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Efficacy and clinical outcome of chemotherapy and endocrine therapy as first-line treatment in patients with hormone receptor-positive her2-negative metastatic breast cancer

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Chinese Medical Journal 2023年第12期136卷 1459-1467页

作者： Yang Yuan Shaohua Zhang Tao Wang Li Bian Min Yan Yongmei Yin Yuhua Song Yi Wen Jianbin Li Zefei Jiang Department of Oncology No.4 Ward The Fifth Medical Center of Chinese People’s Liberation Army(PLA)General HospitalBeijing 100071China Department of Oncology No.3 Ward The Fifth Medical Center of Chinese People’s Liberation Army(PLA)General HospitalBeijing 100071China Department of Breast Disease Henan Breast Cancer CenterThe Affiliated Cancer Hospital of Zhengzhou University&Henan Cancer HospitalZhengzhouHenan 450008 China Department of Breast Cancer Jiangsu Province Hospital&The First Affiliated Hospital of Nanjing Medical UniversityNanjingJiangsu 210029 China Department of Breast Cancer Center The Affiliated Hospital of Qingdao UniversityQingdaoShandong 260000 China Medical Department Medpion(Beijing)Medical Technology Co.LtdBeijing 100062 China

Background:Endocrine therapy(ET)and ET-based regimens are the preferred first-line treatment options for hormone receptor(HR)-positive and human epidermal growth factor receptor 2(her2)-negative metastatic breast cancer(HR+/her2-MBC),while chemotherapy(CT)is commonly used in clinical practice.The aim of this study was to investigate the efficacy and clinical outcome of ET and CT as first-line treatment in Chinese patients with HR+/her2-MBC.Methods:Patients diagnosed with HR+/her2-MBC between January 1st,1996 and September 30th,2018 were screened from the Chinese Society of Clinical Oncology Breast Cancer database.The initial and maintenance first-line treatment,progression-free survival(PFS),and overall survival(OS)were analyzed.Results:Among the 1877 included patients,1215(64.7%)received CT and 662(35.3%)received ET as initial first-line treatment.There were no statistically significant differences in PFS and OS between patients receiving ET and CT as initial first-line treatment in the total population(PFS:12.0 vs.11.0 months,P=0.22;OS:54.0 vs.49.0 months,P=0.09)and propensity score matched population.For patients without disease progression after at least 3 months of initial therapy,maintenance ET following initial CT(CT-ET cohort,n=449)and continuous schedule of ET(ET cohort,n=527)had longer PFS than continuous schedule of CT(CT cohort,n=406)in the total population(CT-ET cohort vs.CT cohort:17.0 vs.8.5 months;P<0.01;ET cohort vs.CT cohort:14.0 vs.8.5 months;P<0.01)and propensity score matched population.OS in the three cohorts yielded the same results as PFS.Conclusions:ET was associated with similar clinical outcome to CT as initial first-line treatment.For patients without disease progression after initial CT,switching to maintenance ET showed superiority in clinical outcome over continuous schedule of CT.

关键词： Breast neoplasms Metastatic breast cancer Hormone receptor-positive her2-negative Chemotherapy Endocrine therapy First-line treatment Maintenance therapy

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Multicenter phaseⅡstudy of apatinib single or combination therapy in her2-negative breast cancer involving chest wall metastasis

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Chinese Journal of Cancer Research 2021年第2期33卷 243-255页

作者： Huiping Li Cuizhi Geng Hongmei Zhao Hanfang Jiang Guohong Song Jiayang Zhang Yaxin Liu Xinyu Gui Jing Wang Kun Li Zhongsheng Tong Fangyuan Zhao Junlan Yang Guoliang Chen Qianyu Liu Xu Liang Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education/Beijing) Department of Breast OncologyPeking University Cancer Hospital&InstituteBeijing 100142China Breast Disease Diagnostic and Therapeutic Center the Fourth Affiliated Hospital of Hebei Medical UniversityShijiazhuang 050019China Department of General Surgery Peking University Third HospitalBeijing 100191China Department of Breast Oncology Key Laboratory of Breast Cancer Prevention and TherapyNational Clinical Research Center for CancerTianjin Medical University Cancer Institute and HospitalTianjin 30060China Department of the Public Health Sciences University of ChicagoChicago 60637USA Department of Medical Oncology Chinese PLA General HospitalBeijing 100853China Jiangsu Hengrui Medicine Co.Ltd. Shanghai 200120China

Objective:Breast cancer(BC)with chest wall metastasis(CWM)usually shows rich neovascularization.This trial explored the clinical effect of apatinib on human epidermal growth factor receptor 2(her2)-negative advanced BC involving CWM.Methods:This trial involved four centers in China and was conducted from September 2016 to March 2020.Patients received apatinib 500 mg/d[either alone or with endocrine therapy if hormone receptor-positive(HR+)]until disease progression or unacceptable toxicity.Progression-free survival(PFS)was the primary endpoint.Results:We evaluated 26 patients for efficacy.The median PFS(mPFS)and median overall survival(mOS)were4.9[range:2.0-28.5;95%confidence interval(95%CI):2.1-8.3]months and 18(range:3-55;95%CI:12.9-23.1)months,respectively.The objective response rate(ORR)was 42.3%(11/26),and the disease-control rate was76.9%(20/26).In the subgroup analysis,HR+patients compared with HR-negative patients had significantly improved mPFS of 7.0(95%CI:2.2-11.8)months vs.2.3(95%CI:1.2-3.4)months,respectively(P=0.001);and mPFS in patients without or with chest wall radiotherapy was 6.4(95%CI:1.6-19.5)months vs.3.0(95%CI:1.3-4.6)months,respectively(P=0.041).In the multivariate analysis,HR+status was the only independent predictive factor for favorable PFS(P=0.014).Conclusions:Apatinib was highly effective for BC patients with CWM,especially when combined with endocrine therapy.PFS improved significantly in patients with HR+status who did not receive chest wall radiotherapy.However,adverse events were serious and should be carefully monitored from the beginning of apatinib treatment.

关键词： Apatinib advanced breast cancer chest wall metastasis her2-negative

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Cost-Effectiveness Analysis of Neoadjuvant Chemotherapy with Zoledronic Acid for her2-negative Breast Cancer in Japan: The JONIE1 Study

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Health 2019年第8期11卷 1017-1027页

作者： Kyoko Nakazawa Shota Saito Masayuki Nagahashi Akimitsu Yamada Akira Toyama Kouhei Akazawa Department of Medical Informatics and Statistics Niigata University Graduate School of Medical and Dental Sciences Niigata Japan Department of Pharmacy Niigata University Medical and Dental Hospital Niigata Japan Department of Health Informatics Niigata University of Health and Welfare Niigata Japan Division of Digestive and General Surgery Niigata University Graduate School of Medical and Dental Sciences Niigata Japan Department of Gastroenterological Surgery Yokohama City University School of Medicine Kanagawa Japan Department of Medical Informatics Niigata University Medical and Dental Hospital Niigata Japan

Objective: Zoledronic acid (ZOL) is a nitrogen-containing bisphosphonate that induces osteoclast apoptosis and inhibits bone resorption. Adding ZOL to neoadjuvant chemotherapy has been shown to have potential anticancer benefits in women with her2-negative breast cancer. The objective of the present study was to investigate ZOL’s cost-effectiveness from the perspective of health care payers in Japan. Methods: A Markov model was developed to evaluate the costs and effectiveness associated with ZOL + chemotherapy (CTZ) and chemotherapy (CT) alone over a 10-year time horizon. Monthly transition probabilities were estimated according to JONIE1 (Japan Organization of Neoadjuvant Innovative Expert) Study data and an extrapolated Weibull model. Health outcomes were measured in quality-adjusted life years (QALYs). Costs were calculated using year-2018 Japanese yen (JPY) (1.00 US dollars (USD) = 110.4 JPY). Model robustness was addressed through one-way and probabilistic sensitivity analysis. The costs and QALYs were discounted at a rate of 2% per year. Results: In the base case, the use of CTZ was associated with a gain of 3.94 QALYs. The incremental cost per QALY of the CTZ gain was 681,056.1 JPY (6168.99 USD) per QALY. Conclusion: It is convincing that neoadjuvant CTZ for patients with breast cancer would be expected to have statistically significant clinical efficacy. Addition of ZOL to CT might be a cost-effective option compared with CT alone.

关键词： Cost-Effectiveness Incremental Cost-Effectiveness Ratio (ICER) Quality-Adjusted Life Year (QALY) Chemotherapy her2-negative Breast Cancer

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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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