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Treatment patterns and clinical outcomes in patients with metastatic breast cancer treated with palbociclib-based therapies:real-world data in the Han population

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Chinese Medical Journal 2022年第14期135卷 1734-1741页

作者： Hongnan Mo Fei Ma qing Li Pin Zhang Peng Yuan Jiayu Wang Yang Luo Ruigang Cai Qiao Li binghe xu Department of Medical Oncology National Cancer CenterNational Clinical Research Center for CancerCancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021China

Background:This study aimed to reveal the treatment patterns and clinical outcomes of diverse palbociclib-based regimens in Han patients with estrogen receptor-positive(ER+)metastatic breast cancer in routine clinical ***:The clinical data of patients with ER+metastatic breast cancer treated with palbociclib were collected from the National Cancer Center *** efficacy profile of palbociclib in this Han population was evaluated,especially for various combination *** efficacy of palbociclib-based therapy in patients with prior everolimus treatment was also ***:A total of 186 patients from 89 cities in 18 provinces in China were *** median progression-free survival(PFS)was similar among different palbociclib-combined groups(P=0.566):10.0 months(95%confidence interval[CI]3.8-16.1)in the+exemestane group,9.7 months(95%CI 6.3-13.1)in the+letrozole group,7.8 months(95%CI 5.5-10.2)in the+fulvestrant group,7.2 months(95%CI 3.2-11.3)in the+toremifene group,and 6.1 months(95%CI 1.2-11.0)in the+anastrozole ***-four patients(18.3%)had received everolimus for their metastatic disease before the prescription of *** disease control rate was significantly lower in patients who had received previous everolimus than in the everolimus-naïve group(50.0%vs.82.2%,P<0.001).Patients pre-treated with everolimus had significantly worse PFS than those in the everolimus-naïve group(3.4 months vs.8.8 months,P=0.001).After propensity score matching,patients pre-treated with everolimus had similar PFS(4.4 months,95%CI 0.5-8.2)compared with everolimus-naïve patients(6.1 months,95%CI 4.7-7.5,P=0.439).Conclusions:Various palbociclib-based regimens have promising efficacy in ER+metastatic breast cancer in real-world settings,even in patients who had been pre-treated with everolimus.

关键词： Metastatic breast cancer Palbociclib Progression-free survival Real-world data

Efficacy and safety of duloxetine in Chinese breast cancer patients with paclitaxel-induced peripheral neuropathy

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Chinese Journal of Cancer Research 2017年第5期29卷 411-418页

作者： Jiani Wang qing Li binghe xu Tongtong Zhang Shanshan Chen Yang Luo Department of Medical Oncology National Cancer Center/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College

Objective： Chemotherapy with paclitaxel is associated with significant neurotoxicity that may offset patients＇ quality of life and therapeutic benefits. This prospective, non-randomized control study evaluated the efficacy and safety of an antidepressant drug, duloxetine, at 30 or 60 mg/d, in the treatment of paclitaxel-induced peripheral neuropathy（PIPN） in Chinese breast cancer ***：A total of 102 patients with a median age of 50（range,25–60）years,treated in the Department of Medical Oncology,National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,between November 2014 and January 2017 were finally *** by baseline characteristics,the patients were classified into two groups,receiving either duloxetine or alternative antineurotoxicity *** the course of the paclitaxel regimen,the eligibility criteria included sensory neuropathy,as evaluated by the National Cancer Institute-Common Toxicity Criteria for Adverse *** treatment consisted of receiving 30 mg duloxetine（for the first 4 weeks）and 60 mg duloxetine for an additional 8 weeks,or any other anti-neurotoxicity drug daily during the same crossover *** improvement associated with PIPN from the patient’s perspective were assessed by the Functional Assessment of Cancer Therapy-Taxane（FACT-Tax）Scales,which contained questions scored from 0 to 4（0,not at all;4,very much;total score range,0–44）.Results：Duloxetine was more effective in decreasing PIPN（odds ratio=5.426;95%confidence interval,1.898–15.514;P=0.002）.Between duloxetine group and control group,the median（25th–75th percentiles）decreasing difference in the FACT-Tax pain score was 4（2–6）vs.1（0–4）（P=0.005）.Conclusions：Duloxetine is a promising and safe option with tolerable toxicity at a dose of 60 mg/d for Chinese breast cancer patients with ***-neuropathy adverse events were mild and similar in both *** major toxicities of duloxetine included nausea,c

关键词： Duloxetine FACT-Tax Scales paclitaxel peripheral neuropathy

Entinostat,a classⅠselective histone deacetylase inhibitor,plus exemestane for Chinese patients with hormone receptor-positive advanced breast cancer:A multicenter,randomized,double-blind,placebo-controlled,phase 3 trial

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Acta Pharmaceutica Sinica B 2023年第5期13卷 2250-2258页

作者： binghe xu qingyuan Zhang Xichun Hu qing Li Tao Sun Wei Li Quchang Ouyang Jingfen Wang Zhongsheng Tong Min Yan Huiping Li Xiaohua Zeng Changping Shan Xian Wang Xi Yan Jian Zhang Yue Zhang Jiani Wang Liang Zhang Ying Lin Jifeng Feng Qianjun Chen Jian Huang Lu Zhang Lisong Yang Ying Tian Hongyan Shang Department of Medical Oncology and State Key Laboratory of Molecular Oncology National Cancer Cener/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021China Department of Medical Oncology Harbin Medical University Cancer HospitalHarbin 150000China Department of Medical Oncology Fudan University Shanghai Cancer CenterShanghai 200000China Department of Galactophore Liaoning Cancer Hospital&InstituteShenyang 110801China Department of Oncology the First Hospital of Jilin UniversityChangchun 130061China Department of Galactophore Hunan Cancer HospitalChangsha 410000China Department of Galactophore Linyi Cancer HospitalLinyi 276000China Department of Breast Medical Oncology Tianjin Medical University Cancer Institute&HospitalTianjin 300000China Department of Breast Disease Henan Breast Cancer Centerthe Affiliated Cancer Hospital of Zhengzhou University&Henan Cancer HospitalZhengzhou 450008China Department of Breast Oncology Beijing Cancer HospitalBeijing 100000China Breast Cancer Center Chongqing University Cancer HospitalChongqing 400000China Department of Breast and Thyroid Oncology Affiliated Hospital of Jining Medical UniversityChangchun 130021China Department of Medical Oncology Run Run Shaw HospitalAffiliated Hospital of Zhejiang UniversityHangzhou 310003China Department of Head and Heck Oncology West China HospitalSichuan UniversityChengdu 610000China Department of Thyroid&Breast Surgery the First Affiliated Hospital of Sun Yat-sen UniversityGuangzhou 510000China Department of Medical Oncology Jiangsu Cancer HospitalNanjing 210000China Department of Galactophore Guangdong Hospital of Traditional Chinese MedicineGuangzhou 510000China Department of Oncological Surgery the Second Affiliated HospitalZhejiang University School of MedicineHangzhou 310000China Taizhou EOC Pharma Co. Ltd.Taizhou 318000China

Entinostat plus exemestane in hormone receptor-positive(HR+)advanced breast cancer(ABC)previously showed encouraging *** multicenter phase 3 trial evaluated the efficacy and safety of entinostat plus exemestane in Chinese patients with HR+ABC that relapsed/progressed after≥1 endocrine *** were randomized(2:1)to oral exemestane 25 mg/day plus entinostat(n=235)or placebo(n=119)5 mg/week in 28-day *** primary endpoint was the independent radiographic committee(IRC)-assessed progression-free survival(PFS).The median age was 52(range,28—75)years and 222(62.7%)patients were ***4/6 inhibitors and fulvestrant were previously used in 23(6.5%)and 92(26.0%)patients,*** baseline characteristics were comparable between the entinostat and placebo *** median PFS was 6.32(95%CI,5.30—9.11)and 3.72(95%CI,1.91—5.49)months in the entinostat and placebo groups(HR,0.76;95%CI,0.58—0.98;P=0.046),***≥3 adverse events(AEs)occurred in 154(65.5%)patients in the entinostat group versus 23(19.3%)in the placebo group,and the most common grade≥3 treatment-related AEs were neutropenia[103(43.8%)],thrombocytopenia[20(8.5%)],and leucopenia[15(6.4%)].Entinostat plus exemestane significantly improved PFS compared with exemestane,with generally manageable toxicities in HR+ABC(***#NCT03538171).

关键词： Advanced breast cancer Hormone receptor-positive Histone deacetylase inhibitors Phase 3 clinical trial

组蛋白去乙酰化酶抑制剂在HR阳性HER-2阴性晚期乳腺癌的研究进展

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中国肿瘤临床 2023年第17期50卷 897-900页

作者：王佳妮李青(综述) 徐兵河(审校) 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肿瘤内科北京市100021

组蛋白去乙酰化酶(histone deacetylase,HDAC)是可调节表观遗传学改变的组蛋白修饰酶,在一些肿瘤中HDACs被异常激活,与肿瘤进展和耐药密切相关。HDAC抑制剂(HDAC inhibitor,HDACi)通过调节肿瘤细胞的表观遗传属性,靶向性控制肿瘤细胞增... 详细信息

组蛋白去乙酰化酶(histone deacetylase,HDAC)是可调节表观遗传学改变的组蛋白修饰酶,在一些肿瘤中HDACs被异常激活,与肿瘤进展和耐药密切相关。HDAC抑制剂(HDAC inhibitor,HDACi)通过调节肿瘤细胞的表观遗传属性,靶向性控制肿瘤细胞增殖、调节肿瘤细胞周期及修复DNA损伤。HDACi可抑制多个乳腺癌致癌信号通路,从而有可能逆转激素受体(hormone receptor,HR)阳性HER-2阴性乳腺癌的治疗耐药。本文将对HDACi在HR阳性HER-2阴性晚期乳腺癌治疗方面进行综述,探讨其在乳腺癌治疗领域中的应用前景。

关键词：组蛋白去乙酰化酶抑制剂晚期乳腺癌激素受体阳性靶向治疗

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 ***: 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 ***: 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 *** 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

关键词： Adjuvant therapy breast cancer HER2 trastuzumab risk factors

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 ***-abine is effective in patients with metastatic breast cancer(MBC).Hand-foot syndrome(HFS)is a common adverse effect of *** 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 ***:We selected 3 genes involved in capecitabine metabolism and screened genetic variants in these target *** 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 *** 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 *** association between SNPs and their corresponding gene expression was analyzed using the Blood expression quantitative trait loci(eQTL)browser online ***: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 *** association between the genotype GT of TYMS rs2606241(OR=1.27,95%CI 0.73-2.23,P=0.012)and HFS was *** eQTL analyses confirmed that the alleles of rs3737964 and rs4846048 affected the gene expression levels of MTHFR in ***:We have identified four potentiall

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

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 *** 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 ***: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 ***-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 ***:Three genotypes,AA,GA,and GG,were detected in the rs473543 of ATG5 *** 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

Dose-dense paclitaxel plus carboplatin *** and cyclophosphamide with paclitaxel as adjuvant chemotherapy for high-risk triple-negative breast cancer

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Chinese Journal of Cancer Research 2020年第4期32卷 485-496页

作者： qing Li Jiani Wang Yuxin Mu Tongtong Zhang Ying Han Jiayu Wang Qiao Li Yang Luo Fei Ma Ying Fan Pin Zhang binghe xulj 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 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 100021China

Objective:The objective of this open-label,randomized study was to compare dose-dense paclitaxel plus carboplatin(PCdd)with dose-dense epirubicin and cyclophosphamide followed by paclitaxel(ECdd-P)as an adjuvant chemotherapy for early triple-negative breast cancer(TNBC).Methods:We included Chinese patients with high recurrence risk TNBC who underwent primary breast cancer *** were randomly assigned to receive PCdd[paclitaxel 150 mg/m2 on d 1 and carboplatin,the area under the curve,(AUC)=3 on d 2]or ECdd-P(epirubicin 80 mg/m2 divided in 2 d and cyclophosphamide 600 mg/m2 on d 1 for 4 cycles followed by paclitaxel 175 mg/m2 on d 1 for 4 cycles)every 2 weeks with granulocyte colony-stimulating factor(G-CSF)*** primary endpoint was 3-year disease-free survival(DFS);the secondary endpoints were overall survival(OS)and ***:The intent-to-treat population included 143 patients(70 in the PCdd arm and 73 in the ECdd-P arm).Compared with the ECdd-P arm,the PCdd arm had significantly higher 3-year DFS[93.9%vs.79.1%;hazard ratio(HR)=0.310;95%confidence interval(95%CI),0.137-0.704;log-rank,P=0.005]and OS(98.5%vs.92.9%;HR=0.142;95%CI,0.060-0.825;log-rank,P=0.028).Worse neutropenia(grade 3/4)was found in the ECdd-P than the PCdd arm(47.9%V5.21.4%,P=0.001).Conclusions:PCdd was superior to ECdd-P as an adjuvant chemotherapy for early TNBC with respect to improving the 3-year DFS and *** also yielded lower hematological ***,PCdd might be a preferred regimen for early TNBC patients with a high recurrence risk.

关键词： Triple-negative breast cancer dose-dense adjuvant chemotherapy carboplatin paclitaxel

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 *** evidence has indicated that heterogeneity of CTCs based on EMT markers is associated with disease progression,no standard recommendations have been established for clinical *** study aimed to evaluate the prognostic significance of dynamic CTC detection based on EMT for metastatic breast cancer ***: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 *** 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 ***: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 nomog

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