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.Establishment of Psoriasis Rat Model with Spleen Deficiency and Dampness Obstruction Syndrome Induced by External Dampness Factors
Yating ZHANG ; Haojie SU ; Fanlu LIU ; Panyu ZHOU ; Qing WANG ; Junhong ZHANG ; Jingjing WU ; Ling HAN
Journal of Traditional Chinese Medicine 2025;66(13):1369-1377
ObjectiveTo construct a rat model of psoriasis with spleen deficiency and dampness obstruction syndrome (external dampness type), and evaluate the macroscopic manifestations and microscopic indicators of the model. MethodsTwenty-two SD rats were divided into normal group (n=3), common psoriasis group (n=5), spleen deficiency and dampness obstruction syndrome (external dampness type) group (n=7), and psoriasis with spleen deficiency and dampness obstruction syndrome (external dampness type) group (n=7). The spleen deficiency and dampness obstruction syndrome (external dampness type) rat model was established through 32-week exposure to an artificially simulated high-humidity environment, while the common psoriasis model was developed via 7-day topical application of imiquimod cream, and these two approaches were combined to construct a composite model of psoriasis with spleen deficiency and dampness obstruction syndrome (external dampness type). Rats in the normal group were housed under normal humidity conditions. The general state, tongue manifestation of rats were observed to evaluate the macroscopic syndrome manifestations; the microscopic syndrome manifestations of rats were evaluated through adipose tissue and liver tissue changes; the severity of psoriasis in rats was evaluated through skin pathological changes, psoriasis area and severity index (PASI), proliferating cell nuclear antigen (PCNA) expression and spleen tissue changes; changes in rat CD4+ interferon-γ+ cells (CD4+IFN-γ+ cells), CD4+ tumour necrosis factor-α+ cells (CD4+ TNF-α+ cells), and forkhead framing protein P3+ regulatory T cells (CD3+CD4+FoxP3+ Treg cells) were detected by flow cytometry. ResultsMacroscopically, both the spleen deficiency and dampness obstruction syndrome (external dampness type) group and psoriasis with spleen deficiency and dampness obstruction syndrome (external dampness type) group exhibited manifestations of spleen deficiency and dampness obstruction, including lethargy, huddling behavior, dull and disheveled fur, as well as soft or loose stools and perianal soiling in some individuals; both these two groups displayed enlarged tongue, swollen, and moist tongue texture, accompanied by slippery tongue surface. Microscopically, compared to the common psoriasis group, the psoriasis with spleen deficiency and dampness obstruction syndrome (external dampness type) group showed increased epididymal fat index (P<0.05); compared to the normal group and spleen deficiency and dampness obstruction syndrome (external dampness type) group, the psoriasis with spleen deficiency and dampness obstruction syndrome (external dampness type) group demonstrated significantly elevated spleen mass (P<0.05), while hepatic gross morphology and HE staining revealed no significant histopathological changes across all groups. Dorsal skin lesions were markedly exacerbated in the psoriasis with spleen deficiency and dampness obstruction syndrome (external dampness type) group when compared to those in common psoriasis group. Both the common psoriasis group and psoriasis with spleen deficiency and dampness obstruction syndrome (external dampness type) group exhibited significantly higher erythema scores, scaling scores, infiltration scores, PASI total scores, and proportions of CD3+CD4+FoxP3+Treg cells compared to the normal group and spleen deficiency and dampness obstruction syndrome (external dampness type) group (P<0.05), with pronounced PCNA-positive expression observed in the epidermal basal layer and dermis; the psoriasis with spleen deficiency and dampness obstruction syndrome (external dampness type) group displayed significantly increased proportions of CD4+TNF-α+cells compared to the spleen deficiency and dampness obstruction syndrome (external dampness type) group (P<0.05); whereas no significant differences were detected in CD4+IFN-γ+cell proportions among groups (P>0.05). ConclusionThe rat model of psoriasis with spleen deficiency and dampness obstruction syndrome (external dampness type) can be successfully constructed by artificially simulating a high-humidity environment combined with imiquimod induction.
5.The association between the zygomatic change and bone setback or resection in L-shaped reduction malarplasty
Qing ZHAO ; Yumo WANG ; Yiyuan WEI ; Xiaoshuang SUN ; Yifan WU ; Zihang ZHOU ; Jihua LI
Chinese Journal of Plastic Surgery 2024;40(10):1041-1048
Objective:To analyze the association between zygomatic change and bone setback or resection and propose a quantitative guidance for L-shaped reduction malarplasty by linear regression analysis based on computed tomographic (CT) scan images.Methods:A retrospective observational study was conducted on patients who underwent L-shaped reduction malarplasty with mortice and tenon joint at the zygomatic arch in Department of Orthognathic and Temporomandibular Joint Surgery, West China Hospital of Stomatology, Sichuan University from January 2017 to September 2022. Bone setback and resection were performed in cases required a classical L-shaped osteoectomy with oblique bone resection (Group Ⅰ). Bone setback was performed in cases required a modified L-shaped osteotomy without bone resection (Group Ⅱ). Wound healing and the occurrence of complications were followed up after operation. The amount of bone setback and resection were calculated by using preoperative and postoperative CT scan images. The unilateral width changes of the anterior, middle, and posterior zygomatic regions(ΔZBP-MFP, ΔZMP-MFP, ΔZAP-MFP, respectively) as well as zygomatic protrusion change(Δzygomatic protrusion) were also evaluated. SPSS 20.0 software was used for statistical analysis. The measurement data was expressed as Mean±SD. Zygomatic width and protrusion change of the two groups was compared by independent t-test. Comparison of complication rates between the two groups was performed using the χ2 test. Correlation analysis using Pearson correlation coefficients was performed between bone resection or setback and zygomatic width or protrusion change. Linear regression analysis was also performed. Results:A total of 80 patients were enrolled. Group Ⅰ consisted of 40 patients [6 males and 34 females; aged (25.2±3.8) years, ranging from 19 to 33 years] who underwent a classical L-shaped osteotomy with both bone setback and resection, while Group Ⅱ consisted of 40 patients [10 males and 30 females; aged (26.0±3.0) years, ranging from 20 to 35 years] who underwent a modified L-shaped osteotomy with bone setback but without bone resection. All patients healed uneventfully during the follow-up period[(12.5±3.3) months, ranging from 5 to 20 months]. There was no significant difference in the incidence of complications such as infection, transient paresthesia, severe swelling and hematoma between the two groups ( P>0.05). No severe complications, such as facial asymmetry, sagging cheek, bone nonunion, were observed. All patients significantly improved facial contours. There was a statistically significant difference (all P<0.01) in ΔZBP-MFP [ (2.52±0.76) mm vs. (1.85±0.40) mm], ΔZMP-MFP [ (3.30±0.54) mm vs. (2.94±0.51) mm] and Δzygomatic protrusion [ (4.42±1.20) mm vs. (3.59±0.84) mm] between Group Ⅰ and Group Ⅱ. No statistical difference was found in ΔZAP-MFP ( P>0.05). Significant correlation was observed between the bone setback or resection and the changes of anterior, middle zygomatic width as well as protrusion in both the two groups ( r=0.60-0.92, all P<0.01), and the linear regression equation was established. The correlation between bone setback or resection and the posterior zygomatic width change was not significant ( P>0.05). Conclusion:There are linear correlations between the unilateral anterior, middle zygomatic width change, zygomatic protrusion change and the unilateral bone setback or resection. The linear regression equations can be used as a quantitative guidance for preoperative surgical planning.
6.Recent Advances in Nanozymes with Hydrolase-like Activity for Sensing Application
Wen-Xuan JIANG ; Yu WU ; Wei-Qing XU ; Ying ZHOU ; Cheng-Zhou ZHU ; Yue-He LIN
Chinese Journal of Analytical Chemistry 2024;52(10):1435-1445
As a new type of artificial enzyme,hydrolytic nanozymes possess both hydrolase-like catalytic activity and unique physicochemical properties,enabling them to overcome the limitations of natural enzymes in practical applications and foster the development of new application scenarios.The rise of biomimetic catalysis has inspired the design and development of various nanozymes with hydrolase-like activities.However,due to the complexity of the catalytic mechanism of natural enzymes,accurately mimicking multiple cofactors remains a great challenge.This article summarized the latest research progress in nanozymes with hydrolase-like activity for sensing applications.First,inspired by the catalytic mechanism of natural hydrolase,the recent advances in the bionic design of hydrolytic nanozymes were introduced,highlighting two key cofactors:metal sites and amino acid microenvironments.Then,the sensing applications for detection of pesticides,ions,and biomolecules were summarized,and the current opportunities and challenges were described.
7.Analysis of 39 Forensic Clinical Sex Identification Cases after Sex Reassignment Surgery
Yu-Jiao WU ; Yue-Qin ZHOU ; Yi-Wen SHEN ; Jie-Qing JIANG
Journal of Forensic Medicine 2024;40(4):365-371
Objective To analyze the characteristics of forensic clinical sex identification cases after sex reassignment surgery for transsexualism,discuss the main point of forensic clinical sex identification in China based on domestic and foreign sex change policies and related cases,so as to standardize relevant identification.Methods A total of 39 cases of forensic clinical sex identification were col-lected from Center for Forensic Science,Shanghai Medical College of Fudan University in recent years,and the ratio of sex,identification time,the location of surgery,secondary sex characteristic and other information were statistically analyzed.Results Transgender woman accounted for 97.4%of the cases,and 94.9%of the cases were operated in Thailand.All cases were identified after the sex reassign-ment surgery,and at least one of the secondary sex characteristics was consistent with the postopera-tive primary sexual characters.There were only 2 cases in which auxiliary examination was applied.Conclusion Forensic clinical sex identification should be based on the principle that the primary and secondary sex characteristics are consistent with the changed sex.
8.Expert consensus on difficulty assessment of endodontic therapy
Huang DINGMING ; Wang XIAOYAN ; Liang JINGPING ; Ling JUNQI ; Bian ZHUAN ; Yu QING ; Hou BENXIANG ; Chen XINMEI ; Li JIYAO ; Ye LING ; Cheng LEI ; Xu XIN ; Hu TAO ; Wu HONGKUN ; Guo BIN ; Su QIN ; Chen ZHI ; Qiu LIHONG ; Chen WENXIA ; Wei XI ; Huang ZHENGWEI ; Yu JINHUA ; Lin ZHENGMEI ; Zhang QI ; Yang DEQIN ; Zhao JIN ; Pan SHUANG ; Yang JIAN ; Wu JIAYUAN ; Pan YIHUAI ; Xie XIAOLI ; Deng SHULI ; Huang XIAOJING ; Zhang LAN ; Yue LIN ; Zhou XUEDONG
International Journal of Oral Science 2024;16(1):15-25
Endodontic diseases are a kind of chronic infectious oral disease.Common endodontic treatment concepts are based on the removal of inflamed or necrotic pulp tissue and the replacement by gutta-percha.However,it is very essential for endodontic treatment to debride the root canal system and prevent the root canal system from bacterial reinfection after root canal therapy(RCT).Recent research,encompassing bacterial etiology and advanced imaging techniques,contributes to our understanding of the root canal system's anatomy intricacies and the technique sensitivity of RCT.Success in RCT hinges on factors like patients,infection severity,root canal anatomy,and treatment techniques.Therefore,improving disease management is a key issue to combat endodontic diseases and cure periapical lesions.The clinical difficulty assessment system of RCT is established based on patient conditions,tooth conditions,root canal configuration,and root canal needing retreatment,and emphasizes pre-treatment risk assessment for optimal outcomes.The findings suggest that the presence of risk factors may correlate with the challenge of achieving the high standard required for RCT.These insights contribute not only to improve education but also aid practitioners in treatment planning and referral decision-making within the field of endodontics.
9.Expert consensus on endodontic therapy for patients with systemic conditions
Xu XIN ; Zheng XIN ; Lin FEI ; Yu QING ; Hou BENXIANG ; Chen ZHI ; Wei XI ; Qiu LIHONG ; Chen WENXIA ; Li JIYAO ; Chen LILI ; Wang ZUOMIN ; Wu HONGKUN ; Lu ZHIYUE ; Zhao JIZHI ; Liang YUHONG ; Zhao JIN ; Pan YIHUAI ; Pan SHUANG ; Wang XIAOYAN ; Yang DEQIN ; Ren YANFANG ; Yue LIN ; Zhou XUEDONG
International Journal of Oral Science 2024;16(3):390-397
The overall health condition of patients significantly affects the diagnosis,treatment,and prognosis of endodontic diseases.A systemic consideration of the patient's overall health along with oral conditions holds the utmost importance in determining the necessity and feasibility of endodontic therapy,as well as selecting appropriate therapeutic approaches.This expert consensus is a collaborative effort by specialists from endodontics and clinical physicians across the nation based on the current clinical evidence,aiming to provide general guidance on clinical procedures,improve patient safety and enhance clinical outcomes of endodontic therapy in patients with compromised overall health.
10.The influence of pre-hospitalization management on shortening the average length of stay
Qing ZHOU ; Weifeng LIAO ; Bihong WU
Modern Hospital 2024;24(9):1423-1425
A large-scale Class A tertiary comprehensive hospital in Hunan Province,as one of the first pilot units for pre-hospitalization in the province,has pioneered the exploration of a pre-hospitalization management model based on intensive bed management.Through measures such as streamlining the pre-hospitalization process,implementing refined services,establishing dedicated examination channels,and utilizing information technology for comprehensive management of pre-hospitalization pa-tients,the hospital has ensured the smooth implementation of pre-hospitalization work.Practical results have shown a significant reduction in the average length of hospital stay in surgical wards.For instance,the average length of stay in the Department of Breast Surgery and the Department of Otolaryngology decreased by 4.41 days and 3.29 days,respectively,when compared before and after implementation.This study will delve into the impact of the pre-hospitalization management model on reducing the aver-age length of hospital stay,providing a reference for large-scale hospitals in China to improve operational efficiency and alleviate the shortage of hospital beds.It also aims to offer insights into enhancing patient experience before hospitalization and improving overall patient satisfaction as part of initiatives to improve healthcare services.

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