We aimed to evaluate the efficacy and safety of adding apatinib,to sintilimab and chemotherapy in the neoadjuvant treatment of early triple-negative breast cancer(TNBC).In the phase 2 NeoSAC trial,patients with early ...We aimed to evaluate the efficacy and safety of adding apatinib,to sintilimab and chemotherapy in the neoadjuvant treatment of early triple-negative breast cancer(TNBC).In the phase 2 NeoSAC trial,patients with early TNBC received six cycles of apatinib,sintilimab,nab-paclitaxel,and carboplatin followed by surgery.The primary endpoint was pathological complete response(pCR)rate.Specimens collected pre-neoadjuvant therapy and post-surgery were retained for comprehensive analysis of predictive biomarkers and the impact on the tumor microenvironment.Among 34 enrolled patients,24 achieved pCR(70.6%;95%confidence interval(CI),53.0-85.3),and 79.4%(95%CI,65.1-93.7)had residual cancer burden 0-I.Imaging evaluation showed 21 complete responses(61.8%)and 13 partial responses(38.2%).The most common grade 3-4 adverse events were leukopenia(47%),neutropenia(36%),and thrombocytopenia(24%).The 36-month disease-free survival rate stood at 94.1%with a median follow-up of 39.1 months.Notably,baseline high ImmuneScore,immune cell infiltration,and enrichment of interferon-related pathways correlated with pCR.Comparison of pre-neoadjuvant and post-surgery data revealed that the pCR group treated with this novel regimen exhibited an upregulation of distinct immune cell subsets,thereby activating the tumor microenvironment.Moreover,higher oxeiptosis scores were associated with an increased likelihood of achieving pCR.Following neoadjuvant therapy,the pCR group showed a decrease in oxeiptosis score,whereas the non-pCR group exhibited an increase.Our study suggests that apatinib,sintilimab combined with carboplatin and nab-paclitaxel chemotherapy showed a promising clinical activity and manageable safety profile in early TNBC and merits further study.ClinicalTrials.gov registration:NCT04722718.展开更多
Background:Breast cancer(BC)is the most diagnosed cancer worldwide,and patients'survival decreases with metastasis.We conducted a retrospective study using data derived from the Surveillance,Epidemiology,and End R...Background:Breast cancer(BC)is the most diagnosed cancer worldwide,and patients'survival decreases with metastasis.We conducted a retrospective study using data derived from the Surveillance,Epidemiology,and End Results(SEER)database and clinicopathological data to construct a clinical predictive model to predict the risk and prognosis of lung metastasis(LM)in patients with different subtypes of BC and validate its performance.Methods:A total of 1650 patients from the SEER database between 2011 and 2015 were enrolled in this study.Cox regression analysis was performed to identify prognostic factors for breast cancer lung metastasis(BCLM).A nomogram was constructed using the independent prognostic factors.The concordance index(C-index),area under the curve(AUC)value,calibration curve,and decision curve analysis(DCA)were used to test the prediction accuracy of the nomogram.External validation(n=112)was performed using clinical data from the Affiliated Hospital of Qinghai University and the General Hospital of Ningxia Medical University.Results:Multivariate Cox regression analyses suggested that age,grade,surgery,chemotherapy,subtype,and liver,bone,and brain metastases were independent prognostic factors for overall survival(OS).Kaplan-Meier survival analysis showed that the median survival times of patients with human epidermal growth factor receptor 2(HER2)-positive,luminal A,luminal B,and triple-negative BC were 25(95%confidence interval[CI],20-37),27(95%CI,23-29),35(95%CI,30-44),and 12(95%CI,11-14),respectively.The C-indexes of the nomogram for predicting OS of the SEER training,SEER validation,and clinical validation cohorts were 0.7,0.6,and 0.6,respectively,and the calculated AUCs at 3 years were 0.765,0.794,and 0.799,respectively.The calibration curve indicates that the nomogram possessed a high level of accuracy.Conclusions:Our nomogram demonstrates significant predictive value,indicating that molecular subtypes,brain metastasis,and liver metastasis are closely associated with the prognosis of patients with LM.This information can guide clinical practice.展开更多
Background The uncertainty and non-standardization of the remanufacturing process result in multi-source heterogeneity of remanufacturing equipment capabilities and knowledge information,which limits the development o...Background The uncertainty and non-standardization of the remanufacturing process result in multi-source heterogeneity of remanufacturing equipment capabilities and knowledge information,which limits the development of informationization and intelligence in remanufacturing.Methods Therefore,we propose a knowledge graph-based modeling method for Remanufacturing Equipment Resource(RMER)information.By analyzing the categories of remanufacturing equipment resources and integrating resource information such as man,machine,material,method,and environment,a unified remanufacturing equipment information model and service capability information model were constructed.Based on the top-down knowledge graph construction process,the RMER semantic association information of the ontology pattern and data layers was extracted and integrated to construct the RMER knowledge graph.Results In this paper,18 enterprise texts,50 experience texts and thesis patent texts were selected as the training set,and 2 enterprise texts,50 experience texts and thesis patent texts were selected as the test set.After multiple rounds of model training,the accuracy rate of entity information extraction reached 91.4%,which proved the accuracy and effectiveness of the model for entity information document extraction.Conclusions This study provides a unified information foundation for mapping and optimizing the resource capabilities of remanufacturing equipment.It can help remanufacturing enterprises to quickly configure equipment resources,and improve the intelligent and automated management level of RMER.展开更多
Background:The wide use of antibody‐drug conjugates(ADCs)is transforming the cancer‐treatment landscape.Understanding the treatment‐related adverse events(AEs)of ADCs is crucial for their clinical application.We co...Background:The wide use of antibody‐drug conjugates(ADCs)is transforming the cancer‐treatment landscape.Understanding the treatment‐related adverse events(AEs)of ADCs is crucial for their clinical application.We conducted a meta‐analysis to analyze the profile and incidence of AEs related to ADC use in the treatment of solid tumors and hematological malignancies.Methods:We searched the PubMed,Embase,and Cochrane Library databases for articles published from January 2001 to October 2022.The overall profile and incidence of all‐grade and grade≥3 treatment‐related AEs were the primary outcomes of the analysis.Results:A total of 138 trials involving 15,473 patients were included in this study.The overall incidence of any‐grade treatment‐related AEs was 100.0%(95%confidence interval[CI]:99.9%–100.0%;I2=89%)and the incidence of grade≥3 treatment‐related AEs was 6.2%(95%CI:3.0%–12.4%;I2=99%).Conclusions:This study provides a comprehensive overview of AEs related to ADCs used for cancer treatment.ADC use resulted in a high incidence of any‐grade AEs but a low incidence of grade≥3 AEs.The AE profiles and incidence differed according to cancer type,ADC type,and ADC components.展开更多
In this study,we aimed to explore the safety and vaccination coverage data of Chinese patients with breast cancer receiving coronavirus disease 2019(COVID-19)vaccination.The patients were recruited from 41 hospitals a...In this study,we aimed to explore the safety and vaccination coverage data of Chinese patients with breast cancer receiving coronavirus disease 2019(COVID-19)vaccination.The patients were recruited from 41 hospitals across 20 Chinese provinces.The vaccination coverage was approximately 22.4%,and the frequency of total adverse events was 13.3%after the first dose and 9.9%after the second dose.The most frequent adverse reaction within 14 days of the first dose was local pain(5.7%).Unvaccinated patients were very likely to reject the vaccine rather than be hesitant in patients with old age(odds ratio[OR],1.238;95%confidence interval[CI],1.101-1.391),chronic disease history(OR,1.189;95%CI,1.057-1.337),and cancer relapse(OR,1.398;95%CI,1.233-1.585).Of the unvaccinated patients with breast cancer,54.1%opted to receive COVID-19 vaccines if more data were available.Considering the safety but low vaccination coverage for breast cancer,increased positive attitudes and acceptance toward COVID-19 vaccines are important.展开更多
Background On average,5-10%of patients are diagnosed with metastatic breast cancer(MBC)at the initial diagnosis.This study aimed to develop a nomogram to predict the overall survival(OS)in these patients.Methods The n...Background On average,5-10%of patients are diagnosed with metastatic breast cancer(MBC)at the initial diagnosis.This study aimed to develop a nomogram to predict the overall survival(OS)in these patients.Methods The nomogram was based on a retrospective study of 9435 patients with de novo MBC from the Surveillance,Epidemiology,and End Results(SEER)database.The predictive accuracy and discriminative ability of the nomogram were determined using the concordance index(C-index),area under the time-dependent receiver operating characteristic curve(AUC),and calibration curve.Decision curve analysis(DCA)was employed to evaluate the benefits and advantages of our new predicting model over the 8th edition of the American Joint Committee on Cancer(AJCC)Tumor Node Metastasis(TNM)staging system.The results were validated in a retrospective study of 103 patients with de novo MBC from January 2013 to June 2022 at an institution in northwest China.Results Multivariate analysis of the primary cohort revealed that independent factors for survival were age at diagnosis,pathological type,histological grade,T stage,N stage,molecular subtype,bone metastasis,brain metastasis,liver metastasis,lung metastasis,surgery,chemotherapy,and radiotherapy.The nomogram achieved a C-index of 0.688(95%confidence interval[CI],0.682-0.694)in the training cohort and 0.875(95%CI,0.816-0.934)in the validation cohort.The AUC of the nomograms indicated good specificity and sensitivity in the training and validation cohorts,respectively.Calibration curves showed favorable consistency between the predicted and actual survival probabilities.Additionally,the DCA curve produced higher net gains than by the AJCC-TNM staging system.Finally,risk stratification can accurately identify groups of patients with de novo MBC at different risk levels.Conclusions The nomogram showed favorable predictive and discriminative abilities for OS in patients with de novo MBC.Other populations from different countries or prospective studies are needed to further validate the nomogram.展开更多
基金funded by the Provincial-Level Clinical Key Specialty Construction in Qinghai Province in China.
文摘We aimed to evaluate the efficacy and safety of adding apatinib,to sintilimab and chemotherapy in the neoadjuvant treatment of early triple-negative breast cancer(TNBC).In the phase 2 NeoSAC trial,patients with early TNBC received six cycles of apatinib,sintilimab,nab-paclitaxel,and carboplatin followed by surgery.The primary endpoint was pathological complete response(pCR)rate.Specimens collected pre-neoadjuvant therapy and post-surgery were retained for comprehensive analysis of predictive biomarkers and the impact on the tumor microenvironment.Among 34 enrolled patients,24 achieved pCR(70.6%;95%confidence interval(CI),53.0-85.3),and 79.4%(95%CI,65.1-93.7)had residual cancer burden 0-I.Imaging evaluation showed 21 complete responses(61.8%)and 13 partial responses(38.2%).The most common grade 3-4 adverse events were leukopenia(47%),neutropenia(36%),and thrombocytopenia(24%).The 36-month disease-free survival rate stood at 94.1%with a median follow-up of 39.1 months.Notably,baseline high ImmuneScore,immune cell infiltration,and enrichment of interferon-related pathways correlated with pCR.Comparison of pre-neoadjuvant and post-surgery data revealed that the pCR group treated with this novel regimen exhibited an upregulation of distinct immune cell subsets,thereby activating the tumor microenvironment.Moreover,higher oxeiptosis scores were associated with an increased likelihood of achieving pCR.Following neoadjuvant therapy,the pCR group showed a decrease in oxeiptosis score,whereas the non-pCR group exhibited an increase.Our study suggests that apatinib,sintilimab combined with carboplatin and nab-paclitaxel chemotherapy showed a promising clinical activity and manageable safety profile in early TNBC and merits further study.ClinicalTrials.gov registration:NCT04722718.
基金supported by the Central Government Guiding Local Scientific and Technological Development Funds and Health Commission for Qinghai Province in China(No.2018-wjzdx-48).
文摘Background:Breast cancer(BC)is the most diagnosed cancer worldwide,and patients'survival decreases with metastasis.We conducted a retrospective study using data derived from the Surveillance,Epidemiology,and End Results(SEER)database and clinicopathological data to construct a clinical predictive model to predict the risk and prognosis of lung metastasis(LM)in patients with different subtypes of BC and validate its performance.Methods:A total of 1650 patients from the SEER database between 2011 and 2015 were enrolled in this study.Cox regression analysis was performed to identify prognostic factors for breast cancer lung metastasis(BCLM).A nomogram was constructed using the independent prognostic factors.The concordance index(C-index),area under the curve(AUC)value,calibration curve,and decision curve analysis(DCA)were used to test the prediction accuracy of the nomogram.External validation(n=112)was performed using clinical data from the Affiliated Hospital of Qinghai University and the General Hospital of Ningxia Medical University.Results:Multivariate Cox regression analyses suggested that age,grade,surgery,chemotherapy,subtype,and liver,bone,and brain metastases were independent prognostic factors for overall survival(OS).Kaplan-Meier survival analysis showed that the median survival times of patients with human epidermal growth factor receptor 2(HER2)-positive,luminal A,luminal B,and triple-negative BC were 25(95%confidence interval[CI],20-37),27(95%CI,23-29),35(95%CI,30-44),and 12(95%CI,11-14),respectively.The C-indexes of the nomogram for predicting OS of the SEER training,SEER validation,and clinical validation cohorts were 0.7,0.6,and 0.6,respectively,and the calculated AUCs at 3 years were 0.765,0.794,and 0.799,respectively.The calibration curve indicates that the nomogram possessed a high level of accuracy.Conclusions:Our nomogram demonstrates significant predictive value,indicating that molecular subtypes,brain metastasis,and liver metastasis are closely associated with the prognosis of patients with LM.This information can guide clinical practice.
基金funded by the National Natural Science Foundation of China(Grant No.52275503)Hubei Outstanding Youth Fund Project(Grant No.2023 AFA092).
文摘Background The uncertainty and non-standardization of the remanufacturing process result in multi-source heterogeneity of remanufacturing equipment capabilities and knowledge information,which limits the development of informationization and intelligence in remanufacturing.Methods Therefore,we propose a knowledge graph-based modeling method for Remanufacturing Equipment Resource(RMER)information.By analyzing the categories of remanufacturing equipment resources and integrating resource information such as man,machine,material,method,and environment,a unified remanufacturing equipment information model and service capability information model were constructed.Based on the top-down knowledge graph construction process,the RMER semantic association information of the ontology pattern and data layers was extracted and integrated to construct the RMER knowledge graph.Results In this paper,18 enterprise texts,50 experience texts and thesis patent texts were selected as the training set,and 2 enterprise texts,50 experience texts and thesis patent texts were selected as the test set.After multiple rounds of model training,the accuracy rate of entity information extraction reached 91.4%,which proved the accuracy and effectiveness of the model for entity information document extraction.Conclusions This study provides a unified information foundation for mapping and optimizing the resource capabilities of remanufacturing equipment.It can help remanufacturing enterprises to quickly configure equipment resources,and improve the intelligent and automated management level of RMER.
基金the Thousand Talents of Program of High-end Innovation of Qinghai Province in China(for Dr.Jiuda Zhao).
文摘Background:The wide use of antibody‐drug conjugates(ADCs)is transforming the cancer‐treatment landscape.Understanding the treatment‐related adverse events(AEs)of ADCs is crucial for their clinical application.We conducted a meta‐analysis to analyze the profile and incidence of AEs related to ADC use in the treatment of solid tumors and hematological malignancies.Methods:We searched the PubMed,Embase,and Cochrane Library databases for articles published from January 2001 to October 2022.The overall profile and incidence of all‐grade and grade≥3 treatment‐related AEs were the primary outcomes of the analysis.Results:A total of 138 trials involving 15,473 patients were included in this study.The overall incidence of any‐grade treatment‐related AEs was 100.0%(95%confidence interval[CI]:99.9%–100.0%;I2=89%)and the incidence of grade≥3 treatment‐related AEs was 6.2%(95%CI:3.0%–12.4%;I2=99%).Conclusions:This study provides a comprehensive overview of AEs related to ADCs used for cancer treatment.ADC use resulted in a high incidence of any‐grade AEs but a low incidence of grade≥3 AEs.The AE profiles and incidence differed according to cancer type,ADC type,and ADC components.
基金Emergency Key Program of Guangzhou Laboratory(EKPG21-30-4)。
文摘In this study,we aimed to explore the safety and vaccination coverage data of Chinese patients with breast cancer receiving coronavirus disease 2019(COVID-19)vaccination.The patients were recruited from 41 hospitals across 20 Chinese provinces.The vaccination coverage was approximately 22.4%,and the frequency of total adverse events was 13.3%after the first dose and 9.9%after the second dose.The most frequent adverse reaction within 14 days of the first dose was local pain(5.7%).Unvaccinated patients were very likely to reject the vaccine rather than be hesitant in patients with old age(odds ratio[OR],1.238;95%confidence interval[CI],1.101-1.391),chronic disease history(OR,1.189;95%CI,1.057-1.337),and cancer relapse(OR,1.398;95%CI,1.233-1.585).Of the unvaccinated patients with breast cancer,54.1%opted to receive COVID-19 vaccines if more data were available.Considering the safety but low vaccination coverage for breast cancer,increased positive attitudes and acceptance toward COVID-19 vaccines are important.
文摘Background On average,5-10%of patients are diagnosed with metastatic breast cancer(MBC)at the initial diagnosis.This study aimed to develop a nomogram to predict the overall survival(OS)in these patients.Methods The nomogram was based on a retrospective study of 9435 patients with de novo MBC from the Surveillance,Epidemiology,and End Results(SEER)database.The predictive accuracy and discriminative ability of the nomogram were determined using the concordance index(C-index),area under the time-dependent receiver operating characteristic curve(AUC),and calibration curve.Decision curve analysis(DCA)was employed to evaluate the benefits and advantages of our new predicting model over the 8th edition of the American Joint Committee on Cancer(AJCC)Tumor Node Metastasis(TNM)staging system.The results were validated in a retrospective study of 103 patients with de novo MBC from January 2013 to June 2022 at an institution in northwest China.Results Multivariate analysis of the primary cohort revealed that independent factors for survival were age at diagnosis,pathological type,histological grade,T stage,N stage,molecular subtype,bone metastasis,brain metastasis,liver metastasis,lung metastasis,surgery,chemotherapy,and radiotherapy.The nomogram achieved a C-index of 0.688(95%confidence interval[CI],0.682-0.694)in the training cohort and 0.875(95%CI,0.816-0.934)in the validation cohort.The AUC of the nomograms indicated good specificity and sensitivity in the training and validation cohorts,respectively.Calibration curves showed favorable consistency between the predicted and actual survival probabilities.Additionally,the DCA curve produced higher net gains than by the AJCC-TNM staging system.Finally,risk stratification can accurately identify groups of patients with de novo MBC at different risk levels.Conclusions The nomogram showed favorable predictive and discriminative abilities for OS in patients with de novo MBC.Other populations from different countries or prospective studies are needed to further validate the nomogram.
