1.A Single-Arm Phase II Clinical Trial of Fulvestrant Combined with Neoadjuvant Chemotherapy of ER+/HER2– Locally Advanced Breast Cancer: Integrated Analysis of 18F-FES PET-CT and Metabolites with Treatment Response
Qing SHAO ; Ningning ZHANG ; Xianjun PAN ; Wenqi ZHOU ; Yali WANG ; Xiaoliang CHEN ; Jing WU ; Xiaohua ZENG
Cancer Research and Treatment 2025;57(1):126-139
Purpose:
This Phase II trial was objected to evaluate the efficacy and safety of adding fulvestrant to neoadjuvant chemotherapy in patients with estrogen receptor (ER)+/human epidermal growth factor receptor 2 (HER2)– locally advanced breast cancer (LABC). Additionally, the study aimed to investigate the association of 16α-18F-fluoro-17β-fluoroestradiol (18F-FES) positron emission tomography (PET)–computed tomography (CT) and metabolites with efficacy.
Materials and Methods:
Fulvestrant and EC-T regimen were given to ER+/HER2– LABC patients before surgery. At baseline, patients received 18F-FES PET-CT scan, and plasma samples were taken for liquid chromatography–mass spectrometry analysis. The primary endpoint was objective response rate (ORR). Secondary endpoints included total pathologic complete response (tpCR) and safety.
Results:
Among the 36 patients enrolled, the ORR was 86.1%, the tpCR rate was 8.3%. The incidence of grade ≥ 3 treatment-emergent adverse events was 22%. The decrease in ER value in sensitive patients was larger than that in non-sensitive patients, as was Ki-67 (p < 0.05). The maximum standardized uptake value, mean standardized uptake values, total lesion ER expression of 18F-FES PET-CT in sensitive patients were significantly higher than those in non-sensitive patients (p < 0.05). Moreover, these parameters were significantly correlated with Miller and Payne grade and the change in ER expression before and after treatment (p < 0.05). Thirteen differential expressed metabolites were identified, which were markedly enriched in 19 metabolic pathways.
Conclusion
This regimen demonstrated acceptable toxicity and encouraging antitumor efficacy. 18F-FES PET-CT might serve as a tool to predict the effectiveness of this therapy. Altered metabolites or metabolic pathways might be associated with treatment response.
2.A Single-Arm Phase II Clinical Trial of Fulvestrant Combined with Neoadjuvant Chemotherapy of ER+/HER2– Locally Advanced Breast Cancer: Integrated Analysis of 18F-FES PET-CT and Metabolites with Treatment Response
Qing SHAO ; Ningning ZHANG ; Xianjun PAN ; Wenqi ZHOU ; Yali WANG ; Xiaoliang CHEN ; Jing WU ; Xiaohua ZENG
Cancer Research and Treatment 2025;57(1):126-139
Purpose:
This Phase II trial was objected to evaluate the efficacy and safety of adding fulvestrant to neoadjuvant chemotherapy in patients with estrogen receptor (ER)+/human epidermal growth factor receptor 2 (HER2)– locally advanced breast cancer (LABC). Additionally, the study aimed to investigate the association of 16α-18F-fluoro-17β-fluoroestradiol (18F-FES) positron emission tomography (PET)–computed tomography (CT) and metabolites with efficacy.
Materials and Methods:
Fulvestrant and EC-T regimen were given to ER+/HER2– LABC patients before surgery. At baseline, patients received 18F-FES PET-CT scan, and plasma samples were taken for liquid chromatography–mass spectrometry analysis. The primary endpoint was objective response rate (ORR). Secondary endpoints included total pathologic complete response (tpCR) and safety.
Results:
Among the 36 patients enrolled, the ORR was 86.1%, the tpCR rate was 8.3%. The incidence of grade ≥ 3 treatment-emergent adverse events was 22%. The decrease in ER value in sensitive patients was larger than that in non-sensitive patients, as was Ki-67 (p < 0.05). The maximum standardized uptake value, mean standardized uptake values, total lesion ER expression of 18F-FES PET-CT in sensitive patients were significantly higher than those in non-sensitive patients (p < 0.05). Moreover, these parameters were significantly correlated with Miller and Payne grade and the change in ER expression before and after treatment (p < 0.05). Thirteen differential expressed metabolites were identified, which were markedly enriched in 19 metabolic pathways.
Conclusion
This regimen demonstrated acceptable toxicity and encouraging antitumor efficacy. 18F-FES PET-CT might serve as a tool to predict the effectiveness of this therapy. Altered metabolites or metabolic pathways might be associated with treatment response.
3.A Single-Arm Phase II Clinical Trial of Fulvestrant Combined with Neoadjuvant Chemotherapy of ER+/HER2– Locally Advanced Breast Cancer: Integrated Analysis of 18F-FES PET-CT and Metabolites with Treatment Response
Qing SHAO ; Ningning ZHANG ; Xianjun PAN ; Wenqi ZHOU ; Yali WANG ; Xiaoliang CHEN ; Jing WU ; Xiaohua ZENG
Cancer Research and Treatment 2025;57(1):126-139
Purpose:
This Phase II trial was objected to evaluate the efficacy and safety of adding fulvestrant to neoadjuvant chemotherapy in patients with estrogen receptor (ER)+/human epidermal growth factor receptor 2 (HER2)– locally advanced breast cancer (LABC). Additionally, the study aimed to investigate the association of 16α-18F-fluoro-17β-fluoroestradiol (18F-FES) positron emission tomography (PET)–computed tomography (CT) and metabolites with efficacy.
Materials and Methods:
Fulvestrant and EC-T regimen were given to ER+/HER2– LABC patients before surgery. At baseline, patients received 18F-FES PET-CT scan, and plasma samples were taken for liquid chromatography–mass spectrometry analysis. The primary endpoint was objective response rate (ORR). Secondary endpoints included total pathologic complete response (tpCR) and safety.
Results:
Among the 36 patients enrolled, the ORR was 86.1%, the tpCR rate was 8.3%. The incidence of grade ≥ 3 treatment-emergent adverse events was 22%. The decrease in ER value in sensitive patients was larger than that in non-sensitive patients, as was Ki-67 (p < 0.05). The maximum standardized uptake value, mean standardized uptake values, total lesion ER expression of 18F-FES PET-CT in sensitive patients were significantly higher than those in non-sensitive patients (p < 0.05). Moreover, these parameters were significantly correlated with Miller and Payne grade and the change in ER expression before and after treatment (p < 0.05). Thirteen differential expressed metabolites were identified, which were markedly enriched in 19 metabolic pathways.
Conclusion
This regimen demonstrated acceptable toxicity and encouraging antitumor efficacy. 18F-FES PET-CT might serve as a tool to predict the effectiveness of this therapy. Altered metabolites or metabolic pathways might be associated with treatment response.
4.Transplacental digoxin treatment for fetal supraventricular arrhythmias: Insights from Chinese fetuses.
Chuan WANG ; Li ZHAO ; Shuran SHAO ; Haiyan YU ; Shu ZHOU ; Yifei LI ; Qi ZHU ; Xiaoliang LIU ; Hongyu DUAN ; Hanmin LIU ; Yimin HUA ; Kaiyu ZHOU
Chinese Medical Journal 2025;138(12):1499-1501
5.CHAF1B promotes the progression of lung squamous-cell carcinoma by inhibiting SETD7 expression.
Zhuo ZHENG ; Yongfang LIN ; Hua GUO ; Zheng LIU ; Xiaoliang JIE ; Guizhen WANG ; Guangbiao ZHOU
Frontiers of Medicine 2025;19(2):318-328
The p60 subunit of the chromatin assembly factor-1 complex, that is, chromatin assembly factor-1 subunit B (CHAF1B), is a histone H3/H4 chaperone crucial for the transcriptional regulation of cell differentiation and self-renewal. CHAF1B is overexpressed in several cancers and may represent a potential target for cancer therapy. However, its expression and clinical significance in lung squamous-cell carcinoma (LUSC) remain unclear. In this study, we performed weighted gene correlation network analysis to analyze the Gene Expression Omnibus GSE68793 LUSC dataset and identified CHAF1B as one of the most important driver gene candidates. Immunohistochemical analysis of 126 LUSC tumor samples and 80 adjacent normal lung tissues showed the marked upregulation of CHAF1B in tumor tissues and the negative association of its expression level with patient survival outcomes. Silencing of CHAF1B suppressed LUSC proliferation in vitro and LUSC tumor growth in vivo. Furthermore, bulk RNA sequencing of CHAF1B knockdown cells indicated SET domain containing 7 (SETD7) as a significant CHAF1B target gene. In addition, CHAF1B competitively binds to the SETD7 promoter region and represses its transcription. Altogether, these results imply that CHAF1B plays a vital role in LUSC tumorigenesis and may represent a potential molecular target for this deadly disease.
Humans
;
Lung Neoplasms/metabolism*
;
Histone-Lysine N-Methyltransferase/metabolism*
;
Carcinoma, Squamous Cell/metabolism*
;
Gene Expression Regulation, Neoplastic
;
Disease Progression
;
Cell Proliferation/genetics*
;
Cell Line, Tumor
;
Chromatin Assembly Factor-1/metabolism*
;
Animals
;
Mice
;
Male
;
Female
6.Contrast-enhanced computed tomography radiomics for the preoperative prediction model of microvascular invasion in intrahepatic cholangiocarcinoma
Zheyu ZHOU ; Shuya CAO ; Chunlong ZHAO ; Qiaoyu LIU ; Xiaoliang XU ; Chaobo CHEN
International Journal of Surgery 2024;51(8):511-516
Objective:To predict the status of microvascular invasion (MVI) in intrahepatic cholangiocarcinoma (ICC) patients preoperatively based on the radiomics analysis of contrast-enhanced CT to provide imaging evidence for early identification of patients at high risk of recurrence.Methods:Clinical data of 40 ICC patients who underwent radical hepatectomy at Nanjing Drum Tower Hospital from January 2021 to May 2024 were retrospectively collected. Patients were divided into the MVI group ( n=8) and the non-MVI group ( n=32) according to the MVI status of the postoperative pathology report. Whether there were differences in each pathological index between the groups and the efficacy of radiomics analysis of contrast-enhanced CT for the preoperative prediction of MVI were analyzed. The regions of interest (ROI) were outlined on the arterial and venous phase images using the 3D Slicer software. Then, radiomics features were extracted from each ROI based on Python. Finally, the LASSO regression and glm function were used to screen radiomics features and establish a prediction model based on the R language. The established predictive model′s diagnostic efficacy, calibration, and net clinical benefit were evaluated using the receiver operating characteristic (ROC) curve, calibration curve, and decision curve analysis (DCA), respectively. Normally distributed measurement data were expressed as mean±standard deviation ( ± s) and compared using the t-test. Count data were expressed as frequency and compared using the chi-square test. Results:Patients in the MVI group had more poorly differentiated tumors and a significantly higher proportion of lymph node metastases ( P<0.05). The established radiomics prediction model included six features, 1 first-order statistical feature and 5 gray texture features. The area under the ROC curve was 0.87, the sensitivity was 75.0%, and the specificity was 90.6%. The calibration curve showed good agreement between the predicted MVI and actual MVI status, and the decision curve demonstrated that the model could provide a large net clinical benefit. Conclusion:Radiomics analysis of contrast-enhanced CT can identify the MVI status of ICC patients preoperatively and aid in clinical decision-making, providing vital evidence for individualized and precise treatment of ICC.
7.Effect of buccal needle therapy on perioperative analgesic effects in patients undergoing laparoscopic radical colon cancer surgery
Yihui ZHOU ; Meihua ZHU ; Haiqing HU ; Cong NIU ; Xiaoliang YANG ; Jiamin ZHANG ; Zhiyong CHEN
The Journal of Clinical Anesthesiology 2024;40(7):704-708
Objective To observe the effect of buccal needle therapy on perioperative analgesia in patients undergoing laparoscopic radical colon cancer surgery.Methods Sixty patients underwent dective laparoscopic radical of colon cancer surgery were selected,32 males and 28 females,aged 45-74 years,BMI 18.5-25.0 kg/m2 and ASA physical status Ⅱ or Ⅲ.The patients were divided into two groups using the randomized numerical table method:buccal needle group and control group,30 patients in each group.Before the induction of anesthesia,the buccal needle group was given buccal needle therapy once,and buc-cal needle therapy was performed once a day at 9 a.m.in the postoperative period,leaving the needle in place for 30 minutes each time,for 3 consecutive days of treatment,and the control group was not treated with buccal needle therapy.The amount of intraoperative propofol,remifentanil,sufentanil used in the 48 hours postoperative period and recorded.VAS pain scores were recorded at 1 hour,4,24,and 48 hours postoperatively.Venous blood was collected at the time of admission to the hand room and at 1 day,2,and 3 days postoperatively,respectively,and the concentrations of plasma C-reactive protein(CRP),interleu-kin-6(IL-6),and tumor necrosis factor-alpha(TNF-α)were measured.The occurrence of adverse reactions within 48 hours after operation was recorded.Results Compared with the control group,intraop-erative propofol,remifentanil,the amount of sufentanil used and the number of analgesic pump presses with-in 48 hours after operation in the buccal needle group were significantly reduced in the buccal needle group(P<0.05),VAS pain scores were significantly lower at 1 hour,4,24,and 48 hours postoperatively(P<0.05),CRP,IL-6,and TNF-α concentrations were significantly lower at 1 day,2,and 3 days postopera-tively(P<0.05),and nausea and vomiting,incidence of laryngospasm and laryngeal discomfort were sig-nificantly reduced(P<0.05).Conclusion The perioperative use of buccal needle therapy in patients un-dergoing laparoscopic radical colon cancer surgery can effectively reduce pain,inhibit inflammatory respon-ses,and decrease the incidence of postoperative adverse reactions.
8.Effects of different doses of sodium valproate on serum TSH,PRL and DA levels in patients with bipolar disorder
Yanlin LIU ; Hui LI ; Xiaoliang ZHOU
The Journal of Practical Medicine 2024;40(1):97-101
Objective To explore the effects of different doses of valproate on serum thyroxine(TSH),prolactin(PRL)and dopamine(DA)in patients with bipolar disorder(BPD)level of influence.Methods A total of 90 patients with BPD who received treatment in hospital from May 2020 to May 2022 were selected as the study objects.They were randomly divided into groups A,B and C,with 30 cases in all.Groups A,B and C were orally administered 10 mg/kg,15 mg/kg and 20 mg/kg sodium valproate every day,respectively.The clinical efficacy,scores of mental diseases before and after treatment,indexes related to blood drug concentration,serum levels before and after treatment,indexes related to liver function and incidence of adverse reactions were compared among the three groups.Results There was no significant difference in the total effective rate among the three groups after treatment(P>0.05).After treatment,the scores of the three groups were significantly improved compared with before treatment(P<0.05).There was significant difference in the time to reach the stable state serum concentration(P<0.05).There were no significant differences in TSH,PRL and DA levels among the three groups after treatment compared with before treatment(P>0.05).ALT and AST levels in the three groups after treatment were increased compared with those before treatment(P<0.05),and there were statistically significant differences in ALT and AST levels among the three groups after treatment(P<0.05).There was significant difference in the incidence of adverse reactions among the three groups(P<0.05).Conclusion Sodium valproate can effectively treat BPD patients and relieve the degree of mania or depression,but has no significant effect on the level of TSH,PRL and DA.Among them,small dose of sodium valproate can guarantee the thera-peutic effect and have less impact on liver function,and less adverse reactions,high safety,worthy of clinical promotion.
9.Risk factors for adjacent vertebral compression fractures after percutaneous vertebroplasty
Dongyuan LIU ; Haishan GUAN ; Haoran SHI ; Xiaoliang LIU ; Haosheng ZHOU
Chinese Journal of Tissue Engineering Research 2024;28(36):5884-5891
BACKGROUND:Percutaneous vertebroplasty is the most widely used method for the treatment of osteoporotic vertebral compression fractures,and most studies have concluded that percutaneous vertebroplasty increases the probability of adjacent vertebral secondary compression fractures in patients with osteoporotic vertebral compression fractures.However,controversy remains regarding the risk factors associated with adjacent vertebral re-fracture caused after percutaneous vertebroplasty. OBJECTIVE:To summarize the influencing factors of adjacent vertebral compression fractures after percutaneous vertebroplasty in patients with osteoporotic vertebral compression fractures,in order to provide a certain reference for reducing the risk of its occurrence as well as formulating the corresponding treatment plan. METHODS:Using"osteoporosis,fracture,percutaneous vertebroplasty,adjacent vertebral compression fractures,risk factors"as the Chinese search terms,"osteoporosis,osteoporotic vertebral compression fractures,percutaneous vertebroplasty,adjacent vertebral compression fractures,risk factors"as English search terms,computerized searches were conducted on CNKI,Wanfang Medical Network,VIP,PubMed,Springer,ScienceDirect,and Elsevier databases.The search timeframe focuses on January 2018 through September 2023,with the inclusion of a few classic forward literature.The literature was screened by reading the titles and abstracts,and 83 papers were finally included in the review. RESULTS AND CONCLUSION:(1)Osteoporotic vertebral compression fractures are one of the most common complications of osteoporosis,placing elderly patients at a significant risk of disability and death.Percutaneous vertebroplasty is a practical and effective treatment for osteoporotic vertebral compression fractures.(2)With the popularity of percutaneous vertebroplasty,its secondary vertebral compression fractures have gradually increased,with adjacent vertebral compression fractures being the most common.(3)Previous studies have only discussed the effects of factors such as bone mineral density,multiple vertebral fractures,body mass index,age,sex,amount of bone cement,cement leakage,and anti-osteoporosis treatment on secondary compression fractures of adjacent vertebrae after percutaneous vertebroplasty,and summarized the number of vertebral fractures,timing of the operation,surgical approach,cement material,diffuse distribution of bone cement,recovery height of the injured vertebrae,and wearing of a support after surgery,which is not yet comprehensive.The analysis of the specific mechanisms of risk factor-induced adjacent vertebral fractures is relatively rare.(4)The results of the article showed that low bone mineral density,advanced age,perimenopausal women,multiple vertebral fractures,excessive recovery of the height of the injured vertebrae,cement leakage,comorbid underlying diseases,and poor lifestyle habits were the risk factors for secondary adjacent vertebral compression fractures after percutaneous vertebroplasty,and that maintaining a normal body mass index,early surgery,bilateral percutaneous vertebroplasty,use of a new type of cement material,an appropriate volume of bone cement injection and uniform cement dispersion,regular anti-osteoporosis treatment,and postoperative brace wearing are protective factors for secondary adjacent vertebral compression fractures after percutaneous vertebroplasty.
10.A national questionnaire survey on endoscopic treatment for gastroesophageal varices in portal hypertension in China
Xing WANG ; Bing HU ; Yiling LI ; Zhijie FENG ; Yanjing GAO ; Zhining FAN ; Feng JI ; Bingrong LIU ; Jinhai WANG ; Wenhui ZHANG ; Tong DANG ; Hong XU ; Derun KONG ; Lili YUAN ; Liangbi XU ; Shengjuan HU ; Liangzhi WEN ; Ping YAO ; Yunxiao LIANG ; Xiaodong ZHOU ; Huiling XIANG ; Xiaowei LIU ; Xiaoquan HUANG ; Yinglei MIAO ; Xiaoliang ZHU ; De'an TIAN ; Feihu BAI ; Jitao SONG ; Ligang CHEN ; Yingcai MA ; Yifei HUANG ; Bin WU ; Xiaolong QI
Chinese Journal of Digestive Endoscopy 2024;41(1):43-51
Objective:To investigate the current status of endoscopic treatment for gastroesophageal varices in portal hypertension in China, and to provide supporting data and reference for the development of endoscopic treatment.Methods:In this study, initiated by the Liver Health Consortium in China (CHESS), a questionnaire was designed and distributed online to investigate the basic condition of endoscopic treatment for gastroesophageal varices in portal hypertension in 2022 in China. Questions included annual number and indication of endoscopic procedures, adherence to guideline for preventing esophagogastric variceal bleeding (EGVB), management and timing of emergent EGVB, management of gastric and isolated varices, and improvement of endoscopic treatment. Proportions of hospitals concerning therapeutic choices to all participant hospitals were calculated. Guideline adherence between secondary and tertiary hospitals were compared by using Chi-square test.Results:A total of 836 hospitals from 31 provinces (anotomous regions and municipalities) participated in the survey. According to the survey, the control of acute EGVB (49.3%, 412/836) and the prevention of recurrent bleeding (38.3%, 320/836) were major indications of endoscopic treatment. For primary [non-selective β-blocker (NSBB) or endoscopic therapies] and secondary prophylaxis (NSBB and endoscopic therapies) of EGVB, adherence to domestic guideline was 72.5% (606/836) and 39.2% (328/836), respectively. There were significant differences in the adherence between secondary and tertiary hospitals in primary prophylaxis of EGVB [71.0% (495/697) VS 79.9% (111/139), χ2=4.11, P=0.033] and secondary prophylaxis of EGVB [41.6% (290/697) VS 27.3% (38/139), χ2=9.31, P=0.002]. A total of 78.2% (654/836) hospitals preferred endoscopic therapies treating acute EGVB, and endoscopic therapy was more likely to be the first choice for treating acute EGVB in tertiary hospitals (82.6%, 576/697) than secondary hospitals [56.1% (78/139), χ2=46.33, P<0.001]. The optimal timing was usually within 12 hours (48.5%, 317/654) and 12-24 hours (36.9%, 241/654) after the bleeding. Regarding the management of gastroesophageal varices type 2 and isolated gastric varices type 1, most hospitals used cyanoacrylate injection in combination with sclerotherapy [48.2% (403/836) and 29.9% (250/836), respectively], but substantial proportions of hospitals preferred clip-assisted therapies [12.4% (104/836) and 26.4% (221/836), respectively]. Improving the skills of endoscopic doctors (84.2%, 704/836), and enhancing the precision of pre-procedure evaluation and quality of multidisciplinary team (78.9%, 660/836) were considered urgent needs in the development of endoscopic treatment. Conclusion:A variety of endoscopic treatments for gastroesophageal varices in portal hypertension are implemented nationwide. Participant hospitals are active to perform emergent endoscopy for acute EGVB, but are inadequate in following recommendations regarding primary and secondary prophylaxis of EGVB. Moreover, the selection of endoscopic procedures for gastric varices differs greatly among hospitals.

Result Analysis
Print
Save
E-mail