3442 - Prospective Phase II Single-Arm Multicenter Study of Nimotuzumab plus Benmelstobart and Platinum-Based Doublet Neoadjuvant Therapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
Presenter(s)
Y. Chen1, Y. Wang2, Y. Piao3, Y. Zhou4, D. Wang5, Z. Li6, Y. Liang5, Y. Chen7, L. Chen8, Y. Mao9, S. Lai10, L. Lu8, G. Xu11, and G. Liao5; 1State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou 510060, P. R. China., Guangzhou, Guanzhou, China, 2Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou 510060, China, Guangzhou, Guangdong, China, 3Department of Radiation Oncology, Shenzhen People's Hospital(The Second Clinical Medical College, jinan University; The First Affiliated Hospital, Southern University of Science and Technology,Shenzhen, Guangdong,People's Republic of China, Shenzhen, China, 4Sun Yat-Sen University Cancer Center, Guang Dong Province, Guangdong, China, 5Hospital of Stomatology, Guanghua School of Stomatology, Sun Yat-sen Univerisity, Guangzhou, China, 6Shenzhen People’s Hospital, Shenzhen, China, 7Department of head and neck surgery, Sun Yat-sen University Cancer Center, Guangzhou, China, 8Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China, 9Sun Yat-sen University Cancer Center, Guangzhou, China, 10Yuebei People's Hospital Affiliated to the Medical College of Shantou University, Shantou, China, 11Department of Radiation Oncology, Shenzhen People's Hospital, Shenzhen, China
Purpose/Objective(s): To assess the safety and effectiveness of nimotuzumab in conjunction with platinum-based doublet neoadjuvant treatment and benmelstobart in patients with locally advanced head and neck squamous cell carcinoma (HNSCC), with the main goal being the objective response rate (ORR).
Materials/Methods: This multicenter experiment was a prospective phase II single-arm study. According to the AJCC 8th edition, eligible patients had stage ?–?b HNSCC with ECOG PS 0-1. The course of treatment consisted of platinum-based doublet chemotherapy (Q3W, 2 cycles), benmelstobart 1200 mg (Q3W, 2 cycles), and nimotuzumab 400 mg (Q3W, 2 cycles). RECIST 1.1 evaluated efficacy, while NCI-CTC version 5.0 evaluated safety. With an 80% beta and a one-sided alpha of 0.025, this study used the Simon two-stage design. With an ineffective rate set at 26.6% and an expected efficacy rate of 46.6%, the combination therapy is expected to require 54 cases (6/19 as first stage, 20/35 as second stage). There will be 60 people registered, assuming a 10% dropout rate.
Results: Thirty patients in all reported short-term efficacy: six stopped treatment, and twenty-four remained. There were 89.66% males and a median age of 56 years (range: 35-68 years). 65 days was the median follow-up (range: 47–257 days). The ORR for the primary endpoint was 100%, with all responses being partial (PR). Anemia (14/15) and hypoalbuminemia (12/15) were the most frequent adverse events for safety (15 assessable individuals). Thrombocytopenia, oral mucositis, and leukopenia were among the grade 3–4 adverse events. Overall safety was tolerable; no serious adverse events were unexpected.
Conclusion: In patients with locally advanced HNSCC, nimotuzumab plus benmelstobart and platinum-based doublet neoadjuvant therapy demonstrated an excellent ORR (100%) in these cases. Adverse events linked to treatment were predictable and under control, indicating the need for more research.