复发或转移性宫颈癌的药物治疗进展

doi:10.12114/j.issn.1007-9572.2025.0036

中国全科医学 ›› 2026, Vol. 29 ›› Issue (32): 4815-4820.DOI: 10.12114/j.issn.1007-9572.2025.0036

复发或转移性宫颈癌的药物治疗进展

张楚¹^,², 孔为民²^,^*(), 邓波儿²

1．100069　北京市，首都医科大学
2．100020　北京市，首都医科大学附属北京妇产医院　北京妇幼保健院妇科

收稿日期:2025-01-06 修回日期:2025-04-13 出版日期:2026-11-15 发布日期:2026-10-10
通讯作者: 孔为民
作者贡献：
张楚负责文章的构思与设计、检索文献并收集整理、撰写论文、绘制图表；孔为民负责提出研究思路和命题、文章的质量控制及审校、对文章整体负责，监督管理；邓波儿负责论文修订。
基金资助:
北京市科学技术委员会生命科学领域前沿技术培育课题(Z161100000116030)

Advances in Pharmacological Treatment of Recurrent or Metastatic Cervical Cancer

ZHANG Chu¹^,², KONG Weimin²^,^*(), DENG Boer²

1. Capital Medical University, Beijing 100069, China
2. Department of Gynecology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University/Beijing Maternal& Child Health Care Hospital, Beijing 100020, China

Received:2025-01-06 Revised:2025-04-13 Published:2026-11-15 Online:2026-10-10
Contact: KONG Weimin

摘要/Abstract

摘要： 宫颈癌发病率居妇科三大恶性肿瘤之首，发病率与死亡率居女性恶性肿瘤第4位，且仍呈上升趋势。宫颈癌早期以手术治疗为主，中晚期以同步放化疗为主，复发或转移以系统治疗为主。复发或转移性宫颈癌患者的生存率低，预后差，治疗选择有限。复发或转移性宫颈癌的药物治疗经历了顺铂单药治疗、含铂双联化疗及以贝伐珠单抗为代表的靶向治疗、免疫治疗和抗体偶联药物治疗等发展阶段，虽已形成较为系统的治疗选择标准，但随着近年来治疗药物的不断迭代开发，药物临床试验成果的不断更新，不同作用机制的药物联合治疗模式也在不断探索中。因此，有必要对复发或转移性宫颈癌的药物治疗进展进行总结，供临床医师掌握，为患者提供更多治疗选择。

关键词: 宫颈癌, 复发或转移性宫颈癌, 化疗, 靶向治疗, 免疫治疗, 抗体偶联药物

Abstract:

Cervical cancer has the highest incidence among the three major gynecological malignancies and ranks fourth in both incidence and mortality among female malignancies, with its incidence continuing to rise. Early-stage cervical cancer is primarily treated with surgery, while concurrent chemoradiotherapy is the main treatment for advanced stages. For recurrent or metastatic cervical cancer, systemic treatment is the primary approach. The survival rate of patients with recurrent or metastatic cervical cancer is low, prognosis is poor, and treatment options are limited. The pharmacological treatment of recurrent or metastatic cervical cancer has evolved through several stages, including cisplatin monotherapy, platinum-based doublet chemotherapy, targeted therapy represented by bevacizumab, immunotherapy, and antibody-drug conjugates. While a relatively systematic treatment guideline has been established, recent advancements in drug development, the continuous updating of clinical trial results, and the exploration of combination therapies with different mechanisms of action underscore the need for an updated summary of the progress in pharmacological treatments for recurrent or metastatic cervical cancer to help clinicians expand therapeutic options for patients.

Key words: Cervical cancer, Recurrent or metastatic cervical cancer, Chemotherapy, Targeted therapy, Immunotherapy, Antibody-drug conjugates

中图分类号:

　R 737.33

张楚,孔为民,邓波儿. 复发或转移性宫颈癌的药物治疗进展[J]. 中国全科医学, 2026, 29(32): 4815-4820. DOI: 10.12114/j.issn.1007-9572.2025.0036.
ZHANG Chu,KONG Weimin,DENG Boer. Advances in Pharmacological Treatment of Recurrent or Metastatic Cervical Cancer[J]. Chinese General Practice, 2026, 29(32): 4815-4820. DOI: 10.12114/j.issn.1007-9572.2025.0036.

图/表 1

参考文献 49

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药物	作用靶点	临床试验	样本量（例）	主要研究结果	临床意义
纳武利尤单抗	PD-1	CheckMate-358^[27]（Ⅰ/Ⅱ期）	19	ORR：26.3%（95%CI=9.1%~51.2%）；mOS：21.6个月	2023.v1版NCCN指南开始将纳武利尤单抗的推荐级别从"PD-L1阳性肿瘤的首选、二线或后线治疗"更改为"在某些情况下可用"
纳武利尤单抗	PD-1	NRG-GY002^[28]（Ⅱ期）	25	PR：4%（90%CI=0.4%~22.9%）；SD：36%（90%CI= 20.2%~54.4%）；6个月PFS：16%；6个月OS：78.4%；≥3级TRAE：32%
西米普利单抗	PD-1	EMPOWER-Cervical 1^[29]（Ⅲ期）	608	ORR：16.4%（95%CI=12.5%~21.1%）（PD-L1阳性18%，PD-L1阴性11%）；mOS：12.0个月（PD-L1阳性12.1个月，PD-L1阴性10.8个月）；≥3级TRAE：45.0%	2024.v1版NCCN指南推荐西米普利单抗为R/M CC首选二线/后线治疗方案
卡度尼利单抗	PD-1/CTLA-4双靶点	AK104-201^[30]（Ⅱ期）	111	ORR：32.3%（95%CI=23.3%~42.5%）（PD-L1阳性42.9%，PD-L1阴性16.7%）；CR：14%；mPFS：3.7个月；mOS：NR；亚组分析：无论PD-L1表达状态或先前是否接受过贝伐珠单抗治疗，均能从卡度尼利单抗单药治疗中获益	2022年6月，国家药品监督管理局（NMPA）附条件批准卡度尼利单抗用于既往接受含铂化疗治疗失败的R/M CC
赛帕利单抗	PD-1	YH-S001-05^[31]（Ⅱ期）	105	ORR：27.8%（95%CI=19.34%~37.20%，P<0.000 1）；CR：5.6%；mPFS：3.7个月；mOS：16.8个月；DCR：54.4%	2023年6月，NMPA批准赛帕利单抗用于既往接受含铂化疗治疗失败的R/M且PD-L1表达阳性的CC患者

药物	作用靶点	临床试验	样本量（例）	主要研究结果	临床意义
纳武利尤单抗	PD-1	CheckMate-358^[27]（Ⅰ/Ⅱ期）	19	ORR：26.3%（95%CI=9.1%~51.2%）；mOS：21.6个月	2023.v1版NCCN指南开始将纳武利尤单抗的推荐级别从"PD-L1阳性肿瘤的首选、二线或后线治疗"更改为"在某些情况下可用"
纳武利尤单抗	PD-1	NRG-GY002^[28]（Ⅱ期）	25	PR：4%（90%CI=0.4%~22.9%）；SD：36%（90%CI= 20.2%~54.4%）；6个月PFS：16%；6个月OS：78.4%；≥3级TRAE：32%
西米普利单抗	PD-1	EMPOWER-Cervical 1^[29]（Ⅲ期）	608	ORR：16.4%（95%CI=12.5%~21.1%）（PD-L1阳性18%，PD-L1阴性11%）；mOS：12.0个月（PD-L1阳性12.1个月，PD-L1阴性10.8个月）；≥3级TRAE：45.0%	2024.v1版NCCN指南推荐西米普利单抗为R/M CC首选二线/后线治疗方案
卡度尼利单抗	PD-1/CTLA-4双靶点	AK104-201^[30]（Ⅱ期）	111	ORR：32.3%（95%CI=23.3%~42.5%）（PD-L1阳性42.9%，PD-L1阴性16.7%）；CR：14%；mPFS：3.7个月；mOS：NR；亚组分析：无论PD-L1表达状态或先前是否接受过贝伐珠单抗治疗，均能从卡度尼利单抗单药治疗中获益	2022年6月，国家药品监督管理局（NMPA）附条件批准卡度尼利单抗用于既往接受含铂化疗治疗失败的R/M CC
赛帕利单抗	PD-1	YH-S001-05^[31]（Ⅱ期）	105	ORR：27.8%（95%CI=19.34%~37.20%，P<0.000 1）；CR：5.6%；mPFS：3.7个月；mOS：16.8个月；DCR：54.4%	2023年6月，NMPA批准赛帕利单抗用于既往接受含铂化疗治疗失败的R/M且PD-L1表达阳性的CC患者

复发或转移性宫颈癌的药物治疗进展

Advances in Pharmacological Treatment of Recurrent or Metastatic Cervical Cancer

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