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尼妥珠单抗联合同步放化疗治疗局部晚期宫颈癌的预后分析:一项多中心真实世界研究

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

作者信息

Li Jiwei, Wu Tao, Cai Manbo, Xie Changjun, Ding Sijuan, Zou Wen, Yao Jia, Wang Jingjing

机构信息

Department of Oncology, The Second Xiangya Hospital of Central South University, Changsha, China.

Department of Oncology, Xiangya School of Medicine, Changde Hospital, Changde, China.

出版信息

Sci Rep. 2025 May 7;15(1):15877. doi: 10.1038/s41598-025-98359-4.

Abstract

Nimotuzumab is a monoclonal antibody against EGFR. The therapeutic efficacy of nimotuzumab in cervical cancer treatment remains inconclusive, with current evidence insufficient to establish a definitive clinical benefit. Therefore, this study compares the efficacy and safety of nimotuzumab combined with concurrent chemoradiotherapy (CCRT) and CCRT in locally advanced cervical cancer (LACC). 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. Propensity score (PS) matching analysis was used to compare nimotuzumab group and no-nimotuzumab group. Clinical outcomes were analyzed. There were 195 patients enrolled. The 2-year overall survival (OS) and progression-free survival (PFS) rates were 92.5% and 89.5%, respectively. The objective response rate (ORR) was 90.8%. There were 60 patients in the nimotuzumab group and 135 patients in the no-nimotuzumab group. The nimotuzumab group had a better CR rate (51.7% vs. 26.7%, P = 0.001) and ORR (98.3% vs. 87.4%, p = 0.015) compared to the no-nimotuzumab group. After PS matching, there were 54 patients in each group. There were no significant differences in 2-year OS rate and PFS rate between the two groups before and after matching. However, the nimotuzumab group had also a better CR rate and ORR compared to the no-nimotuzumab group after matching. The incidence of grade 3-4 anemia was relatively higher in nimotuzumab group than in no-nimotuzumab group after matching, while no difference was observed in other adverse events between the two groups. The combination of nimotuzumab and CCRT for LACC improved CR rate and ORR, without increasing side effects, which might become a potential treatment strategy for LACC patients.

摘要

尼妥珠单抗是一种抗表皮生长因子受体(EGFR)的单克隆抗体。尼妥珠单抗在宫颈癌治疗中的疗效尚无定论,目前的证据不足以确定其明确的临床益处。因此,本研究比较了尼妥珠单抗联合同步放化疗(CCRT)与单纯CCRT治疗局部晚期宫颈癌(LACC)的疗效和安全性。收集了2021年1月至2022年12月期间在五个癌症中心接受CCRT联合尼妥珠单抗或单纯CCRT治疗的IIB-IVA期宫颈癌患者的信息。采用倾向评分(PS)匹配分析比较尼妥珠单抗组和非尼妥珠单抗组。分析临床结局。共纳入195例患者。2年总生存(OS)率和无进展生存(PFS)率分别为92.5%和89.5%。客观缓解率(ORR)为90.8%。尼妥珠单抗组60例,非尼妥珠单抗组135例。与非尼妥珠单抗组相比,尼妥珠单抗组的完全缓解(CR)率(51.7%对26.7%,P = 0.001)和ORR(98.3%对87.4%,p = 0.015)更高。PS匹配后,每组各有54例患者。匹配前后两组的2年OS率和PFS率无显著差异。然而,匹配后尼妥珠单抗组的CR率和ORR也高于非尼妥珠单抗组。匹配后,尼妥珠单抗组3-4级贫血的发生率相对高于非尼妥珠单抗组,而两组在其他不良事件方面未观察到差异。尼妥珠单抗与CCRT联合用于LACC可提高CR率和ORR,且不增加副作用,这可能成为LACC患者的一种潜在治疗策略。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4125/12059138/9d3d574f9458/41598_2025_98359_Fig1_HTML.jpg

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