Nimotuzumab combined with induction chemotherapy and concurrent chemoradiotherapy for locally advanced nasopharyngeal carcinoma: A prospective, multicenter, randomized controlled trial—Preliminary analysis.

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Background: To evaluate nimotuzumab combined with standard chemoradiotherapy in locally advanced nasopharyngeal carcinoma (NPC). Methods: This prospective, multicenter, randomized trial enrolled 172 patients with stage III-IVa NPC across 8 hospitals in Guangxi (NCT05717790). Patients were randomly assigned (1:1) to receive either standard therapy (2 cycles of gemcitabine/cisplatin induction followed by cisplatin-based CCRT) or nimotuzumab plus standard therapy (200mg weekly during induction, then 200mg every 3 weeks for 8 cycles as maintenance). The primary endpoint was 5-year overall survival; secondary endpoints included response rates, safety, and quality of life. Results: At interim analysis, induction chemotherapy yielded comparable objective response rates (ORR) between groups for primary tumor (88.2% vs 87.4%, P = 0.860) and lymph nodes (70.6% vs 80.5%, P = 0.132). After CCRT and maintenance therapy, the nimotuzumab group achieved significantly higher complete response rate (22.35% vs 10.34%, P = 0.033) with similar ORR (P > 0.05). At 2 years, both groups showed excellent outcomes: overall survival 100% in both; progression-free survival 99.0% vs 97.1%; distant metastasis-free survival 99.0% vs 98.2%; locoregional relapse-free survival 100% vs 99.0%. Grade 3-4 neutropenia (8.2% vs 0%, P = 0.006) and thrombocytopenia (5.9% vs 0%, P = 0.022) were more common with nimotuzumab, but other toxicities were similar between groups. Conclusion: Adding nimotuzumab to standard induction chemotherapy and CCRT significantly improved complete response rates in locally advanced NPC. Increased myelosuppression was manageable. Long-term survival data are pending. Clinical trial information: NCT05717790 .