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Immunotherapy Integration and Immuno Biomarkers Across Mucosal and Cutaneous SCC
Efficacy and Safety of an Adaptive Treatment Strategy for Locoregionally Advanced Nasopharyngeal Carcinoma Based on Response Stratification to Nimotuzumab Plus Induction Chemotherapy: A Prospective Multicenter Phase II Clinical Study

Sep 28

SS 15 - Immunotherapy Integration and Immuno Biomarkers Across Mucosal and Cutaneous SCC

176 - Efficacy and Safety of an Adaptive Treatment Strategy for Locoregionally Advanced Nasopharyngeal Carcinoma Based on Response Stratification to Nimotuzumab Plus Induction Chemotherapy: A Prospective Multicenter Phase II Clinical Study

11:25am - 11:35am ET

Room 107

Presenter(s)

Lei Zeng, MD - The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi

M. M. Liu¹, J. W. Li², J. W. Ding¹, Z. B. Lu³, J. L. Hu¹, R. H. Hu¹, W. W. Wu², D. Y. Zou², and L. Zeng¹; ¹Department of Oncology, The second Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, JiangXi, China, ²Department of Oncology, Ganzhou Cancer Hospital, Ganzhou, JiangXi, China, ³Department of Oncology, Pingxiang People’s Hospital, Nanchang, JiangXi, China

Purpose/Objective(s):

Induction chemotherapy (IC) followed by concurrent chemoradiotherapy (CCRT), with or without EGFR-targeted agents, is a standard approach for locoregionally advanced nasopharyngeal carcinoma (LA-NPC) but is associated with substantial toxicity. The optimal integration of EGFR-targeted therapy and treatment intensity during radiotherapy remains unclear. This study evaluated a response-adapted treatment strategy based on nimotuzumab (NTZ) plus IC, aiming to de-escalate concurrent treatment for good responders while intensifying therapy for poor responders, thereby maintaining efficacy and reducing toxicity.

Materials/Methods:

This prospective, single-arm multicenter phase II non-inferiority trial enrolled patients aged 18–70 years with newly diagnosed non-keratinizing stage III–IVA (excluding T3–4N0, AJCC 8th edition) NPC. All patients received three cycles of IC with NTZ, gemcitabine, and nedaplatin. Tumor response was assessed using RECIST 1.1. Patients achieving complete response (CR) or partial response (PR) =50% were assigned to radiotherapy (RT) plus NTZ (de-escalation group), while those with PR <50% or stable disease (SD) received CCRT plus NTZ (intensification group). The primary endpoint was 3-year disease-free survival (DFS). Secondary endpoints included overall survival (OS), distant metastasis-free survival (DMFS), locoregional relapse-free survival (LRRFS), and treatment-related toxicity.

Results:

Seventy-six patients were enrolled. After IC, 71 patients (93.4%) achieved PR and 5 (6.6%) had SD. Sixty-one patients (80.3%) entered the de-escalation group, and 15 (19.7%) received intensified treatment. With a median follow-up of 39.5 months, 3-year DFS, OS, DMFS, and LRRFS were 88.1%, 96.0%, 90.9%, and 98.4%, respectively. The most common grade 3–4 acute toxicities were mucositis (55.3%), elevated transaminases (38.1%), leukopenia (13.1%), and neutropenia (7.8%). The most frequent grade 3–4 late toxicities were xerostomia (32.9%) and deafness or otitis (17.1%). No treatment-related deaths were observed.

Conclusion:

A response-adapted strategy based on NTZ plus IC allows safe de-escalation of concurrent therapy during radiotherapy in good responders without compromising survival outcomes, supporting personalized treatment for LA-NPC and warranting validation in phase III trials. (Registration No. ChiCTR2000041139).