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.Efficacy and safety of liposomal bupivacaine in transversus abdominis plane block for post-cesarean analgesia
Xiaohua GUO ; Qian CHEN ; Qing ZHAO ; Xinying GUO ; Yongying PAN ; Wanqing JI ; Yulin JIN
The Journal of Practical Medicine 2025;41(11):1724-1729
Objective To comparatively evaluate the clinical efficacy of liposomal bupivacaine and ropiva-caine in transversus abdominis plane(TAP)block combined with intravenous patient-controlled analgesia(PCA)following cesarean section,and to explore the analgesic advantages of liposomal bupivacaine.Methods Eighty parturients scheduled for elective cesarean section were recruited and randomly allocated into two groups via a random number table:the liposomal bupivacaine group and the ropivacaine group.At the conclusion of the surgical procedure,both groups underwent ultrasound-guided bilateral TAP block.In the ropivacaine group,20 mL of 0.5%ropivacaine was administered per side.In the liposomal bupivacaine group,266 mg of liposomal bupivacaine was dissolved in 0.9%normal saline to a total volume of 40 mL,with 20 mL injected per side.The following parameters were compared between the two groups:Visual Analog Scale(VAS)scores at rest and during movement at various postop-erative time points,the overall scores of the 15-item Quality of Recovery(QoR-15)scale,postoperative opioid consumption,the time to first ambulation,the time to first flatus,and the incidence of adverse drug reactions such as nausea,vomiting,constipation,and pruritus.Results In comparison with the ropivacaine group,the liposomal bupivacaine group exhibited significantly lower Visual Analogue Scale(VAS)scores both at rest and during move-ment at 12 hours,24 hours,and 48 hours postoperatively(P<0.001).Significantly higher Quality of Recovery-15(QoR-15)scores were recorded in the liposomal bupivacaine group at 24 hours and during the 24-48-hour period postoperatively(P<0.001).The postoperative opioid consumption within 48 hours was markedly lower in the liposo-mal bupivacaine group(P<0.001).The time to first flatus was significantly shorter in the liposomal bupivacaine group(P<0.001).No significant differences were detected in the incidence of nausea,vomiting,or constipation between the two groups(P>0.05),and no cases of pruritus or other severe adverse reactions were observed.Conclusion Liposomal bupivacaine used for TAP block following cesarean section offers extended analgesia,reduces the need for opioids,enhances the quality of postoperative recovery,promotes gastrointestinal motility,and demonstrates excellent safety.
5.Coverage of National Immunization Program vaccines and vaccination information consistency rate among children born during 2020-2021 in 3 provinces in China
Wenqi HUANG ; Miao XU ; Xiaohua QI ; Qing WANG ; Jing CHEN ; Ming GUANG ; Yu LIU ; Xu CHEN ; Fangfang ZENG ; Dan LIU ; Xiaofeng LIANG
Chinese Journal of Epidemiology 2025;46(8):1393-1399
Objective:To understand the coverage and information consistency rate of National Immunization Program (NIP) vaccines among children born during 2020-2021 in Zhejiang Province, Chongqing City, and Shanxi Province (3 provinces) of China .Methods:A simple random sampling method was used to randomly select 3 counties (districts) from each of the 3 provinces, 5 townships from each county (district), and 5 villages from each township. Vaccination information for seven NIP vaccines was collected for children born between 2020 and 2021 in each village. The vaccination coverage, timely coverage, and consistency rates between the survey data and the Immunization Planning Information System data were analyzed.Results:A total of 1 117 children were investigated. The vaccination coverage for each dose of NIP vaccine ranged from 99.10% to 100.00%, with those in Zhejiang Province, Chongqing City, and Shanxi Province ranging from 99.19% to 100.00%, 98.92% to 100.00%, and 99.20% to 100.00%, respectively. The timely coverage of each dose of NIP vaccine ranged from 89.79% to 99.82%, with those in Zhejiang Province, Chongqing City, and Shanxi Province ranging from 94.09% to 99.73%, 89.52% to 99.73%, and 78.55% to 100.00%, respectively. The consistency rate of information on each dose of NIP vaccine ranged from 94.36% to 99.91%, with those in Zhejiang Province, Chongqing City, and Shanxi Province ranging from 97.85% to 99.73%, 98.92% to 100.00%, and 86.06% to 100.00%, respectively.Conclusions:Coverage of NIP vaccines was generally high among children born during 2020-2021 in the 3 provinces of China, but there were regional differences in the timely coverage of some vaccine doses and the vaccination information consistency rate. It is necessary to strengthen the timely vaccination of children's vaccine booster doses and optimize the management of vaccination services.
6.Early results of modified double-orifice valve plasty via total thoracoscopy for partial atrioventricular septal defect
Hailong QIU ; Tianyu CHEN ; Zewen CHEN ; Zhanhao SU ; Miao TIAN ; Zhao CHEN ; Hongkun QING ; Shusheng WEN ; Jianzheng CEN ; Jimei CHEN ; Xiaohua LI
Chinese Journal of Thoracic and Cardiovascular Surgery 2025;41(6):328-333
Objective:To evaluate the safety, efficacy, advantages and disadvantages of the modified double-orifice valve plasty via total thoracoscopy for partial atrioventricular septal defect(PAVSD) through a retrospective analysis of early postoperative results.Methods:Patients diagnosed with PAVSD who underwent the standardized modified double-orifice valve plasty via total thoracoscopy between September 2023 and August 2024 were retrospectively enrolled. Baseline characteristics, surgical parameters, and follow-up outcomes were systematically analyzed.Results:A total of 14 patients(6 males, 8 females) were included, with a mean age of(32.9±15.5) years old and body weight of(55.1±11.6) kg. All procedures were successfully completed. The mean operative time, cardiopulmonary bypass time, and aortic cross-clamp time were(266.6±67.2) min, (160.7±34.2) min, and(97.0±31.1) min, respectively. Postoperative ICU stay, hospital stay, and total hospitalization duration were(1.7±1.1) days, (6.4±4.2) days, and(12.6±4.5) days, respectively. The mean follow-up duration was(7.9±3.6) months. Preoperatively, left atrioventricular valve regurgitation(LAVVR) was graded as mild, moderate, or severe in 5, 4, and 5 patients. Postoperatively, 13 patients exhibited mild or less LAVVR, with 1 case of moderate regurgitation. By 3 months, all patients demonstrated LAVVR of mild or lower severity, which remained stable through follow-up. Peak LAVV gradients were(4.6±2.7) mmHg(1 mmHg=0.133 kPa)(range: 1.8-10.2 mmHg) postoperatively, improving to(3.6±0.6) mmHg(3.2-4.0) mmHg at 1 year. Right atrioventricular valve regurgitation improved from preoperative moderate-severe(50.0%) to LAVVR of mild or lower severity in all patients by 3 months. No mortality, residual shunts, or high-grade atrioventricular block occurred through follow-up. By 1 month, NYHA functional class improved to Ⅰ in all patients, which remained stable through follow-up.Conclusion:Standardized modified double-orifice valve plasty via total thoracoscopy for PAVSD demonstrates safety, minimal invasiveness, and rapid recovery, with favorable early outcomes.
7.Coverage of National Immunization Program vaccines and vaccination information consistency rate among children born during 2020-2021 in 3 provinces in China
Wenqi HUANG ; Miao XU ; Xiaohua QI ; Qing WANG ; Jing CHEN ; Ming GUANG ; Yu LIU ; Xu CHEN ; Fangfang ZENG ; Dan LIU ; Xiaofeng LIANG
Chinese Journal of Epidemiology 2025;46(8):1393-1399
Objective:To understand the coverage and information consistency rate of National Immunization Program (NIP) vaccines among children born during 2020-2021 in Zhejiang Province, Chongqing City, and Shanxi Province (3 provinces) of China .Methods:A simple random sampling method was used to randomly select 3 counties (districts) from each of the 3 provinces, 5 townships from each county (district), and 5 villages from each township. Vaccination information for seven NIP vaccines was collected for children born between 2020 and 2021 in each village. The vaccination coverage, timely coverage, and consistency rates between the survey data and the Immunization Planning Information System data were analyzed.Results:A total of 1 117 children were investigated. The vaccination coverage for each dose of NIP vaccine ranged from 99.10% to 100.00%, with those in Zhejiang Province, Chongqing City, and Shanxi Province ranging from 99.19% to 100.00%, 98.92% to 100.00%, and 99.20% to 100.00%, respectively. The timely coverage of each dose of NIP vaccine ranged from 89.79% to 99.82%, with those in Zhejiang Province, Chongqing City, and Shanxi Province ranging from 94.09% to 99.73%, 89.52% to 99.73%, and 78.55% to 100.00%, respectively. The consistency rate of information on each dose of NIP vaccine ranged from 94.36% to 99.91%, with those in Zhejiang Province, Chongqing City, and Shanxi Province ranging from 97.85% to 99.73%, 98.92% to 100.00%, and 86.06% to 100.00%, respectively.Conclusions:Coverage of NIP vaccines was generally high among children born during 2020-2021 in the 3 provinces of China, but there were regional differences in the timely coverage of some vaccine doses and the vaccination information consistency rate. It is necessary to strengthen the timely vaccination of children's vaccine booster doses and optimize the management of vaccination services.
8.Efficacy and safety of liposomal bupivacaine in transversus abdominis plane block for post-cesarean analgesia
Xiaohua GUO ; Qian CHEN ; Qing ZHAO ; Xinying GUO ; Yongying PAN ; Wanqing JI ; Yulin JIN
The Journal of Practical Medicine 2025;41(11):1724-1729
Objective To comparatively evaluate the clinical efficacy of liposomal bupivacaine and ropiva-caine in transversus abdominis plane(TAP)block combined with intravenous patient-controlled analgesia(PCA)following cesarean section,and to explore the analgesic advantages of liposomal bupivacaine.Methods Eighty parturients scheduled for elective cesarean section were recruited and randomly allocated into two groups via a random number table:the liposomal bupivacaine group and the ropivacaine group.At the conclusion of the surgical procedure,both groups underwent ultrasound-guided bilateral TAP block.In the ropivacaine group,20 mL of 0.5%ropivacaine was administered per side.In the liposomal bupivacaine group,266 mg of liposomal bupivacaine was dissolved in 0.9%normal saline to a total volume of 40 mL,with 20 mL injected per side.The following parameters were compared between the two groups:Visual Analog Scale(VAS)scores at rest and during movement at various postop-erative time points,the overall scores of the 15-item Quality of Recovery(QoR-15)scale,postoperative opioid consumption,the time to first ambulation,the time to first flatus,and the incidence of adverse drug reactions such as nausea,vomiting,constipation,and pruritus.Results In comparison with the ropivacaine group,the liposomal bupivacaine group exhibited significantly lower Visual Analogue Scale(VAS)scores both at rest and during move-ment at 12 hours,24 hours,and 48 hours postoperatively(P<0.001).Significantly higher Quality of Recovery-15(QoR-15)scores were recorded in the liposomal bupivacaine group at 24 hours and during the 24-48-hour period postoperatively(P<0.001).The postoperative opioid consumption within 48 hours was markedly lower in the liposo-mal bupivacaine group(P<0.001).The time to first flatus was significantly shorter in the liposomal bupivacaine group(P<0.001).No significant differences were detected in the incidence of nausea,vomiting,or constipation between the two groups(P>0.05),and no cases of pruritus or other severe adverse reactions were observed.Conclusion Liposomal bupivacaine used for TAP block following cesarean section offers extended analgesia,reduces the need for opioids,enhances the quality of postoperative recovery,promotes gastrointestinal motility,and demonstrates excellent safety.
9.Early results of modified double-orifice valve plasty via total thoracoscopy for partial atrioventricular septal defect
Hailong QIU ; Tianyu CHEN ; Zewen CHEN ; Zhanhao SU ; Miao TIAN ; Zhao CHEN ; Hongkun QING ; Shusheng WEN ; Jianzheng CEN ; Jimei CHEN ; Xiaohua LI
Chinese Journal of Thoracic and Cardiovascular Surgery 2025;41(6):328-333
Objective:To evaluate the safety, efficacy, advantages and disadvantages of the modified double-orifice valve plasty via total thoracoscopy for partial atrioventricular septal defect(PAVSD) through a retrospective analysis of early postoperative results.Methods:Patients diagnosed with PAVSD who underwent the standardized modified double-orifice valve plasty via total thoracoscopy between September 2023 and August 2024 were retrospectively enrolled. Baseline characteristics, surgical parameters, and follow-up outcomes were systematically analyzed.Results:A total of 14 patients(6 males, 8 females) were included, with a mean age of(32.9±15.5) years old and body weight of(55.1±11.6) kg. All procedures were successfully completed. The mean operative time, cardiopulmonary bypass time, and aortic cross-clamp time were(266.6±67.2) min, (160.7±34.2) min, and(97.0±31.1) min, respectively. Postoperative ICU stay, hospital stay, and total hospitalization duration were(1.7±1.1) days, (6.4±4.2) days, and(12.6±4.5) days, respectively. The mean follow-up duration was(7.9±3.6) months. Preoperatively, left atrioventricular valve regurgitation(LAVVR) was graded as mild, moderate, or severe in 5, 4, and 5 patients. Postoperatively, 13 patients exhibited mild or less LAVVR, with 1 case of moderate regurgitation. By 3 months, all patients demonstrated LAVVR of mild or lower severity, which remained stable through follow-up. Peak LAVV gradients were(4.6±2.7) mmHg(1 mmHg=0.133 kPa)(range: 1.8-10.2 mmHg) postoperatively, improving to(3.6±0.6) mmHg(3.2-4.0) mmHg at 1 year. Right atrioventricular valve regurgitation improved from preoperative moderate-severe(50.0%) to LAVVR of mild or lower severity in all patients by 3 months. No mortality, residual shunts, or high-grade atrioventricular block occurred through follow-up. By 1 month, NYHA functional class improved to Ⅰ in all patients, which remained stable through follow-up.Conclusion:Standardized modified double-orifice valve plasty via total thoracoscopy for PAVSD demonstrates safety, minimal invasiveness, and rapid recovery, with favorable early outcomes.
10.Expert consensus on perioperative basic prevention for lower extremity deep venous thrombosis in elderly patients with hip fracture (version 2024)
Yun HAN ; Feifei JIA ; Qing LU ; Xingling XIAO ; Hua LIN ; Ying YING ; Junqin DING ; Min GUI ; Xiaojing SU ; Yaping CHEN ; Ping ZHANG ; Yun XU ; Tianwen HUANG ; Jiali CHEN ; Yi WANG ; Luo FAN ; Fanghui DONG ; Wenjuan ZHOU ; Wanxia LUO ; Xiaoyan XU ; Chunhua DENG ; Xiaohua CHEN ; Yuliu ZHENG ; Dekun YI ; Lin ZHANG ; Hanli PAN ; Jie CHEN ; Kaipeng ZHUANG ; Yang ZHOU ; Sui WENJIE ; Ning NING ; Songmei WU ; Jinli GUO ; Sanlian HU ; Lunlan LI ; Xiangyan KONG ; Hui YU ; Yifei ZHU ; Xifen YU ; Chen CHEN ; Shuixia LI ; Yuan GAO ; Xiuting LI ; Leling FENG
Chinese Journal of Trauma 2024;40(9):769-780
Hip fracture in the elderly is characterized by high incidence, high disability rate, and high mortality and has been recognized as a public health issue threatening their health. Surgery is the preferred choice for the treatment of elderly patients with hip fracture. However, lower extremity deep venous thrombosis (DVT) has an extremely high incidence rate during the perioperative period, and may significantly increase the risk of patients′ death once it progresses to pulmonary embolism. In response to this issue, the clinical guidelines and expert consensuses all emphasize active application of comprehensive preventive measures, including basic prevention, physical prevention, and pharmacological prevention. In this prevention system, basic prevention is the basis of physical and pharmacological prevention. However,there is a lack of unified and definite recommendations for basic preventive measures in clinical practice. To this end, the Orthopedic Nursing Professional Committee of the Chinese Nursing Association and Nursing Department of the Orthopedic Branch of the China International Exchange and Promotive Association for Medical and Health Care organized relevant nursing experts to formulate Expert consensus on perioperative basic prevention for lower extremity deep venous thrombosis in elderly patients with hip fracture ( version 2024) . A total of 10 recommendations were proposed, aiming to standardize the basic preventive measures for lower extremity DVT in elderly patients with hip fractures during the perioperative period and promote their subsequent rehabilitation.

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