Dynamic circulating tumor DNA-driven, risk-adapted systematic therapy in nasopharyngeal carcinoma: The EP-STAR trial.

作者：Ying Sun, Jun Ma, Jia-Wei Lyu, Xudong Xu, Guan-Qun Zhou, Lin Li, Ning Zhang, Jibin Li, Jinhui Liang, Bin Deng, Jianye Yan, Tian-Sheng Gao, Lusi Chen · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.6010 · 被引用次数：4 · 研究领域：Cancer Genomics and Diagnostics、Sarcoma Diagnosis and Treatment

6010 Background: Circulating tumor-derived Epstein-Barr virus (EBV) DNA (ctDNA) during treatment has been established as a biomarker in nasopharyngeal carcinoma (NPC). However, how this information would facilitate individualized management remains unknown. We designed EP-STAR, a multicentre, phase II, adaptive trial to investigate whether the dynamic on-treatment ctDNA-driven, risk-adapted treatment strategy improved survival for NPC patients. Methods: Locoregionally advanced NPC (stage III-IVA) with detectable pretreatment EBV DNA (excluding T3N0 with EBV DNA<2000 copy/mL), who received gemcitabine plus cisplatin induction chemotherapy (IC) concurrently with longitudinal on-treatment EBV DNA monitoring were enrolled and classified into different ctDNA risk subgroups. Low-risk patients (EBV DNA post-IC1-3 =0) did not undergo treatment adaptation and continued standard therapy (chemoradiotherapy, CCRT) (No_adaptive_Arm-control). At-risk patients (intermediate/high-risk) underwent risk-based treatment adaptation (Adaptive population): intermediate-risk patients (EBV DNA post-IC1 >0, EBV DNA post-IC3 =0 or EBV DNA post-IC1 =0, EBV DNA post-IC2 >0, EBV DNA post-IC3 =0) started treatment intensification with addition of adjuvant metronomic capecitabine to CCRT (650 mg/m² orally twice daily) (Adaptive_Arm-I_cap); high-risk patients (EBV DNA post-IC1 >/=0, EBV DNA post-IC3 >0) started treatment intensification with addition of 12 cycles sintilimab to CCRT (anti-PD-1 ...