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.Association between high normal blood pressure, hypertension and microalbuminuria
LI Qing ; PAN Ningning ; LIU Min ; LI Yuan ; ZHANG Puhong ; BAI Yamin ; XU Jianwei
Journal of Preventive Medicine 2024;36(11):961-964
Objective:
To investigate the association between high normal blood pressure, hypertension and microalbuminuria (MAU), so as to provide the basis for early screening and prevention of renal injury caused by hypertension.
Methods:
A multi-stage cluster random sampling method was used to select permanent residents aged 18 to 75 years from six provinces including Hebei, Hunan, Sichuan, Heilongjiang, Qinghai and Jiangxi from September to October 2021. Basic information and lifestyle behaviors were collected through questionnaires. Indices including height, weight and blood pressure were measured. Urinary microalbumin and creatinine were measured in 24-hour urine samples. The associations between high normal blood pressure, hypertension, and MAU were analyzed by using a multivariable logistic regression model.
Results:
A total of 1 982 residents were surveyed, with 996 residents aged <50 years (50.25%) and 986 residents aged ≥50 years (49.75%). There were 958 males (48.34%) and 1 024 females (51.66%). Normal blood pressure was observed in 653 residents (32.95%), high normal blood pressure in 748 (37.74%) and hypertension in 581 (29.31%). MAU was detected in 164 participants, with a detection rate of 8.27%. The detection rates of MAU among residents with normal blood pressure, high normal blood pressure, and hypertension were 2.14%, 8.16% and 15.32%, respectively, and the difference was statistically significant (P<0.05). Multivariable logistic regression analysis showed that after adjusting for gender, age, educational level, smoking, alcohol consumption, regular exercise and body mass index, the residents with high normal blood pressure (OR=3.535, 95%CI: 1.898-6.585) and hypertension (OR=7.232, 95%CI: 3.808-13.732) had higher risks of MAU compared to those with normal blood pressure; the residents with hypertension (OR=1.914, 95%CI: 1.340-2.735) had a higher risk of MAU compared to those with high normal blood pressure.
Conclusions
High normal blood pressure and hypertension are associated with an increased risk of MAU.
5.Status and influencing factors of fear of falling in patients with maintenance hemodialysis
Yuxin FU ; Huiqing XU ; Kuijing PAN ; Ningning XIA ; Jing LIU
Chinese Journal of Modern Nursing 2024;30(24):3232-3236
Objective:To understand the current status of fear of falling in patients receiving maintenance hemodialysis and analyze the influencing factors.Methods:The convenient sampling method was used to select maintenance hemodialysis patients admitted to BenQ Hospital Affiliated to Nanjing Medical University from August to October 2022 as the research objects. A survey was conducted on patients using the general information questionnaire, modified falls efficacy scale (MFES), fatigue, resistance, ambulation, illness, loss of weight (FRAIL), and Braden Mobility Subscale.Results:A total of 219 questionnaires were sent out, and 219 were effectively collected, with an effective recovery rate of 100.00%. Among 219 patients with maintenance hemodialysis, 96 had fear of falling, and the incidence of fear of falling was 43.84%. Binary logistic regression analysis showed that age, type of kidney disease, fall history, and score of FRAIL were the influencing factors of fear of falling in patients with maintenance hemodialysis ( P< 0.05) . Conclusions:The incidence of fear of falling in patients with maintenance hemodialysis is relatively high. Age, diabetic nephropathy, history of falls, and frailty are the risk factors for fear of falling in patients with maintenance hemodialysis. Medical staff can develop targeted intervention measures for maintenance hemodialysis patients based on risk factors to reduce their fear of falling.
6.Effect of honey on bowel preparation before colonoscopy
Jie PAN ; Shaoli GE ; Yao WANG ; Zhonghua LIN ; Yujiao LIN ; Ningning MAO ; Rongrong HAN ; Jianqing SUI
China Journal of Endoscopy 2024;30(9):33-40
Objective To explore the clinical effect of honey in preoperative bowel preparation for colonoscopy in hospitalized patients.Methods 87 patients from April 2022 to July 2022 and underwent preoperative bowel preparation for colonoscopy were selected as the research subjects.Convenience sampling was used to divide them into a control group(n=43)and an observation group(n=44).The control group received a conventional regimen of taking compound polyethylene glycol(PEG)electrolyte powder(Heshuang),while the observation group added 20 mL of honey to the Heshuang solution.Compare the cleanliness of intestine,and palatability of the taste,the incidence of adverse reactions,satisfaction of patients,and the rate of willingness for prepeat bowel preparation between the two groups.Results The intestinal cleanliness of the two groups of patients was equivalent,the difference was not statistically significant(P>0.05).The incidence and severity of nausea,abdominal bloating,hypoglycemia,and anal irritation in the observation group were lower than those in the control group,the differences were statistically significant(P<0.05).The observation group had better taste,patients satisfaction,and the willingness for prepeat bowel preparation compared to the control group,the differences were statistically significant(P<0.05).Conclusion Honey can improve the taste of Heshuang,reduce the severity of oral adverse reactions,increase patient satisfaction,and increase the rate of willingness for prepeat bowel preparation.
7.Analysis of symptom characteristics and influencing factors in maintenance hemodialysis patients based on latent class analysis
Ningning XIA ; Jing LIU ; Kuijing PAN
Chongqing Medicine 2024;53(21):3312-3317
Objective To explore the latent class of the symptom characteristics in the patients with maintenance hemodialysis(MHD),and to analyze the factors affecting different latent class.Methods The convenience sampling method was adopted to select 380 cases of MHD in the Blood Purification Center of a class 3A hospital in Nanjing City from March to May 2022 as the respondents.The general data questionnaire,disease related data questionnaire and dialysis patient symptom assessment scale(DSI)were adopted to con-duct the questionnaire survey.The symptoms characteristics of the respondents conducted the latent class a-nalysis(LCA).Then the influencing factors of different latent categories were analyzed by the univariate anal-ysis and multivariate logistic regression.Results The symptom characteristics in the patients with MHD could be divided into 3 categories:symptom high incidence type(24.7%),sexual dysfunction type(31.3%)and symptom low incidence type(43.9%).Compared with the patients with symptom low incidence type,the patients with low age group and low income were more likely to be classified as the symptoms high incidence type.The patients with entering middle age(45-60 years old),having spouse,low income and short dialysis age were more likely to be classified as the sexual dysfunction type.Conclusion Medical staff should effective-ly identify the different symptoms characteristics in the same group of the patients,and give the personalized intervention management.
8.Identification and characterization of one Spiroplasma species isolated from blood culture of a rare case of sepsis
Chao YANG ; Yan CHEN ; Shunguang LI ; Dexiang ZHENG ; Jianping LONG ; Junjun PAN ; Pinghua QU ; Ningning XIU
Chinese Journal of Microbiology and Immunology 2023;43(8):574-581
Objective:To identify and characterize one Spiroplasma strain (designated as DGKH1) isolated from the blood of a patient with sepsis. Methods:The traditional bacterial culture, staining, morphological observation, physiological and biochemical identification, 16S rRNA gene sequencing, phylogenetic analysis, genome sequencing, and the genome-related index analysis were performed to accurately determine the taxonomic status of the strain DGKH1. Antibiotic susceptibility testing was performed using a specific kit for culturing and testing Ureaplasma urealyticum/ Metamycoplasma hominis. Results:The strain DGKH1 could weakly grow on Columbia blood agar, chocolate agar, and Haemophilus chocolate 2 agar. However, it did not grow in liquid culture medium containing tetracycline (4 μg/ml), doxycycline (1 μg/ml), minocycline (1 μg/ml), josamycin (2 μg/ml), roxithromycin (1 μg/ml), clarithromycin (1 μg/ml), or telithromycin (1 μg/ml). DGKH1 resembling Metamycoplasma hominis formed "fried egg-like colonies" on Mycoplasma solid culture medium. DGKH1 could not be stained by Gram staining. When observed under transmission electron microscopy (TEM) using phosphate buffer as the matrix, the bacteria were spiral-shaped. Results of 16S rRNA gene sequence alignment showed that DGKH1 was highly similar (99.85%) to Spiroplasma eriocheiris CCTCC M 207170 T. However, the urea decomposition test was positive, which was different from all of the known Spiroplasma species. The phylogenetic analysis based on whole genome showed that DGKH1 was clustered in a small branch along with Spiroplasma eriocheiris CCTCC M 207170 T. However, the average nucleotide identity (ANI) and digital DNA-DNA hybridization (dDDH) values between the two strains were 94.14% and 56.00%, respectively, both below the threshold for prokaryotic species identification. Conclusions:DGKH1 represented a potential new species of genus Spiroplasma, closely related to Spiroplasma eriocheiris. Some microbiological characteristics of DGKH1 were similar to Mycoplasmas. However, the natural host and epidemiological data of DGKH1 need to be further studied.
9.Clinical features and prognostic analysis of transarterial chemoembolization combined with targeted immunotherapy in the treatment of patients with hepatitis B virus-related intermediate-and advanced-stage hepatocellular carcinoma with secondary cholestasis
Ningning WANG ; Jiaming SHEN ; Huili LI ; Xia WANG ; Guangde YANG ; Xiucheng PAN ; Jie LI
Chinese Journal of Hepatology 2023;31(11):1149-1155
Objective:To study the clinical features and prognostic impact of transarterial chemoembolization (TACE), immune checkpoint inhibitors (ICIs), and tyrosine kinase inhibitors (TKIs) combination therapy regimens in the treatment of patients with hepatitis B virus-related intermediate-and advanced-stage hepatocellular carcinoma with secondary cholestasis.Methods:Patients with HBV-related intermediate-and advanced-stage hepatocellular carcinoma (HBV) who visited the Affiliated Hospital of Xuzhou Medical University between January 1, 2020, and December 31, 2022, were enrolled. TACE+TKIs +ICIs combination therapy was used to treat all patients. The occurrence and factors influencing cholestasis, as well as the impact on prognosis after combined therapy, were analyzed. The measurement data were compared using a t-test and a non-parametric rank sum test. The count data was compared using the χ2 test. The survival rates were compared using a log-rank test between different groups. Results:A total of 106 cases with HBV-related intermediate-and advanced-stage hepatocellular carcinoma were enrolled. The probabilities of secondary cholestasis within 3 and 6 months, 1, 2, and 3 years after TACE+ICIs+TKIs combination therapy were 9.4%, 12.3%, 14.2%, 24.5%, and 24.5%, respectively. Patients with secondary cholestasis had persistent symptoms and rapid progression. During the treatment course, the median survival time was significantly longer in patients with hepatocellular carcinoma without secondary cholestasis than that of patients with cholestasis (26.9 months vs. 13.7 months, respectively, P < 0.05). Secondary cholestasis, baseline aspartate aminotransferase, and prothrombin activity levels were independent risk factors that affected the survival and prognosis of patients treated with combination therapy. There was no statistically significant difference in the occurrence of other adverse reactions between the two groups with secondary and non-secondary cholestasis during the treatment course (47.5% vs. 43.3%, χ2=0.058, P = 0.810). Conclusion:TACE+ICIs+TKIs therapy combination is relatively common in the treatment of patients with HBV-related intermediate-and advanced-stage hepatocellular carcinoma with secondary cholestasis. Moreover, accelerated disease progression is an independent risk factor affecting the survival and prognosis of patients.
10.Levonorgestrel-releasing intrauterine system-based therapies for early-stage endometrial cancer: a systematic review and meta-analysis
Hongyi WEI ; Ningning PAN ; Wen ZHANG ; Guangwu XIONG ; Wenping GUO ; Zhe DONG ; Caihong MA
Journal of Gynecologic Oncology 2023;34(2):e36-
Objective:
To conduct a systematic review and meta-analysis of studies evaluating the oncological and fertility outcomes of early-stage endometrial cancer (EC) treated with the levonorgestrel-releasing intrauterine system (LIUS)-based regimens.
Methods:
The Meta-analyses Of Observational Studies in Epidemiology statement for meta-analyses was followed. Searches were conducted on MEDLINE, Embase, PubMed, Preprints, and the Cochrane Central Register of Controlled Trials from January 1990 to August 4, 2022. The Joanna Briggs Institute Critical Appraisal Checklist was used for quality assessment. The primary endpoint was the complete response (CR) rate and the secondary endpoints were relapse, pregnancy, and live birth rate.
Results:
A total of 25 studies (821 women) were included. The CR rate of LIUS-based regimens was 63.4% (95% confidence interval [CI]=52.3%–73.2%), with 29.6% (95% CI=23.3%–36.8%) of cases experiencing recurrence during follow-up. In sensitivity analyses, patients younger than 45 years of age with a body mass index <30 kg/m2 who were treated with LIUS-based regimens achieved a high CR rate of 84.6% (95% CI=80.3%–88.1%) over a median follow-up of more than 24 months. Overall pregnancy and live birth rates were 37.9% (95% CI=24.1%–53.9%) and 39.3% (95% CI=24.0%–57.0%), respectively. No statistical differences were apparent in CR or relapse rates among the LIUS+GnRH agonist, LIUS+oral progesterone, or hysteroscopic resection followed by LIUS subgroups.
Conclusion
LIUS-based therapies are viable for the conservative management of early-stage endometrioid EC on CR and fertility outcome.


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