Identifying optimal clinical trial candidates for locoregionally advanced nasopharyngeal carcinoma: Analysis of 9468 real-world cases and validation by two phase 3 multicentre, randomised controlled trial

•N2-3 or T4 patients were ideal candidates for locoregionally advanced NPC trials.•Patients with pre-treatment EBV DNA ≥4,000 copies/mL might be eligible for trials.•Patients with detectable post-treatment EBV DNA are candidates for adjuvant trials. This study aims to identify the optimal high-risk...

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Published in:Radiotherapy and oncology 2022-02, Vol.167, p.179-186
Main Authors: Tang, Si-Qi, Chen, Lei, Li, Wen-Fei, Chan, Anthony T.C., Huang, Shao Hui, Chua, Melvin L.K., O'Sullivan, Brian, Lee, Anne W.M., Lee, Nancy Y., Zhang, Yuan, Chen, Yu-Pei, Xu, Cheng, Sun, Ying, Tang, Ling-Long, Ma, Jun
Format: Article
Language:English
Subjects:
Clinical trial
DNA, Viral
Epstein-Barr virus DNA
Epstein-Barr Virus Infections
Herpesvirus 4, Human - genetics
Humans
Nasopharyngeal carcinoma
Nasopharyngeal Carcinoma - pathology
Nasopharyngeal Neoplasms - pathology
Neoplasm Staging
Prognosis
Recursive partitioning analysis
Survival
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Summary:•N2-3 or T4 patients were ideal candidates for locoregionally advanced NPC trials.•Patients with pre-treatment EBV DNA ≥4,000 copies/mL might be eligible for trials.•Patients with detectable post-treatment EBV DNA are candidates for adjuvant trials. This study aims to identify the optimal high-risk candidates for clinical trials in locoregionally advanced nasopharyngeal carcinoma (NPC). Non-metastatic NPC patients (n = 9,468) were included. Recursive partitioning analyses (RPA) were performed to generate risk stratification. Receiver operating characteristics curve was used to determine the cut-off value of pre-treatment Epstein-Barr virus (EBV) DNA for progression-free survival (PFS). Individual-level data from two clinical trials were used for validation. Anatomic stratification based on T and N category (eighth edition TNM, TNM-8) classified the N2-3 or T4 as an anatomic high-risk group with 5-year PFS of 69% (95% confidence interval: 68–71%). Prognostic stratification identified patients with pre-treatment EBV DNA ≥4000 copies/mL as a prognostic high-risk group with 5-year PFS of 69% (67–70%). The c-index was significantly higher for anatomic stratification (0.621, p 
ISSN:0167-8140
1879-0887
DOI:10.1016/j.radonc.2021.12.029