1.RAD51B-AS1 promotes the malignant biological behavior of ovarian cancer through upregulation of RAD51B
WEI XINYI ; WANG CONGHUI ; TANG SANGSANG ; YANG QIAN ; SHEN ZHANGJIN ; ZHU JIAWEI ; CHENG XIAODONG ; WANG XINYU ; XIE XING ; XU JUNFEN ; LU WEIGUO
Journal of Zhejiang University. Science. B 2024;25(7):581-593,中插4-中插16
Long non-coding RNAs(lncRNAs)play an indispensable role in the occurrence and development of ovarian cancer(OC).However,the potential involvement of lncRNAs in the progression of OC is largely unknown.To investigate the detailed roles and mechanisms of RAD51 homolog B-antisense 1(RAD51B-AS1),a novel lncRNA in OC,reverse transcription-quantitative polymerase chain reaction(RT-qPCR)was performed to verify the expression of RAD51B-AS1.Cellular proliferation,metastasis,and apoptosis were detected using the cell counting kit-8(CCK-8),colony-formation,transwell,and flow cytometry assays.Mouse xenograft models were established for the detection of tumorigenesis.The results revealed that RAD51B-AS1 was significantly upregulated in a highly metastatic human OC cell line and OC tissues.RAD51B-AS1 significantly increased the proliferation and metastasis of OC cells and enhanced their resistance to anoikis.Biogenetics prediction analysis revealed that the only target gene of RAD51B-AS1 was RAD51B.Subsequent gene function experiments revealed that RAD51B exerts the same biological effects as RAD51B-AS1.Rescue experiments demonstrated that the malignant biological behaviors promoted by RAD51B-AS1 overexpression were partially or completely reversed by RAD51B silencing in vitro and in vivo.Thus,RAD51B-AS1 promotes the malignant biological behaviors of OC and activates the protein kinase B(Akt)/B cell lymphoma protein-2(Bcl-2)signaling pathway,and these effects may be associated with the positive regulation of RAD51B expression.RAD51B-AS1 is expected to serve as a novel molecular biomarker for the diagnosis and prediction of poor prognosis in OC,and as a potential therapeutic target for disease management.
2.Efficacy of dexmedetomidine for foraminal endoscopic surgery
Xinyu XING ; Yang SONG ; Jing SHEN
Chinese Journal of Primary Medicine and Pharmacy 2024;31(3):417-421
Objectives:To investigate the efficacy of dexmedetomidine for foraminal endoscopic surgery.Methods:A total of 75 patients with lumbar disc herniation who received treatment at the First Affiliated Hospital of Anhui Medical University between September 2020 and May 2021 were included in this study. Using a case-control study method, these patients were divided into three groups according to different treatment methods, with 25 patients in each group. The three groups underwent a single-segment unilateral approach for foraminal endoscopic surgery. Group A received simple process infiltration anesthesia, while Group B and Group C received a pump injection of 0.5 μg/kg/h dexmedetomidine for 20 minutes prior to surgery. Group B underwent post-surgical anesthesia adjustments, which involved joint process infiltration anesthesia that was seamlessly integrated with a pump-administered dexmedetomidine infusion at a rate of 0.4 μg/kg/h throughout the surgical procedure. Group C received joint process infiltration anesthesia that was seamlessly integrated with a pump-administered dexmedetomidine infusion at a rate of 0.6 μg/kg/h throughout the surgical procedure. Vital signs, sedation status, sedation score, length of hospital stay, pain score (VAS) immediately after surgery, pain scores at 3 and 6 hours after surgery, and changes in vital signs at different points during surgery were compared among the three groups.Results:There were no significant differences in age, sex, or surgical segment among the three groups (all P > 0.05). The postoperative length of hospital stay in Groups A, B, and C was (5.12 ± 1.15) days, (3.02 ± 0.42) days, and (3.82 ± 0.54) days, respectively ( F = 32.04, P < 0.01). At the beginning of surgery, the sedation scores in Groups A, B, and C were (1.22 ± 0.29) points, (1.28 ± 0.36) points, and (1.46 ± 0.38) points, respectively ( F = 3.28, P < 0.05). At 30 minutes after surgery, the sedation scores in the three groups were (2.12 ± 0.22) points, (2.16 ± 0.24) points, and (2.20 ± 0.24) points, respectively ( F = 3.72, P < 0.01). Immediately after surgery, the Visual Analogue Scale (VAS) scores in the three groups were (3.52 ± 0.33) points, (2.92 ± 0.55) points, and (2.82 ± 0.54) points, respectively ( F = 15.16, P < 0.01). At 3 hours after surgery, the VAS scores in the three groups were (3.64 ± 0.39) points, (2.60 ± 0.58) points, and (2.74 ± 0.54) points ( F = 30.47, P < 0.01). At 6 hours after surgery, the VAS scores in the three groups were (3.78 ± 0.43) points, (2.52 ± 0.47) points, and (2.74 ± 0.52) points, respectively ( F = 49.90, P < 0.01). There were significant differences in VAS score, heart rate, and mean arterial pressure among the three groups during articular process puncture, cannula expansion of the intervertebral foramen, and capture of the perinerve protrusion nucleus pulposus ( F = 34.59, 148.65, 164.08, 5.08, 10.81, 38.06, 43.62, 37.46, and 38.76, all P < 0.05). Conclusion:Preoperative dexmedetomidine can effectively maintain hemodynamic stability, ensure sedation levels, reduce postoperative pain, and accelerate patient recovery after surgery.
3.Research progress in effect of CXC chemokine receptor 3 on occurrence and development of nervous system diseases
Wenhui LIU ; Miao YU ; Ying GUO ; Yupeng LIU ; Yang XING ; Xinyu HONG ; Jiale CUI
Journal of Jilin University(Medicine Edition) 2024;50(5):1474-1480
Chemokines and their receptors play crucial roles in nervous system diseases,among which the CXC chemokine receptor 3(CXCR3)is an important mediator of intercellular communication.CXCR3 not only participates in inflammatory chemotaxis and malignant behaviors of tumor cells but also regulates the neurologic diseases.CXCR3 and its ligands directly or indirectly contribute to neuroinflammation and neuroimmunity,and potentially serve as therapeutic targets for diseases like multiple sclerosis,Alzheimer's disease,and glioma and so on.This review discusses the expression and impact of CXCR3 and its ligands in neurological diseases such as multiple sclerosis,neurologic tumors,neurodegenerative diseases,and neuropathic pain,as well as their associations with CXCR3 ligands.Understanding the mechanisms linking CXCR3 to these diseases could facilitate its potential as an early diagnostic biomarker and a target for drug intervention,and provide the basis of studying the occurrence and developmant of nervous system disease.
4.Progress in resource utilization and model animal research of Daurian ground squirrel
Xin XING ; Youtao FU ; Xinyu LIU ; Ming YANG
Acta Laboratorium Animalis Scientia Sinica 2024;32(8):1052-1058
The Daurian ground squirrel(Spermophilus dauricus)is the main animal model used for hibernation research in China.This species has many striking physiological adaptive characteristics,such as an adaptation to extreme hypothermia,a low metabolism,resistance to ischemia-reperfusion injury,disuse muscular atrophy,and unique mechanisms of body fat accumulation.These characteristics make the Daurian ground squirrel a unique and significant reference model with research value in clinical and space flight applications.The application of the Daurian ground squirrel as a model animal will help us to further explore the physiological mechanisms mentioned above.This review summarizes the biological characteristics and research values of Daurian ground squirrels in clinical and space flight applications.We also introduce the current progress made in the breeding and experimental animalization of Daurian ground squirrels for laboratory and field research,and advise on precautions that need to be considered during the experimental animalization of this species.
5.Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients (version 2024)
Yao LU ; Yang LI ; Leiying ZHANG ; Hao TANG ; Huidan JING ; Yaoli WANG ; Xiangzhi JIA ; Li BA ; Maohong BIAN ; Dan CAI ; Hui CAI ; Xiaohong CAI ; Zhanshan ZHA ; Bingyu CHEN ; Daqing CHEN ; Feng CHEN ; Guoan CHEN ; Haiming CHEN ; Jing CHEN ; Min CHEN ; Qing CHEN ; Shu CHEN ; Xi CHEN ; Jinfeng CHENG ; Xiaoling CHU ; Hongwang CUI ; Xin CUI ; Zhen DA ; Ying DAI ; Surong DENG ; Weiqun DONG ; Weimin FAN ; Ke FENG ; Danhui FU ; Yongshui FU ; Qi FU ; Xuemei FU ; Jia GAN ; Xinyu GAN ; Wei GAO ; Huaizheng GONG ; Rong GUI ; Geng GUO ; Ning HAN ; Yiwen HAO ; Wubing HE ; Qiang HONG ; Ruiqin HOU ; Wei HOU ; Jie HU ; Peiyang HU ; Xi HU ; Xiaoyu HU ; Guangbin HUANG ; Jie HUANG ; Xiangyan HUANG ; Yuanshuai HUANG ; Shouyong HUN ; Xuebing JIANG ; Ping JIN ; Dong LAI ; Aiping LE ; Hongmei LI ; Bijuan LI ; Cuiying LI ; Daihong LI ; Haihong LI ; He LI ; Hui LI ; Jianping LI ; Ning LI ; Xiying LI ; Xiangmin LI ; Xiaofei LI ; Xiaojuan LI ; Zhiqiang LI ; Zhongjun LI ; Zunyan LI ; Huaqin LIANG ; Xiaohua LIANG ; Dongfa LIAO ; Qun LIAO ; Yan LIAO ; Jiajin LIN ; Chunxia LIU ; Fenghua LIU ; Peixian LIU ; Tiemei LIU ; Xiaoxin LIU ; Zhiwei LIU ; Zhongdi LIU ; Hua LU ; Jianfeng LUAN ; Jianjun LUO ; Qun LUO ; Dingfeng LYU ; Qi LYU ; Xianping LYU ; Aijun MA ; Liqiang MA ; Shuxuan MA ; Xainjun MA ; Xiaogang MA ; Xiaoli MA ; Guoqing MAO ; Shijie MU ; Shaolin NIE ; Shujuan OUYANG ; Xilin OUYANG ; Chunqiu PAN ; Jian PAN ; Xiaohua PAN ; Lei PENG ; Tao PENG ; Baohua QIAN ; Shu QIAO ; Li QIN ; Ying REN ; Zhaoqi REN ; Ruiming RONG ; Changshan SU ; Mingwei SUN ; Wenwu SUN ; Zhenwei SUN ; Haiping TANG ; Xiaofeng TANG ; Changjiu TANG ; Cuihua TAO ; Zhibin TIAN ; Juan WANG ; Baoyan WANG ; Chunyan WANG ; Gefei WANG ; Haiyan WANG ; Hongjie WANG ; Peng WANG ; Pengli WANG ; Qiushi WANG ; Xiaoning WANG ; Xinhua WANG ; Xuefeng WANG ; Yong WANG ; Yongjun WANG ; Yuanjie WANG ; Zhihua WANG ; Shaojun WEI ; Yaming WEI ; Jianbo WEN ; Jun WEN ; Jiang WU ; Jufeng WU ; Aijun XIA ; Fei XIA ; Rong XIA ; Jue XIE ; Yanchao XING ; Yan XIONG ; Feng XU ; Yongzhu XU ; Yongan XU ; Yonghe YAN ; Beizhan YAN ; Jiang YANG ; Jiangcun YANG ; Jun YANG ; Xinwen YANG ; Yongyi YANG ; Chunyan YAO ; Mingliang YE ; Changlin YIN ; Ming YIN ; Wen YIN ; Lianling YU ; Shuhong YU ; Zebo YU ; Yigang YU ; Anyong YU ; Hong YUAN ; Yi YUAN ; Chan ZHANG ; Jinjun ZHANG ; Jun ZHANG ; Kai ZHANG ; Leibing ZHANG ; Quan ZHANG ; Rongjiang ZHANG ; Sanming ZHANG ; Shengji ZHANG ; Shuo ZHANG ; Wei ZHANG ; Weidong ZHANG ; Xi ZHANG ; Xingwen ZHANG ; Guixi ZHANG ; Xiaojun ZHANG ; Guoqing ZHAO ; Jianpeng ZHAO ; Shuming ZHAO ; Beibei ZHENG ; Shangen ZHENG ; Huayou ZHOU ; Jicheng ZHOU ; Lihong ZHOU ; Mou ZHOU ; Xiaoyu ZHOU ; Xuelian ZHOU ; Yuan ZHOU ; Zheng ZHOU ; Zuhuang ZHOU ; Haiyan ZHU ; Peiyuan ZHU ; Changju ZHU ; Lili ZHU ; Zhengguo WANG ; Jianxin JIANG ; Deqing WANG ; Jiongcai LAN ; Quanli WANG ; Yang YU ; Lianyang ZHANG ; Aiqing WEN
Chinese Journal of Trauma 2024;40(10):865-881
Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.
6.Prediction of Prostate Cancer Risk Stratification Based on A Nonlinear Transformation Stacking Learning Strategy
Xinyu CAO ; Yin FANG ; Chunguang YANG ; Zhenghao LIU ; Guoping XU ; Yan JIANG ; Peiyan WU ; Wenbo SONG ; Hanshuo XING ; Xinglong WU
International Neurourology Journal 2024;28(1):33-43
Purpose:
Prostate cancer (PCa) is an epithelial malignancy that originates in the prostate gland and is generally categorized into low, intermediate, and high-risk groups. The primary diagnostic indicator for PCa is the measurement of serum prostate-specific antigen (PSA) values. However, reliance on PSA levels can result in false positives, leading to unnecessary biopsies and an increased risk of invasive injuries. Therefore, it is imperative to develop an efficient and accurate method for PCa risk stratification. Many recent studies on PCa risk stratification based on clinical data have employed a binary classification, distinguishing between low to intermediate and high risk. In this paper, we propose a novel machine learning (ML) approach utilizing a stacking learning strategy for predicting the tripartite risk stratification of PCa.
Methods:
Clinical records, featuring attributes selected using the lasso method, were utilized with 5 ML classifiers. The outputs of these classifiers underwent transformation by various nonlinear transformers and were then concatenated with the lasso-selected features, resulting in a set of new features. A stacking learning strategy, integrating different ML classifiers, was developed based on these new features.
Results:
Our proposed approach demonstrated superior performance, achieving an accuracy of 0.83 and an area under the receiver operating characteristic curve value of 0.88 in a dataset comprising 197 PCa patients with 42 clinical characteristics.
Conclusions
This study aimed to improve clinicians’ ability to rapidly assess PCa risk stratification while reducing the burden on patients. This was achieved by using artificial intelligence-related technologies as an auxiliary method for diagnosing PCa.
7.Adjuvant chemotherapy versus adjuvant concurrent chemoradiotherapy after radical surgery for early-stage cervical cancer: a randomized, non-inferiority, multicenter trial.
Danhui WENG ; Huihua XIONG ; Changkun ZHU ; Xiaoyun WAN ; Yaxia CHEN ; Xinyu WANG ; Youzhong ZHANG ; Jie JIANG ; Xi ZHANG ; Qinglei GAO ; Gang CHEN ; Hui XING ; Changyu WANG ; Kezhen LI ; Yaheng CHEN ; Yuyan MAO ; Dongxiao HU ; Zimin PAN ; Qingqin CHEN ; Baoxia CUI ; Kun SONG ; Cunjian YI ; Guangcai PENG ; Xiaobing HAN ; Ruifang AN ; Liangsheng FAN ; Wei WANG ; Tingchuan XIONG ; Yile CHEN ; Zhenzi TANG ; Lin LI ; Xingsheng YANG ; Xiaodong CHENG ; Weiguo LU ; Hui WANG ; Beihua KONG ; Xing XIE ; Ding MA
Frontiers of Medicine 2023;17(1):93-104
We conducted a prospective study to assess the non-inferiority of adjuvant chemotherapy alone versus adjuvant concurrent chemoradiotherapy (CCRT) as an alternative strategy for patients with early-stage (FIGO 2009 stage IB-IIA) cervical cancer having risk factors after surgery. The condition was assessed in terms of prognosis, adverse effects, and quality of life. This randomized trial involved nine centers across China. Eligible patients were randomized to receive adjuvant chemotherapy or CCRT after surgery. The primary end-point was progression-free survival (PFS). From December 2012 to December 2014, 337 patients were subjected to randomization. Final analysis included 329 patients, including 165 in the adjuvant chemotherapy group and 164 in the adjuvant CCRT group. The median follow-up was 72.1 months. The three-year PFS rates were both 91.9%, and the five-year OS was 90.6% versus 90.0% in adjuvant chemotherapy and CCRT groups, respectively. No significant differences were observed in the PFS or OS between groups. The adjusted HR for PFS was 0.854 (95% confidence interval 0.415-1.757; P = 0.667) favoring adjuvant chemotherapy, excluding the predefined non-inferiority boundary of 1.9. The chemotherapy group showed a tendency toward good quality of life. In comparison with post-operative adjuvant CCRT, adjuvant chemotherapy treatment showed non-inferior efficacy in patients with early-stage cervical cancer having pathological risk factors. Adjuvant chemotherapy alone is a favorable alternative post-operative treatment.
Female
;
Humans
;
Uterine Cervical Neoplasms/drug therapy*
;
Prospective Studies
;
Quality of Life
;
Neoplasm Staging
;
Chemoradiotherapy
;
Chemotherapy, Adjuvant/adverse effects*
;
Adjuvants, Immunologic
;
Antineoplastic Combined Chemotherapy Protocols/therapeutic use*
;
Retrospective Studies
8.Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial.
Chengyuan GU ; Zengjun WANG ; Tianxin LIN ; Zhiyu LIU ; Weiqing HAN ; Xuhui ZHANG ; Chao LIANG ; Hao LIU ; Yang YU ; Zhenzhou XU ; Shuang LIU ; Jingen WANG ; Linghua JIA ; Xin YAO ; Wenfeng LIAO ; Cheng FU ; Zhaohui TAN ; Guohua HE ; Guoxi ZHU ; Rui FAN ; Wenzeng YANG ; Xin CHEN ; Zhizhong LIU ; Liqiang ZHONG ; Benkang SHI ; Degang DING ; Shubo CHEN ; Junli WEI ; Xudong YAO ; Ming CHEN ; Zhanpeng LU ; Qun XIE ; Zhiquan HU ; Yinhuai WANG ; Hongqian GUO ; Tiwu FAN ; Zhaozhao LIANG ; Peng CHEN ; Wei WANG ; Tao XU ; Chunsheng LI ; Jinchun XING ; Hong LIAO ; Dalin HE ; Zhibin WU ; Jiandi YU ; Zhongwen FENG ; Mengxiang YANG ; Qifeng DOU ; Quan ZENG ; Yuanwei LI ; Xin GOU ; Guangchen ZHOU ; Xiaofeng WANG ; Rujian ZHU ; Zhonghua ZHANG ; Bo ZHANG ; Wanlong TAN ; Xueling QU ; Hongliang SUN ; Tianyi GAN ; Dingwei YE
Chinese Medical Journal 2023;136(10):1207-1215
BACKGROUND:
LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer.
METHODS:
We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels.
RESULTS:
On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]).
CONCLUSION:
LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT04563936.
Humans
;
Male
;
Antineoplastic Agents, Hormonal/therapeutic use*
;
East Asian People
;
Gonadotropin-Releasing Hormone/agonists*
;
Goserelin/therapeutic use*
;
Prostate-Specific Antigen
;
Prostatic Neoplasms/drug therapy*
;
Testosterone
9.Application of virtual intelligent system in bronchoscopy theory and operation training for PCCM physicians
Lü XING ; Weiyun BI ; Yan ZHANG ; Xinyu TI
Chinese Journal of Medical Education Research 2023;22(7):1074-1078
Objective:To evaluate the role of virtual bronchoscopy intelligent system in improving the theory and operation level of bronchoscopy in pulmonary and critical care medicine (PCCM) teaching for standardized training specialists.Methods:A total of 50 PCCM physicians who had participated in virtual bronchoscopy training in Xijing Hospital, Air Force Medical University from 2018 to 2021 were selected as research subjects. In this study, self-controlled method was adopted to evaluate the change of assessment indicators after 1 week and 2 weeks of training. Questionnaire survey was also used to evaluate the training effect. SPSS 23.0 software was used for paired t-test and Chi-square test. Results:All the 50 PCCM physicians successfully completed the training of virtual bronchoscopy operation. The theoretical score was significantly improved after the training [(80.0±5.2) points vs. (92.4±3.8) points]. The basic operation time [(1 050.9±103.3) s vs. (386.4±47.7) s], and the number of hitting the bronchial wall [(88.3±12.7) times vs. (27.0±5.3) times] were significantly reduced. The recovery rate of alveolar lavage fluid [(27.6±7.4)% vs. (58.0±8.2)%] and the positive rate of biopsy [(19.2±13.1)% vs. (86.8±10.8)%] were significantly increased. The learning curve of the final score indicated that the score improved more rapidly in the first week of training, and the score improved more slowly in the second week of training. Questionnaires before and after the training indicated that virtual intelligent training could significantly improve the confidence and proficiency of students in bronchoscopy.Conclusion:Through the systematic training of virtual bronchoscopy intelligent system, the PCCM physicians have significantly improved their theoretical knowledge and operational proficiency. Therefore, the virtual bronchoscopy training system has practical significance for improving the overall training effect of clinical bronchoscopy for PCCM trainees, which is worthy of promotion.
10.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)
Yang LI ; Changkun ZHU ; Hongyu XIE ; Yaxia CHEN ; Weiguo LV ; Xing XIE ; Xinyu WANG
Journal of Gynecologic Oncology 2023;34(2):e37-
Background:
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.
Methods
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.

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