Nimotuzumab plus concurrent chemoradiotherapy for locally advanced cervical squamous cell carcinoma: The randomized, phase 3 CC3 study.

• DOI: 10.1200/jco.2024.42.16_suppl.5514
• Publication Date: 2024-06-06T19:11:49Z
• Authors: Jun jie Wang; Ping Jiang; Ang Qu; Lichun Wei; Lijuan Zou; Xiaofan Li; Chunyan Wang; Xiaoge Sun; Li Ding; Xiangkun Yuan; Huijun Cheng; Dehua Wu; Rong Cai; Rutie Yin; Jidong Zhang; Hui Qiu; Tiejun Wang; Kun Gao; Yanhong Zhuo; Yun Yan Zhang
• Keywords: Nimotuzumab; Chemoradiotherapy

5514 Background: Cervical cancer is the fourth common malignancy in women, with a 5-year overall survival rate of 24%-76.1%. At present, there are few studies on targeted drugs combined concurrent chemoradiotherapy (CCRT) for locally advanced cervical (LACC) and results were not satisfactory. This CC3 study first randomized, controlled, multicenter phase 3 trial EGFR CCRT cancer, aims to evaluate efficacy safety nimotuzumab (humanized EGFR) combination LACC. (NCT04678791). Methods: All patients squamous cell carcinoma randomized (1:1) receive (400mg, iv, weekly, 6 weeks) (cisplatin: 40 mg/m 2 , weeks; IMRT/VMAT: 45-50.4 Gy/25-28f; high-dose brachytherapy: 30-40 Gy, 8 or alone. The primary endpoint was 3-year progression free (PFS) per RECIST 1.1. secondary endpoints (OS), objective response (ORR), complete (CR) v1.1, CTCAE v5.0. Results: Totally 286 enrolled. 142 Nimo group (nimotuzumab CCRT) 144 (CCRT alone). baseline characteristics balanced between two groups. 1-year PFS longer than that (96.1% vs. 92.1%, P=0.506). There no significant difference risk ratio groups (HR=0.76, 95% CI: 0.33-1.72, P=0.507), OS reached. A total 62 (43.99%) achieved partial (PR) 57 (40.14%) CR group, 50 (34.72%) (39.58%) respectively. ORR 83.80% 74.31% (P=0.049). most AEs graded 1-2 as reported before. Follow-up ongoing. Conclusions: Nimotuzumab showed improvement, trend good treatment LACC patients. Clinical information: NCT04678791 . [Table: see text]