were 21.3% and 18.1% (P = .56).The IMRT + C arm met both prespecified end points justifying advancement to a phase III study. Higher rates of grade = 3 acute AEs were reported in the IMRT + C arm.

View details for DOI 10.1200/JCO.20.03128

View details for PubMedID 33507809