Nimotuzumab combined with chemotherapy in the first-line treatment for patients with stage IVB, recurrent or persistent cervical squamous cell carcinoma: A multi-center, randomized, double-blind, and controlled study.

作者：Jusheng An, Jing Wang, Chunyan Wang, Qi Zhou, Rutie Yin, Xinfeng Yang, Huijun Cheng, Hanmei Lou, Yunong Gao, Ge Lou, Pengpeng Qu, Hongying Yang, Cailing Ma, Yu‐Mei Wu, Qiubo Lv, Junjie Wang, Zexuan Liu, Lingying Wu · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.5510 · 被引用次数：2 · 研究领域：Cervical Cancer and HPV Research、Endometrial and Cervical Cancer Treatments、Colorectal and Anal Carcinomas

5510 Background: Stage IVb, recurrent or persistent cervical cancer patients have limited treatment options and poor survival prognosis. Additionally, 70-90% of cervical cancers have overexpression of EGFR (epidermal growth factor receptor), a promising therapeutic target. Nimotuzumab (nimo), an EGFR antibody, 95% humanization degree, had applied in the treatment of various advanced solid tumors. So, we conducted the study to investigate its efficacy and safety. Methods: This trial is a prospective study with a total of 118 patients enrolled. There were 55 patients (pts) in the experimental group (nimo+chemotherapy) and 63 pts in the control group (chemotherapy alone). Primary efficacy endpoint is overall survival (OS). Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), quality of life (QoL) and exploratory endpoints including the relationship between EGFR expression level and clinical efficacy and prognosis. The study of NCT approval number is 06781073. Results: The median age of the study population was 51.3 (range, 24.7-69.5) years. The average number of organs involved in the lesion was 2. The disease stage at initial diagnosis (2018 FIGO stage) was Ia-IVb. According to the disease status at the time of enrollment, IVB/recurrence/persistence accounted for 14.4%, 92.4%, and 9.3%, respectively. The results showed that the median OS was 15.7 (95% CI, 11.8-26.9) months in the nimo arm and 12.4 (95% CI, 7.9-21.0) months in the control ...