妇科恶性肿瘤免疫治疗中国专家共识（2023年版）

doi:10.19401/j.cnki.1007-3639.2023.10.008

摘要/Abstract

摘要：

免疫治疗作为第四大抗肿瘤治疗方法，已在癌症治疗领域取得了突破性进展，其中免疫检查点抑制剂已广泛应用于多种恶性肿瘤的治疗，在妇科恶性肿瘤领域也积累了较多的临床证据和经验。但目前国内外在免疫检查点抑制剂等免疫疗法应用于妇科恶性肿瘤的治疗方面尚缺乏规范。因此，由中国抗癌协会肿瘤内分泌专业委员会牵头，组织多领域专家，以高质量临床研究结果、2023年美国临床肿瘤学会（American Society of Clinical Oncology，ASCO）会议研究结果等为循证医学依据，通过共同讨论及投票，从而形成《妇科恶性肿瘤免疫治疗中国专家共识（2023年版）》。本共识就妇科常见子宫颈癌、子宫内膜癌、卵巢癌及其他恶性肿瘤分类推荐了免疫检查点抑制剂单药或联合化疗、靶向治疗等临床应用方案。总结了肿瘤疫苗、过继性细胞免疫治疗和细胞因子等免疫治疗在妇科恶性肿瘤中的相关研究及应用情况，供国内同行参考，以期进一步规范妇科恶性肿瘤免疫治疗的临床实践。

关键词: 免疫治疗, 妇科恶性肿瘤, 免疫检查点抑制剂

Abstract:

Immunotherapy, as the fourth largest anti-tumor treatment method, has made breakthrough progress in the field of cancer treatment. Checkpoint inhibitors have been widely used in the treatment of various malignant tumors, and a lot of clinical evidence and experience have also been accumulated in the field of gynecological malignant tumors. However, there is still a lack of standardization in the application of immunotherapy such as immune checkpoint inhibitors for the treatment of gynecological malignant tumors. Therefore, led by the Cancer Endocrine Professional Committee of the China Anti-Cancer Association, experts from multiple fields were organized to use high-quality clinical research results as well as the results of the 2023 American Society of Clinical Oncology (ASCO) conference as evidence. Through discussion and voting, the consensus of Chinese experts on immunotherapy for gynecological malignant tumors (2023 version) has been formed. This consensus recommended the clinical application of immune checkpoint inhibitors for the classification of common gynecological cervical cancer, endometrial cancer, ovarian cancer and other malignant tumors, such as single drug or combination chemotherapy, targeted therapy, etc. It summarized the research and application of tumor vaccines, adoptive cell immunotherapy and cytokine immunotherapy in gynecological malignant tumors, and provided reference for domestic peers, in order to further standardize the clinical practice of immunotherapy for gynecological malignant tumors.

Key words: Immunotherapy, Gynecological malignant tumors, Immune checkpoint inhibitors

中图分类号:

R737.3

中国抗癌协会肿瘤内分泌专业委员会. 妇科恶性肿瘤免疫治疗中国专家共识（2023年版）[J]. 中国癌症杂志, 2023, 33(10): 954-967.

Society of Onco-Endocrinology of Chinese Anti-Cancer Association. Chinese expert consensus on immunotherapy for gynecological malignant tumors (2023 edition)[J]. China Oncology, 2023, 33(10): 954-967.

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证据级别	解释
证据质量分级
高	未来研究几乎不可能改变现有疗效评价结果的可信度
中	未来研究可能对现有疗效评价有重要影响，可能改变评价结果可信度
低	未来研究很可能对现有疗效评价有重要影响，改变评价结果可信度可能性比较大
极低	任何疗效的评价都很不确定
共识推荐强度分级
强	明确提示干预措施利大于弊或弊大于利
弱	利弊不确定或无论质量高低的证据均显示利弊相当

推荐	证据级别	推荐级别	备注
纳武利尤单抗用于复发性子宫内膜癌的二线治疗其他可选择方案	中	弱	dMMR/MSI-H
帕博利珠单抗用于治疗复发性子宫内膜癌	中	弱	MSI-H/dMMR或TMB-H，≥10个突变/Mb
多塔利单抗用于治疗复发性子宫内膜癌	中	弱	dMMR/MSI-H
阿维鲁单抗用于复发性子宫内膜癌的二线治疗其他可选择方案	中	弱	dMMR/MSI-H
帕博利珠单抗联合仑伐替尼治疗既往系统治疗失败复发性子宫内膜癌患者的一线治疗	高	强	非MSI-H/dMMR
帕博利珠单抗或多塔利珠单抗联合化疗（紫杉醇和卡铂）用于晚期、复发性子宫内膜癌患者的一线治疗	高	强

推荐	证据级别	推荐级别	备注
帕博利珠单抗用于复发、转移性子宫颈癌二线及以上治疗	中	强	TMB-H 、PD-L1阳性、MSI-H/dMMR
纳武利尤单抗应用于既往治疗失败的复发、转移性子宫颈癌治疗	低	弱	PD-L1阳性
西米普利单抗或卡度尼利单抗应用于既往治疗失败的复发、转移性子宫颈癌治疗	高	弱
推荐卡度尼利单抗应用于既往治疗失败的复发、转移性子宫颈癌治疗。	中	强
帕博利珠单抗联合铂类药物/紫杉醇±贝伐珠单抗用于持续性、复发性和转移性子宫颈癌一线治疗	高	强	CPS≥1或dMMR或TMB-H

推荐	证据级别	推荐级别
帕博利珠单抗适用于TMB-H、PD-L1阳性或MSI-H/dMMR的晚期或复发、转移性外阴癌的二线或后线治疗	低	弱
纳武利尤单抗用于HPV相关的晚期或复发、转移性外阴癌	低	弱
推荐帕博利珠单抗或纳武利尤单抗和（或）伊匹木单抗用于用于治疗不可切除或转移性外阴/阴道黑色素瘤患者	低	强
推荐特瑞普利单抗、普特利单抗用于经全身治疗失败的不可切除或转移性黑色素瘤的治疗	低	强
推荐对高危耐药/复发的GTN患者，可以选择单药帕博利珠单抗或卡瑞利珠单抗联合甲磺酸阿帕替尼治疗	中	强

机制	靶向/脱靶
通过B细胞扩增现有的自身抗体	靶向
抑制破坏正常组织的 T 细胞	靶向
T 细胞分泌高水平的细胞因子	靶向
抗体与组织的结合及补体的固定	脱靶