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.Renin-angiotensin system inhibitor is associated with the reduced risk of all-cause mortality in COVID-19 among patients with/without hypertension.
Huai-Yu WANG ; Suyuan PENG ; Zhanghui YE ; Pengfei LI ; Qing LI ; Xuanyu SHI ; Rui ZENG ; Ying YAO ; Fan HE ; Junhua LI ; Liu LIU ; Shuwang GE ; Xianjun KE ; Zhibin ZHOU ; Gang XU ; Ming-Hui ZHAO ; Haibo WANG ; Luxia ZHANG ; Erdan DONG
Frontiers of Medicine 2022;16(1):102-110
Consecutively hospitalized patients with confirmed coronavirus disease 2019 (COVID-19) in Wuhan, China were retrospectively enrolled from January 2020 to March 2020 to investigate the association between the use of renin-angiotensin system inhibitor (RAS-I) and the outcome of this disease. Associations between the use of RAS-I (angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)), ACEI, and ARB and in-hospital mortality were analyzed using multivariate Cox proportional hazards regression models in overall and subgroup of hypertension status. A total of 2771 patients with COVID-19 were included, with moderate and severe cases accounting for 45.0% and 36.5%, respectively. A total of 195 (7.0%) patients died. RAS-I (hazard ratio (HR)= 0.499, 95% confidence interval (CI) 0.325-0.767) and ARB (HR = 0.410, 95% CI 0.240-0.700) use was associated with a reduced risk of all-cause mortality among patients with COVID-19. For patients with hypertension, RAS-I and ARB applications were also associated with a reduced risk of mortality with HR of 0.352 (95% CI 0.162-0.764) and 0.279 (95% CI 0.115-0.677), respectively. RAS-I exhibited protective effects on the survival outcome of COVID-19. ARB use was associated with a reduced risk of all-cause mortality among patients with COVID-19.
Angiotensin Receptor Antagonists/therapeutic use*
;
Angiotensin-Converting Enzyme Inhibitors/therapeutic use*
;
COVID-19
;
Humans
;
Hypertension/drug therapy*
;
Renin-Angiotensin System
;
Retrospective Studies
5.Analysis on the department distribution and workload of physicians in China
Boheng DUAN ; Guangpeng ZHANG ; Xianjun ZENG
Chinese Journal of Hospital Administration 2022;38(6):421-424
Objective:To analyze the department distribution and workload of China′s physician team, and promote the establishment of a well-structured physician team.Methods:Based on the relevant data of Health Statistics Yearbook, the distribution of departments and workload of diagnosis and treatment of physicians during the 13th Five-Year Plan period were analyzed. Results:During the " 13th Five-Year Plan" period, the number of physicians increased by an average of 6.11% per year, of which the average annual growth rate in medical cosmetology and rehabilitation medicine exceeded 10%, and the number of infectious disease physicians declined. The daily visits per physician decreased by an average of 4.67% per year, and the daily inpatients per physician decreased by 4.14%. Among them, the daily visits per physician in infectious diseases, preventive health care, oncology had increased overall, and the daily inpatients per physician in medical cosmetology, dental had decreased the most.Conclusions:It is suggested to optimize the professional structure and department distribution in accordance with the principle of " matching medical service needs with a certain workload" , and promote the establishment of a physician team with reasonable distribution to better meet medical service needs.
6.Investigation and analysis of staff turnover in health institutions
Boheng DUAN ; Guangpeng ZHANG ; Xianjun ZENG
Chinese Journal of Hospital Administration 2022;38(6):425-428
Objective:To investigate and analyze the loss of personnel in health institutions, and put forward the suggestions.Methods:The staff turnover in various health institutions was analyzed based on a continuous monitoring data from 2012 to 2019.Results:In 2012-2019, the turnover rate of health institutions had generally remained at about 1.5%-2.0%. In 2015-2019, the natural attrition rate was 0.44%-0.70% and the job-changing rate was 0.06%-0.12%. Among all kinds of institutions, the loss of staff in township health centers and Centers for Disease Control and Prevention were the most serious.Conclusions:Some new characteristics have emerged in the flow of health personnel, which have gradually adapted to the demand for health services, and the role of market mechanisms in the allocation of health human resources has gradually emerged.For the institutions with serious attrition, it is suggested to strengthen policy integration, guide the rational flow of health personnel.
7.Application of digital technology in the treatment of secondary deformity of orbitozygomatic fracture
Hengxin LIU ; Bo XIAO ; Xianjun FU ; Juan ZHANG ; Xianhui ZENG ; Xi ZHANG
Chinese Journal of Plastic Surgery 2021;37(1):59-65
Objective:To investigate the clinical effect of digital technology in the treatment of secondary deformity of orbitozygomatic fracture.Methods:The clinical data of 20 patients with secondary deformity of orbitozygomatic fracture treated in the Department of Plastic Surgery, the First Affiliated Hospital of Air Force Medical University from October 2015 to May 2019 were retrospectively analyzed, including 14 males and 6 females, aged 18-56 years. A computed tomography scan of the skull was performed before the operation. The data was three-dimensional(3D) reconstructed by Mimics software. The digital model was used to determine the surgical plan. Then the 3D head model was printed, osteotomy guide plate and reduction guide plate were used to guide osteotomy and reduction during surgery. Using Mimics software, the angle between orbital horizontal level and bilateral tragus linkage(A-OT value), the absolute value of the distance difference between bilateral zygomatic process point and facial midline (face width difference), and the absolute value of the distance difference between bilateral zygomatic process points and the vertical line passing through the central point of bony external auditory canal(facial process difference) were measured before and 3 days after operation. The exophthalmos of the affected side was measured by Hertel exophthalmos meter before and 6 months after operation. The paired t-test was used for comparison before and after operation. P<0.05 was statistically significant. Results:All the wounds healed well and the 20 patients were followed up for 6 months to 3 years. Before and after surgery, the A-OT values were (8.41 ± 2.46)° and (2.67 ± 0.55)°, with statistically significant difference ( t=11.242, P<0.001). Face width differences were (9.12 ± 1.02) mm and (1.51 ± 0.40) mm, with statistically significant difference( t=33.946, P<0.001). Facial process differences were (9.22 ± 0.95) mm and (1.53 ± 0.61) mm, with statistically significant difference ( t=33.484, P<0.001). Except for 4 patients with enucleation, the exophthalmos of the other patients was (7.81 ± 1.25) mm before operation and (12.78 ± 0.65) mm 6 months after operation. The difference was statistically significant ( t=-13.183, P<0.001). There was no diplopia and abnormal eye movement after operation. Conclusions:The application of digital technology in the treatment of secondary deformity of orbitozygomatic fracture is helpful to accurately diagnosis and reduction, and to improve the surgical effect.
8.Application of digital technology in the treatment of secondary deformity of orbitozygomatic fracture
Hengxin LIU ; Bo XIAO ; Xianjun FU ; Juan ZHANG ; Xianhui ZENG ; Xi ZHANG
Chinese Journal of Plastic Surgery 2021;37(1):59-65
Objective:To investigate the clinical effect of digital technology in the treatment of secondary deformity of orbitozygomatic fracture.Methods:The clinical data of 20 patients with secondary deformity of orbitozygomatic fracture treated in the Department of Plastic Surgery, the First Affiliated Hospital of Air Force Medical University from October 2015 to May 2019 were retrospectively analyzed, including 14 males and 6 females, aged 18-56 years. A computed tomography scan of the skull was performed before the operation. The data was three-dimensional(3D) reconstructed by Mimics software. The digital model was used to determine the surgical plan. Then the 3D head model was printed, osteotomy guide plate and reduction guide plate were used to guide osteotomy and reduction during surgery. Using Mimics software, the angle between orbital horizontal level and bilateral tragus linkage(A-OT value), the absolute value of the distance difference between bilateral zygomatic process point and facial midline (face width difference), and the absolute value of the distance difference between bilateral zygomatic process points and the vertical line passing through the central point of bony external auditory canal(facial process difference) were measured before and 3 days after operation. The exophthalmos of the affected side was measured by Hertel exophthalmos meter before and 6 months after operation. The paired t-test was used for comparison before and after operation. P<0.05 was statistically significant. Results:All the wounds healed well and the 20 patients were followed up for 6 months to 3 years. Before and after surgery, the A-OT values were (8.41 ± 2.46)° and (2.67 ± 0.55)°, with statistically significant difference ( t=11.242, P<0.001). Face width differences were (9.12 ± 1.02) mm and (1.51 ± 0.40) mm, with statistically significant difference( t=33.946, P<0.001). Facial process differences were (9.22 ± 0.95) mm and (1.53 ± 0.61) mm, with statistically significant difference ( t=33.484, P<0.001). Except for 4 patients with enucleation, the exophthalmos of the other patients was (7.81 ± 1.25) mm before operation and (12.78 ± 0.65) mm 6 months after operation. The difference was statistically significant ( t=-13.183, P<0.001). There was no diplopia and abnormal eye movement after operation. Conclusions:The application of digital technology in the treatment of secondary deformity of orbitozygomatic fracture is helpful to accurately diagnosis and reduction, and to improve the surgical effect.
9.Study on screening for 274 suspected cases of corona virus disease 2019
Xuli YANG ; Zhihui WANG ; Xing LIU ; Shanshan WU ; Xiaoping WU ; Guilan WEN ; Xianjun ZENG ; Huawei XIONG ; Jie LIU ; Tao HONG
Chinese Journal of Infectious Diseases 2020;38(4):199-203
Objective:To evaluate the diagnostic efficacies of computed tomography (CT), clinical manifestations and 2019 novel coronavirus (2019-nCoV) nucleic acid test results for the screening and diagnosis of novel coronavirus pneumonia.Methods:The clinical data of suspected cases with corona virus disease 2019 (COVID-19) visited fever clinic or stayed in emergency room of the First Affiliated Hospital of Nanchang University from January 23 to February 9, 2020 were collected. Totally 274 cases who met the inclusion criteria were enrolled. Four screening schemes including chest CT screening, scoring, chest CT and scoring series screening, chest CT and scoring parallel screening were designed. The statistical analysis was performed by using chi-square test. The sensitivities, specificities and the areas under the receiver operator characteristic curve of the four screening schemes were calculated, and the diagnostic efficacies were evaluated.Results:Among the 274 cases, 93.80%(257/274) presented with typical clinical symptoms, 47.81%(131/274) had epidemiological history, and the blood routine examination results of 45.26%(124/274) cases met the positive criteria of the scoring , and chest CT results of 43.07%(118/274) cases met the positive criteria of chest CT screening. The 2019-nCoV nucleic acid test positive rate of cases with epidemiological history was 30.53%(40/131), which was higher than that of cases without epidemiological history (9.09%(13/143)), and that of cases with typical imaging performance on chest CT was 40.68%(48/118), which was higher than cases without typical imaging performance (3.21%(5/156)). The differences between the above groups were both statistically significant ( χ2=20.150、60.468, respectively, both P<0.01). The positive rates of viral nucleic acid detection in cases with positive findings of chest CT screening, scoring, series screening, and parallel screening were 40.68%(48/118), 23.74%(47/198), 44.68%(42/94) and 23.87%(53/222), respectively, while those in cases with negative findings of the four screening schemes were 3.20%(5/156), 7.89%(6/76), 6.11%(11/180) and 0(0/52), respectively. The positive rates of the four screening schemes were all significantly different from that of viral nucleic acid detection ( κ=0.402, 0.100, 0.431, 0.106, all P<0.01). The chest CT screening method had a sensitivity of 90.57%and a specificity of 68.33%, and an area under the operating characteristic curve of the subject was 0.794, which had higher diagnostic value than those of the other three screening schemes. Conclusions:For the screening and diagnosis of COVID-19 cases, epidemiological history, positive 2019-nCoV nucleic acid test with ≥2 typical clinical manifestations have highly diagnostic value. On the basis of the preliminary screening of chest CT examination, flexible analysis of the diagnostic results could improve the diagnostic value of each detection method.
10.CT manifestationsandmisdiagnosisofatypicalpulmonaryhamartoma
Jiaqi LIU ; Shunda HONG ; Jian JIANG ; Fuqing ZHOU ; Laichang HE ; Honghan GONG ; Xianjun ZENG
Journal of Practical Radiology 2019;35(5):730-733
Objective ToanalyzetheCTimagingfeaturesofatypicalpulmonaryhamartomas,soastounderstandthecausesof misdiagnosisandimprovetheaccuracyofdiagnosis.Methods 18caseswithatypicalpulmonaryhamartomasconfirmedbypathology inourhospitalwerecollectedretrospectively,including9 malesand9females.18caseswereexaminedbychestCTscans,among which,2caseswithplainscans,and16caseswithenhancedscans.TheresultsofCTimagingwereanalyzedbytwoassociatechief radiologistswithdoubleblindmethod,observingthelesionlocation,size,edge,border,density,enhancementfeatures,theremaining lungtissue,theageofonset,history,andclinicalmanifestations.Results Inall18cases,3caseswereendotracheallesion,ofwhich1 casewasinleftmainbronchus,theothertwowereinrightmiddleandupperbronchusrespectively,showingcalcificationdensityand subsequentatelectasis;15caseswereperipherallesions,including7casespresentingrightpulmonarynodulesand8casespresenting leftpulmonarynodules.Allperipheralcasesweresolitarypulmonarynoduleswithoutcalcificationandfatdensity.Thediameterof nodulesrangedfrom0.3cmto2.1cm.5casesshowedsmoothroundisolatednodulesand10casesshowedshallowlobulatednodules. In16casesofenhancedscan,1lesionshowedremarkableenhancement,6lesionsshowedslightlyenhancement,and9lesionsshowed nosignificantenhancement.Conclusion PulmonaryhamartomaislackofcharacteristicofCTimaging,whichisthemainreasonof misdiagnosis.Recognizingitsdiverseimageperformancesincludingshallowlobulation,roughedge,remarkableenhancementandetc. helpsusavoidmisdiagnosis.

Result Analysis
Print
Save
E-mail