Survival and pain treatment de-escalation of concurrent chemoradiotherapy combined with nimotuzumab and analgesics for patients with advanced head and neck cancer: A randomized, controlled clinical study.

e18001 Background: Patients with advanced head and neck cancer (HNC) have a poor prognosis. Pain is a disruptive complication of cancer, especially in HNC patients, and reduces the survival rate and quality of life. Anti-epidermal growth factor receptor (EGFR) antibody together with cyclooxygenase-2 reduces cancer pain in previous study. Nimotuzumab is a humanized monoclonal EGFR antibody with anti-tumor activity. We investigated the clinical effectiveness and observed pain palliation of nimotuzumab combined with concurrent chemoraditherapy (CCRT) and analgesics for patients with advanced HNC. Methods: In this open-label, randomized, controlled clinical study, the clinical stage with III-IVb HNSCC patients were randomized (1:1) to control group (analgesics plus CCRT) and study group (nimotuzumab plus analgesics and CCRT). Intensity-modulated radiation therapy was performed with a total dose of 66-70Gy (2Gy/F, 35F) for 6 consecutive weeks. Chemotherapy regimen was cisplatin at a dose of 30mg/m 2 /w for 6 weeks. Nimotuzumab was administered at a dose of 200mg weekly for 6 weeks. The primary endpoint was progression-free survival (PFS). The secondary endpoints were overall survival (OS), numerical rating scale (NRS), and safety. Results: In total, 194 patients were included in this study, 99 patients were assigned in study group and 95 in control group. The median follow-up was 39.0 month (95%CI: 37.4, NA) in study group and 35.1 month (95%CI: 29.9, NA) in control group. Compared to the control group, study group showed prolonged PFS (2-year PFS: 30.1% vs. 14.8%, P＜0.0001, mPFS: 16.2 month vs. 10.1 month), and OS (2-year OS: 58.2% vs. 24.7%, P＜0.0001, mOS: 29.8 month vs. 17.1 month). The addition of nimotuzumab significantly alleviates the cancer pain of patients in NRS score and de-escalation analgesic ladder (P<0.05), even 3 month after treatment (while without analgesic drug administration). Especially the day after first dosage, the NRS score decreased sharply in nimotuzumab group, also de-escalation the analgesic use. Graded 3-4 adverse events (AEs) in two groups exhibited no significant differences. No serious AEs and fatal outcomes occurred. Conclusions: The addition of nimotuzumab showed a promising survival profile and tolerable toxicity, also in coordination with cancer pain alleviation for advanced HNC patients. Clinical trial information: NCT06879691 .