Chinese expert consensus on immunotherapy for gynecological malignant tumors (2023 edition)

doi:10.19401/j.cnki.1007-3639.2023.10.008

Abstract

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

CLC Number:

R737.3

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.

Figures/Tables 8

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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