Prognostic analysis of nimotuzumab combined with concurrent chemoradiotherapy in locally advanced cervical cancer: A multicenter real-world study.

5532 Background: Nimotuzumab is a monoclonal antibody against EGFR, which can improve the radiotherapy efficacy of nasopharyngeal carcinoma with EGFR positive. Most cervical cancers are induced by virus and express EGFR. Therefore, this study explores the efficacy and safety of Nimotuzumab combined with concurrent chemoradiotherapy (CCRT) in locally advanced cervical cancer (LACC). Methods: Information on patients with stage IIB-IVa cervical cancer who received CCRT combined with Nimotuzumab or CCRT alone at five cancer centers from January 2021 to December 2022 were collected. Nimotuzumab was administered 200mg once a week for a total of 6 weeks, starting on the same day as CCRT. The imaging examination was carried out 2 months after the end of radiotherapy. The reduction rate of lesions = (pre-treatment diameter - post-treatment diameter)/pre-treatment diameter. Patients were classified into the Nimotuzumab group and No-Nimotuzumab group. Categorical variables were compared using the χ2 test or Fisher’s exact test. Clinical outcomes were analyzed using the Kaplan–Meier method with log-rank test. Results: There are 224 patients enrolled, median age 57 years (32–90 years). The median follow-up time was 20 months (12–36months). The 2-year overall survival (OS) and progression-free survival (PFS) rates were 93% and 89.5%, respectively. The objective response rate (ORR) was 91.96%. There were 64 patients in Nimotuzumab group and 160 patients in No-Nimotuzumab group. The number of patients in Nimotuzumab group with stage IIIC and IVa, as well as those without chemotherapy, is higher than that in No-Nimotuzumab group. There was no significant difference between the Nimotuzumab and No-Nimotuzumab groups in terms of 2-year OS rate (93.2% vs.93%, p = 0.895), and PFS rate (96.2% vs.90.4%, p = 0.645). However, The Nimotuzumab group has a better CR rate (53.13% vs. 35%, P=0.012), ORR (98.44% vs. 89.38%, p=0.024), and reduction rate of cervical lesions (79.26% vs.70.94%, p=0.046) compared to the No-Nimotuzumab group (Table). Also, there was no significant difference between the Nimotuzumab and No-Nimotuzumab groups in terms of hematological toxicity (89.83% vs. 94.48%, p=0.730), nausea and vomiting (35.59% vs. 38.19, p=0.865), radiation proctitis (45% vs. 33.1%, p=0.371), radiation cystitis (8.47% vs. 7.64%, p=0.761), and grade 3-4 toxicities. Conclusions: The combination of Nimotuzumab and CCRT for LACC has a better reduction rate of lesions and ORR, without increasing side effects. Table: see text