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Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2(HER2)-positive early-stage breast cancer: A real-world retrospective study in Chinese patients

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Chinese Journal of Cancer Research 2019年第5期31卷 759-770页

作者： Jihong Guo Qing Li Pin Zhang Peng Yuan Jiayu Wang Fei Ma Ying Fan Ruigang Cai Yang Luo Qiao 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 100021China Department of Oncology Beijing Chaoyang HospitalCapital Medical UniversityBeijing 100020China State Key Laboratory of Molecular Oncology National Cancer Center/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021China

Objective: To assess the long-term effectiveness and safety of trastuzumab in adjuvant therapy for Chinese patients with early-stage human epidermal growth factor 2(HER2)-positive breast cancer in a real-world setting.Methods: This retrospective observational study analyzed the medical records of HER2-positive breast cancer patients between 2000 and 2012 at the Chinese Academy of Medical Sciences. Patients who received adjuvant chemotherapy alone or adjuvant chemotherapy followed by/combined with trastuzumab were included. The Kaplan-Meier method was used to estimate disease-free survival(DFS) and overall survival(OS). Hazard ratios(HR) and 95% confidence intervals(95% CI) were calculated using the Cox regression model.Results: Of the 1,348 patients analyzed, 909 received chemotherapy alone and 439 received chemotherapy plus trastuzumab. The 3-year, 5-year and 10-year DFS rates were 83.70%, 76.38% and 68.94%, respectively, in the chemotherapy-alone cohort, and 90.21%, 86.19% and 83.45% in the chemotherapy plus trastuzumab cohort. The3-year, 5-year and 10-year OS rates were 96.10%, 91.40% and 81.88% in the chemotherapy-alone cohort, and98.17%, 94.91% and 90.01% in the chemotherapy plus trastuzumab cohort. The chemotherapy plus trastuzumab group had a significantly lower risk of disease recurrence and death than the chemotherapy-alone group(DFS:HR=0.50, 95% CI, 0.37-0.68;P<0.001;OS: HR=0.53, 95% CI, 0.34-0.81;P=0.004) after adjusting for covariates.In the 439 patients treated with trastuzumab, multivariate analysis suggested that lymph node positivity, higher T stages, and hormone receptor-negative status were significantly associated with higher risks of disease recurrence,and lymph node positivity and hormone receptor-negative status were significantly associated with higher risks of death. Grade 3/4 adverse events(incidence ≥1%) were more common in patients receiving trastuzumab(54.44% vs.15.73%).Conclusions: Early-stage HER2-positive breast cancer patients treated with trastuzumab plus adjuvant chemotherapy hav

关键词： Adjuvant therapy breast cancer HER2 trastuzumab risk factors

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Anlotinib has good efficacy and low toxicity: a phase Ⅱ study of anlotinib in pre-treated HER-2 negative metastatic breast cancer

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Cancer Biology & Medicine 2021年第3期18卷 849-859页

作者： Nanlin Hu Yiran Si Jian Yue Tingting Sun xue Wang Zhuqing Jia Songlin Gao Qiao Li Yang Shao Jiayu Wang Yang Luo Fei Ma binghe xu Peng Yuan Department of Medical Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021China Department of VIP Medical Services National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021China Nanjing Geneseeq Technology Inc. Nanjing 210032China Cancer Hospital of Huanxing Chaoyang District Beijing Beijing 100021China

Objective:Anlotinib is a novel tyrosine kinase inhibitor blocking angiogenesis.This study was performed to assess the efficacy and safety of anlotinib in patients with metastatic breast cancer.Methods:Patients with HER2-negative breast cancer,who were pre-treated with anthracycline or taxanes in a neoadjuvant,adjuvant,or metastatic setting,and had treatment failure after at least one prior chemotherapy regimen in the metastatic setting were enrolled.Anlotinib was administered at 12 mg daily for 14 days in a 21-day cycle until disease progression or unacceptable toxicity occurred.Simultaneously,5–10 m L of venous blood was collected to perform circulating tumor DNA(ct DNA)testing every 2 treatment cycles.The primary endpoint was the objective response rate(ORR).Secondary endpoints included the disease control rate(DCR),progression-free survival(PFS),overall survival,safety,and biomarkers.Results:Twenty-six eligible patients were enrolled,with a median age of 56(30–75)years.The median follow-up time was 10.5 months.The ORR was 15.4%,the DCR was 80.8%,and the median PFS was 5.22 months(95%confidence interval 2.86–6.24).Fourteen(53.8%)patients survived for more than 10 months.The changes in the detectable ct DNA variant allele frequency were consistent with the tumor response.The most common treatment-related adverse events were hypertension(57.7%),thyroidstimulating hormone elevation(34.6%),and hand-foot syndrome(23.1%).Conclusion:Anlotinib showed objective efficacy with tolerable toxicity in heavily pre-treated,metastatic HER2-negative breast cancer.The dynamic changes in the ct DNA variant allele fraction may be predictive of the tumor response.

关键词： Anlotinib angiogenesis HER2-negative breast cancer ct DNA

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Expert consensus on the clinical application of antibody‐drug conjugates in the treatment of malignant tumors(2021 edition)

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Cancer Innovation 2022年第1期1卷 3-24页

作者： Professional Committee on Clinical Research of Oncology Drugs,Chinese Anti‐Cancer Association Expert Committee for Monitoring the Clinical Application of Antitumor Drugs Breast Cancer Expert Committee of National Cancer Quality Control Center| Cancer Chemotherapy Quality Control Expert Committee of Beijing Cancer Treatment Quality Control and Improvement Center Fei Ma binghe xu 不详 Department of Medical Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021China DepartmentofMedical Oncology andClinicalTrialCenter National CancerCenter/NationalClinical Research CenterforCancer/Cancer HospitalChineseAcademyofMedical Sciences andPekingUnionMedical CollegeBeijing100021China

Antibody‐drug conjugates(ADCs)are targeted biological agents composed of a cytotoxic drug linked to a monoclonal antibody through a linker.The monoclonal antibody targets tumor cells and transports small‐molecule cytotoxic drugs for specific delivery and minimal off‐target side effects.It is necessary for clinicians to understand the molecular characteristics and mechanisms of ADCs.Patients'survival mainly depends on the appropriate dose and course of treatment and also on proper management of adverse reactions.This consensus provides a systematic review of commercially available ADCs and further discusses the clinical application and management of ADCs.

关键词： malignant tumors antibody‐drug conjugates monoclonal antibodies cytotoxic drugs safety management

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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

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Genetic polymorphisms of autophagy-related gene 5 (ATG5) rs473543 predict different disease-free survivals of triple-negative breast cancer patients receiving anthracycline- and/or taxane-based adjuvant chemotherapy

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Cancer Communications 2018年第1期38卷 31-38页

作者： Meiying Li Fei Ma Jiayu Wang Qing Li Pin Zhang Peng Yuan Yang Luo Ruigang Cai Ying Fan Shanshan Chen Qiao Li binghe xu Department of Medical Oncology National Cancer Center/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeNo.17Panjiayuan NanliChaoyang DistrictBeijing 100021P.R.China

Background:Autophagy plays a crucial role in chemotherapy resistance of triple-negative breast cancer(TNBC).Hence,autophagy-related gene 5(ATG5),an essential molecule involved in autophagy regulation,is presumably associated with recurrence of TNBC.This study was aimed to investigate the potential influence of single-nucleotide polymorphisms in ATG5 on the disease-free survival(DFS)of early-stage TNBC patients treated with anthracycline-and/or taxane-based chemotherapy.Methods:We genotyped ATG5 SNP rs473543 in a cohort of 316 TNBC patients treated with anthracycline-and/or taxane-based chemotherapy using the sequenom’s MassARRAY system.Kaplan-Meier survival analysis and Cox proportional hazard regression analysis were used to analyze the association between ATG5 rs473543 genotypes and the clinical outcome of TNBC patients.Results:Three genotypes,AA,GA,and GG,were detected in the rs473543 of ATG5 gene.The distribution of ATG5 rs473543 genotypes was significantly different between patients with and without recurrence(P=0.024).Kaplan-Meier survival analysis showed that patients carrying A allele of ATG5 rs473543 had an increased risk of recurrence and shorter DFS compared with those carrying the variant genotype GG in rs473543(P=0.034).In addition,after adjust-ing for clinical factors,multivariate Cox regression analyses revealed that the AA/GA genotype of rs473543 was an independent predictor for DFS(hazard risk[HR],1.73;95%confidence interval[CI],1.04-2.87;P=0.034).In addition,DFS was shorter in node-negative patients with the presence of A allele(AA/GA)than in those with the absence of A allele(P=0.027).Conclusion:ATG5 rs473543 genotypes may serve as a potential marker for predicting recurrence of early-stage TNBC patients who received anthracycline-and/or taxane-based regimens as adjuvant chemotherapy.

关键词： Autophagy-related gene 5 Triple-negative breast cancer Disease-free survival Anthracycline Taxanes

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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

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Irinotecan plus S-1 versus S-1 in patients with previously treated recurrent or metastatic esophageal cancer(ESWN 01):a prospective randomized,multicenter,open-labeled phase 3 trial

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Cancer Communications 2019年第1期39卷 151-160页

作者： Jing Huang binghe xu Ying Liu Junxing Huang Ping Lu Yi Ba Lin Wu Yuxian Bai Shu Zhang Jifeng Feng Ying Cheng Jie Li Lu Wen Xianglin Yuan Changwu Ma Chunhong Hu Qingxia Fan Xi Wang Department of Medical Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeNo 17 Panjiayuan NanliChaoyang DistrictBeijing 100021P.R.China Department of Medical Oncology Henan Cancer HospitalZhengzhou 450008HenanP.R.China Department of Medical Oncology Taizhou People’s HospitalTaizhou 225300JiangsuP.R.China Department of Medical Oncology First Affiliated Hospital of Xinxiang Medical UniversityXinxiang 453100HenanP.R.China Department of Medical Oncology Tianjin Cancer HospitalTianjin 300060P.R.China Department of Medical Oncology Hunan Cancer HospitalChangsha 410006HunanP.R.China Department of Medical Oncology Harbin Medical University Cancer HospitalHarbin 150040HeilongjiangP.R.China Department of Medical Oncology Shandong Cancer HospitalJinan 250117ShandongP.R.China Department of Medical Oncology Jiangsu Cancer HospitalNanjing 210009JiangsuP.R.China Department of Medical Oncology Jilin Cancer HospitalChangchun 130012JilinP.R.China Department of Radiotherapy Shanxi Cancer HospitalTaiyuan 030013ShanxiP.R.China Department of Medical Oncology Shanxi Cancer HospitalTaiyuan 030013ShanxiP.R.China Department of Medical Oncology Tongji HospitalWuhan 430030HubeiP.R.China Department of Medical Oncology Chifeng Municipal HospitalChifeng 024000Inner MongoliaP.R.China Department of Oncology The Second Xiangya Hospital of Central South UniversityChangsha 410011HunanP.R.China Department of Oncology The First Affiliated Hospital of Zhengzhou UniversityZhengzhou 450052HenanP.R.China

Background:The benefit of systemic treatments in esophageal squamous cell carcinoma(ESCC)which has pro-gressed after chemotherapy is still uncertain and optimal regimens based on randomized trials have not yet been established.We aimed to compare the efficacy of irinotecan plus S-1 with S-1 monotherapy in recurrent or metastatic ESCC patients who had resistance to platinum-or taxane-based chemotherapy.Methods:We conducted a prospective randomized,multicenter,open-label,phase 3 trial in 15 centers across China.Eligible patients were adults with histologically confirmed recurrent or metastatic ESCC,and were randomly assigned(ratio,1:1)to receive either irinotecan plus S-1(intravenous infusion of irinotecan[160 mg/m2]on day 1 and oral S-1[80-120 mg]on days 1-10,repeated every 14 days)or oral S-1 monotherapy(80-120 mg/day on days 1-14,repeated every 21 days)using a central computerized minimization procedure.The primary endpoint was progression-free survival(PFS).Results:Between December 23,2014 and July 25,2016,we screened 148 patients and randomly assigned 123 patients to receive either irinotecan plus S-1 regimen(n=61)or S-1 monotherapy(n=62).After a median follow-up of 29.2 months(95%confidence interval[CI]17.5-40.9 months),the median PFS was significantly longer in the irinotecan plus S-1 group than in the S-1 monotherapy group(3.8 months[95%CI 2.9-4.3 months]vs.1.7 months[95%CI 1.4-2.7 months],hazard ratio=0.58,95%CI 0.38-0.86,P=0.006).The objective response rates were 24.6%in the irinotecan plus S-1 group and 9.7%in the S-1 monotherapy group(P=0.002).The patients in the irinotecan plus S-1 group presented with increased rates of grade 3-4 leukopenia(16.4%vs.0%),neutropenia(14.8%vs.1.6%),and nausea(4.9%vs.0%).No significant difference in grade 3-4 diarrhea and no treatment-related deaths were observed in both groups.Conclusions: The combination of irinotecan with S-1 was similarly tolerable but significantly prolonged PFS compared to S-1 monotherapy as a second- or third-line treatment in patients with recurren

关键词： Esophageal squamous cell carcinoma Recurrent Metastasis Multicenter open-label randomized trial Irinotecan S-1 Overall survival Progression-free survival Objective response rate Disease control rate

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Phase Ⅱ study of apatinib in combination with oral vinorelbine in heavily pretreated HER2-negative metastatic breast cancer and clinical implications of monitoring ctDNA

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Cancer Biology & Medicine 2021年第3期18卷 875-887页

作者： Anjie Zhu Peng Yuan Nanlin Hu Mingzhou Li Wenmiao Wang xue Wang Jian Yue Jiayu Wang Yang Luo Fei Ma Pin Zhang Qing Li binghe xu Shanbo Cao Giuseppe Lippi Yoichi Naito Mohammed A.Osman Gustavo N.Marta Gianluca Franceschini Armando Orlandi Department of Medical Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021China Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education/Beijing) Department of BreastOncologyPeking University Cancer Hospital&InstituteBeijing 100142China Department of VIP Medical Services National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021China Department of Pathology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021China Acorn Med Biotechnology Co. Ltd.Beijing 101102China Section of Clinical Biochemistry University Hospital of VeronaVeronaVerona 37100Italy Department of Breast and Medical Oncology National Cancer Center Hospital EastKashiwa 277-8577Japan Clinical Oncology General Organization for Teaching HospitalsCairo 11435Egypt Department of Radiation Oncology Hospital Sírio-LibanêsSao Paulo 01308-050Brazil Multidisciplinary Breast Center Fondazione Policlinico Universitario A.Gemelli IRCCSUniversitàCattolica del Sacro CuoreRome 00176Italy Unit of Medical Oncology Fondazione Policlinico Universitario A.Gemelli IRCCSRoma 00176Italy

Objective:Apatinib is an oral TKI targeting VEGFR-2.Single-agent apatinib treatment has been shown to produce an objective response in patients with pretreated m BC.Oral vinorelbine also holds promise as a treatment of choice in patients with m BC.This study aimed to investigate the efficacy and safety of the oral vinorelbine-apatinib combination in patients with pretreated m BC.In addition,we detected gene variants in ct DNA to explore the therapeutic implications.Methods:This study enrolled patients with HER2-negative m BC who were pretreated with anthracycline/taxanes.Patients were treated with apatinib at 500 mg/425 mg daily plus oral vinorelbine 60 mg/m2 on days 1,8,and 15 of every cycle(3 weeks).The primary endpoint was PFS.The secondary endpoints were ORR,CBR,OS,and safety.Patients eligible for ct DNA detection were evaluated before and during treatment.Results:Forty patients were enrolled.The median PFS was 5.2 months(95%CI,3.4–7.0 months),and the median OS was 17.4 months(95%CI,8.0–27.0 months).The ORR was 17.1%(6/35),and the CBR was 45.7%(16/35).The most common AEs included gastrointestinal reaction,myelosuppression,and hypertension.In 20 patients,ct DNA was detected at baseline and during treatment.A significant difference was found in PFS for undetected vs.detected baseline ct DNA(13.9 months vs.3.6 months,P=0.018).Conclusions:All-oral therapy with apatinib plus vinorelbine displayed objective efficacy in patients with heavily pretreated HER2-negative m BC,with acceptable and manageable toxicity profiles.Patients with no gene variant detected and lower variant allele frequencies in ct DNA at baseline showed longer PFS.

关键词： Metastatic breast cancer apatinib oral vinorelbine ct DNA

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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

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中国县域乳腺癌防治管理路径与质量控制指南(2023版)

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中华肿瘤杂志 2024年第1期46卷 1-18页

作者：国家肿瘤质控中心乳腺癌专家委员会健康中国研究中心癌症防治专家委员会马飞徐兵河兰波路平刘梦友不详国家癌症中心、国家肿瘤临床医学研究中心、中国医学科学院北京协和医学院肿瘤医院内科北京100021 国家癌症中心、国家肿瘤临床医学研究中心、中国医学科学院北京协和医学院肿瘤医院药物临床试验研究中心北京100021 新乡医学院第一附属医院肿瘤内科利辛县人民医院甲乳外科

乳腺癌是威胁中国女性健康的第一大恶性肿瘤。2016年中国女性新发乳腺癌30.60万例, 其中中国县域地区(包含农村地区)新发乳腺癌约10.04万例, 约占同年中国总新发乳腺癌的33%。县域(县级或县级市)医院是多数县域乳腺癌患者的首诊单位, ... 详细信息

乳腺癌是威胁中国女性健康的第一大恶性肿瘤。2016年中国女性新发乳腺癌30.60万例, 其中中国县域地区(包含农村地区)新发乳腺癌约10.04万例, 约占同年中国总新发乳腺癌的33%。县域(县级或县级市)医院是多数县域乳腺癌患者的首诊单位, 在乳腺癌的预防、筛查、维持治疗、康复随访和转诊等方面发挥重要作用。县域医院由于经济和地理等因素的限制, 在医疗设备、人才、药物可及性等方面都相对不足, 亟需适合县域实际情况的乳腺癌防治管理指南。因此, 在分级诊疗的政策背景下, 国家肿瘤质控中心乳腺癌专家委员会和健康中国研究中心癌症防治专家委员会起草并制定了《中国县域乳腺癌防治管理路径与质量控制指南(2023版)》, 旨在进一步促进优质医疗资源扩容下沉、区域均衡布局, 提高整体乳腺癌的防控效果, 改善县域乳腺癌患者的预后和生活质量。指南采用路径形式, 更加简明清晰且实操性强, 以供广大县域临床医师参考。

关键词：乳腺肿瘤防治管理质量控制县域指南

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