International journal of radiation oncology, biology, physics · 2026
Long-Term Outcomes of Reduced-Dose Radiation Therapy in Patients with Epstein-Barr Virus DNA-Selected Stage III Nasopharyngeal Carcinoma: A 5-Year Follow-Up Secondary Analysis of a Phase II Trial.
СтатьяКлиническое исследование II фазыНазвание и аннотация: Перевод в очереди
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Xiao Yu-Xi, Yang Jin-Hao, Sun Xue-Song, Liu Li-Zhi, Liu Li-Ting, Liu Sai-Lan, Li Xiao-Yun, Li Ji-Bin, Liu Qing, He Jia-Rui, Guo Hong-Bo, Chen Qiu-Yan, Tang Lin-Quan, Mai Hai-Qiang, Guo Shan-Shan
Аннотация
PURPOSE: We previously reported that reduced-dose (60 Gy) radiation was associated with favorable survival outcomes and limited toxicities in patients with low-risk stage III nasopharyngeal carcinoma (NPC) sensitive to induction chemotherapy (IC). However, the consistency of long-term outcomes remains unclear.
METHODS AND MATERIALS: This 5-year follow-up secondary analysis of a single-arm phase II trial enrolled patients with nonkeratinizing stage III NPC with pretreatment Epstein-Barr virus (EBV) DNA <4000 copies/mL. All 215 eligible patients received 2 cycles of IC. After IC, 116 patients achieved complete response/partial response and undetectable EBV DNA, and they were assigned to receive intensity-modulated radiation therapy (IMRT) at 60 Gy in 30 fractions. The remaining 99 patients were assigned to receive standard IMRT at 70 Gy in 33 fractions. The primary endpoint was progression-free survival.
RESULTS: At a median follow-up of 68.1 months, the 5-year progression-free survival was 90.5% (95% CI, 85.3%-96.0%) in the 60 Gy cohort and 79.8% (72.3%-88.1%) in the 70 Gy cohort, whereas the 5-year overall survival was 96.6% (93.3%-99.9%) and 94.9% (90.7%-99.4%), respectively. The 5-year locoregional relapse-free survival was 93.1% in the 60 Gy cohort and 82.8% in the 70 Gy cohort; the 5-year distant metastasis-free survival was 93.1% in the 60 Gy cohort and 89.9% in the 70 Gy cohort. No grade 3-4 late toxicity was observed in the 60 Gy group. In the 70 Gy cohort, 10.1% of patients experienced grade 3-4 late toxicities, with dry mouth and deafness/otitis being the most frequently reported.
CONCLUSIONS: Long-term analysis showed that in patients with low-risk stage III NPC selected by EBV DNA and IC response, reduced-dose IMRT (60 Gy) achieved favorable survival outcomes with limited late toxicities.
METHODS AND MATERIALS: This 5-year follow-up secondary analysis of a single-arm phase II trial enrolled patients with nonkeratinizing stage III NPC with pretreatment Epstein-Barr virus (EBV) DNA <4000 copies/mL. All 215 eligible patients received 2 cycles of IC. After IC, 116 patients achieved complete response/partial response and undetectable EBV DNA, and they were assigned to receive intensity-modulated radiation therapy (IMRT) at 60 Gy in 30 fractions. The remaining 99 patients were assigned to receive standard IMRT at 70 Gy in 33 fractions. The primary endpoint was progression-free survival.
RESULTS: At a median follow-up of 68.1 months, the 5-year progression-free survival was 90.5% (95% CI, 85.3%-96.0%) in the 60 Gy cohort and 79.8% (72.3%-88.1%) in the 70 Gy cohort, whereas the 5-year overall survival was 96.6% (93.3%-99.9%) and 94.9% (90.7%-99.4%), respectively. The 5-year locoregional relapse-free survival was 93.1% in the 60 Gy cohort and 82.8% in the 70 Gy cohort; the 5-year distant metastasis-free survival was 93.1% in the 60 Gy cohort and 89.9% in the 70 Gy cohort. No grade 3-4 late toxicity was observed in the 60 Gy group. In the 70 Gy cohort, 10.1% of patients experienced grade 3-4 late toxicities, with dry mouth and deafness/otitis being the most frequently reported.
CONCLUSIONS: Long-term analysis showed that in patients with low-risk stage III NPC selected by EBV DNA and IC response, reduced-dose IMRT (60 Gy) achieved favorable survival outcomes with limited late toxicities.