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.Mechanisms and research progress of circular RNAs in radon exposure-induced diseases
Jia ZHANG ; Xiaoliang LI ; Jianlei RUAN ; Jianxiang LIU
Chinese Journal of Radiological Health 2025;34(2):303-308
Radon, the only naturally occurring radioactive noble gas, is among the most common radioactive nuclides to which humans are exposed. Radon can induce various biological effects in the human body and is a risk factor for lung cancer. Circular RNAs (circRNAs) are stable, tissue-specific, and abundantly expressed in body fluids. circRNAs can regulate gene expression and play an important role in the development of cancer. In this paper, we summarized the changes in the expression and function of circRNAs, highlighting the potential mechanisms of circRNAs in radon exposure-induced cancers. Our results provided theoretical support for the use of circRNAs as a biomarker of radon exposure-induced radiation damage, and offer a theoretical basis for the early diagnosis, treatment, and prevention of radon exposure-induced diseases.
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.Treatment of severe calciphylaxis with different sodium thiosulfate usage: a case report and literature review
Mingrui YAO ; Tian XU ; Hong LIU ; Li SUN ; Liyuan ZHANG ; Xiaoliang ZHANG
Chinese Journal of Nephrology 2025;41(5):372-375
Calciphylaxis, also known as calcific uremic arteriopathy (CUA), is a rare arteriosclerosis disease characterized by skin ischemia and necrosis with severe pain, which occurs in end-stage renal disease patients. The efficacy of sodium thiosulfate (STS) in CUA has been widely verified and affirmed. However, there is no unified standard for the use of STS at home and abroad.This article introduced a case of severe CUA patient who had achieved good results under different STS usage treatments, and summarized the different STS usage treatments for CUA combined with literature.
5.A case of lupus nephritis complicated with thrombotic microangiopathy
Yuqiu LIU ; Chun JIANG ; Fengmei WANG ; Yan YANG ; Bin WANG ; Xiaoliang ZHANG
Chinese Journal of Nephrology 2025;41(1):58-62
This paper reported a case of severe lupus nephritis in an adolescent with progressive hemolytic anemia, thrombocytopenia, and multiple organs involvement, in which renal damage was characterized by sustained elevation of serum creatinine and oliguria. Accurate diagnosis of lupus nephritis complicated with thrombotic microangiopathy was achieved through genetic testing and molecular technology. The use of double filtration plasmapheresis, blocking B-cell targets and complement activation targets, and supplementing frozen plasma provided more accurate, safe and effective treatment options for patients, which significantly improved prognosis.
6.Analysis of circRNAs expression in peripheral blood of residents around radon hot springs
Jia ZHANG ; Jianlei RUAN ; Xiaoliang LI ; Jianxiang LIU
Chinese Journal of Radiological Medicine and Protection 2025;45(3):178-182
Objective:To investigate the effect of circular RNAs (circRNAs) expressions in peripheral blood of residents around radon hot springs.Methods:Totally 51 residents around radon hot springs were selected as the radon hot sping group, and another 51 residents around non-radon hot springs were selected as the control group. Questionnaires were used to collect demographic information and the radon exposure levels in the two groups. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to detect the relative expressions of selected circRNA candidates in peripheral blood of the two groups. Mann-Whitney U test was used to compare the differences in the relative expressions of the circRNAs between the two groups. Results:The cumulative doses of radon exposure per capita for residents around radon hot springs was (111.47±99.03) mSv, with dose range 3.32-458.68 mSv. The difference in the relative expressions of hsa_circ_0040573 between the two groups was statistically significant ( Z=-2.88, P<0.05). The expression of hsa_circ_0040573 was suppressed by radon exposure ( t=-2.52, P<0.05) with a dose-dependent manner ( H=12.21, P<0.05). Conclusion:Hsa_circ_0040573 has a potential to serve as a radiological response biomarker for radon exposure, contributing to early diagnosis and monitoring of health risks associated with radon exposure.
7.Clinical presentation and treatment outcomes of 24 adult patients with thrombotic thrombocytopenic purpura
Xinru LI ; Fengmei WANG ; Xiaoliang ZHANG ; Bicheng LIU
Chinese Journal of Nephrology 2025;41(8):579-586
Objective:To investigate the clinical features, treatment strategies and prognosis of adult thrombotic thrombocytopenic purpura (TTP) patients and improve the clinicians' understanding of TTP.Methods:It was a case series analysis study. The clinical data of TTP patients admitted to ZhongDa Hospital affiliated to Southeast University from August 2013 to November 2024 were retrospectively collected. The clinical manifestations, laboratory tests, treatment methods and prognosis of TTP patients were analyzed. Kaplan-Meier method and multivariate Cox proportional hazards regression model were utilized to assess the association between rituximab treatment and survival outcomes.Results:The study included 24 TTP patients, with age of (58.38±15.03) years (21 to 87 years), 14 females (58.33%) and 10 males (41.67%). The first symptoms were often neurological abnormalities (lethargy, coma, sudden glossolalia or unconsciousness (10 patients, 41.67%). Five patients (20.83%) had the quinary syndrome, including fever, microangiopathic hemolytic anemia, thrombocytopenia, renal insufficiency and neurological symptoms, and 13 patients (54.17%) had the triad syndrome, including neurological syndromes, microangiopathic hemolytic anemia and thrombocytopenia. Twenty-three patients (95.83%) had anemia. Twenty patients (83.33%) presented with neurological abnormalities, among which 10 patients died of neurological events. Renal insufficiency occurred in 14 patients (58.33%). Nine patients (37.50%) presented with large areas of skin ecchymosis. Except for 1 patient complicating with lung adenocarcinoma and 1 patients complicating with bone metastasis tumor, the other patients had no active tumors. All 24 patients had PLASMIC scores ≥ 4 points, of which 11 patients (45.83%) had PLASMIC scores ≥ 6 points. Fourteen patients (58.33%) received the treatment for plasma exchange, and 7 patients (29.17%) did not undergo plasma exchange and received component transfusion and glucocorticoids therapy with poor prognosis due to rapid disease progression, old age or severe disease. Furthermore, 3 patients (12.50%) were only treated with component transfusion and glucocorticoids therapy for economic reasons, and died shortly after hospital discharge. Eight patients received plasma exchange, glucocorticoids combined with rituximab, of which one died, four survived, and three were lost to follow-up. Finally, fifteen patients (62.50%) died, 4 patients survived, and 5 patients were lost to follow-up (still alive before hospital discharge). Kaplan-Meier survival analysis demonstrated that mortality in the rituximab group was significantly lower than that in the non-rituximab group (Log-rank test, χ2=13.185, P<0.001). Multivariate Cox proportional hazards regression analysis further confirmed that no receiving rituximab was an independent correlated factor of death ( HR=10.453, 95% CI 1.309-83.436, P=0.027). Conclusions:TTP usually starts with neurological symptoms, and can affect multiple systems. The patients with neurological abnormalities have a poor prognosis. The patients with TTP have a rapid disease progression and a high mortality rate. Rapid identification and timely treatment are crucial for improving the prognosis of TTP. Combining rituximab based on plasma exchange and glucocorticoids may reduce mortality of TTP patients.
8.Nomogram based on clinical and DCE-MRI characteristics for predicting the depth of myometrial invasion and grade of endometrioid endometrial carcinoma
Xiaoliang MA ; Songqi CAI ; Jinwei QIANG ; Guofu ZHANG ; Jianjun ZHOU ; Mengsu ZENG ; Xiaojun REN ; Rong JIANG ; Minhua SHEN
Chinese Journal of Obstetrics and Gynecology 2025;60(3):202-215
Objective:To investigate the feasibility and value of nomogram based on base line clinical and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) characteristics for pretreatment predicting the depth of myometrial invasion and tumor grade of endometrioid endometrial carcinoma (EEC).Methods:Preoperative baseline clinical characteristics and DCE-MRI characteristics of 194 EEC patients were prospectively collected at Obstetrics and Gynecology Hospital, Fudan University from October 2020 to January 2022 and used as a training set. Univariate analysis was conducted to compare baseline clinical characteristics and DCE-MRI quantitative parameters [including tumor volume, and mean, median, and standard deviation of volume transfer constant (K trans), rate constant (K ep), extravascular extracellular volume fraction (V e), and initial area under the enhancement curve (iAUC)] between patients with deep myometrial invasion (DMI) and those with superficial myometrial invasion (SMI), as well as between high-grade and low-grade EEC. Multivariate logistics regression analysis was used to identify independent predictors for the construction of nomogram. An independent external testing set comprising 127 EEC patients was retrospectively collected from Zhongshan Hospital, Fudan University and Zhongshan Hospital, Fudan University (Xiamen Branch). The area under the receiver operating characteristic curve (AUC) and decision curve analysis (DCA) were used for evaluating the model′s predictive performance and clinical net benefit, respectively. Results:(1) The depth of myometrial invasion: univariate analysis showed that in the training set, the EEC patients with DMI differed significantly from those with SMI in clinical characteristics including higher proportion of postmenopausal state and overweight [body mass index (BMI)≥25 kg/m2], and abnormal levels of serum cancer antigen (CA) 125, CA 199, and human epididymis protein 4 (HE4), and in DCE-MRI quantitative parameters including tumor volume, and median, mean, and standard deviation of K trans, median of V e, as well as median, mean, and standard deviation of iAUC (all P<0.05). Multivariate analysis showed that the patient′s menstrual status, BMI, CA 199, tumor volume, and mean of iAUC were independent predictors of the depth of myometrial invasion, and constructed the nomogram (recorded as Nomogram_1), achieving an AUC of 0.861 (95% CI: 0.803-0.919) in the training set. In the independent external testing set, the AUC was 0.876 (95% CI: 0.815-0.938), with corresponding sensitivity of 82.0%, specificity of 80.7%, accuracy of 81.1%, positive predictive value (PPV) of 65.3%, and negative predictive value (NPV) of 91.0% for predicting DMI. (2) The EEC grade: univariate analysis showed that in the training set, high-grade EEC patients differed significantly from low-grade EEC in clinical characteristics including patient′s age, the proportion of postmenopausal state and overweight, and abnormal levels of serum CA 125, and in DCE-MRI quantitative parameters including tumor volume, median, mean, and standard deviation of K trans, median and mean of V e, as well as median, mean, and standard deviation of iAUC (all P<0.05). Multivariate analysis showed that the patient′s menstrual status, BMI, tumor volume, and median of V e emerged as independent predictors of EEC grade, and constructed the nomogram (recorded as Nomogram_2), achieving an AUC of 0.845 (95% CI: 0.786-0.893) in the training set. While in the external testing set, the AUC was 0.819 (95% CI: 0.744-0.894), with corresponding sensitivity of 72.4%, specificity of 72.4%, accuracy of 72.4%, PPV of 43.8%, and NPV of 89.9% for predicting high-grade EEC. (3) The DCA curves demonstrated that both Nomogram_1 and Nomogram_2 yielded obvious positive clinical net benefits across a wide range of threshold probabilities. Conclusion:The nomogram based on pretreatment clinical and DCE-MRI characteristics has the potential to noninvasive predict the depth of myometrial invasion and grade of EEC, providing valuable reference information for clinical management decision-making.
9.Measurement and analysis of activity concentrations of varying forms of 131I in nuclear medicine workplaces
Shuo WANG ; Fei TUO ; Jianfeng ZHANG ; Xiaoliang LI ; Baolu YANG ; Qiang ZHOU
Chinese Journal of Radiological Medicine and Protection 2025;45(5):465-471
Objective:To understand the activity concentrations of varying chemical forms of 131I in nuclear medicine workplaces and assess the internal irradiation doses of 131I to workers. Methods:A high-volume air sampler was used for air sampling of 131I. Glass fiber filters, activated carbon filters, and iodine cartridges, which were connected in series, were employed to collect aerosol iodine, gaseous inorganic iodine, and gaseous organic iodine, respectively. A method for analyzing the activity of 131I unevenly distributed in the iodine cartridge was developed, and an HPGe γ spectrometer was used to determine the activity of 131I in samples collected from the nuclear medicine workplaces of 15 hospitals. Results:The concentrations of aerosol iodine, inorganic iodine, and organic iodine in 15 hospitals were determined at 0.19-206.67, 0.27-138.45, and 2.35-3 821.11 Bq/m 3, respectively, with arithmetic means of 22.04, 12.79 and 365.08 Bq/m 3, respectively. The maximum annual committed effective doses of varied forms of 131I inhaled by workers were determined at 0.19, 0.19, and 3.81 mSv, respectively, with a maximum total committed effective dose of 4.13 mSv. Conclusions:Gaseous organic iodine is identified as the primary form of 131I in the air within nuclear medicine workplaces. Therefore, it is necessary to highlight the monitoring and protection of gaseous organic iodine.
10.Analysis of internal exposure of staff performing 131I treatment in radiodiagnosis and radiotherapy institutions in China
Xiaoliang LI ; Quanfu SUN ; Fei TUO ; Weihong CHEN ; Keyi LU ; Jianfeng ZHANG ; Jianxiang LIU
Chinese Journal of Radiological Medicine and Protection 2025;45(6):506-511
Objective:To investigate the number of medical institutions and staff involved in 131I diagnosis and therapy in China, and to ascertain the level of 131I activity incorporated in thyroid of medical staff performing the 131I treatment. Methods:Questionnaires were used to investigate the basic information on nuclear medicine practices in all the non-military hospitals in China. Portable gamma spectrometers were used to determine and analyze the 131I activity in thyroid of the medical staff in some radioiodine treatment workplaces. The result were reported through National Radiological Health Information Platform. Results:Until December 2022, there had been 959 hospitals performing clinical nuclear medicine practices in China, with a total of 10 820 medical staff. In China, there have been 623 hospitals performing 131I therapeutical procedures, accounting for 65.0% of all nuclear medicine hospitals, and 333 hospitals performing 131I treatment of thyroid cancer, accounting for 34.7%. The hospitals equipped with automated radiopharmaceutical dispenser accounted for 61.3% of the 623 hospitals. A total of 2 210 nuclear medicine staff were monitored for internal exposure in 20 provinces in 2022, with 249 (11.3%) having activities above 100 Bq and the maximum value of 2.9 × 10 4 Bq. A total of 426 nuclear medicine staff in four provinces were detected using HPGe detectors, with 101 (23.7%) detected to have 131I in their thyroid glands. A total of 1 748 in 17 provinces were detected using NaI or LaBr detectors, with 379 (21.2%) detected to have 131I in their thyroid glands. The detection rate of 131I in the staff was found to increase with the increased amount of 131I purchased by hospitals. The detection rate of 131I in the hosptitals having purchased the amount of 131I≥3.70 × 10 6 MBq in 2021 was 32.1%. This value was notably higher than in the other three groups whose purchased amount <3.70 × 10 6 MBq, with a statistically significant difference( χ2=15.46, P < 0.001). Conclusions:There were great differences in the number of both hospitals and staff performing 131I treatment between different provinces in China. About one fifth of the staff in the 131I treatment workplaces could be detected to have incorporated 131I in their thyroid glands.

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