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.Effect of Video-based Educational Intervention Combined with Maternal Presence on Perioperative Adverse Outcomes in Preschool Children under General Anesthesia
Jiayu TAN ; Fengqiu GONG ; Wenqi HUANG ; Xia FENG ; Qiongfang ZHU ; Yubo KANG ; Wenyan WU ; Xiuhong LI
Journal of Sun Yat-sen University(Medical Sciences) 2025;46(3):519-527
ObjectiveTo investigate the effect of video-based educational intervention combined with maternal presence on perioperative adverse outcomes in preschool children undergoing general anesthesia, including cooperation in anesthesia induction, perioperative anxiety, pain and agitation during recovery. MethodsA total of 300 preschool children scheduled for general anesthesia in our hospital from June to December 2023 were randomly assigned to control group (n=150) and intervention group (n=150). The control group received routine recovery care. For the intervention group, in addition to routine recovery care, a preoperative visit was scheduled one day before surgery. During this visit, mothers were guided to watch anesthesia videos with their children. During the waiting period in the operating room and 30 minutes after awakening, the mothers were guided to accompany the children for more than 30 minutes. Recovery conditions were recorded using the surgical anesthesia information system, and the children’s anesthetic induction compliance, perioperative anxiety, pain, and agitation were evaluated and recorded using the modified Yale Preoperative Anxiety Scale (m-YPAS), the Induction Compliance Scale (ICC), the Children’s Pain Behavior Scale (FLACC), and the Pediatric Agitation and Emergence Delirium Scale (PAED). ResultsOn the preoperative visit day, there were no statistically significant differences in baseline data between the two groups (P > 0.05). For perioperative anxiety, the m-YPAS scores of the intervention group were significantly lower than those of the control group, both when entering the operating room waiting area (35.27±6.48 vs. 41.79±6.68, P < 0.05) and 30 minutes after postoperative recovery (20.13±7.05 vs. 35.75±9.51, P < 0.05). In terms of anesthesia induction cooperation, the ICC scores of the intervention group were significantly lower than those of the control group (1.84±0.95 vs. 3.17±0.62, P < 0.05), and the proportion of good induction cooperation was significantly higher than that of the control group (24.00% vs. 12.67%, P < 0.05). There was no significant difference in awakening duration between the two groups, but the intervention group had a significantly shorter length of stay in the post-anesthesia care unit than the control group (0.90±0.29 hours vs. 1.29±0.42 hours, P < 0.001). For perioperative agitation, the PAED scores of the intervention group were significantly lower than those of the control group (entering in the operating room waiting area: 8.5 vs. 9.2, P < 0.05; 30 minutes after postoperative recovery: 4.2 vs. 7.8, P < 0.05). In terms of pain scores, the FLACC scores of the intervention group were also significantly lower than those of the control group, both when entering the operating room waiting area ( 5.3 vs. 6.7, P < 0.05; 30 minutes after postoperative recovery: 2.1 vs. 4.9, P < 0.05). ConclusionsVideo-based educational intervention combined with maternal presence reduces the perioperative anxiety, pain and agitation of preschool children undergoing general anesthesia, and improved the compliance of anesthesia induction. It is recommended to promote this intervention measure in clinical practice.
5.Application of negative pressure suction technique in flexible ureteroscopic lithotripsy
Wenqi WU ; Yiming TANG ; Peng XU ; Rongpei WU
Journal of Modern Urology 2025;30(3):183-187
Flexible ureteroscopic lithotripsy (FURL) is one of the major minimally invasive endoscopic techniques in the management of upper urinary tract stones,but it has problems of low stone-free rate,high intraoperative intra-pelvic pressure,and high risk of postoperative infection.Since the negative pressure suction technique has been applied to FURL,it can actively suck out the stone powder and perfusion fluid during operation,thus significantly improving the immediate intraoperative stone removal rate,effectively reducing the intrarenal pelvic pressure,increasing the clarity of the operation field,and significantly improving the efficiency and safety of FURL.With the continuous progress of technology,the negative pressure suction technique has evolved from the initial simple negative pressure suction to the intelligent pressure control system integrating ‘perfusion-measurement-negative pressure'.Although this technique is now widely used in FURL,there is still optimizing space in terms of device design and operational application.This article will focus on the clinical application,technical progress and operational experience of the negative pressure suction technique in the light of domestic and international literature.
6.Basiliximab is superior to low dose rabbit anti-thymocyte globulin in pediatric kidney transplant recipients: The younger, the better.
Lan ZHU ; Lei ZHANG ; Wenjun SHANG ; Wenhua LIU ; Rula SA ; Zhiliang GUO ; Longshan LIU ; Jinghong TAN ; Hengxi ZHANG ; Yonghua FENG ; Wenyu ZHAO ; Wenqi CONG ; Jianyong WU ; Changxi WANG ; Gang CHEN
Chinese Medical Journal 2025;138(2):225-227
7.Research on the Correlation between White Blood Cell Count,Serum Lipid,Blood Glucose and the Occurrence of Acute Myocardial Infarc-tion in Elderly Coronary Atherosclerotic Heart Disease
Nan SHEN ; Zhengran LV ; Wenqi WU
Journal of Medical Research 2024;53(10):118-122
Objective To investigate the predictive value of white blood cell count,LDL-C and fasting blood glucose on the occur-rence of AMI in elderly patients with coronary atherosclerotic heart disease(CAD).Methods A total of 210 elderly patients with CAD were selected and divided into the AMI group as the case group and the chronic CAD group as the control group based on clinical manifes-tations and laboratory and coronary angiography results.The general data,laboratory data,coronary angiography results,and other clinical information of the two groups were retrospectively analyzed.We used the Logistic regression analysis to explore the risk factors for acute myocardial infarction in elderly CAD patients and the receiver operating characteristic curve(ROC)to evaluate the predictive efficacy of white blood cell count,LDL-C and fasting blood glucose on the occurrence of AMI in elderly CAD patients.Results Compared with the chronic CAD group,the AMI group had a higher smoking rate,white blood cell count,CRP,ALT,AST,D-D dimer,fasting blood glu-cose,total cholesterol,LDL-C and Gensini score and lower LVEF(P<0.05).The Logistic regression analysis showed that white blood cell count(β=0.859,P<0.001,OR=2.361),LDL-C(β=1.003,P=0.009,OR=2.728)and fasting blood glucose(β=0.495,P=0.007,OR=1.641)were independent risk factors for AMI in elderly CAD patients.The ROC curve analysis showed that when the cut-off values of fasting blood glucose,white blood cell count,and LDL-C were 4.895mmol/L,7.19 x 109/L and 2.635 mmol/L respectively,the area under the curve for predicting AMI was the largest,with values of 0.734,0.859 and 0.735.The area un-der the ROC curve of the combination of the three is 0.902.Conclusion White blood cell count,LDL-C and fasting blood glucose are associated with AMI in elderly patients with CAD.Higher levels of white blood cell count,LDL-C and fasting blood glucose indicate a higher risk of AMI.The combination of the three can serve as a more valuable predictive index.
8.Current status of laparoscopic surgery for gallbladder cancer
Huicong HUANG ; Jian DUAN ; Zhe QING ; Wenqi WU ; Liming ZHOU ; Yujun FANG
Chinese Journal of Hepatobiliary Surgery 2024;30(11):876-880
Gallbladder cancer is a common malignant tumor of the biliary tract, characterized by a stealthy onset, high invasiveness, and poor prognosis. The 5-year survival rate of gallbladder cancer patients is only 5%-20%. Currently, radical surgery remains the only potentially curative method for gallbladder cancer. Historically, gallbladder cancer was once considered a contraindication for laparoscopic surgery. In recent years, with the improvement of preoperative diagnosis level of gallbladder cancer, progress in surgical techniques and laparoscopic equipment, an increasing number of clinicians have explored and recognized the effectiveness of laparoscopic surgery for the treatment of gallbladder cancer. This review summarizes the latest advances in laparoscopic surgery for gallbladder cancer.
9.Effect of urine mixing degree on 24-hour urinary total protein in patients with chronic kidney disease based on generalized estimating equation
Shanfang QIU ; Weiwei WU ; Yang LI ; Yi FANG ; Xiaoyan JIAO ; Wenqi SHAO ; Shuan ZHAO ; Jie TENG ; Jieru CAI ; Xiaoqiang DING
Chinese Journal of Clinical Medicine 2024;31(3):428-432
Objective To explore the effect of urine mixing degree on 24-hour urinary total protein(24 h UTP)in patients with chronic kidney disease(CKD).Methods From October 1,2023 to December 31,2023,30 hospitalized patients who needed to complete 24 h UTP testing in Zhongshan Hospital,Fudan University were selected.A 5 L unified container was used to collect urine for 24 hours.After collection and one hour's standing,the urine sample was divided into upper,middle,and lower equal parts according to volume,which was defined as direct-sampling group.Then,the urine samples were fully mixed with a magnetic stirrer and sampled again according to the above-mentioned three-equal sampling method,which was defined as mixed-sampling group.The generalized estimating equation was used to compare the urinary protein concentration before and after mixing and at different sampling location.Results The results of generalized estimating equation showed that after controlling the variable"sampling position",there was no significant difference in urinary protein concentration between the direct-sampling group and the mixed-sampling group.After controlling the variable"mixing method",there was still no significant difference in urinary protein concentration at different sampling positions.After adjusting the covariates such as age,gender,and estimated glomerular filtration rate(eGFR),the results were consistent.Conclusions With standard protocol,the entire 24-hour urine sample is a relatively even-distributed solution.After the total urine collection is completed,the temporary sample can be directly extracted from any level of the original urine within 1 hour,and the urine protein concentration of the sample multiplied by the urine volume can reflect the 24 h UTR.
10.Impact of Baseline Non-high-density Lipoprotein Cholesterol Level on New-onset Cardiovascular Disease Among Postmenopausal Women
Lisha ZHANG ; Shouling WU ; Zhiqiang SHAO ; Jia GUO ; Jian WANG ; Wenqi XU ; Lu GUO ; Wenjuan LI ; Shuohua CHEN ; Yijun GAO
Chinese Circulation Journal 2024;39(1):61-67
Objectives:To investigate the impact of baseline non-high-density lipoprotein cholesterol(non-HDL-C)levels on new-onset cardiovascular disease(CVD)in postmenopausal women. Methods:This prospective cohort study selected 8 893 postmenopausal women who participated from 2006 to 2018 employee health examination of Kailuan Group and had complete total cholesterol(TC)and HDL-C data and no history of CVD.Participants were followed up to 31 December,2021.The primary endpoint was the occurrence of CVD or death.According to the Chinese Lipid Management Guidelines(2023),the participants were divided into non-HDL-C<4.1 mmol/L group(n=6 079),4.1 mmol/L≤non-HDL-C<4.9 mmol/L group(n=1 824)and non-HDL-C≥4.9 mmol/L group(n=990).The cumulative incidence of CVD in different groups of non-HDL-C levels was calculated using the Kaplan-Meier method and tested by log-rank analysis.Multivariate Cox regression model was used to analyze the effects of different non-HDL-C levels on CVD. Results:The mean follow-up time was(10.78±4.48)years,the cumulative incidence of CVD in different non-HDL-C level groups was 1.82%,3.24%and 2.89%,respectively.Kaplan-Meier survival curve showed a statistically significant difference in cumulative incidence among the three groups(log-rank P<0.0001).The results of Cox regression analysis showed that after adjusting for confounding factors such as age and sex,the HR(95%CI)values for CVD in the 4.1≤non-HDL-C<4.9 mmol/L group and the non-HDL-C≥4.9 mmol/L group were 1.40(1.13-1.74)and 1.35(1.03-1.78),respectively. Conclusions:High non-HDL-C levels are an independent risk factor for new-onset CVD in postmenopausal women.

Result Analysis
Print
Save
E-mail