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A phase Ⅰ study of Hemay022, an irreversible dual EGFR/HER2 tyrosine kinase inhibitor in Chinese patients with HER2-positive advanced breast cancer
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作者 Pin Zhang Lin Wang +4 位作者 Yueying Zhen Zhihong Wang Hesheng Zhang Richard Jones Binghe Xu 《Chinese Journal of Cancer Research》 SCIE CAS CSCD 2024年第1期46-54,共9页
Objective: Hemay022 is a novel small-molecule and an irreversible tyrosine kinase inhibitor with the target of epidermal growth factor receptor(EGFR)/human epidermal growth factor receptor 2(HER2), which demonstrated ... Objective: Hemay022 is a novel small-molecule and an irreversible tyrosine kinase inhibitor with the target of epidermal growth factor receptor(EGFR)/human epidermal growth factor receptor 2(HER2), which demonstrated anti-tumor activity in preclinical studies. This first-in-human study evaluated the safety, pharmacokinetics,tolerability and preliminary anti-tumor activity of Hemay022 in HER2-positive advanced breast cancer patients.Methods: Heavily pretreated patients with HER2-positive advanced breast cancer were assigned to eight dose cohorts in a 3+3 dose-escalation pattern at doses of 50-600 mg QD and 300 mg BID. Eligible patients were given a single dose of Hemay022 on d 1 in week 0, followed by once daily continuous doses for four weeks in 28-day cycles.Pharmacokinetic samples were obtained on d 1 and d 28. Clinical responses were assessed every eight weeks.Results: Twenty-eight patients with advanced breast cancer were treated with Hemay022. The most frequently reported drug-related adverse events were diarrhoea(85.7%), vomiting(28.6%), nausea(25.0%) and decreased appetite(17.9%). No grade 4 drug-related adverse events were reported. At 50-600 mg doses, steady state areas under the concentration-time curve and peak concentrations increased with doses. One patient achieved complete response(CR), and three achieved partial response(PR). The objective response rate(ORR) and disease control rate(DCR) were 14.3% and 46.4% in 28 patients, respectively. The median progression-free survival(PFS) was3.98 months.Conclusions: Hemay022 at the dose of 500 mg once daily was well tolerated. The pharmacokinetic properties and encouraging anti-tumor activities of Hemay022 in advanced breast cancer patients warranted further evaluation of Hemay022 for treating breast cancer patients in the current phase Ⅲ trial(No. NCT05122494). 展开更多
关键词 Advanced breast cancer HER2-positive Hemay022 first-in-human trial
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Sequential neoadjuvant chemotherapy using pegylated liposomal doxorubicin and cyclophosphamide followed by taxanes with complete trastuzumab and pertuzumab treatment for HER2-positive breast cancer: A phase Ⅱ single-arm study
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作者 Yaping Yang Liang Jin +11 位作者 Yudong Li Nanyan Rao Chang Gong Shunrong Li Jiannan Wu Jinghua Zhao Linxiaoxiao Ding Fengxia Gan Jun Zhang Ruifa Feng Zhenzhen Liu Qiang Liu 《Chinese Journal of Cancer Research》 SCIE CAS CSCD 2024年第1期55-65,共11页
Objective: Despite cardiotoxicity overlap, the trastuzumab/pertuzumab and anthracycline combination remains crucial due to significant benefits. Pegylated liposomal doxorubicin(PLD), a less cardiotoxic anthracycline, ... Objective: Despite cardiotoxicity overlap, the trastuzumab/pertuzumab and anthracycline combination remains crucial due to significant benefits. Pegylated liposomal doxorubicin(PLD), a less cardiotoxic anthracycline, was evaluated for efficacy and cardiac safety when combined with cyclophosphamide and followed by taxanes with trastuzumab/pertuzumab in human epidermal growth factor receptor-2(HER2)-positive early breast cancer(BC).Methods: In this multicenter, phase II study, patients with confirmed HER2-positive early BC received four cycles of PLD(30-35 mg/m^(2)) and cyclophosphamide(600 mg/m^(2)), followed by four cycles of taxanes(docetaxel,90-100 mg/m^(2) or nab-paclitaxel, 260 mg/m^(2)), concomitant with eight cycles of trastuzumab(8 mg/kg loading dose,then 6 mg/kg) and pertuzumab(840 mg loading dose, then 420 mg) every 3 weeks. The primary endpoint was total pathological complete response(tp CR, yp T0/is yp N0). Secondary endpoints included breast p CR(bp CR),objective response rate(ORR), disease control rate, rate of breast-conserving surgery(BCS), and safety(with a focus on cardiotoxicity).Results: Between May 27, 2020 and May 11, 2022, 78 patients were treated with surgery, 42(53.8%) of whom had BCS. After neoadjuvant therapy, 47 [60.3%, 95% confidence interval(95% CI), 48.5%-71.2%] patients achieved tp CR, and 49(62.8%) achieved bp CR. ORRs were 76.9%(95% CI, 66.0%-85.7%) and 93.6%(95% CI,85.7%-97.9%) after 4-cycle and 8-cycle neoadjuvant therapy, respectively. Nine(11.5%) patients experienced asymptomatic left ventricular ejection fraction(LVEF) reductions of ≥10% from baseline, all with a minimum value of >55%. No treatment-related abnormal cardiac function changes were observed in mean N-terminal pro-BNP(NT-pro BNP), troponin I, or high-sensitivity troponin.Conclusions: This dual HER2-blockade with sequential polychemotherapy showed promising activity with rapid tumor regression in HER2-positive BC. Importantly, this regimen showed an acceptable safety profile,especially a low risk of cardiac events, suggesting it as an attractive treatment approach with a favorable risk-benefit balance. 展开更多
关键词 Breast cancer HER2-positive breast cancer dual HER2 blockade neoadjuvant therapy sequential therapy
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Quercetin inhibits truncated isoform of dopamine-and cAMP-regulated phosphoprotein as adjuvant treatment for trastuzumab therapy resistance in HER2-positive breast cancer
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作者 Han-Sheng Chang Tzu-Chun Cheng +6 位作者 Shih-Hsin Tu Chih-Hsiung Wu You-Cheng Liao Jungshan Chang Min-Hsiung Pan Li-Ching Chen Yuan-Soon Ho 《Food Science and Human Wellness》 SCIE CAS CSCD 2024年第5期2653-2667,共15页
Trastuzumab resistance is one of the causes of poor prognosis in patients with human epidermal growth factor receptor 2(HER2)-positive(HER2+)breast cancer(BC).The truncated isoform of dopamine-and cAMPregulated phosph... Trastuzumab resistance is one of the causes of poor prognosis in patients with human epidermal growth factor receptor 2(HER2)-positive(HER2+)breast cancer(BC).The truncated isoform of dopamine-and cAMPregulated phosphoprotein(t-DARPP)has been reported to be involved in trastuzumab therapy resistance and promoting tumor progression.To evaluate the t-DARPP expression in BC,paired tumors and surrounding normal tissues were analyzed by real-time polymerase chain reaction and confirmed higher DARPP-32 kDa family mRNA expression in HER2+BC tumor tissues.We established 2 patient-derived xenografts(PDX)mice models to test the efficacy of trastuzumab,named model 1(non-responder)and model 2(responder).t-DARPP and p95-HER2 protein-protein interactions were detected in PDX tumor tissue from non-responders using Förster resonance energy transfer assays.Instead,there is no response from the responder.Furthermore,mechanistic studies using transwell and western blot assays demonstrated that t-DARPP could upregulate epithelial-mesenchymal transition signaling proteins,enhance p95-HER2 expression and promote cell migration.We found that quercetin effectively reduced t-DARPP expression in HER2+BC cells.In t-DARPP ShRNA-suppressed cells,quercetin synergistically enhanced trastuzumab-induced apoptotic cell death and G2/M phase arrest.In conclusion,the combination of quercetin and trastuzumab treatment by targeting t-DARPP in HER2+BC patients has the potential as a biomarker for mitigating drug resistance. 展开更多
关键词 p95-Human epidermal growth factor receptor 2 (HER2) HER2-positive breast cancer QUERCETIN Trastuzumab resistance Truncated isoform of dopamine-and cAMPregulated PHOSPHOPROTEIN
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Inetetamab combined with S-1 and oxaliplatin as first-line treatment for human epidermal growth factor receptor 2-positive gastric cancer
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作者 Ying Kong Qi Dong +6 位作者 Peng Jin Ming-Yan Li Li Ma Qi-Jun Yi Yu-E Miao Hai-Yan Liu Jian-Gang Liu 《World Journal of Gastroenterology》 SCIE CAS 2024年第40期4367-4375,共9页
BACKGROUND Patients with human epidermal growth factor receptor 2(HER2)-positive advanced gastric cancer have poor outcomes.Trastuzumab combined with chemotherapy is the first-line standard treatment for HER2-positive... BACKGROUND Patients with human epidermal growth factor receptor 2(HER2)-positive advanced gastric cancer have poor outcomes.Trastuzumab combined with chemotherapy is the first-line standard treatment for HER2-positive advanced gastric cancer.Inetetamab is a novel anti-HER2 drug,and its efficacy and safety in gastric cancer have not yet been reported.AIM To evaluate the efficacy and safety of the S-1 plus oxaliplatin(SOX)regimen combined with inetetamab as a first-line treatment for HER2-positive advanced gastric cancer.METHODS Thirty-eight patients with HER2-positive advanced gastric cancer or gastroeso-phageal junction adenocarcinoma were randomly divided into two groups:One group received inetetamab combined with the SOX regimen,and the other group received trastuzumab combined with the SOX regimen.After 4-6 cycles,patients with stable disease received maintenance therapy.The primary endpoints were progression-free survival(PFS)and overall survival(OS),and the secondary endpoints were the objective response rate,disease control rate,and adverse events(AEs).RESULTS Thirty-seven patients completed the trial,with 18 patients in the inetetamab group and 19 patients in the trastuzumab group.In the inetetamab group,the median PFS was 8.5 months,whereas it was 7.3 months in the trastuzumab group(P=0.046);this difference was significant.The median OS in the inetetamab group vs the trastuzumab group was 15.4 months vs 14.3 months(P=0.33),and the objective response rate was 50%vs 42%(P=0.63),respectively;these differences were not significant.Common AEs included leukopenia,thrombocytopenia,nausea,and vomiting.The incidence rates of grade≥3 AEs were 56%in the inetetamab group and 47%in the trastuzumab group(P=0.63),with no significant difference.CONCLUSION In the first-line treatment of HER2-positive advanced gastric cancer,inetetamab and trastuzumab showed comparable efficacy.The inetetamab group showed superior PFS,and both groups had good safety. 展开更多
关键词 Human epidermal growth factor receptor 2-positive Advanced gastric cancer Inetetamab TRASTUZUMAB EFFICACY Safety
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A multicenter study on efficacy of dual-target neoadjuvant therapy for HER2-positive breast cancer and a consistent analysis of efficacy evaluation of neoadjuvant therapy by Miller-Payne and RCB pathological evaluation systems(CSBrS-026) 被引量:3
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作者 Hongyu Xiang Ling Xin +4 位作者 Jingming Ye Ling Xu Hong Zhang Shuang Zhang Yinhua Liu 《Chinese Journal of Cancer Research》 SCIE CAS CSCD 2023年第6期702-712,共11页
Objective: The aim of this study was to investigate the factors influencing pathological complete response(pCR)rate in early breast cancer patients receiving neoadjuvant dual-target [trastuzumab(H) + pertuzumab(P)] th... Objective: The aim of this study was to investigate the factors influencing pathological complete response(pCR)rate in early breast cancer patients receiving neoadjuvant dual-target [trastuzumab(H) + pertuzumab(P)] therapy combined with chemotherapy. Additionally, the consistency of the Miller-Payne and residual cancer burden(RCB)systems in evaluating the efficacy of neoadjuvant therapy for early human epidermal growth factor receptor-2(HER2)+ breast cancer was analyzed.Methods: The clinicopathological data of female patients with early-stage HER2+ breast cancer who received dual-target neoadjuvant therapy at 26 hospitals of the Chinese Society of Breast Surgery(CSBrS) from March 2019 to December 2021 were collected. Patients were allocated to four groups: the HER2 immunohistochemistry(IHC)3+/hormone receptor(HR)-, IHC3+/HR+, IHC2+ in situ hybridization(ISH)+/HR-and IHC2+ ISH+/HR+groups. The overall pCR rate for patients, the pCR rate in each group and the factors affecting the pCR rate were analyzed. The consistency between the Miller-Payne and RCB systems in assessing the efficacy of neoadjuvant therapy was analyzed.Results: From March 1, 2019, to December 31, 2021, 77,376 female patients with early-stage breast cancer were treated at 26 hospitals;18,853(24.4%) of these patients were HER2+. After exclusion of unqualified patients, 2,395 patients who received neoadjuvant dual-target(H+P) therapy combined with chemotherapy were included in this study. The overall pCR rate was 53.0%, and the patients' HR statuses and different HER2+ statuses were significantly correlated with the pCR rate(P<0.05). The consistency of the pathological efficacy assessed by the Miller-Payne and RCB systems was 88.0%(κ=0.717, P<0.001).Conclusions: Different HER2 expression statuses and HR expression statuses are correlated with the pCR rate after dual-target neoadjuvant therapy in HER2+ breast cancer patients. There is a relatively good consistency between Miller-Payne and RCB systems in evaluating the pathologic efficacy of neoadjuvant therapy for HER2+breast cancer. 展开更多
关键词 Breast cancer HER2-positive neoadjuvant therapy Miller-Payne system RCB system
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The efficacy of tucatinib-based therapeutic approaches for HER2-positive breast cancer 被引量:5
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作者 Zaid Sirhan Anita Thyagarajan Ravi P.Sahu 《Military Medical Research》 SCIE CAS CSCD 2022年第5期628-636,共9页
Overexpression of human epidermal growth factor receptor 2 (HER2) occurs in approximately 15–20% of breast cancer cases. HER2 is a member of the epidermal growth factor receptor (EGFR) family with tyrosinase kinase a... Overexpression of human epidermal growth factor receptor 2 (HER2) occurs in approximately 15–20% of breast cancer cases. HER2 is a member of the epidermal growth factor receptor (EGFR) family with tyrosinase kinase activity, and its overexpression is linked to poor prognosis and shorter progression-free survival (PFS) and overall survival (OS). Among various treatment options, HER2-targeting monoclonal antibodies and tyrosine kinase inhibitors (TKIs) have mostly been applied in recent decades to treat HER2-positive (HER2^(+)) breast cancer patients. Although positive clinical outcomes were documented in both advanced disease and neoadjuvant settings, the development of resistance mechanisms to such approaches has been one of the major challenges with the continuous usage of these drugs. In addition, patients who experience disease progression after treatment with multiple HER2-targeted therapies often have limited treatment options. The Food and Drug Administration (FDA) has recently approved a new TKI (i.e., tucatinib) for use in combination with immunotherapy and/or chemotherapeutic agents for the treatment of advanced-stage/metastatic HER2^(+) breast cancer. This review highlights recent updates on the efficacy of tucatinib-based therapeutic approaches in experimental models as well as in the clinical settings of HER2^(+) breast cancer. 展开更多
关键词 HER2-positive(HER2^(+)) Breast cancer Targeted therapy Tucatinib IMMUNOTHERAPY
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Inetetamab combined with pyrotinib and chemotherapy in the treatment of breast cancer brain metastasis: A case report 被引量:1
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作者 Qing-Qing Dou Ting-Ting Sun +1 位作者 Guo-Qiang Wang Wei-Bing Tong 《World Journal of Clinical Cases》 SCIE 2024年第3期575-581,共7页
BACKGROUND Breast cancer brain metastasis(BCBM)is an advanced breast disease that is difficult to treat and is associated with a high risk of death.Patient prognosis is usually poor,with reduced quality of life.In thi... BACKGROUND Breast cancer brain metastasis(BCBM)is an advanced breast disease that is difficult to treat and is associated with a high risk of death.Patient prognosis is usually poor,with reduced quality of life.In this context,we report the case of a patient with HER-2-positive BCBM treated with a macromolecular mAb(ine-tetamab)combined with a small molecule tyrosine kinase inhibitor(TKI).CASE SUMMARY The patient was a 58-year-old woman with a 12-year history of type 2 diabetes.She was compliant with regular insulin treatment and had good blood glucose control.The patient was diagnosed with invasive carcinoma of the right breast(T3N1M0 stage IIIa,HER2-positive type)through aspiration biopsy of the ipsilateral breast due to the discovery of a breast tumor in February 2019.Immunohistochemistry showed ER(-),PR(-),HER-2(3+),and Ki-67(55-60%+).Preoperative neoadjuvant chemotherapy,i.e.,the AC-TH regimen(epirubicin,cyclophosphamide,docetaxel-paclitaxel,and trastuzumab),was administered for 8 cycles.She underwent modified radical mastectomy of the right breast in November 2019 and received tocilizumab targeted therapy for 1 year.Brain metastasis was found 9 mo after surgery.She underwent brain metastasectomy in August 2020.Immunohistochemistry showed ER(-)and PR.(-),HER-2(3+),and Ki-67(10-20%+).In November 2020,the patient experienced headache symptoms.After an examination,tumor recurrence in the original surgical region of the brain was observed,and the patient was treated with inetetamab,pyrotinib,and capecitabine.Whole-brain radiotherapy was recommended.The patient and her family refused radiotherapy for personal reasons.In September 2021,a routine examination revealed that the brain tumor was considerably larger.The original systemic treatment was continued and combined with intensity-modulated radiation therapy for brain metastases,followed by regular hospitalization and routine examinations.The patient’s condition is generally stable,and she has a relatively high quality of life.This case report demonstrates that in patients with BCBM and resistance to trastuzumab,inetetamab combined with pyrotinib and chemotherapy can prolong survival.CONCLUSION Inetetamab combined with small molecule TKI drugs,chemotherapy and radiation may be an effective regimen for maintaining stable disease in patients with BCBM. 展开更多
关键词 Breast cancer brain metastasis Resistance to trastuzumab Macromolecule inetetamab Small molecule tyrosine kinase inhibitor Radiation therapy HER2-positive Case report
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德曲妥珠单抗对比化疗方案二线治疗HER-2低表达晚期乳腺癌的经济学评价
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作者 李雪 贾才凤 +3 位作者 郑颖 张森 王美祺 王明霞 《中国药房》 CAS 北大核心 2024年第19期2383-2390,共8页
目的 从我国卫生体系角度出发,评价德曲妥珠单抗方案对比医生选择化疗(TPC)方案二线治疗人表皮生长因子受体2(HER-2)低表达晚期乳腺癌的经济性。方法 基于DESTINY-Breast04临床试验数据构建动态Markov模型,模拟时限为10年,循环周期为3... 目的 从我国卫生体系角度出发,评价德曲妥珠单抗方案对比医生选择化疗(TPC)方案二线治疗人表皮生长因子受体2(HER-2)低表达晚期乳腺癌的经济性。方法 基于DESTINY-Breast04临床试验数据构建动态Markov模型,模拟时限为10年,循环周期为3周。以成本、质量调整生命年(QALY)、增量成本-效果比(ICER)作为模型产出指标,采用5%的贴现率,以3倍2023年我国人均国内生产总值(GDP)作为意愿支付(WTP)阈值,采用成本-效用分析法分析激素受体阳性队列和所有患者队列中两种治疗方案的经济性,再通过不确定性分析验证基础分析结果的稳健性。结果 基础分析结果显示,德曲妥珠单抗方案与TPC方案相比,在激素受体阳性队列和所有患者队列中的ICER值分别为1 045 655.76、906 404.99元/QALY,均高于WTP阈值(268 074元/QALY)。单因素敏感性分析结果显示,疾病无进展状态效用值、德曲妥珠单抗价格、疾病进展状态效用值等参数对模型结果影响较大。概率敏感性分析结果显示,当WTP阈值为3倍2023年我国人均GDP时,德曲妥珠单抗方案具有经济性的概率为0。情境分析结果显示,在考虑援助计划时,德曲妥珠单抗方案具有经济性的概率为0;当德曲妥珠单抗价格降低70%时,该方案具有经济性的概率显著提高至82.80%。结论 在以3倍2023年我国人均GDP作为WTP阈值时,德曲妥珠单抗方案相对于TPC方案二线治疗HER-2低表达晚期乳腺癌不具有经济性;按地区适当降低德曲妥珠单抗的价格,可以提高其经济性。 展开更多
关键词 德曲妥珠单抗 晚期乳腺癌 HER-2低表达 二线治疗 MARKOV模型 药物经济学
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阿贝西利联合非甾体类芳香化酶抑制剂一线治疗HR+/HER2-绝经后晚期乳腺癌患者的效果观察
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作者 陈燕红 王玮 +2 位作者 刘玉娟 覃清清 黄江昌 《科技与健康》 2024年第15期113-116,共4页
探讨针对激素受体阳性/人类表皮生长因子受体2阴性(HR+/HER2-)绝经后晚期乳腺癌患者应用阿贝西利联合非甾体类芳香化酶抑制剂一线治疗的效果。以玉林市红十字会医院在2022年1月—2023年4月收治的92例HR+/HER2-绝经后晚期乳腺癌患者为研... 探讨针对激素受体阳性/人类表皮生长因子受体2阴性(HR+/HER2-)绝经后晚期乳腺癌患者应用阿贝西利联合非甾体类芳香化酶抑制剂一线治疗的效果。以玉林市红十字会医院在2022年1月—2023年4月收治的92例HR+/HER2-绝经后晚期乳腺癌患者为研究对象,采用随机数字表法将其分为对照组(n=46,应用非甾体类芳香化酶抑制剂一线治疗)和研究组(n=46,在对照组基础上应用阿贝西利治疗),对比两组疗效、不良反应发生率、生活质量。研究发现,针对HR+/HER2-绝经后晚期乳腺癌患者应用阿贝西利联合非甾体类芳香化酶抑制剂一线治疗,疗效有所提高,不良反应未增加,安全性较高,患者生活质量显著提高,值得推广。 展开更多
关键词 激素受体阳性 晚期乳腺癌 阿贝西利 人类表皮生长因子受体2阴性
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激素受体阳性/人表皮生长因子受体2阳性晚期乳腺癌生物学特点及治疗进展
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作者 刘德桐 李超 +2 位作者 许焱 丁丽 张永强 《中国医学前沿杂志(电子版)》 CSCD 北大核心 2024年第4期73-80,共8页
激素受体阳性(hormone receptor-positive,HR+)/人表皮生长因子受体2阳性(human epidermal growth factor receptor 2-positive,HER2+)晚期乳腺癌是一种异质性较高的肿瘤亚型,各大指南对于HER2+晚期乳腺癌,不论HR阳性或阴性,均建议在抗H... 激素受体阳性(hormone receptor-positive,HR+)/人表皮生长因子受体2阳性(human epidermal growth factor receptor 2-positive,HER2+)晚期乳腺癌是一种异质性较高的肿瘤亚型,各大指南对于HER2+晚期乳腺癌,不论HR阳性或阴性,均建议在抗HER2治疗基础上首选联合化疗,专门针对HR+/HER2+晚期乳腺癌的临床研究不多,其最佳治疗特别是后线治疗选择仍存在争议。晚期乳腺癌很难治愈,兼顾不同治疗手段比如化疗与内分泌治疗的疗效和患者的生活质量等显得非常重要。加之近几年针对HR+的细胞周期蛋白依赖性激酶4/6 (cyclin-dependent kinase 4/6 inhibitor,CDK4/6)抑制剂等靶向药物和针对HER2+乳腺癌的新型抗HER2靶向药物和抗体药物偶联物(antibody-drug conjugate,ADC)的应用,为HR+/HER2+晚期乳腺癌的治疗带来了诸多选择和疗效以及安全性的不确定性。本文综述HR+/HER2+晚期乳腺癌分子生物学和临床病理特点、研究进展和治疗选择,为临床医生治疗决策提供参考。 展开更多
关键词 晚期乳腺癌 激素受体阳性 人表皮生长因子受体2阳性 生物学特点 治疗进展
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Multicenter phaseⅡstudy of apatinib single or combination therapy in HER2-negative breast cancer involving chest wall metastasis 被引量:4
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作者 Huiping Li Cuizhi Geng +13 位作者 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 《Chinese Journal of Cancer Research》 SCIE CAS CSCD 2021年第2期243-255,共13页
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 B... 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. 展开更多
关键词 Apatinib advanced breast cancer chest wall metastasis HER2-negative
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拉帕替尼联合微波热疗治疗HER2阳性晚期乳腺癌的疗效
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作者 朱月丰 宋建文 戴妍妍 《中国现代医生》 2024年第16期4-8,共5页
目的 研究拉帕替尼联合微波热疗治疗人类表皮生长因子受体2(human epidermal growth factor receptor 2,HER2)阳性晚期乳腺癌患者的疗效。方法 选取2019年1月至2020年1月于湖州市中心医院就诊的HER2阳性晚期乳腺癌患者134例,根据抽签法... 目的 研究拉帕替尼联合微波热疗治疗人类表皮生长因子受体2(human epidermal growth factor receptor 2,HER2)阳性晚期乳腺癌患者的疗效。方法 选取2019年1月至2020年1月于湖州市中心医院就诊的HER2阳性晚期乳腺癌患者134例,根据抽签法将其分为对照组和观察组,每组各67例。两组均使用拉帕替尼治疗,观察组患者在此基础上联合微波热疗治疗。比较两组患者治疗前后的肿瘤标志物[糖类抗原153(carbohydrate antigen 153,CA153)、癌胚抗原(carcinoembryonic antigen,CEA)、组织多肽抗原(tissue peptide antigen,TPA)]、循环肿瘤细胞(circulating tumor cell,CTC)数量、波形蛋白表达和生存质量,统计两组患者的临床疗效及生存状态。结果 治疗后,两组患者的CA153、CEA、TPA、CTC数量、波形蛋白表达均显著低于本组治疗前,生存质量评分均显著高于本组治疗前(P<0.05);观察组患者的CA153、CEA、TPA、CTC数量、波形蛋白表达均显著低于对照组,生存质量评分显著高于对照组(P<0.05)。观察组患者的治疗总有效率显著高于对照组(χ^(2)=5.350,P=0.021)。两组患者的不良反应比较差异均无统计学意义(P>0.05)。随访24个月,观察组患者的总生存期、无进展生存期均显著长于对照组,24个月累积生存率显著高于对照组(P<0.05)。结论 拉帕替尼联合微波热疗治疗HER2阳性晚期乳腺癌效果良好,可改变波形蛋白表达抑制疾病进展,延长患者的生存期。 展开更多
关键词 拉帕替尼 微波热疗 人类表皮生长因子受体2 晚期乳腺癌 波形蛋白 生存期
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帕妥珠单抗联合白蛋白结合型紫杉醇和卡铂治疗人表皮生长因子受体2阳性晚期乳腺癌患者的疗效
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作者 李鸿业 张菡 +1 位作者 温琳琳 梁丽 《癌症进展》 2024年第18期1994-1997,共4页
目的探讨帕妥珠单抗联合白蛋白结合型紫杉醇和卡铂治疗人表皮生长因子受体2(HER2)阳性晚期乳腺癌患者的疗效。方法根据治疗方式的不同将108例HER2阳性晚期乳腺癌患者分为观察组(n=63)和对照组(n=45),对照组患者给予白蛋白结合型紫杉醇... 目的探讨帕妥珠单抗联合白蛋白结合型紫杉醇和卡铂治疗人表皮生长因子受体2(HER2)阳性晚期乳腺癌患者的疗效。方法根据治疗方式的不同将108例HER2阳性晚期乳腺癌患者分为观察组(n=63)和对照组(n=45),对照组患者给予白蛋白结合型紫杉醇联合卡铂治疗,观察组患者给予帕妥珠单抗联合白蛋白结合型紫杉醇和卡铂治疗。比较两组患者的肿瘤标志物[癌胚抗原(CEA)、糖类抗原125(CA125)、糖类抗原15-3(CA15-3)]水平、血管内皮生长因子(VEGF)水平、临床疗效及不良反应发生情况。结果治疗后,两组患者CEA、CA125、CA15-3、VEGFA、VEGFB水平均低于本组治疗前,观察组患者CEA、CA125、CA15-3、VEGFA、VEGFB水平均低于对照组,差异均有统计学意义(P﹤0.05)。观察组患者的疾病控制率高于对照组,差异有统计学意义(P﹤0.05)。两组患者的不良反应总发生率比较,差异无统计学意义(P﹥0.05)。结论帕妥珠单抗联合白蛋白结合型紫杉醇和卡铂治疗HER2阳性晚期乳腺癌患者的疗效显著,可降低肿瘤标志物及VEGFA、VEGFB水平,且具有一定的安全性。 展开更多
关键词 帕妥珠单抗 白蛋白结合型紫杉醇 卡铂 人表皮生长因子受体2 晚期乳腺癌
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哌柏西利、来曲唑及氟维司群联合用药治疗晚期HR^(+)/HER2^(-)乳腺癌的疗效与安全性观察 被引量:1
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作者 陈静静 系祖斌 +3 位作者 裴小卉 李明磊 白首龙 姚立成 《现代肿瘤医学》 CAS 2024年第5期838-842,共5页
目的:探讨晚期激素受体阳性/人类表皮生长因子受体2阴性(HR^(+)/HER2^(-))乳腺癌采用哌柏西利、来曲唑及氟维司群联合用药的临床效果。方法:本研究选取湖北省肿瘤医院2021年01月至2023年01月治疗的晚期HR^(+)/HER2^(-)乳腺癌患者120例,... 目的:探讨晚期激素受体阳性/人类表皮生长因子受体2阴性(HR^(+)/HER2^(-))乳腺癌采用哌柏西利、来曲唑及氟维司群联合用药的临床效果。方法:本研究选取湖北省肿瘤医院2021年01月至2023年01月治疗的晚期HR^(+)/HER2^(-)乳腺癌患者120例,根据治疗方案将患者分为观察组(n=62)和对照组(n=58),对照组给予来曲唑及氟维司群治疗,观察组给予哌柏西利、来曲唑及氟维司群治疗,观察两组治疗疗效、不良反应及生存情况,同时分析两组治疗前后血清肿瘤标志物、免疫功能差异。结果:观察组客观缓解率(ORR)和疾病控制率(DCR)分别为11.29%和82.26%,明显高于对照组(P<0.05);观察组治疗后癌胚抗原(CEA)、糖类抗原15-3(CA15-3)和糖类抗原125(CA125)分别为(19.49±6.67)ng/mL、(11.54±3.34)U/mL和(43.34±17.28)U/mL,明显低于对照组(P<0.05);观察组治疗后CD3^(+)、CD4^(+)和CD4^(+)/CD8^(+)分别为(49.98±6.90)%、(31.02±7.00)%和(1.18±0.39),高于对照组(P<0.05),而CD8^(+)为(26.38±3.35)%,低于对照组(P<0.05);观察组和对照组不良反应比较差异无统计学意义(P>0.05);观察组中位无进展生存期和总生存期分别为20个月(95%CI:18.87~21.14)和25个月(95%CI:24.41~25.59),明显长于对照组(P<0.05)。结论:哌柏西利、来曲唑及氟维司群治疗晚期HR^(+)/HER2^(-)乳腺癌有较好的临床效果,安全性好,可有效调节肿瘤标志物水平,提高患者预后。 展开更多
关键词 激素受体 人类表皮生长因子受体2 乳腺癌 晚期 哌柏西利 来曲唑 氟维司群
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吡咯替尼联合化疗在人表皮生长因子受体-2阳性晚期乳腺癌一线及一线以上治疗中的应用效果
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作者 郭玛丽 林丽平 +1 位作者 丁晓芬 樊燕丹 《中国当代医药》 CAS 2024年第7期114-118,共5页
目的探索吡咯替尼联合化疗在人表皮生长因子受体-2(HER-2)阳性晚期乳腺癌(ABC)一线或一线以上治疗中的应用效果。方法回顾性分析2020年3月至2023年5月福建医科大学附属三明第一医院收治的106例HER-2阳性ABC患者临床资料,依据治疗方法的... 目的探索吡咯替尼联合化疗在人表皮生长因子受体-2(HER-2)阳性晚期乳腺癌(ABC)一线或一线以上治疗中的应用效果。方法回顾性分析2020年3月至2023年5月福建医科大学附属三明第一医院收治的106例HER-2阳性ABC患者临床资料,依据治疗方法的不同分为对照组(53例)与观察组(53例),所有患者只需具有一个可测量病灶。对照组采用曲妥珠单抗+帕妥珠单抗+卡培他滨方案治疗,观察组采用吡咯替尼+卡培他滨方案治疗。比较两组的疾病控制率(DCR)及客观缓解率(ORR)、不良反应、肿瘤标志物水平[癌抗原153(CA153)、癌抗原199(CA199)及胸苷激酶1(TK1)]及生活质量。结果所有患者至少完成两个周期曲妥珠单抗+帕妥珠单抗+卡培他滨或吡咯替尼+卡培他滨治疗。两组ORR、DCR的比较,差异无统计学意义(P>0.05);两组不良反应包括腹泻、白细胞减少、恶心/呕吐、血小板减少、肝功能损害,不良反应发生率比较,差异无统计学意义(P>0.05);观察组治疗后的左室射血分数(LVEF)高于对照组,差异有统计学意义(P<0.05)。两组治疗后的CA153、CA199、TK1水平均低于治疗前,差异有统计学意义(P<0.05);两组治疗后的CA153、CA199、TK1水平比较,差异无统计学意义(P>0.05)。观察组治疗后的生活质量各指标评分高于对照组,差异有统计学意义(P<0.05)。结论吡咯替尼联合化疗在一线或一线以上药物治疗HER-2阳性ABC安全有效,能够降低心脏毒性,提高患者生活质量。 展开更多
关键词 晚期乳腺癌 人表皮生长因子受体-2阳性 吡咯替尼 曲妥珠单抗 帕妥珠单抗 卡培他滨 肿瘤标志物 不良反应
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吡咯替尼联合含紫杉醇化疗方案治疗对晚期HER2阳性乳腺癌患者免疫功能及预后的影响
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作者 牛增志 张玉洁 张伟 《实用癌症杂志》 2024年第6期1028-1032,共5页
目的探讨吡咯替尼联合含紫杉醇化疗方案治疗对晚期人表皮生长因子受体-2(HER2)阳性乳腺癌(BC)患者免疫功能及预后的影响。方法选取62例晚期HER2阳性BC患者,采用随机数字表法分为观察组和对照组,各31例。对照组接受含紫杉醇化疗方案治疗... 目的探讨吡咯替尼联合含紫杉醇化疗方案治疗对晚期人表皮生长因子受体-2(HER2)阳性乳腺癌(BC)患者免疫功能及预后的影响。方法选取62例晚期HER2阳性BC患者,采用随机数字表法分为观察组和对照组,各31例。对照组接受含紫杉醇化疗方案治疗,观察组接受吡咯替尼联合含紫杉醇化疗方案联合治疗,均持续治疗12周。治疗后,评估2组疾病控制率(DCR)。比较2组治疗前后T淋巴细胞亚群水平和治疗期间不良反应发生率。应用Kaplan-Meier法分析2组中位无进展生存期和12个月生存率。结果观察组DCR为70.97%,显著高于对照组的45.16%(P<0.05)。治疗后观察组CD3+、CD4+水平高于对照组,CD4+/CD8+水平低于对照组(P<0.05);2组治疗期间肝功能损害、白细胞减少、胃肠道反应、神经毒性反应和皮疹发生率无显著差异(P>0.05)。Kaplan-Meier生存分析,观察组12个月生存率为77.41%,高于对照组的54.83%(χ^(2)=3.946,P<0.05);观察组中位PFS时间为(10.79±0.61)个月,高于对照组的(8.36±0.75)个月(t=4.793,P<0.05)。结论吡咯替尼联合含紫杉醇化疗方案可提高晚期HER2阳性BC患者疾病控制率,改善机体T淋巴细胞免疫功能,延长无进展生存期,安全有效。 展开更多
关键词 吡咯替尼 含紫杉醇化疗方案 晚期乳腺癌 人表皮生长因子受体-2 免疫功能 无进展生存期
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The change of paradigm in the treatment of HER2-positive breast cancer with the development of newgeneration antibody-drug conjugates
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作者 Santiago Escriva-de-Romani Cristina Saura 《Cancer Drug Resistance》 2023年第1期45-58,共14页
HER2-positive breast cancer is an aggressive disease.As a result of the development of specific HER2-targeted therapies,such as trastuzumab,more than 20 years ago,the prognosis of these patients has improved.Metastati... HER2-positive breast cancer is an aggressive disease.As a result of the development of specific HER2-targeted therapies,such as trastuzumab,more than 20 years ago,the prognosis of these patients has improved.Metastatic HER2-positive breast cancer patients are achieving better survival rates upon treatment with anti-HER2 therapies than patients with HER2-negative disease.Double HER2 blockade with trastuzumab and pertuzumab combined with a taxane achieved an unprecedented survival of over 57 months in first-line patients.Trastuzumab emtansine,the first antibody-drug conjugate approved for patients in second-line treatment was a potent cytotoxic agent bound to trastuzumab and is currently a standard therapeutic strategy.Despite the progress in treatment development,most patients develop resistance and eventually relapse.Advances in the design of antibody-drug conjugates have led to the development of new generation drugs with enhanced properties,such as trastuzumab deruxtecan and trastuzumab duocarmazine,which are significantly changing the paradigm in the treatment of HER2-positive metastatic breast cancer. 展开更多
关键词 Breast cancer HER2-positive ADCS New drugs Mechanisms of resistance
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白蛋白紫杉醇联合曲妥珠单抗及帕妥珠单抗对人表皮生长因子受体2阳性乳腺癌患者的疗效 被引量:4
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作者 夏蕾 马文飚 《川北医学院学报》 CAS 2023年第11期1522-1525,1567,共5页
目的:探讨白蛋白紫杉醇联合曲妥珠单抗及帕妥珠单抗治疗人表皮生长因子受体2(HER2)阳性的晚期乳腺癌(ABC)患者的疗效。方法:选取60例HER2阳性ABC患者为研究对象,根据不同治疗方式,将其分为对照组(n=30)和观察组(n=30)。对照组采用多西... 目的:探讨白蛋白紫杉醇联合曲妥珠单抗及帕妥珠单抗治疗人表皮生长因子受体2(HER2)阳性的晚期乳腺癌(ABC)患者的疗效。方法:选取60例HER2阳性ABC患者为研究对象,根据不同治疗方式,将其分为对照组(n=30)和观察组(n=30)。对照组采用多西他赛联合曲妥珠单抗、帕妥珠单抗治疗;观察组采用白蛋白紫杉醇联合曲妥珠单抗、帕妥珠单抗治疗。两组患者均治疗6个周期(以21 d为1个周期)。比较两组患者临床疗效、生存期、肿瘤标志物水平和不良反应发生情况。结果:观察组客观有效率(ORR)、临床获益率(CBR)均高于对照组(P<0.05)。治疗后,两组患者糖类抗原(CA)15-3、癌胚抗原(CEA)、CA125水平均降低(P<0.05),且观察组低于对照组(P<0.05);两组患者CA15-3、CEA水平差异均为高效应[95%CI:1.142(4.347~11.533)、1.485(1.900~3.941)],CA125水平差异为中效应[95%CI:0.670(0.652,5.048)]。观察组无进展生存期(PFS)、总生存期(OS)均高于照组(P<0.05);两组患者PFS、OS水平差异均为弱效应[95%CI:-2.760(-4.892~3.366)、-3.604(-5.813~4.353)]。两组患者不良反应发生率无统计学差异(P>0.05)。结论:白蛋白紫杉醇联合曲妥珠单抗及帕妥珠单抗治疗HER2阳性ABC患者具有明显疗效,可调节肿瘤标志物分泌,延长患者生存期,且具有一定安全性。 展开更多
关键词 白蛋白紫杉醇 曲妥珠单抗 帕妥珠单抗 人表皮生长因子受体2阳性 晚期乳腺癌 肿瘤标志物
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卡培他滨节拍化疗联合氟维司群治疗HR阳性HER-2阴性晚期乳腺癌的短期预后研究 被引量:3
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作者 龙成根 李媛媛 +3 位作者 凌华海 杨春亮 陈日上 梁秋龙 《中国实用医药》 2023年第5期39-43,共5页
目的探讨卡培他滨节拍化疗联合氟维司群治疗激素受体(HR)阳性人表皮生长因子受体-2(HER-2)阴性晚期乳腺癌的短期预后。方法60例HR阳性HER-2阴性晚期乳腺癌患者,按治疗方法不同分为对照组和观察组,各30例。对照组患者采用氟维司群治疗,... 目的探讨卡培他滨节拍化疗联合氟维司群治疗激素受体(HR)阳性人表皮生长因子受体-2(HER-2)阴性晚期乳腺癌的短期预后。方法60例HR阳性HER-2阴性晚期乳腺癌患者,按治疗方法不同分为对照组和观察组,各30例。对照组患者采用氟维司群治疗,观察组患者采用卡培他滨节拍化疗联合氟维司群治疗。比较两组治疗效果、肿瘤指标、不良反应发生情况及预后。结果观察组客观缓解率(ORR)63.33%、疾病控制率(DCR)96.67%均高于对照组的36.67%、73.33%,差异有统计学意义(P<0.05)。治疗前,两组血清糖类抗原153(CA153)水平比较,差异无统计学意义(P>0.05);治疗16周,两组血清CA153水平低于本组治疗前,且观察组血清CA153水平(22.45±5.30)U/ml低于对照组的(32.31±7.26)U/ml,差异有统计学意义(P<0.05)。两组不良反应发生率比较,差异无统计学意义(P>0.05)。随访1年,观察组无进展生存期(PFS)(7.63±1.27)个月、总生存期(OS)(9.87±1.02)个月均长于对照组的(6.25±1.08)、(8.26±1.25)个月,差异有统计学意义(P<0.05)。结论HR阳性HER-2阴性晚期乳腺癌患者采用卡培他滨节拍化疗联合氟维司群治疗效果显著,可调节肿瘤标志物水平,改善患者短期预后,且有一定的安全性。 展开更多
关键词 晚期乳腺癌 激素受体 人表皮生长因子受体-2 卡培他滨 节拍化疗 氟维司群
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HER2-Specific T Lymphocytes Kill both Trastuzumab-Resistant and Trastuzumab-Sensitive Breast Cell Lines In Vitro 被引量:5
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作者 Xiao-lin Lin Xiao-li Wang +9 位作者 BO Ma Jun Jia Ying Yan Li-jun Di Yan-hua Yuan Feng-ling Wan Yuan-li Lu Xu Liang Tao Shen Jun Ren 《Chinese Journal of Cancer Research》 SCIE CAS CSCD 2012年第2期143-150,共8页
Objective: Although the development of trastuzumab has improved the outlook for women with human epidermal growth factor receptor 2 (HER2)-positive breast cancer, the resistance to anti-HER2 therapy is a growing cl... Objective: Although the development of trastuzumab has improved the outlook for women with human epidermal growth factor receptor 2 (HER2)-positive breast cancer, the resistance to anti-HER2 therapy is a growing clinical dilemma. We aim to determine whether HER2-specific T cells generated from dendritic cells (DCs) modified with HER2 gene could effectively kill the HER2-positive breast cancer cells, especially the trastuzumab-resistant cells. Methods: The peripheral blood mononuclear cells (PBMCs) from healthy donors, whose HLA haplotypes were compatible with the tumor cell lines, were transfected with reconstructive human adeno-association virus (rhAAV/HER2) to obtain the specific killing activities of T cells, and were evaluated by lactate dehydrogenase (LDH) releasing assay. Results: Trastuzumab produced a significant inhibiting effect on SK-BR-3, the IC50 was 100ng/ml. MDA-MB-453 was resistant to trastuzumab even at a concentration of 10,000 ng/ml in vitro. HER2-specific T lymphocytes killed effectively SK-BR-3 [(69.86±13.41)%] and MDA-MB-453 [(78.36±10.68)%] at 40:1 (effector:target ratio, E:T), but had no significant cytotoxicity against HER2-negative breast cancer cell lines MDA-MB-231 or MCF-7 (less than 10%). Conclusion: The study showed that HER2-specific T lymphocytes generated from DCs modified by rhAAV/HER2 could kill HER2-positive breast cancer cell lines in a HER2-dependent manner, and result in significantly high inhibition rates on the intrinsic trastuzumab-resistant cell line MDA-MB-453 and the tastuzumab-sensitive cell line SK-BR-3. These results imply that this immunotherapy might be a potential treatment to HER2-positive breast cancer. 展开更多
关键词 HER2-positive breast cancer Trastuzumab-resistant Dendritic cells Immunotherapy Reconstructivehuman adeno-association virus
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