卡瑞利珠单抗联合化疗及靶向治疗在复发、转移及初治晚期宫颈癌中的疗效与安全性分析：一项回顾性队列研究

范素梅; 信聪伶; 朱来芳; 刘畅; 徐蕊; 周正荣; 程玺

doi:10.19401/j.cnki.1007-3639.2025.06.006

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卡瑞利珠单抗联合化疗及靶向治疗在复发、转移及初治晚期宫颈癌中的疗效与安全性分析：一项回顾性队列研究

论著 | 更新时间：2025-12-31

- 卡瑞利珠单抗联合化疗及靶向治疗在复发、转移及初治晚期宫颈癌中的疗效与安全性分析：一项回顾性队列研究
- Effectiveness and safety analysis of camrelizumab combined with chemotherapy and targeted therapy in patients with recurrent, metastatic, and treatment-naive advanced cervical cancer: a retrospective cohort study
- 中国癌症杂志 2025年35卷第6期页码：570-577
- 作者机构：
  
  1. 复旦大学附属肿瘤医院闵行院区肿瘤妇科，上海 201100
  2. 复旦大学附属肿瘤医院闵行院区药剂科，上海 201100
  3. 复旦大学附属肿瘤医院放射诊断科，复旦大学上海医学院肿瘤学系，上海 200032
  4. 复旦大学附属肿瘤医院闵行院区放射诊断科，上海 201100
  5. 复旦大学附属肿瘤医院肿瘤妇科，复旦大学上海医学院肿瘤学系，上海 200032
- 作者简介：
  
  [ "范素梅（0009-0007-3361-8455），学士，主治医师。" ]
  程玺（0000-0001-5568-7709），博士，主任医师，教授。
- 基金信息：
- DOI：10.19401/j.cnki.1007-3639.2025.06.006
  中图分类号： R737.33
- 收稿：2025-01-13，
  
  修回：2025-05-27，
  
  纸质出版：2025-06-30
- 稿件说明：
移动端阅览
范素梅, 信聪伶, 朱来芳, 等. 卡瑞利珠单抗联合化疗及靶向治疗在复发、转移及初治晚期宫颈癌中的疗效与安全性分析：一项回顾性队列研究[J]. 中国癌症杂志, 2025,35(6):570-577.

Sumei FAN, Congling XIN, Laifang ZHU, et al. Effectiveness and safety analysis of camrelizumab combined with chemotherapy and targeted therapy in patients with recurrent, metastatic, and treatment-naive advanced cervical cancer: a retrospective cohort study[J]. China Oncology, 2025, 35(6): 570-577.
范素梅, 信聪伶, 朱来芳, 等. 卡瑞利珠单抗联合化疗及靶向治疗在复发、转移及初治晚期宫颈癌中的疗效与安全性分析：一项回顾性队列研究[J]. 中国癌症杂志, 2025,35(6):570-577. DOI： 10.19401/j.cnki.1007-3639.2025.06.006.

Sumei FAN, Congling XIN, Laifang ZHU, et al. Effectiveness and safety analysis of camrelizumab combined with chemotherapy and targeted therapy in patients with recurrent, metastatic, and treatment-naive advanced cervical cancer: a retrospective cohort study[J]. China Oncology, 2025, 35(6): 570-577. DOI： 10.19401/j.cnki.1007-3639.2025.06.006.

摘要

背景与目的：

复发、转移及初治晚期宫颈癌的治疗仍面临挑战，免疫治疗联合化疗及靶向治疗初步显示出临床获益，但现有证据有限。本研究旨在评估卡瑞利珠联合化疗及靶向治疗对复发、转移及初治晚期宫颈癌患者预后的影响。

方法：

回顾性分析2019—2025年复旦大学附属肿瘤医院闵行院区收治的符合纳入和排除标准的复发、转移及初治晚

期宫颈癌患者的临床资料，使用对数秩检验进行生存分析，并通过单因素和多因素Cox比例风险回归模型分析探讨预后的相关因素。本研究获得了复旦大学附属肿瘤医院闵行院区伦理委员会的审批[伦理批号：（2024）伦审第（015）号

]

并豁免患者知情同意。

结果：

本研究共纳入130例患者。根据是否接受卡瑞利珠单抗分为观察组70例（卡瑞利珠单抗，可联合化疗与靶向治疗）和对照组60例（化疗联合靶向治疗）。观察组的客观缓解率（objective response rate，ORR）为72.9%，疾病控制率（disease control rate，DCR）为80.0%，显著优于未接受免疫治疗的对照组（ORR=20.0%，

=36.1，

0.001；DCR=40.0%，

=21.8，

0.001）。观察组未达到中位无进展生存期（progression-free survival，PFS），优于对照组（中位PFS=7.0个月，

0.001），Cox比例风险回归模型分析显示卡瑞利珠单抗治疗是PFS的独立保护因素（

0.001），而患者的年龄、复发转移部位、初始治疗方式和病理学类型对PFS无显著影响。观察组有29例患者（41.4%）发生≥3级不良反应，主要包括血管增生、甲减、过敏和腹泻等。

结论：

在复发、转移及初治晚期宫颈癌的治疗中，卡瑞利珠单抗治疗显著改善了患者的治疗效果和预后，延长了患者的PFS。尽管存在一定比例的≥3级不良反应，但整体上患者可接受。在实际临床中，免疫治疗联合化疗及靶向治疗为患者提供了更为有效的治疗选择。

Abstract

Background and purpose:

The treatment of recurrent

metastatic

and treatment-naïve advanced cervical cancer remains challenging. Immunotherapy in combination with chemotherapy and targeted therapy has shown preliminary clinical benefits

however

current evidence remains limited. This study aimed to evaluate the impact of camrelizumab combined with chemotherapy and targeted therapy on the prognosis of patients with recurrent

metastatic

and treatment-naïve advanced cervical cancer.

Methods:

In this study

we conducted a retrospective analysis of the clinical data from 130 patients with recurrent

metastatic

and treatment-naïve advanced cervical cancer admitted to Minhang Branch of Fudan University Shanghai Cancer Center from 2019 to 2025. The patients were categorized into the observation group (

=70)

which included those who received camrelizumab with or without chemotherapy and targeted therapy

and the control group (

=60)

including those who received chemotherapy and targeted therapy. Survival analysis was performed using the log-rank test

d univariate and multivariate Cox regression analyses were conducted to explore prognostic factors. This study was approved by the Ethics Committee of the Minhang Branch of Fudan University Shanghai Cancer Center[Approval number: (2024) Review No. (015)

]

and all informed consents were exempted.

Results:

The objective response rate (ORR) in the observation group was 72.9%

and the disease control rate (DCR) was 80.0%

which were significantly higher than those in the control group with an ORR of 20.0% (

=36.1

0.001) and a DCR of 40.0% (

=21.8

0.001). The median progression-free survival (PFS) in the observation group was not reached

significantly longer than that in the control group of 7.0 months (

0.001). Multivariate Cox regression analysis identified camrelizumab treatment as an independent protective factor for PFS (

0.001). Age

site of recurrence/metastasis

initial treatment approach

and histopathological type were not significantly associated with PFS. In the observation group

adverse events of grade 3 or higher were reported in 29 patients (41.4%)

which primarily included vasculitis

hypothyroidism

hypersensitivity reactions

and diarrhea.

Conclusion:

The use of camrelizumab significantly improved treatment outcomes and prognosis for patients with recurrent

metastatic

and treatment-naïve advanced cervical cancer

with significantly improved progression-free survival. Although a certain proportion of patients experienced adverse events of grade 3 or higher

the overall safety profile was acceptable. In clinical practice

immunotherapy offers a more effective treatment option for patients.

关键词

Keywords

references

BUSKWOFIE A , DAVID-WEST G , CLARE C A . A review of cervical cancer: incidence and disparities [J ] . J Natl Med Assoc , 2020 , 112 ( 2 ): 229 - 232 . DOI: S0027-9684(20)30043-2 http://doi.org/S0027-9684(20)30043-2

BRAY F , LAVERSANNE M , SUNG H , et al . Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries [J ] . CA Cancer J Clin , 2024 , 74 ( 3 ): 229 - 263 .

QI J L , LI M L , WANG L J , et al . National and subnational trends in cancer burden in China, 2005-20: an analysis of national mortality surveillance data [J ] . Lancet Public Health , 2023 , 8 ( 12 ): e943-e955.

MCCORMACK M , EMINOWICZ G , GALLARDO D , et al . Induction chemotherapy followed by standard chemoradiotherapy versus standard chemoradiotherapy alone in patients with locally advanced cervical cancer (GCIG INTERLACE): an international, multicentre, randomised phase 3 trial [J ] . Obstet Gynecol Surv , 2025 , 80 ( 3 ): 162 - 164 .

TANGKANANAN A , THONGKHAO P , JANMUNEE N , et al . Impact of chemotherapy cycles on oncological outcomes in elders with locally advanced cervical cancer treated with concurrent chemoradiotherapy [J ] . J Med Imaging Radiat Oncol , 2022 , 66 ( 7 ): 1014 - 1021 .

FERRALL L , LIN K Y , RODEN R B S , et al . Cervical cancer immunotherapy: facts and hopes [J ] . Clin Cancer Res , 2021 , 27 ( 18 ): 4953 - 4973 . DOI: 10.1158/1078-0432.CCR-20-2833 http://doi.org/10.1158/1078-0432.CCR-20-2833

GRAU-BEJAR J F , GARCIA-DURAN C , GARCIA-ILLESCAS D , et al . Advances in immunotherapy for cervical cancer [J ] . Ther Adv Med Oncol , 2023 , 15 : 17588359231163836.

COLOMBO N , DUBOT C , LORUSSO D , et al . Pembrolizumab for persistent, recurrent, or metastatic cervical cancer [J ] . N Engl J Med , 2021 , 385 ( 20 ): 1856 - 1867 .

TEWARI K S , MONK B J , VERGOTE I , et al . Survival with cemiplimab in recurrent cervical cancer [J ] . N Engl J Med , 2022 , 386 ( 6 ): 544 - 555 .

CHEN J , LI K , HAN Y , et al . Neoadjuvant camrelizumab plus chemotherapy in patients with locally advanced cervical cancer (NACI): a prospective, single-arm, phase Ⅱ trial [J ] . Ann Oncol , 2022 , 33 : S804 .

CHEN J , HAN Y Y , HU Y J , et al . Neoadjuvant camrelizumab plus chemotherapy for locally advanced cervical cancer (NACI Study): a study protocol of a prospective, single-arm, phase Ⅱ trial [J ] . BMJ Open , 2023 , 13 ( 5 ): e067767 .

LI K Z , CHEN J , HU Y J , et al . Neoadjuvant chemotherapy plus camrelizumab for locally advanced cervical cancer (NACI study): a multicentre, single-arm, phase 2 trial [J ] . Lancet Oncol , 2024 , 25 ( 1 ): 76 - 85 . DOI: 10.1016/S1470-2045(23)00531-4 http://doi.org/10.1016/S1470-2045(23)00531-4

LIU Z P , LIU S H , ZHAO H , et al . Pathologically complete response to camrelizumab and apatinib in advanced cervical cancer with PTEN , PIK3CA , MTOR , and ARID1A mutations: a case report [J ] . Case Rep Oncol , 2025 , 18 ( 1 ): 480 - 492 .

JIAN X L , ZHANG J J , HUANG Y , et al . Early salvage therapy with anti-PD-1 antibody camrelizumab in patients with advanced cervical cancer: a retrospective study [J ] . Clin Transl Oncol , 2025 , 27 ( 2 ): 693 - 698 .

TURINETTO M , VALSECCHI A A , TUNINETTI V , et al . Immunotherapy for cervical cancer: are we ready for prime time? [J ] . Int J Mol Sci , 2022 , 23 ( 7 ): 3559 .

YADAV A , YADAV S , ALAM M A . Immunotherapies landscape and associated inhibitors for the treatment of cervical cancer [J ] . Med Oncol , 2023 , 40 ( 11 ): 328 . DOI: 10.1007/s12032-023-02188-2 http://doi.org/10.1007/s12032-023-02188-2

GUO L P , HUA K Q . Cervical cancer: emerging immune landscape and treatment [J ] . Onco Targets Ther , 2020 , 13 : 8037 - 8047 .

MEZACHE L , PANICCIA B , NYINAWABERA A , et al . Enhanced expression of PD-L1 in cervical intraepithelial neoplasia and cervical cancers [J ] . Mod Pathol , 2015 , 28 ( 12 ): 1594 - 1602 .

ENWERE E K , KORNAGA E N , DEAN M , et al . Expression of PD-L1 and presence of CD8-positive T cells in pre-treatment specimens of locally advanced cervical cancer [J ] . Mod Pathol , 2017 , 30 ( 4 ): 577 - 586 .

MAURICIO D , ZEYBEK B , TYMON-ROSARIO J , et al . Immunotherapy in cervical cancer [J ] . Curr Oncol Rep , 2021 , 23 ( 6 ): 61 . DOI: 10.1007/s11912-021-01052-8 http://doi.org/10.1007/s11912-021-01052-8

CHUNG H C , ROS W , DELORD J P , et al . Efficacy and safety of pembrolizumab in previously treated advanced cervical cancer: results from the phase Ⅱ KEYNOTE-158 study [J ] . J Clin Oncol , 2019 , 37 ( 17 ): 1470 - 1478 .

LORUSSO D , XIANG Y , HASEGAWA K , et al . Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 trial [J ] . Lancet , 2024 , 404 ( 10460 ): 1321 - 1332 .

LAN C Y , SHEN J X , WANG Y , et al . Camrelizumab plus apatinib in patients with advanced cervical cancer (CLAP): a multicenter, open-label, single-arm, phase Ⅱ trial [J ] . J Clin Oncol , 2020 , 38 ( 34 ): 4095 - 4106 .

LAN C Y , LU H W , ZHOU L , et al . Long-term survival outcomes and immune checkpoint inhibitor retreatment in patients with advanced cervical cancer treated with camrelizumab plus apatinib in the phase Ⅱ CLAP study [J ] . Cancer Commun (Lond) , 2024 , 44 ( 6 ): 654 - 669 .

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