Long-Term Update of NRG Oncology RTOG 0522: A Randomized Phase III Trial of Concurrent Radiation and Cisplatin with or without Cetuximab in Locoregionally Advanced Head and Neck Cancer

• Authors: Jimmmy J Caudell, Moffitt Cancer Center, Tampa, FL; Pedro Torres-Saavedra, American College of Radiology, Philadelphia, PA; David I Rosenthal, MD Anderson Cancer Center, Houston, TX; Rita S Axelrod, Thomas Jefferson University Hospital; Phuc Felix Nguyen-Tan, Centre Hospitalier de l’Universite de Montreal, Montreal, Canada; Eric Sherman, Memorial Sloan Kettering Cancer Center, New York City; Randal S Weber, MD Anderson Cancer Center; James M Galvin, Imaging and Radiation Oncology Core (IROC) Philadelphia; Adel K El-Naggar, MD Anderson Cancer Center, Houston, TX; Andre A Konski, Chester County Hospital/University of Pennsylvania; Michelle I Echevarria, Moffitt Cancer Center, Tampa, FL; Neal E Dunlap, University of Louisville, James Graham Brown Cancer Center, Louisville, KY; George Shenouda, McGill University; Anurag K Singh, Roswell Park Comprehensive Cancer Center, Buffalo, N; Jonathan Beitler, Emory University; Adam Garsa, University of Southern California; James A Bonner, University of Alabama at Birmingham Cancer Center; Adam S Garden, Univ Texas MD Anderson Canc Ctr; Ozer Algan, University of Oklahoma Health Sciences Center; Jonathan Harris, American College of Radiology, Philadelphia; Quynh-Thu Le, Stanford Cancer Institute
• Journal Title: INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS
• Volume: Volume 106, Number 5
• Publisher: ELSEVIER SCIENCE INC | 2020-04-01, Pages 1116-1117
• Type of Work: Article | Post-print: After Peer Review
• Publisher DOI: http://doi.org/10.5603/RPOR.a2021.0099
• Subjects: Health Sciences, Oncology; Health Sciences, Radiology; Health Sciences, Medicine and Surgery
• Keywords: Science & Technology; Life Sciences & Biomedicine; Oncology; Radiology, Nuclear Medicine & Medical Imaging

Abstract

Purpose: The combination of cisplatin and radiation or cetuximab and radiation improves overall survival of patients with locoregionally advanced head and neck carcinoma. NRG Oncology conducted a phase 3 trial to test the hypothesis that adding cetuximab to radiation and cisplatin would improve progression-free survival (PFS). Methods and Materials: Eligible patients with American Joint Committee on Cancer sixth edition stage T2 N2a-3 M0 or T3-4 N0-3 M0 were accrued from November 2005 to March 2009 and randomized to receive radiation and cisplatin without (arm A) or with (arm B) cetuximab. Outcomes were correlated with patient and tumor features. Late reactions were scored using Common Terminology Criteria for Adverse Events (version 3). Results: Of 891 analyzed patients, 452 with a median follow-up of 10.1 years were alive at analysis. The addition of cetuximab did not improve PFS (hazard ratio [HR], 1.06; 95% confidence interval [CI], 0.89-1.26; P = .74), with 10-year estimates of 43.6% (95% CI, 38.8- 48.4) for arm A and 40.2% (95% CI, 35.4-45.0) for arm B. Cetuximab did not reduce locoregional failure (HR, 1.21; 95% CI, 0.95-1.53; P = .94) or distant metastasis (HR, 0.79; 95% CI, 0.54-1.14; P = .10) or improve overall survival (HR, 0.97; 95% CI, 0.80-1.16; P = .36). Cetuximab did not appear to improve PFS in either p16-positive oropharynx (HR, 1.30; 95% CI, 0.87-1.93) or p16-negative oropharynx or nonoropharyngeal primary (HR, 0.94; 95% CI, 0.73-1.21). Grade 3 to 4 late toxicity rates were 57.4% in arm A and 61.3% in arm B (P = .26). Conclusions: With a median follow-up of more than 10 years, this updated report confirms the addition of cetuximab to radiation therapy and cisplatin did not improve any measured outcome in the entire cohort or when stratifying by p16 status.