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1
Keynote-158 study, FDA granted accelerated approval of pembrolizumab for the treatment of patients with advanced PD-L1-positive cervical cancer.在KEYNOTE-158研究中，美国食品药品监督管理局（FDA）批准帕博利珠单抗加速用于治疗晚期PD-L1阳性宫颈癌患者。
Ann Transl Med. 2020 Dec;8(23):1611. doi: 10.21037/atm-20-2656.
2
FDA Approval Summary: Pembrolizumab for Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD-L1.FDA 批准概要：帕博利珠单抗用于表达 PD-L1 的复发性局部晚期或转移性胃或胃食管连接部腺癌。
Oncologist. 2019 Jan;24(1):103-109. doi: 10.1634/theoncologist.2018-0221. Epub 2018 Aug 17.
3
FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin-Containing Chemotherapy.FDA 批准概要：阿替利珠单抗或帕博利珠单抗用于治疗不符合顺铂化疗条件的晚期尿路上皮癌患者。
Oncologist. 2019 Apr;24(4):563-569. doi: 10.1634/theoncologist.2018-0084. Epub 2018 Dec 12.
4
Safety and efficacy of pembrolizumab monotherapy in elderly patients with PD-L1-positive advanced non-small-cell lung cancer: Pooled analysis from the KEYNOTE-010, KEYNOTE-024, and KEYNOTE-042 studies.帕博利珠单抗单药治疗 PD-L1 阳性晚期非小细胞肺癌老年患者的安全性和有效性：来自 KEYNOTE-010、KEYNOTE-024 和 KEYNOTE-042 研究的汇总分析。
Lung Cancer. 2019 Sep;135:188-195. doi: 10.1016/j.lungcan.2019.07.004. Epub 2019 Jul 8.
5
FDA Approval Summary: Pembrolizumab for the Treatment of Patients With Metastatic Non-Small Cell Lung Cancer Whose Tumors Express Programmed Death-Ligand 1.美国食品药品监督管理局批准摘要：帕博利珠单抗用于治疗肿瘤表达程序性死亡配体1的转移性非小细胞肺癌患者。
Oncologist. 2016 May;21(5):643-50. doi: 10.1634/theoncologist.2015-0498. Epub 2016 Mar 29.
6
Efficacy and Safety of Pembrolizumab in Previously Treated Advanced Cervical Cancer: Results From the Phase II KEYNOTE-158 Study.帕博利珠单抗治疗既往治疗的晚期宫颈癌的疗效和安全性：来自 II 期 KEYNOTE-158 研究的结果。
J Clin Oncol. 2019 Jun 10;37(17):1470-1478. doi: 10.1200/JCO.18.01265. Epub 2019 Apr 3.
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Pembrolizumab in paediatric patients with advanced melanoma or a PD-L1-positive, advanced, relapsed, or refractory solid tumour or lymphoma (KEYNOTE-051): interim analysis of an open-label, single-arm, phase 1-2 trial.帕博利珠单抗治疗晚期黑色素瘤或 PD-L1 阳性、晚期、复发、难治性实体瘤或淋巴瘤的儿科患者（KEYNOTE-051）：一项开放标签、单臂、1-2 期临床试验的中期分析。
Lancet Oncol. 2020 Jan;21(1):121-133. doi: 10.1016/S1470-2045(19)30671-0. Epub 2019 Dec 4.
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FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond.FDA 批准概要：帕博利珠单抗治疗转移性非小细胞肺癌：一线治疗及以上。
Oncologist. 2017 Nov;22(11):1392-1399. doi: 10.1634/theoncologist.2017-0078. Epub 2017 Aug 23.
9
Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial.帕博利珠单抗对比多西他赛用于治疗后 PD-L1 阳性的、晚期非小细胞肺癌（KEYNOTE-010）：一项随机对照试验。
Lancet. 2016 Apr 9;387(10027):1540-1550. doi: 10.1016/S0140-6736(15)01281-7. Epub 2015 Dec 19.
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Pembrolizumab as first-line therapy for patients with PD-L1-positive advanced non-small cell lung cancer: a phase 1 trial.帕博利珠单抗作为程序性死亡受体配体1（PD-L1）阳性晚期非小细胞肺癌患者的一线治疗：一项1期试验。
Ann Oncol. 2017 Apr 1;28(4):874-881. doi: 10.1093/annonc/mdx008.

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1
HPV infection and the immune microenvironment in cervical cancer.宫颈癌中的人乳头瘤病毒感染与免疫微环境
Front Immunol. 2025 Jul 30;16:1645019. doi: 10.3389/fimmu.2025.1645019. eCollection 2025.
2
Efficacy and safety of cadonilimab (PD-1/CTLA-4 bi-specific antibody) and adjuvant anti-angiogenesis therapy in treated, recurrent, or metastatic cervical cancer.卡度尼利单抗（PD-1/CTLA-4双特异性抗体）联合辅助抗血管生成疗法在经治、复发或转移性宫颈癌中的疗效与安全性
Front Oncol. 2025 Jun 30;15:1614434. doi: 10.3389/fonc.2025.1614434. eCollection 2025.
3
Pathologically Complete Response to Camrelizumab and Apatinib in Advanced Cervical Cancer with PTEN, PIK3CA, MTOR, and ARID1A Mutations: A Case Report.帕博利珠单抗和阿帕替尼对伴有PTEN、PIK3CA、MTOR和ARID1A突变的晚期宫颈癌的病理完全缓解：一例报告
Case Rep Oncol. 2025 Mar 13;18(1):480-492. doi: 10.1159/000545068. eCollection 2025 Jan-Dec.
4
Dual Topoisomerase Inhibitor Is Highly Potent and Improves Antitumor Response to Radiotherapy in Cervical Carcinoma.双拓扑异构酶抑制剂具有高效能，并能改善宫颈癌对放疗的抗肿瘤反应。
Int J Mol Sci. 2025 Mar 21;26(7):2829. doi: 10.3390/ijms26072829.
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PRGN-2009 and bintrafusp alfa for patients with advanced or metastatic human papillomavirus-associated cancer.PRGN-2009和双特异性融合蛋白阿法用于晚期或转移性人乳头瘤病毒相关癌症患者。
Cancer Immunol Immunother. 2025 Mar 21;74(5):155. doi: 10.1007/s00262-025-04009-z.
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Revolutionary Cancer Therapy for Personalization and Improved Efficacy: Strategies to Overcome Resistance to Immune Checkpoint Inhibitor Therapy.用于个性化治疗和提高疗效的革命性癌症疗法：克服免疫检查点抑制剂疗法耐药性的策略
Cancers (Basel). 2025 Mar 4;17(5):880. doi: 10.3390/cancers17050880.
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Bridging the Gap: Immune Checkpoint Inhibitor as an Option in the Management of Advanced and Recurrent Cervical Cancer in Sub-Saharan Africa.缩小差距：免疫检查点抑制剂作为撒哈拉以南非洲地区晚期和复发性宫颈癌治疗的一种选择
Cureus. 2024 Sep 10;16(9):e69136. doi: 10.7759/cureus.69136. eCollection 2024 Sep.
8
PD-1 inhibitor plus concurrent chemoradiotherapy for high-risk locally advanced cervical cancer.PD-1 抑制剂联合同期放化疗治疗高危局部晚期宫颈癌。
Future Oncol. 2024;20(20):1415-1426. doi: 10.1080/14796694.2024.2342241. Epub 2024 Jun 3.
9
Case report: A case of recurrent cervical cancer with bronchial and esophageal metastases presenting with hemoptysis and dysphagia.病例报告：一例复发性宫颈癌伴支气管和食管转移，表现为咯血和吞咽困难。
Front Oncol. 2024 Apr 19;14:1375035. doi: 10.3389/fonc.2024.1375035. eCollection 2024.
10
Comparison of programmed death-ligand 1 expression in adenocarcinoma and squamous cell carcinoma of the cervix in paraffin blocks of patients with cervical cancer.宫颈癌患者石蜡块中宫颈腺癌与鳞状细胞癌程序性死亡配体1表达的比较。
Cancer Rep (Hoboken). 2024 Apr;7(4):e2057. doi: 10.1002/cnr2.2057.

本文引用的文献

1
Phase II evaluation of nivolumab in the treatment of persistent or recurrent cervical cancer (NCT02257528/NRG-GY002).尼伏鲁单抗治疗持续性或复发性宫颈癌的 II 期评价（NCT02257528/NRG-GY002）。
Gynecol Oncol. 2020 Apr;157(1):161-166. doi: 10.1016/j.ygyno.2019.12.034. Epub 2020 Jan 7.
2
Safety and Efficacy of Nivolumab Monotherapy in Recurrent or Metastatic Cervical, Vaginal, or Vulvar Carcinoma: Results From the Phase I/II CheckMate 358 Trial.尼伏鲁单抗单药治疗复发性或转移性宫颈癌、阴道癌或外阴癌的安全性和疗效：来自 I/II 期 CheckMate 358 试验的结果。
J Clin Oncol. 2019 Nov 1;37(31):2825-2834. doi: 10.1200/JCO.19.00739. Epub 2019 Sep 5.
3
Association of Ipilimumab With Safety and Antitumor Activity in Women With Metastatic or Recurrent Human Papillomavirus-Related Cervical Carcinoma.Ipilimumab 与转移性或复发性人乳头瘤病毒相关宫颈癌女性的安全性和抗肿瘤活性的关联。
JAMA Oncol. 2018 Jul 12;4(7):e173776. doi: 10.1001/jamaoncol.2017.3776.
4
Safety and Efficacy of Pembrolizumab in Advanced, Programmed Death Ligand 1-Positive Cervical Cancer: Results From the Phase Ib KEYNOTE-028 Trial.帕博利珠单抗治疗晚期程序性死亡配体 1 阳性宫颈癌的安全性和有效性：来自 Ib 期 KEYNOTE-028 试验的结果。
J Clin Oncol. 2017 Dec 20;35(36):4035-4041. doi: 10.1200/JCO.2017.74.5471. Epub 2017 Nov 2.
5
Management of patients with recurrent/advanced cervical cancer beyond first line platinum regimens: Where do we stand? A literature review.一线铂类方案治疗后复发/晚期宫颈癌患者的管理：我们目前的状况如何？文献综述
Crit Rev Oncol Hematol. 2016 Dec;108:164-174. doi: 10.1016/j.critrevonc.2016.11.006. Epub 2016 Nov 15.
6
Prognostic effect of different PD-L1 expression patterns in squamous cell carcinoma and adenocarcinoma of the cervix.不同PD-L1表达模式在宫颈鳞癌和腺癌中的预后作用
Mod Pathol. 2016 Jul;29(7):753-63. doi: 10.1038/modpathol.2016.64. Epub 2016 Apr 8.
7
Enhanced expression of PD L1 in cervical intraepithelial neoplasia and cervical cancers.程序性死亡配体1（PD-L1）在宫颈上皮内瘤变和宫颈癌中的表达增强。
Mod Pathol. 2015 Dec;28(12):1594-602. doi: 10.1038/modpathol.2015.108. Epub 2015 Sep 25.
8
Changing paradigms in the systemic treatment of advanced cervical cancer.晚期宫颈癌全身治疗模式的转变
Am J Obstet Gynecol. 2016 Jan;214(1):22-30. doi: 10.1016/j.ajog.2015.07.022. Epub 2015 Jul 26.
9
Global cancer statistics, 2012.全球癌症统计数据，2012 年。
CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
10
Improved survival with bevacizumab in advanced cervical cancer.贝伐珠单抗治疗晚期宫颈癌可提高生存率。
N Engl J Med. 2014 Feb 20;370(8):734-43. doi: 10.1056/NEJMoa1309748.

Keynote-158 study, FDA granted accelerated approval of pembrolizumab for the treatment of patients with advanced PD-L1-positive cervical cancer.

作者信息

Borcoman Edith, Le Tourneau Christophe

机构信息

Department of Drug Development and Innovation (D3i), Institut Curie, Paris & Saint-Cloud, France.

INSERM U900 Research Unit, Saint-Cloud, France.

出版信息

Ann Transl Med. 2020 Dec;8(23):1611. doi: 10.21037/atm-20-2656.

DOI:10.21037/atm-20-2656
PMID:33437810
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7791256/
Abstract
摘要