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.Value of early radiotherapy for EGFR mutation-positive non-small cell lung cancer with brain metastasis in the era of third-generation targeted drugs: a single center retrospective study of 85 cases
Junlan WU ; Mianshun PAN ; Zhaoming MA ; Haitao LIU ; Yong LI ; Xianjun SHAO ; Yan WEI ; Qian YUE
Chinese Journal of Radiation Oncology 2024;33(3):212-217
Objective:To explore the reasonable timing of radiotherapy for epidermal growth factor receptor ( EGFR) mutation-positive non-small cell lung cancer patients with brain metastasis in the era of third-generation targeted drugs. Methods:Clinical data of EGFR mutation-positive non-small cell lung cancer patients with brain metastasis who received first-line treatment with third-generation targeted drugs and stereotactic radiotherapy at Shanghai Armed Police Corps Hospital from September 2019 to May 2022 were retrospectively analyzed. According to the timing of radiotherapy before / after targeted drug resistance, all patients were divided into the early and salvage radiotherapy groups. The proportion of brain metastasis, physical fitness, complete response rate, objective response rate, delaying the progression of brain metastasis and overall survival (OS) were compared between two groups. Kaplan-Meier method was used for survival analysis, log-rank test was used for univariate prognostic analysis, and factors with P <0.1 were included in Cox multivariate analysis. Results:A total of 85 patients were included, including 51 (60%) cases receiving early radiotherapy. Patients who participated in early radiotherapy had a higher proportion of symptomatic brain metastasis (82% vs. 56%, P=0.013) and poorer physical fitness (Kanofsky performance score <70: 61% vs. 26%, P=0.002) compared to patients who underwent salvage radiotherapy. Early radiotherapy significantly improved the complete response rate of intracranial lesions (35% vs. 12%, P=0.015) and objective response rate (88% vs. 71%, P=0.041), delayed the progression of brain metastasis (median intracranial progression free survival: 23.0 months vs. 16.0 months, P=0.005; median intracranial secondary progression free survival: 31.0 months vs. 22.0 months, P=0.021), and improved OS (median OS: 44.0 months vs. 35.0 months, P=0.046). In multivariate analysis, diagnosis-specific graded prognostic assessment score <2.5, mutation of EGFR exon 21, and salvage brain radiotherapy were adverse prognostic factors for OS. Conclusion:In the era of third-generation targeted drugs therapy, early involvement of stereotactic radiotherapy in non-small cell lung cancer patients with brain metastasis can bring greater clinical benefits.
5.Single-fraction SRS and multi-fraction SRT for brain metastases from colorectal cancer
Mianshun PAN ; Meng WANG ; Yong LI ; Junlan WU ; Peng WANG ; Xianjun SHAO ; Xiaohua LIANG ; Feifei ZHANG ; Meihua SHEN
Chinese Journal of Radiation Oncology 2022;31(4):347-351
Objective:To compare the efficacy and side effects of multi-fraction stereotactic radiotherapy (SRT) and single-fraction stereotactic radiosurgery (SRS) in the treatment of brain metastases from colorectal cancer.Methods:A total of 98 patients with brain metastases from colorectal cancer searched from the database of Professional Committee of Brain Metastasis of Shanghai Anticancer Association were recruited in this study. Among them, 46 patients weretreated with SRT and 52 patients with SRS. Clinical characteristics of all patients were analyzed between two groups and the local tumor control rate, median survival time and the incidence of radiation-induced brain injury were compared between two groups.Results:The objective remission rates (ORR) in the SRT and SRS groups were 76.1% and 67.3%, respectively. The 12-month local tumor control rates were 88.3% and 83.9% between two groups, with no statistical difference ( P=0.689). The median overall survival time of all patients was 11.6 months, 10.8 months in the SRT group and 12.7 months in the SRS group. There was no statistical difference between two groups ( P=0.129). Multivariate analysis showed that the main factors leading to poor prognosis included the number of tumors of >3( P=0.026), low GPA score ( P=0.035), and lack of systematic treatment mode and bevacizumab ( P=0.001). There was no statistical difference in the incidence of acute and late radiation-induced brain injury between two groups. Conclusions:Both SRT and SRS are effective therapies for brain metastases from colorectal cancer. The synergistic application of systematic treatment mode may be one of the main reasons affecting the survival time of the patients.
6.The Chinese guidelines for the diagnosis and treatment of pancreatic neuroendocrine neoplasms (2020)
Wenming WU ; Jie CHEN ; Chunmei BAI ; Yihebali CHI ; Yiqi DU ; Shiting FENG ; Li HUO ; Yuxin JIANG ; Jingnan LI ; Wenhui LOU ; Jie LUO ; Chenghao SHAO ; Lin SHEN ; Feng WANG ; Liwei WANG ; Ou WANG ; Yu WANG ; Huanwen WU ; Xiaoping XING ; Jianming XU ; Huadan XUE ; Ling XUE ; Yang YANG ; Xianjun YU ; Chunhui YUAN ; Hong ZHAO ; Xiongzeng ZHU ; Yupei ZHAO
Chinese Journal of Digestive Surgery 2021;20(6):579-599
Pancreatic neuroendocrine neoplasms (pNENs) are highly heterogeneous, and the management of pNENs patients can be intractable. To address this challenge, an expert committee was established on behalf of the Chinese Pancreatic Surgery Association, Chinese Society of Surgery, Chinese Medical Association, which consisted of surgical oncologists, gastroenterologists, medical oncologists, endocrinologists, radiologists, pathologists, and nuclear medicine specialists. By reviewing the important issues regarding the diagnosis and treatment of pNENs, the committee concluded evidence-based statements and recommendations in this article, in order to further improve the management of pNENs patients in China.
7.The Chinese guidelines for the diagnosis and treatment of pancreatic neuroendocrine neoplasms (2020)
Wenming WU ; Jie CHEN ; Chunmei BAI ; Yihebali CHI ; Yiqi DU ; Shiting FENG ; Li HUO ; Yuxin JIANG ; Jingnan LI ; Wenhui LOU ; Jie LUO ; Chenghao SHAO ; Lin SHEN ; Feng WANG ; Liwei WANG ; Ou WANG ; Yu WANG ; Huanwen WU ; Xiaoping XING ; Jianming XU ; Huadan XUE ; Ling XUE ; Yang YANG ; Xianjun YU ; Chunhui YUAN ; Hong ZHAO ; Xiongzeng ZHU ; Yupei ZHAO
Chinese Journal of Surgery 2021;59(6):401-421
Pancreatic neuroendocrine neoplasms (pNENs) are highly heterogeneous, and the management of pNENs patients can be intractable. To address this challenge, an expert committee was established on behalf of the Group of Pancreatic Surgery, Chinese Society of Surgery, Chinese Medical Association, which consisted of surgical oncologists, gastroenterologists, medical oncologists, endocrinologists, radiologists, pathologists, and nuclear medicine specialists. By reviewing the important issues regarding the diagnosis and treatment of pNENs, the committee concluded evidence-based statements and recommendations in this article, in order to further improve the management of pNENs patients in China.
8.The Chinese guidelines for the diagnosis and treatment of pancreatic neuroendocrine neoplasms (2020)
Wenming WU ; Jie CHEN ; Chunmei BAI ; Yihebali CHI ; Yiqi DU ; Shiting FENG ; Li HUO ; Yuxin JIANG ; Jingnan LI ; Wenhui LOU ; Jie LUO ; Chenghao SHAO ; Lin SHEN ; Feng WANG ; Liwei WANG ; Ou WANG ; Yu WANG ; Huanwen WU ; Xiaoping XING ; Jianming XU ; Huadan XUE ; Ling XUE ; Yang YANG ; Xianjun YU ; Chunhui YUAN ; Hong ZHAO ; Xiongzeng ZHU ; Yupei ZHAO
Chinese Journal of Surgery 2021;59(6):401-421
Pancreatic neuroendocrine neoplasms (pNENs) are highly heterogeneous, and the management of pNENs patients can be intractable. To address this challenge, an expert committee was established on behalf of the Group of Pancreatic Surgery, Chinese Society of Surgery, Chinese Medical Association, which consisted of surgical oncologists, gastroenterologists, medical oncologists, endocrinologists, radiologists, pathologists, and nuclear medicine specialists. By reviewing the important issues regarding the diagnosis and treatment of pNENs, the committee concluded evidence-based statements and recommendations in this article, in order to further improve the management of pNENs patients in China.
9. A comparative analysis of SRT and SRS in the treatment of brain metastases from lung adenocarcinoma
Yong LI ; Fenghua LIU ; Kangning LIANG ; Xianjun SHAO ; Li ZHANG ; Xiaohua LIANG ; Mianshun PAN
Chinese Journal of Radiation Oncology 2020;29(2):88-92
Objective:
To compare the clinical efficacy of stereotactic radiotherapy (SRT) and stereotactic radiosurgery (SRS) in the treatment of brain metastases from January 2006 to December 2016, lung adenocarcinoma and analyze the related factors.
Methods:
In this multi-center retrospective analysis, clinical data of 208 patients with brain metastases from lung adenocarcinoma were retrospectively analyzed and assigned into the SRT (
10.Efficacy and safety of stereotactic radiotherapy combined with bevacizumab for brain metastases of lung adenocarcinoma
Mianshun PAN ; Yong LI ; Shujun QIU ; Yutian GUO ; Lei CHEN ; Xianjun SHAO ; Li ZHANG ; Guoyu ZHANG ; Fenghua ZHUGE
Chinese Journal of Radiation Oncology 2017;26(8):880-883
Objective To evaluate the clinical efficacy and safety of stereotactic radiotherapy (SRT) combined with bevacizumab for brain metastases in patients with lung adenocarcinoma.MethodsThe clinical data of 95 patients with brain metastases of lung adenocarcinoma were retrospectively analyzed, including 36 patients treated with SRT and bevacizumab (bevacizumab group) and 59 patients treated with SRT, corticosteroids, and mannitol (traditional drug group).The tumor response rate, peritumoral edema control rate, improvement in Karnofsky Performance Scale (KPS) score, and adverse reactions were analyzed.Results Compared with the traditional drug group, the bevacizumab group had significantly higher tumor response rate (P=0.033) and peritumoral edema control rate (P=0.000) at 1-4 weeks after treatment, as well as an obvious improvement in KPS score and reduced doses of corticosteroids and mannitol.In addition, the adverse reactions in the bevacizumab group were mild and controllable.Conclusions SRT combined with bevacizumab for brain metastases in patients with lung adenocarcinoma can achieve higher short-term tumor response rate and peritumoral edema control rate and improve patients' quality of life.

Result Analysis
Print
Save
E-mail