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Pyrotinib plus capecitabine could significantly improve overall survival in HER2-positive metastatic breast cancer

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Signal Transduction and Targeted Therapy 2023年第4期8卷 1378-1380页

作者： Xiuwen guan Fei Ma Qiao Li Shanshan Chen Ying Fan Jiayu Wang Yang Luo Pin Zhang Qing Liand binghe Xu Department of Medical Oncology and State Key Laboratory of Molecular Oncology National Cancer Center/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijingChina

Dear Editor,The irreversible pan-ErbB tyrosine kinase inhibitors(TKIs),including neratinib and pyrotinib,demonstrated more complete inhibition towards ErbB-family and promising antitumor activity compared to lapatinib,a reversible TKI.1 In the phase III NALA study for HER2-positive metastatic breast cancer(MBC)who were progressed after two lines of HER2-targeted regimens,2 significant improvement was observed in progression-free survival(PFS)in patients receiving neratinib combined with capecitabine when compared to lapatinib plus capecitabine(L+C)group.However,the 2.2-month PFS improvement in neratinib plus capecitabine cohort failed to translate to a significant benefit in the overall survival(OS,24.0 vs 22.2 months,P=0.2086).2 While another irreversible TKI,pyrotinib combined with capecitabine(P+C)achieved clinically and statistically significant improvement in the PFS and a trend of benefits in the OS when compared to the L+C group,based on the interim analysis(with the cutoff of March 31,2019)of the phase III PHOEBE study.3 Generally speaking,current evidence was still limited regarding the survival data of irreversible TKIs.

关键词： capecitabine HER2 breast

从阳化气阴成形角度探讨阴阳二气与能量代谢的内在联系

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中国中医药现代远程教育 2024年第14期22卷 85-88页

作者：毕珊榕古文霞关冰河梁家辉王彬深圳市宝安纯中医治疗医院治未病中心广东深圳518100

阴阳既相互依存,又相互转化。能量代谢是生命活动的重要表现。“阳化气,阴成形”理论指出,阴气是为阳气提供能量转化的物质基础,阳气是为阴气提供能量转化的原动力,是物质与能量相互转化的形式之一。氧化还原平衡是维持机体正常能量代... 详细信息

阴阳既相互依存,又相互转化。能量代谢是生命活动的重要表现。“阳化气,阴成形”理论指出,阴气是为阳气提供能量转化的物质基础,阳气是为阴气提供能量转化的原动力,是物质与能量相互转化的形式之一。氧化还原平衡是维持机体正常能量代谢的重要因素,若机体线粒体功能下降,氧化还原失衡,则会引起自由基累积和氧化应激,从而导致能量代谢异常。阴阳平衡与氧化还原平衡之间存在共性,对维持机体内稳态有重要作用。文章从“阳化气,阴成形”角度探讨阴阳二气与能量代谢的内在联系,进一步探索深圳地区亚健康人群阳气功能下降与阳虚质形成的原因,为阳虚质客观化评估提供新思路。

关键词：阳化气阴成形能量代谢氧化还原平衡阴阳学说

Pooled analyses of randomized controlled trials onpyrotinib plus capecitabine and a rethink of the first-line options for HER2-positive relapsed or metastatic breast cancer

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Cancer Innovation 2022年第2期1卷 119-123页

作者： Xiuwen guan Fei Ma binghe Xu Department of Medical Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijingChina Department of Medical Oncology and Clinical Trial Center National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijingChina

Human epidermal growth factor receptor 2(HER2)-positive breast cancer,which accounts for 15%-20% of breast cancers,is associated with aggressive tumor behavior and conferred a poor outcome before the era of HER2-targeted therapy.The advent of anti-HER2 antibodies(trastuzumab and pertuzumab),antibody-drug conjugates(ADCs,ado-trastuzumab emtansine and trastuzumab deruxtecan),and HER2‐tyrosine kinase inhibitors(TKIs,neratinib and lapatinib),have dramatically improved the treatment response and survival of this aggressive subtype.

关键词： breast cancer tyrosine kinase inhibitor HER2-targeted therapy

Clinical spectrum and prognostic value of TP53 mutations in circulating tumor DNA from breast cancer patients in China

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Cancer Communications 2020年第6期40卷 260-269页

作者： Zongbi Yi Fei Ma Guohua Rong Yanfang guan Chunxiao Li binghe Xu Department of Medical Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021P.R.China Geneplus-Beijing Institute Beijing 100021P.R.China State Key Laboratory of Molecular Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021P.R.China

Background:TP53 mutations are common in breast cancer.There is currently no large-scale cohort study to investigate the TP53 landscape in breast cancer patients from China.The predictive value of TP53 mutations for the efficacy of human epidermal growth factor receptor 2(HER2)-targeted therapy in breast cancer remains controversial.In the present study,we aimed to analyze the clinical spectrum and prognostic value of TP53 mutations in circulating tumor DNA(ctDNA)from breast cancer patients in China.Methods:We retrospectively analyzed the clinical data and TP53 mutation features in ctDNA samples from 804 patients withmetastatic breast cancer.TP53 mutations were detected by target region capture-based next-generation sequencing.The relationship between TP53 mutation status and disease-free survival(DFS)was analyzed in 444 patientswithmetastatic breast cancer.Moreover,the relationship between TP53 mutation status and progression-free survival(PFS)was analyzed in 55 HER2-positive patients treated with first-line trastuzumab-based therapy.Kaplan-Meier analysis was performed to estimate the survival curves of the different subgroups,and the log-rank test was used to compare the curves.A Cox regression model was used to estimate multivariable-adjusted hazard ratios and their 95%confidence intervals(CIs)associated with the DFS and PFS.Results:Among the 804 investigated patients,431(53.6%)patients harbored TP53 mutations.TP53 mutations were differentially distributed among different molecular subtypes of breast cancer(P<0.05).Patients with TP53 mutations had a shorter DFS than those with wild-type TP53(hazard ratio=1.32,95%CI=1.09-1.61,P=0.005).TP53 mutations in exons 5-8 were associated with worse outcome(hazard ratio=1.50,95%CI=1.11-2.03,P=0.009).However,TP53 mutation status was not significantly associated with PFS in HER2-positive patients who received firstline trastuzumab-based therapy(P=0.966).Interestingly,in the taxane combination group,patients with TP53 mutations exhibited longer PFS than those without TP53 mut

关键词： breast cancer TP53 mutation circulating tumor DNA next-generation sequencing Chinese prognosis trastuzumab taxanes

The molecular tumor burden index as a response evaluation criterion in breast cancer

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Signal Transduction and Targeted Therapy 2021年第8期6卷 2494-2501页

作者： Zongbi Yi Fei Ma Guohua Rong Binliang Liu Yanfang guan Jin Li Xiaoying Sun Wenna Wang Xiuwen guan Hongnan Mo Jiani Wang Haili Qian binghe Xu Department of Medical Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijingChina Geneplus-Beijing Institute BeijingChina Department of Medical Oncology Huanxing Cancer HospitalBeijingChina State Key Laboratory of Molecular Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijingChina

Circulating tumor DNA(ctDNA)is a potential biomarker of prognosis and therapeutic response.We conducted this study to explore the role of the molecular tumor burden index(mTBI)in ctDNA as a therapeutic response and prognostic biomarker in a larger cohort prospective phase III randomized multicenter study.We collected 291 plasma samples from 125 metastatic breast cancer patients from the CAMELLIA study(NCT01917279).Target-capture deep sequencing of 1021 genes was performed to detect somatic variants in ctDNA from the plasma samples.The pretreatment mTBI value was correlated with tumor burden(P=0.025).Patients with high-level pretreatment mTBI had shorter overall survival than patients with low-level pretreatment mTBI,and the median overall survival was 40.9 months and 68.4 months,respectively(P=0.011).Patients with mTBI decrease to less than 0.02%at the first tumor evaluation had longer progression-free survival and overall survival(P<0.001 and P=0.007,respectively).The mTBI has good sensitivity to identify complete response/partial response and progressive disease based on computed tomography scans(88.5%and 87.5%,respectively).The patients classified as molecular responders had longer progression-free survival and overall survival than the nonmolecular responders in the overall cohort(P<0.001 and P=0.036,respectively),as well as in the cohort in which computed tomography scans were defined as representing stable disease(P=0.027 and P=0.015,respectively).The mTBI in ctDNA detected in liquid biopsies is a potential biomarker of therapeutic response and prognosis in patients with metastatic breast cancer.

关键词： breast cancer index

Mutational characteristics determined using circulating tumor DNA analysis in triple-negative breast cancer patients with distant metastasis

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Cancer Communications 2020年第12期40卷 738-742页

作者： Guohua Rong Zongbi Yi Fei Ma Yanfang guan Yaping Xu Lifeng Li binghe Xu Department of Medical Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021P.R.China Geneplus-Beijing Institute Beijing 100021P.R.China

Dear editor,Breast cancer has been considered as the most common malignancy and the leading cause of death in women worldwide[1].Triple-negative breast cancer(TNBC)accounts for 10%-20%of breast cancers,which are characterized by the absence of estrogen receptor(ER),progesterone receptor(PR),and amplification of human epidermal growth factor receptor 2(HER2)[2].TNBC is well known for its rapid progressiveness,high rate of distant organ recurrence,and poor prognosis.Metastasis remains the major cause of death for patients with TNBCs.Up to date,the only direct treatment for metastatic TNBCs is chemotherapy,which has been challenged by tumor heterogeneity and drug resistance.Lack of effective targeted therapy for metastatic TNBCs impels researchers to focus on discovering potentially actionable targets through mutational profiling.

关键词： breast patients metastasis

Polymorphisms of MTHFR and TYMS predict capecitabine-induced hand-foot syndrome in patients with metastatic breast cancer

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Cancer Communications 2019年第1期39卷 514-525页

作者： Shaoyan Lin Jian Yue Xiuwen guan Peng Yuan Jiayu Wang Yang Luo Ying Fan Ruigang Cai Qiao Li Shanshan Chen Pin Zhang Qing Li Fei Ma binghe Xu Department of Medical Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences&Peking Union Medical CollegeNo.17Panjiayuan NanliChaoyang DistrictBeijing 100021P.R.China Department of VIP Medical Services National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing 100021P.R.China

Background:Breast cancer is a global problem,and a large number of new cases are diagnosed every year.Capecit-abine is effective in patients with metastatic breast cancer(MBC).Hand-foot syndrome(HFS)is a common adverse effect of capecitabine.In this study,we investigated the association between single nucleotide polymorphisms(SNPs)in genes involved in capecitabine metabolism pathways and capecitabine-induced HFS in Chinese patients with MBC to identify some predictive genetic biomarkers.Methods:We selected 3 genes involved in capecitabine metabolism and screened genetic variants in these target genes.We genotyped a total of 22 SNPs in the thymidylate synthase gene(TYMS),the methylene tetrahydrofolate reductase gene(MTHFR),and the ribonucleotide reductase M1 gene(RRM1)in 342 MBC patients treated with capecit-abine-based chemotherapy.The genotype distributions of each SNP in patients with and without HFS were assessed using Pearson’sχ^(2)test,and the relationship between HFS and genotypes of SNPs was determined using logistic regression analysis.The association between SNPs and their corresponding gene expression was analyzed using the Blood expression quantitative trait loci(eQTL)browser online tools.Results:We found 4 positive sites for HFS in the TYMS and MTHFR genes:TYMS rs2606241(P=0.022),TYMS rs2853741(P=0.019),MTHFR rs3737964(P=0.029),and MTHFR rs4846048(P=0.030).Logistic regression analyses showed that the genotype AG of MTHFR rs3737964[odds ratio(OR)=0.54,95%confidence interval(CI)0.31-0.97,P=0.038]and MTHFR rs4846048(OR=0.54,95%CI 0.30-0.98,P=0.042)were protective factors of HFS,whereas the genotype CT of TYMS rs2853741(OR=2.25,95%CI 1.31-3.87,P=0.012)increased the risk of HFS.The association between the genotype GT of TYMS rs2606241(OR=1.27,95%CI 0.73-2.23,P=0.012)and HFS was uncertain.Further eQTL analyses confirmed that the alleles of rs3737964 and rs4846048 affected the gene expression levels of MTHFR in cis.Conclusions:We have identified four potentially useful pharmacogenetic markers,TYMS rs2606241,

关键词： Capecitabine Polymorphism Metastatic breast cancer Hand-foot syndrome TYMS MTHFR

The prognostic and therapeutic implications of circulating tumor cell phenotype detection based on epithelial-mesenchymal transition markers in the first-line chemotherapy of HER2-negative metastatic breast cancer

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Cancer Communications 2019年第1期39卷 1-10页

作者： Xiuwen guan Fei Ma Chunxiao Li Shiyang Wu Shangying Hu Jiefen Huang Xiaoying Sun Jiayu Wang Yang Luo Ruigang Cai Ying Fan Qiao Li Shanshan Chen Pin Zhang Qing Li binghe Xu Department of Medical Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeNo.17Panjiayuan NanliChaoyang DistrictBeijing 100021P.R.China State Key Laboratory of Molecular Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021P.R.China SurExam Bio-Tech Guangzhou Technology Innovation BaseScience CityGuangzhou 510000GuangdongP.R.China Department of Cancer Epidemiology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021P.R.China Department of Medical Oncology Huanxing Cancer HospitalBeijing 100021P.R.China

Background:Epithelial-mesenchymal transition(EMT)is implicated in the metastatic process and presents a chal-lenge to epithelial cell adhesion molecule-based detection of circulating tumor cells(CTCs),which have been demon-strated to be a prognostic indicator in metastatic breast cancer.Although evidence has indicated that heterogeneity of CTCs based on EMT markers is associated with disease progression,no standard recommendations have been established for clinical practice.This study aimed to evaluate the prognostic significance of dynamic CTC detection based on EMT for metastatic breast cancer patients.Methods:We enrolled 108 human epidermal growth factor receptor 2-negative metastatic breast cancer patients from the prospective phase III CAMELLIA study and applied the CanPatrol CTC enrichment technique to identify CTC phenotypes(including epithelial CTCs,biphenotypic epithelial/mesenchymal CTCs,and mesenchymal CTCs)in peripheral blood samples.Receiver operating characteristic curve analyses of total CTC count and the proportion of mesenchymal CTCs for predicting the 1-year progression-free survival(PFS)rate were conducted to determine the optimal cut-off values,and Kaplan-Meier analysis and Cox proportional hazards regression analysis were performed to investigate the prognostic value of the cut-off values of both total CTC count and the proportion of mesenchymal CTCs in combination.Results:For predicting the 1-year PFS rate,the optimal cut-off value of total CTC count was 9.5(Area under the curve[AUC]=0.538,95%confidence interval[CI]=0.418-0.657),and that of the proportion of mesenchymal CTCs was 10.7%(AUC=0.581,95%CI=0.463-0.699).We used the two cut-off values in combination to forecast PFS in which the total CTC count was equaled to or exceeded 10/5 mL with the proportion of mesenchymal CTCs surpassed 10.7%.Patients who met the combined criteria had significantly shorter median PFS than did those who did not meet the criteria(6.2 vs.9.9 months,P=0.010).A nomogram was constructed based on the criteria and si

关键词： Breast cancer Circulating tumor cells Epithelial-mesenchymal transition Prognosis Therapeutic implication

The association between early-onset cardiac events caused by neoadjuvant or adjuvant chemotherapy in triple-negative breast cancer patients and some novel autophagy-related polymorphisms in their genomic DNA: a real-world study

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Cancer Communications 2018年第1期38卷 759-769页

作者： Binliang Liu Tao An Meiying Li Zongbi Yi Chunxiao Li Xiaoying Sun Xiuwen guan Lixi Li Yanfeng Wang Yuhui Zhang binghe Xu Fei Ma Yixin Zeng Department of Medical Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021P.R.China State Key Laboratory of Cardiovascular Disease Heart Failure CenterFuwai HospitalNational Center for Cardiovascular DiseaseChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100037P.R.China Shandong Cancer Hospital and Institute Shandong UniversityJinan 250117ShandongP.R.China State Key Laboratory of Molecular Oncology Cancer Institute/HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021P.R.China Department of Medical Oncology Cancer Hospital of HuanxingBeijing 100065P.R.China Department of Comprehensive Oncology National Cancer Center/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021P.R.China Chinese Academy of Medical Sciences and Peking Union Medical College Beijing 100730P.R.China Collaborative Innovation Center for Cancer Medicine State Key Laboratory of Oncology in South ChinaSun Yat-sen University Cancer Center651 Dongfeng Road EastGuangzhou 510060GuangdongP.R.China

Background:An increasing number of cancer patients die of cardiovascular diseases.The cardiotoxicity of chemo-therapy is particularly important in triple-negative breast cancer(TNBC)with limited therapeutic options.Cardiac autophagy is an important mechanism of cardiotoxicity.This research was aimed to investigate the cardiotoxicity of chemotherapy in TNBC,screen the susceptible population,and determine the relationship between cardiotoxicity and autophagy-related polymorphisms.Methods:From a total of 2450 stage I-III TNBC patients,147 met the inclusion criteria and finally recruited.Electro-cardiography(ECG)was performed before most chemotherapy cycles,and echocardiography(UCG)was performed according to clinical needs.All ECG and UCG records were re-interpreted by cardiologists at the National Center for Cardiovascular Disease,Fuwai Hospital.According to the National Center for Biotechnology Information and the Catalog of Somatic Mutations in Cancer database,we selected 25 single nucleotide polymorphisms(SNPs)related to autophagy and genotyped the 147 TNBC patients.Paired-sample T tests,Chi squared tests,and logistic regression models were employed for the analysis.Results:Only 46(31.3%)patients had normal ECG records after every chemotherapy cycle.Among the 16 patients who underwent UCG,2(12.5%)had a reversible decrease of left ventricular ejection fraction.The use of anthracyclines and excessive alcohol consumption were risk factors of ECG abnormalities.With the continuation of chemotherapy,heart rate gradually increased.Anthracyclines were associated with QRS duration abnormalities(P=0.043).After genotyping for 25 autophagy-related SNPs,we found that the G allele of autophagy-related 13(ATG13)rs10838611 was significantly associated with ECG abnormalities(odds ratio=2.258,95%confidence interval=1.318-3.869;P=0.003).Conclusion:ECG abnormalities caused by chemotherapy are common in the real world.Autophagy-related SNPs are associated with chemotherapy-induced cardiotoxicity,thereby providing new evidence for aut

关键词： Triple-negative breast cancer Chemotherapy Cardiotoxicity Autophagy Single nucleotide polymorphisms