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.Deciphering the placental abnormalities associated with somatic cell nuclear transfer at single-nucleus resolution.
Liyuan JIANG ; Xin WANG ; Leyun WANG ; Sinan MA ; Yali DING ; Chao LIU ; Siqi WANG ; Xuan SHAO ; Ying ZHANG ; Zhikun LI ; Wei LI ; Guihai FENG ; Qi ZHOU
Protein & Cell 2023;14(12):924-928
5.Abnormal Brain Structure and Function in First-Episode Childhood- and Adolescence-Onset Schizophrenia: Association with Clinical Symptoms.
Yanhong XIA ; Dan LV ; Yinghui LIANG ; Haisan ZHANG ; Keyang PEI ; Rongrong SHAO ; Yali LI ; Yan ZHANG ; Yuling LI ; Jinghua GUO ; Luxian LV ; Suqin GUO
Neuroscience Bulletin 2019;35(3):522-526
6.Clinical trial of Supplemented Xijiao Powder treating HBV associated prior acute-on-chronic liver failure
Yanyao YIN ; Yunhua LIN ; Fazhu SHAO ; Huimin LIN ; Yali ZONG ; Yong WAN
Chinese Traditional Patent Medicine 2017;39(8):1591-1594
AIM To observe the clinical role for Supplemented Xijiao Powder (Bubali cornu,Coptidis Rhizoma,Cimicifugae Rhizoma,etc.) in management of hepatitis B virus (HBV) associated acute-on-chronic liver failure.METHOD Seventy-five patients,including the ones receiving internal medicine treatment,were divided into control group and experimental group.The experimental group received conventional treatment and additionally took Supplemented Xijiao Powder for one month.The clinical symptoms and signs were observed.Levels of ALT,AST,TBIL,ALB,CHE,PTA were measured,and the incidence of liver failure was evaluated.RESULTS Supplemented Xijiao Powder could improve symptoms,signs and the level of PTA.The incidence of liver failure tended to reduce.The comparison of other indexes had no marked difference.CONCLUSION Supplemented Xijiao Powder has a certain therapeutic effect on HBV associated prioracute-on-chronic liver failure.Its mechanism may be related to blocking the occurrence of liver failure.
7.Study of the uniformity between MRI and 18F-FDG PET/CT in detection of spinal metastatic tumor
Yali ZHU ; Dongfang CHEN ; Xiangyang GONG ; Yuan SHAO
Journal of Practical Radiology 2017;33(7):1073-1076
Objective To compare the uniformity between spine MRI and 18F-FDG PET/CT in detection of spinal metastatic tumor, and to analyze the reasons for the discrepancy between them.Methods Data of 42 malignant tumor patients underwent spine MRI and 18F-FDG PET/CT were analyzed retrospectively.And the two tests were underwent within 30 days.The author censused and analyzed the number of centrums with metastatic tumor detected by spine MRI and 18F-FDG PET/CT,and supposed that 18F-FDG PET/CT was gold standard,to evaluate the sensitivity and specificity of spine MRI.The inconsistent between two tests was analysed.Results The study included 509 centrums of 42 patients.123 positive centrums (24.2%) were detected on spine MRI,and 114 positive centrums (22.4%) on 18F-FDG PET/CT(P=0.22>0.05).The uniformity between two tests was good (Kappa=0.76).Supposing that 18F-FDG PET/CT was gold standard,the sensitivity,specificity,positive predictive value, negative predictive value,false negative rate and false positive rate of spine MRI was 85.1%(97/114),93.4%(369/395),85.1%(97/114),93.4% (369/395),14.9%(17/114) and 6.6%(26/395) respectively.43 centrums of 14 patients were diagnosed inconsistently by spine MRI and 18F-FDG PET/CT.The main reasons for the inconformity were as following: types of primary tumors, insensitivity of spine MRI for diffuse scattered spinal metastatic tumors, the existence of misdiagnosis on spine MRI, misdiagnosis of spine MRI for metastatic lesions located in the vertebral appendix and paramedian vertebral body,misdiagnosis of 18F-FDG PET/CT for metastatic lesions located in the sacral centrum, existence of false positive on 18F-FDG PET/CT and so on.Conclusion The uniformity between spine MRI and 18F-FDG PET/CT is good.The inconformity still existes in some cases.Carefully comparative analysis of them contributes to find metastatic lesions.
8.The situation of the core competence of humanistic quality of the surgical nurses in primary hospitals and the countermeasures
Yueqing CHEN ; Heping RAO ; Yali SHAO ; Jing YU
Chinese Journal of Modern Nursing 2014;20(26):3310-3312
Objective To investigate the core competence of humanistic quality of the surgical nurses in primary hospitals ,therefore to detect problems and find corresponding solutions .Methods Based on the scale of core competence of registered nurses of China , we adopted the method of stratified cluster sampling , and choose one grade-three comprehensive hospital , two grade-two comprehensive hospitals and conducted the survey among 189 surgical nurses .The competence difference was compared between nurses of different professional titles and hospitals , and the correlation analysis was made .Results Among the 189 nurses surveyed , the average scores of the critical thinking and scientific research , ethics and legal practice , interpersonal relationship, and education and consultation were (21.32 ±2.54),(20.49 ±1.56),(20.75 ±1.67), (17.81 ±2.20)respectively, with the scoring rates of 53.3%,64.0%,64.8%, and 63.6%respectively.The scores of the senior nurses were higher than those of the junior and intermediate nurses with statistical significance (F=78.814,P<0.01).In terms of interpersonal relationship and ethics and legal practice the scores in grade-three hospitals were higher than those in the grade-two hospitals with statistical significance ( t=2.603,2.249,respectively;P<0.01).The four items of core competence of humanistic quality in the surgical nurses of primary hospitals were positively correlated ( P <0.01 ).Conclusions The core competence of humanity quality of the surgical nurses was comparatively low , with the phenomenon more obvious in junior and intermediate nurses .The cooperation between hospitals and colleges and universities should be promoted so as to strengthen the education on the core competence of humanistic quality in the students .Meanwhile long-term training programs should be implemented by hospitals to give stratified education on the core competence of humanistic quality .
9.Serum TRACP5b detection and its significance in breast cancer with negative axillary lymph nodes
Longzhou CHEN ; Jing TANG ; Yali WANG ; Qingguo LI ; Weizhou SHAO ; Jinxing WANG ; Fengliang WANG ; Shui WANG
Journal of Endocrine Surgery 2011;05(6):377-379
Objective To study the value of serum tartrate-resistant acid phosphatase 5b (TRACP5b) in bone metastasis in early breast cancer patients with negative axillary lymph nodes.Methods The serum level of TRACP5b was determined by enzyme-linked immumosorbent assay (ELISA) in 26 breast cancer patients and 18 healthy female adults.Results The serum level of TRACP5b was (3.85 ± 0.85) U/L in the group of breast cancer patients and (2.08 ± 0.84) U/L in the control group.The difference had statistical significance (P <0.05 ).The sensitivity was 42.31% and the specificity was 94.44% for TRACP5 b in predicting bone metastasis of breast cancer with negtive axillary lymph nodes.Conclusions TRACP5b has higher sensitivity and specificity in breast cancer patients than in healthy female adults.TRACP5b is a useful serum marker to predict bone metastasis in breast cancer patients.
10.In vitro anti-proliferation effect of a histone deacetylase inhibitor,chidamide,on a malignant melanoma cell line,A375
Jia CHEN ; Wuqing ZHOU ; Hao CHEN ; Yali SONG ; Limin CAI ; Chonmei XIN ; Xuebao SHAO ; Yi LIU ; Xuesi ZENG ; Jianfang SUN
Chinese Journal of Dermatology 2009;42(4):255-258
Objective To investigate the in vitro anti-proliferation effect of a histone deacetylase inhibitor,chidamide,on a cutaneous malignant melanoma cell line,A375.Methods Cultured A375 cells were treated with different concentrations of chidamide(5,10,50,100,500 μmol/L)and aichostatin A (TSA)(0.1,0.25,0.5,1.0 μmol/L),respectively,for various durations(24,48,72,96,120 hours).Subsequently,cell proliferation,apoptosis and cell cycle were detected by MTT assay,annexin Vfluorescein isothiocyanate and propidium iodide double staining,and DNA ploid analysis,respectively.Results The proliferation of A375 cells was inhibited in a dose-dependent manner by chidamide of 5-500μmol/L and TSA of 0.1-1 μmol/L,and in a time-dependent manner from 0 to 120 hours after the beginning of trealment with ehidamide of 5-500μmol/L and TSA of 0.25-1μmol/L.The 48-hour 50% growth inhibition concentration(IC50)of ehidamide and TSA on A375 cells was about 250 μmol/L and 0.7μmol/L,respectively.After 48-hour treatment,the apoptosis mte was 80.27%±3.06%,79.53%±5.70%,83.13%±6.90%in A375 cells treated with chidamide of 62.5,125,250 μmol/L,respectively,16.27%±2.46%,28.83%±2.55%,83.40%±8.65%in those treated with TSA of 0.175,0.35,0.7 μmol/L,respectively,10.43%±0.96%in ontreated cells;a statistical increase was noticed in chidamide-treated cells and TSA-treated cells vs.untreated cells(all P<0.001).A positive correlation was observed between the apoptosis rate and concentrations of TSA(r=0.955,P=0.000).Cell cycle analysis indicated that treatment with chidamide induced cell cycle arrest in G0/G1 phase,with the cell proportion in G0/G1 phase being 76.30%±6.06%,82.79%±0.74%,88.91%±5.29%in A375 cells treated with chidamide of 62.5,125,250μmol/L,respectively,versus 38.73%±3.36%in untreated cells.While after 48-hour treatment with TSA of 0.35 and 0.7 μmol/L,the proportion of cells in G2/M phases was 25.15%±2.71%and 58.71%±3.45%,respectively,compared to 15.73%±0.23%in untreated cells(P<0.01).Conclusion Chidamide and TSA could induce cell cycle arrest and apoptosis,as well as inhibit the growth of A375 ceils in vitro.

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