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Final Report of NRG Oncology RTOG 0022: A Phase I/II Study of Conformal and Intensity.
Final Report of NRG Oncology RTOG 0022: A Phase I/II Study of Conformal and Intensity. International journal of radiation oncology, biology, physics Garden, A. S., Harris, J., Eisbruch, A., Chao, K. S., Morrison, W. H., Harari, P. M., Swanson, T. A., Jones, C. U., Yom, S. S., Spencer, S. A., Scrimger, R., Shenouda, G., Shukla, M., Lau, H. Y., Mierzwa, M., Torres-Saavedra, P., Le, Q. T. 2023Abstract
BACKGROUND: XXXX XXXX XXXX XXXX (XXXX) XXXX was the first clinical trial evaluating multi-institution feasibility of IMRT for head and neck cancer. The primary endpoints of 2-year local-regional failure and reduction in acute xerostomia were reported previously. This report provides secondary endpoints with long-term follow-up.METHODS: Eligibility included patients diagnosed with T1-2, N0-1 oropharyngeal cancer. Secondary endpoints included disease control and overall survival. Local-regional failure rates were estimated by the cumulative incidence method, and disease-free and overall survival rates were estimated by the Kaplan-Meier method. Late toxicities were graded by XXXX/EORTC criteria and are reported with descriptive statistics.RESULTS: Sixty-seven of 69 enrolled patients were analyzed. Fifty patients (75%) had T2 disease and 38 (57%) were node negative (N0). Median follow-up was 11.9 years. Estimated 10-year local-regional failure, disease-free survival and overall survival rates were 15% (95%CI 8-25), 50% (95%CI 38-62) and 67% (95%CI 55-78), respectively. Highest reported late toxicities were: grade 5: 0%, grade 4: 9%, grade 3: 13%, and grade 2: 63%. Grade 3-4 late toxicities involved mucous membranes (7%), bone (4%), esophagus (4%), salivary gland (4%), pain (3%), weight loss (1%), and hemorrhage (1%). Grade 2-3 salivary gland toxicity was reported in 70% but improved over time. Forty-one (74.5%) and 17 (42.5%) of surviving patients had a toxicity assessment at > 5 years and >10 years, respectively.CONCLUSIONS: This report of XXXX/XXXX XXXX, based on an early, prospectively collected dataset of head and neck IMRT treatments, provides benchmark long-term outcomes of this early version of the technology. At 10 years, 2/3 of patients were alive, with an acceptable level of grade 3-4 late toxicities.
View details for DOI 10.1016/j.ijrobp.2023.02.057
View details for PubMedID 36925074