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 progress on the prognostic risk factors and prognostic models of perihilar cholangiocarcinoma
Yujun FANG ; Jian DUAN ; Zhe QING ; Huicong HUANG ; Wenqi WU ; Liming ZHOU ; Jinlan HE
International Journal of Surgery 2024;51(4):278-282
For Perihilar cholangiocarcinoma (pCCA), surgical resection is the only effective way to cure this disease. However, it has high postoperative mortality and high recurrence rate. Domestic and foreign scholars have constructed statistics-based evaluation methods to predict patients′ postoperative survival and complications, such as nomogram, scoring system and other prognostic models. Based on these methods, clinicians can better select patients who can benefit from surgery and choose the optimal? treatment for more severe patients. Through the adoption of other treatments or some ways to ameliorate some preoperative condition, to improve the patient′s mortality and survival. This article reviews the prognostic risk factors and prognostic models of pCCA in order to provide a reference for clinicians to predict the prognosis about the surgery.
8.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.
9.Clinical Characteristics of Mycoplasma Pneumoniae Infection and Factors Associated with Co-infections in Children
Zixin LI ; Wenqi WU ; Ling YANG
Journal of Medical Research 2024;53(2):138-142,73
Objective To analyze the clinical characteristics of mycoplasma pneumoniae pneumonia(MPP)in children with atopic constitution and exploring the predictors of disease conditions.Methods A total of 250 children diagnosed with MPP in the Department of Pediatric Respiratory Medicine,Xinhua Hospital,Shanghai Jiaotong University School of Medicine from September 2019 to September 2022 were selected and divided into atopic group(n=149)and non-atopic group(n=101)according to whether they were atopic,to explore the clinical characteristics of MPP in children with atopic constitution and the risk factors of severe mycoplasma pneumoniae pneu-monia(SMPP).The efficacy of the combined test of lactate dehydrogenase(LDH),immunoglobulin E(IgE)and serum amyloid A(SAA)in predicting the development of SMPP in MPP children with atopic constitution was evaluated by the receiver operating character-istic(ROC)curve.Results Children in the atopic group had more pronounced symptoms of cough,wheezing,nasal congestion,croup,combined pleural effusion with severe pneumonia and the proportion requiring hormone therapy than those in the non-atopic group,and the differences were statistically significant(P<0.05).Logistic regression analysis showed that serum IgE,SAA and LDH levels were in-dependent risk factors for the development of SMPP in MPP children with atopic constitution(P<0.05);ROC curve analysis showed that the combined test of IgE,LDH and SAA could be used to predict the development of SMPP in MPP children with atopic constitution,with an area under the curve(AUC)of 0.881,sensitivity of 81.0%,and specificity of 85.0%.Conclusion MPP children with atopic con-stitution are more likely to develop SMPP and require hormone therapy.The combined detection of serum IgE,SAA and LDH can effec-tively predict the occurrence of SMPP in MPP children with atopic constitution.
10.Correlation between Triglyceride Glucose Product Index and Coronary Heart Disease
Zhengran LV ; Wenqi WU ; Fang LIU
Journal of Medical Research 2024;53(2):151-155
Objective To investigate the correlation of triglyceride glucose product index(TyG index)with the diagnosis of coronary heart disease(CHD)and the severity of coronary stenosis.Methods A total of 404 patients who received coronary angiography for the first time in Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine with unexplained chest pain from December 2021 to October 2022 were included.All subjects were divided into CHD group(n=216)and non-CHD group(n=188).General clin-ical data,laboratory information and coronary angiography results of all participants were collected.The CHD group(n=123)and the non-CHD group(n=123)were obtained after the propensity score matching(PSM).Patients in CHD group were further divided into low Gensini score(Gensini score<35,n=59)group and high Gensini score(Gensini score ≥ 35,n=64)group according to the me-dian Gensini score.The differences among groups were compared and the relation between TyG index and the severity of coronary artery stenosis was analyzed.Then the predictive value of TyG index for CHD and the severity of coronary lesion was evaluated by Logistic regres-sion and receiver operating characteristic(ROC)curve.Results After PSM,the differences in TyG index,TG,FPG,HDL-C in CHD group were statistically significant compared with the non-CHD group(P<0.05).Multivariate Logistic regression analysis showed that the TyG index was an independent risk factor for CHD.Spearman correlation analysis showed that the TyG index was positively correlated with the Gensini score(r=0.618,P<0.001).The ROC curve analysis showed that the area under the curve(AUC)of the TyG index predicting a high Gensini score was 0.873(95%CI:0.802-0.943,P<0.001).A cut-off value was 7.08,and the sensitivity and specificity were 95.2%and 67.3%,respectively.Conclusion TyG index can be used as an independent risk factor for CHD,and has certain predictive value for the severity of coronary stenosis.

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