Long-term update of NRG/RTOG 0522: a randomized phase III trial of concurrent radiation and cisplatin with or without cetuximab in locoregionally advanced head and neck cancer. International journal of radiation oncology, biology, physics Caudell, J. J., Torres-Saavedra, P. A., Rosenthal, D. I., Axelrod, R. S., Nguyen-Tan, P. F., Sherman, E. J., Weber, R. S., Galvin, J. M., El-Naggar, A. K., Konski, A. A., Echevarria, M. I., Dunlap, N. E., Shenouda, G., Singh, A. K., Beitler, J. J., Garsa, A., Bonner, J. A., Garden, A. S., Algan, O., Harris, J., Le, Q. 2022


PURPOSE/OBJECTIVE: The combination of cisplatin and radiation or cetuximab and radiation improves overall survival (OS) of patients with locoregionally advanced head and neck carcinoma (HNC). xxxx conducted a phase III trial to test the hypothesis that adding cetuximab to radiation and cisplatin would improve progression-free survival (PFS).MATERIALS/METHODS: Eligible patients with AJCC 6th edition stage T2 N2a-3 M0 or T3-4 N0-3 M0 were accrued from 11/2005 - 3/2009 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 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=0.74], 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=0.94] or distant metastasis [HR 0.79 (95% CI 0.54 - 1.14), p=0.10], or improve overall survival [HR 0.97 (95% CI 0.80 - 1.16), p=0.36]. 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 non-oropharyngeal primary [HR 0.94 (95% CI 0.73 - 1.21)]. Grade 3-4 late toxicity rates were 57.4% in Arm A and 61.3% in arm B (p=0.26).CONCLUSION: With a median follow-up of over 10 years, this updated report confirms the addition of cetuximab to RT and cisplatin did not improve any measured outcome in the entire cohort, or when stratifying by p16 status.

View details for DOI 10.1016/j.ijrobp.2022.12.015

View details for PubMedID 36549347