基于分子特征的建议:对于高中等或中等风险的早期子宫内膜癌的术后辅助治疗:PROBEAT的中国随机III期试验。
Molecular profile-based recommendations for postoperative adjuvant therapy in early endometrial cancer with high-intermediate or intermediate risk: a Chinese randomized phase III trial (PROBEAT).
发表日期:2023 Jan 10
作者:
Yang Li, Changkun Zhu, Hongyu Xie, Yaxia Chen, Weiguo Lv, Xing Xie, Xinyu Wang
来源:
Journal of Gynecologic Oncology
摘要:
分子分类的使用正在引领范式转移,以利用分子信息来细化子宫内膜癌(EC)的风险分层。迄今为止,支持分子引导治疗的证据仅限于回顾性研究和接受标准治疗的患者的次级分子分析。PROBEAT研究是第一个通过WHO认可的分子分类评估定制辅助治疗的随机III期试验,针对中国EC患者。预期将提供一种临床决策工具,以更好地优化和个性化高中间风险(HIR)或中间风险(IR)EC患者的辅助治疗,并增加无复发生存率。PROBEAT试验由浙江大学妇女医院妇科肿瘤学小组领导的前瞻性多中心研究。招募于2022年1月24日开始,预计从中国的13个临床中心招募590名HIR或IR子宫内膜样EC患者。根据WHO认可的分子分类,将所有肿瘤组织分为四个分子亚型(POLEmut、MMRd、p53abn或NSMP)。患者将以2:1的比例随机分配到实验组或标准组。实验组将接受分子谱基础的辅助治疗(在POLEmut亚组中进行观察,在MMRd或NSMP亚组中接受阴道腔内放疗,在p53abn亚组中接受化学放疗),而标准组将按照最新的全国综合癌症网络指南v1(2022年)推荐的首选辅助放疗方案。主要结果是3年的复发率。次要结果是无复发生存率、总体生存率、不良事件和健康相关癌症特异性生命质量。 ClinicalTrials.gov识别号:NCT05179447 © 2023,亚洲妇科肿瘤学会、韩国妇科肿瘤学会和日本妇科肿瘤学会。
The use of molecular categorisation is shifting paradigm towards the use of molecular information to refine risk stratification in endometrial cancer (EC). To date, evidence to support molecular-guided therapies is limited to retrospective studies and secondary molecular analyses of patients receiving standard treatment. The PROBEAT study is the first randomized phase III trial to evaluate tailored adjuvant treatment based on WHO-endorsed molecular classification in Chinese EC patients. It is expected to provide a clinical decision-making tool for adjuvant treatment of patients with high-intermediate risk (HIR) or intermediate risk (IR) EC to better optimise and personalise patient care and increase relapse-free survival.The PROBEAT trial is a prospective, multicentre study led by Women's Hospital of Zhejiang University Gynaecologic Oncology Group. Recruitment started on January 24, 2022, and 590 patients with HIR or IR endometrioid EC are expected to be recruited from 13 clinical centres in China. All tumor tissues will be classified into four molecular subtypes (POLEmut, MMRd, p53abn, or NSMP) based on WHO-endorsed molecular classification. Patients will be randomly assigned at a 2:1 ratio to either experimental arm and will receive molecular profile-based adjuvant treatment (observation in the POLEmut subgroup, vaginal brachytherapy in the MMRd or NSMP subgroup, or chemoradiotherapy in the p53abn subgroup) or to standard arm and will receive preferred adjuvant radiotherapy as recommended by the recent National Comprehensive Cancer Network guidelines version 1 (2022). The primary outcome is 3-year rates of recurrence. Secondary outcomes are relapse-free survival, overall survival, adverse events and health-related cancer-specific quality of life.ClinicalTrials.gov Identifier: NCT05179447.© 2023. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology, and Japan Society of Gynecologic Oncology.