Humanized anti-EGFR monoclonal antibody(Henan Shengming Biotechnology Research Institute Co Ltd)

Nasopharyngeal carcinoma (NPC) is the most prevalent geographically-specific head and neck cancer. Its incidence was high in the Asian population, especially in certain parts such as Southern China and South East Asia. Most patients with NPC are presented with intermediate-stage or locally advanced disease requiring chemoradiation as the primary treatment of choice. Epidermal Growth Factor Receptor (EGFR) was found overexpressed in most patients with NPC associated with poor prognosis making its inhibitor one of the most plausible treatment options in addition to chemoradiation. In EGFR-positive NPC patients, nimotuzumab, a humanized anti-EGFR monoclonal antibody will bind the extracellular domain of EGFR leading to tumor growth suppressions. This study's objective was to assess the real-world clinical efficacy of nimotuzumab for patients with intermediate-stage and locally advanced NPC when in combination with concurrent chemoradiation.

This retrospective real-world study examined a sample of intermediate-stage and locally advanced NPC patients who were treated with or without adding nimotuzumab to concurrent chemoradiation at Dr. Cipto Mangunkusumo General Hospital in Indonesia from January 2009 to December 2017. The outcomes were patients' real-world five-year overall survival (rwOS) and progression-free survival (rwPFS) compared using Kaplan-Meier analysis and Cox proportional hazard models adjusting for age, gender, comorbidities, clinical staging, staging based on Tumor status (T), staging based on Nodes status (N), and types of radiotherapy.  Results: A total of 407 patients were included in the analysis, 61 patients receiving concurrent nimotuzumab and chemoradiation and 346 patients receiving chemoradiation alone. Patients receiving concurrent nimotuzumab and chemoradiation tended to have less aggressive NPC than patients receiving chemoradiation alone. Multivariate-adjusted Cox models revealed that combining nimotuzumab with chemoradiation was associated with a statistically significant longer rwOS gain (hazard ratio (HR)=0.46 (95% CI: 0.26-0.82, p=0.008)) and a trend of longer rwPFS (hazard ratio (HR)=0.67 (95% CI: 0.41-1.09, p=0.109)) in comparison to chemoradiation alone.  Conclusion: In this retrospective real-world study, concurrent nimotuzumab and chemoradiation usage was associated with a significant overall survival benefit than chemoradiation alone for intermediate-stage and locally advanced NPC patients. Hence, adding nimotuzumab to patients' chemoradiation should be considered in patients with intermediate-stage and locally advanced NPC.