Department of Gynecology and Oncology, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
Zhejiang Provincial Key Laboratory of Precision Diagnosis and Therapy for Major Gynecological Diseases, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
J Gynecol Oncol. 2023 Mar;34(2):e37. doi: 10.3802/jgo.2023.34.e37. Epub 2023 Jan 10.
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 (mut, 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 mut 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.
分子分类的应用正在将范式转向利用分子信息来细化子宫内膜癌（EC）的风险分层。迄今为止，支持分子指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二次分子分析。PROBEAT 研究是第一项评估基于世界卫生组织（WHO）认可的分子分类的个体化辅助治疗的前瞻性、III 期随机临床试验，旨在为中国 EC 患者的高-中危（HIR）或中危（IR）患者的辅助治疗提供临床决策工具，以更好地优化和个性化患者护理，提高无复发生存率。
PROBEAT 试验是由浙江大学医学院附属妇产科医院妇科肿瘤学组领导的一项前瞻性、多中心研究。招募于 2022 年 1 月 24 日开始，预计将从中国 13 个临床中心招募 590 例 HIR 或 IR 子宫内膜样 EC 患者。所有肿瘤组织将根据 WHO 认可的分子分类分为四个分子亚型（突变型、错配修复缺陷型、p53 异常型或非特殊型子宫内膜样癌）。患者将按照 2:1 的比例随机分配到实验组和标准组。实验组将根据分子谱进行辅助治疗（突变型亚组观察，错配修复缺陷型或非特殊型子宫内膜样癌亚组阴道近距离放疗，p53 异常型亚组放化疗），标准组将根据最近的美国国家综合癌症网络指南 1 版（2022 年）推荐接受首选辅助放疗。主要结局是 3 年复发率。次要结局是无复发生存率、总生存率、不良事件和与癌症相关的健康特定生活质量。
ClinicalTrials.gov 标识符：NCT05179447。
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