靶向药物曲妥珠单抗联合化疗对人类表皮生长因子受体2阳性局部晚期乳腺癌患者临床疗效研究

目的:观察曲妥珠单抗联合化疗对人类表皮生长因子受体2(HER-2)阳性的局部晚期乳腺癌(LABC)临床治疗结果。方法:将228例HER-2阳性手术无法切除的晚期乳腺癌病例随机分到曲妥珠单抗辅助疗法+化疗组或单纯化疗组。其中115例接受曲妥珠单抗+化疗,113例单纯接受化疗,经过10个疗程治疗后,观察两组患者中临床和病理的完全缓解人数及符合手术要求的人数。结果:数据显示与单纯化疗相比,曲妥珠单抗+化疗组病例对治疗的临床完全缓解病例(cCR)(化疗+曲妥珠单抗组89%,单纯化疗组77%)、病理学完全缓解(pCR)病例(两组分别为43%和23%)以及乳房和腋下淋巴结完全缓解(tpCR)病例(分别为39%和20%)比例更高,同时可以使更多的患者获得手术和保留乳房的机会。结论:曲妥珠单抗联合化疗药物治疗HER-2过度表达的局部晚期乳腺癌均有较好的临床疗效,是治疗晚期乳癌并延长生存时间的一种新方法。     

曲妥珠单抗联合多西他赛治疗HER2阳性的转移性乳腺癌

目的探讨曲妥珠单抗联合多西他赛治疗HER2阳性的转移性乳腺癌的疗效和不良反应。方法采用随机对照实验,治疗组21例,对照组22例,对象均为HER2阳性的转移性乳腺癌患者。对照组仅给予多西他赛化疗,治疗组给予曲妥珠单抗联合多西他赛方案化疗。结果治疗组有效率为71.4%(15/21),对照组为31.8%(7/22),两组比较,差异有统计学意义(P<0.05)。两组不良反应发生情况无明显差异。结论曲妥珠单抗联合多西他赛是转移性乳腺癌的有效安全的治疗方案。     

曲妥珠单抗联合化疗治疗晚期乳腺癌的观察与护理

目的：观察曲妥珠单抗联合化疗治疗晚期乳腺癌。方法：曲妥珠单抗联合化疗治疗晚期乳腺癌49例,并针对患者心理、并发症等采取护理措施。结果：49例患者顺利完成化疗,总有效率为89.8%,引起了血液系统、消化系统及神经系统等毒副作用,但可耐受。结论：治疗期间重点做到针对患者心理、并发症的观察与护理,能有效控制曲妥珠单抗联合化疗治疗晚期乳腺癌的不良反应,提高疗效。     

曲妥珠单抗联合多西他赛和铂类对HER-2阳性转移性乳腺癌的临床疗效和不良反应

目的：探讨曲妥珠单抗联合多西他赛和铂类治疗HER-2阳性晚期转移性乳腺癌的临床疗效分析。方法：收集我院2008～2015年HER-2阳性转移性乳腺癌74例,随机分为对照组和治疗组,对照组36例,治疗组38例。对照组使用多西他赛联合卡铂、顺铂或奈达铂,治疗组在此基础上联合曲妥珠单抗靶向治疗,分析对比两组的临床疗效及不良反应情况。结果：对照组治疗有效率为41.6%,治疗组为62.8%,两组治疗效果具有显著差异（P<0.05）,具有统计学意义;两组的不良反应发生率没有明显差异,不具有统计学意义。结论：曲妥珠单抗联合多西他赛和铂类治疗HER-2阳性晚期转移性乳腺癌疗效更佳,比单纯化疗临床效果更好,不良反应发生率没有明显增加,在临床值得推广。     

曲妥珠单抗联合术前辅助化疗用于Her-2阳性乳腺癌的临床观察

目的:观察曲妥珠单抗联合术前辅助化疗用于人表皮生长因子受体2(Her-2)阳性乳腺癌的疗效,并探讨其临床应用价值。方法:选取Her-2阳性乳腺癌患者80例,按随机数字表法分为对照组和观察组,各40例。对照组患者接受常规术前辅助化疗+Her-2阳性乳腺癌改良根治术;观察组患者在对照组的基础上,术前加用曲妥珠单抗静脉滴注,首次剂量为4 mg/kg,而后以2mg/kg静脉滴注,每周1次,持续3周。比较两组方案对Her-2阳性乳腺癌病灶组织HER-2、CD34、人乳腺球蛋白(MGA)、上皮性钙黏附蛋白(E-cadherin)、巨囊性病液体蛋白-15(GCDFP-15)表达的影响,并记录不良反应及随访情况。结果:与化疗前比较,观察组患者的HER-2蛋白(+)表达显著上升,而HER-2蛋白(+++)表达显著下降;MGA阳性率显著下降,E-cadherin阳性率显著上升,GCDFP-15阳性率显著下降;CD34表达微血管密度值显著降低,差异均有统计学意义(P<0.05或P<0.01)。观察组患者的复发率、远处转移率均显著低于对照组,差异有统计学意义(P<0.05)。两组方案的不良反应发生率比较差异无统计学意义(P>0.05)。结论:曲妥珠单抗联合术前辅助化疗治疗Her-2阳性乳腺癌具有良好的临床效果和安全性,能够有效改善Her-2阳性乳腺癌病灶组织的相关指标,对减少术后肿瘤复发和转移具有临床意义。     

曲妥珠单抗联合阿霉素脂质体治疗HER-2过度表达乳腺癌的临床疗效分析

目的:总结曲妥珠单抗联合阿霉素与曲妥珠单抗联合阿霉素脂质体治疗人表皮生长因子-2(HER-2)过度表达的乳腺癌的疗效和安全性。方法:经细胞学证实的HER-2过度表达的60例乳腺癌患者,25例接受曲妥珠单抗联合阿霉素化疗方案(A组),35例接受曲妥珠单抗联合阿霉素脂质体(B组)方案化疗。参照实体瘤疗效评价标准进行疗效判定,按照美国国立研究院通用毒性标准评价不良反应。结果:58例患者可评价疗效,A组完全缓解率为16.0%,部分缓解率为20.0%,总有效率为36.0%;B组完全缓解率为18.2%,部分缓解率为30.3%,总有效率为48.5%;B组患者的生存时间比A组患者的生存时间长;A组和B组的主要不良反应为粒细胞减少、心脏毒性、恶心呕吐等。结论:曲妥珠单抗联合阿霉素脂质体可以提高治疗HER-2阳性表达的乳腺癌患者的有效率,并且延长患者的生存时间。     

曲妥珠单抗联合化疗治疗34例晚期乳腺癌的疗效观察

背景国外已有多项研究证实曲妥珠单抗联合化疗治疗晚期乳腺癌疗效优于单独应用。中国乳腺癌患者与国外乳腺癌患者相比有不同的发病和临床特征。目的观察曲妥珠单抗联合化疗治疗晚期乳腺癌的疗效和毒性。方法 2001年2月至2006年2月期间我院内科以曲妥珠单抗单药以及曲妥珠单抗联合化疗治疗乳腺癌患者34例,中位化疗周期数为3个周期(1～7)。曲妥珠单抗中位用药时间为14周(2～128)。结果可评价疗效和毒性34例,完全缓解3例,部分缓解7例,稳定15例,病变进展9例,总有效率29.4%,中位疾病进展时间为7个月,一线治疗的有效率为38.4%,临床获益率84.6%。二线及三线治疗的有效率为23.1%,临床获益率为53.8%。结论曲妥珠单抗联合化疗是治疗人表皮生长因子受体2过表达晚期乳腺癌较好的治疗方法。     

曲妥珠单抗联合新辅助化疗对乳腺癌术后临床疗效及相关指标的影响

目的:分析曲妥珠单抗、新辅助化疗联合疗法对乳腺癌术后的临床疗效,并指出联合用药方案对术后相关指标的影响.方法:选取2014年4月～2016年3月56例乳腺癌术后患者,随机分组,对照组(n=28)给予常规治疗方法,观察组(n=28)给予曲妥珠单抗、新辅助化疗联合疗法,对比两组临床治疗效果.结果:观察组治疗有效率为96.43％高于对照组(75.00％),组间差异明显(P<0.05);观察组治疗后血清VEGF各项指标改善程度均优于对照组,差异具有统计学意义(P<0.05).结论:曲妥珠单抗、新辅助化疗联合疗法临床效果明显,能改善血清指标水平.     

曲妥珠单抗联合长春瑞滨治疗人表皮生长因子受体2(HER-2)阳性晚期乳腺癌的效果观察

目的:分析曲妥珠单抗联合长春瑞滨治疗人表皮生长因子受体2(HER-2)阳性晚期乳腺癌的临床效果。方法:选取2018年6月—2019年6月我院收治的88例人表皮生长因子受体2(HER-2)阳性晚期乳腺癌患者,随机分成两组。对照组给予曲妥珠单抗治疗,观察组给予曲妥珠单抗联合长春瑞滨治疗。结果:不良反应发生率对比观察组低于对照组,生存率观察组高于对照组,临床治疗有效率观察组高于对照组,差异明显(P<0.05)。结论:在人表皮生长因子受体2(HER-2)阳性晚期乳腺癌治疗中,采用曲妥珠单抗联合长春瑞滨,有助于提升临床治疗效果,使治疗更有安全性。     

曲妥珠单抗联合长春瑞滨治疗HER-2阳性晚期乳腺癌患者的疗效分析

目的探讨曲妥珠单抗联合长春瑞滨治疗HER-2阳性晚期乳腺癌患者的疗效。方法自2010年1月至2014年1月,前瞻性研究我院收治的HER-2阳性的晚期乳腺癌患者120例,将患者随机分为研究组和对照组,每组60例。研究组采用曲妥珠单抗联合长春瑞滨治疗,对照组采用曲妥珠单抗联合卡培他滨治疗。观察两组患者化疗期间相关并发症、生存时间、健康相关的生存质量(SF-36)、实体瘤疗效评价等级。结果与对照组比较,研究组患者部分缓解率显著升高(53.00%vs.28.33%,P=0.005);健康相关的生存质量(SF-36)显著提高(72.95±10.37 vs.65.32±10.40,P<0.01)。随访2年后,研究组共11例患者死亡,对照组共19例患者死亡,两组比较差异无统计学意义(18.33%vs.31.67%,P=0.092)。Wilcoxon检验显示,研究组患者生存期显著高于对照组(P=0.041)。两组患者末梢神经炎、手足综合征、转氨酶升高、胆红素升高、中性粒细胞减少、白细胞减少和消化道症状等差异均无统计学意义(P>0.05)。结论曲妥珠单抗联合长春瑞滨有助于改善晚期乳腺癌患者生存时间,改善其生活质量。     

辅助化疗联合曲妥珠单抗治疗人表皮生长因子受体-2阳性晚期或转移性乳腺癌的系统评价

目的：系统评价辅助化疗联合曲妥珠单抗治疗人表皮生长因子受体-2（HER2）阳性晚期或转移性乳腺癌的临床效果。方法：检索国内外公开发表的关于辅助化疗联合曲妥珠单抗治疗HER2阳性晚期或转移性乳腺癌的中英文文献,对纳入的研究进行比较。结果：共纳入6篇随机对照试验（RCT）研究。辅助化疗联合曲妥珠单抗治疗HER2阳性晚期或转移性乳腺癌的反应率和病理完全缓解率的风险比（RR）分别为1.46（P=0.02）和0.98（P=0.91）。结论：尽管研究存在一定的局限性,但在不考虑治疗成本的情况下,辅助化疗联合曲妥珠单抗治疗要优于标准治疗,临床上具有较强的可替代性。     

Trastuzumab: a review of its use in the management of HER2-positive metastatic and early-stage breast cancer

Trastuzumab (Herceptin) is a humanised monoclonal antibody used in the treatment of breast cancer that overexpresses human epidermal growth factor receptor 2 (HER2), which is associated with clinically aggressive disease and a poor prognosis. The addition of intravenous trastuzumab to first-line chemotherapy improved the time to disease progression, objective response rate, duration of response, and overall survival in randomised, multicentre trials in women with HER2-positive metastatic breast cancer. As such, trastuzumab has become the standard of care in this setting, despite its high acquisition cost and potential for cardiac events, and is licensed for use in combination with paclitaxel (Europe and the US) or docetaxel (Europe). In addition, trastuzumab monotherapy is approved for use in patients with HER2-positive metastatic breast cancer who have previously received chemotherapy for their metastatic disease. Recent data from large phase III trials with trastuzumab in the adjuvant setting revealed significant improvements in disease-free and overall survival. Thus, trastuzumab is also rapidly becoming a standard component of adjuvant therapy for patients with HER2-positive early-stage breast cancer.     

Trastuzumab: a pharmacoeconomic review of its use in early breast cancer

Trastuzumab (Herceptin) is a monoclonal antibody approved for the treatment of breast cancer that overexpresses human epidermal growth factor receptor 2 (HER2). Well designed clinical trials in women with early breast cancer have demonstrated that 1 years' therapy with adjuvant intravenous trastuzumab (a loading dose followed by 6 mg/kg every 3 weeks or 2 mg/kg weekly) significantly improves disease-free survival and overall survival compared with observation (subsequent to chemotherapy) or chemotherapy alone in women with HER2-positive disease. In the HERA trial, disease-free survival was estimated to improve by 6.3% at 3 years in the trastuzumab group compared with the observation group. Trastuzumab is generally well tolerated. The most common adverse events are infusion-related symptoms, such as fever and chills, which usually occur with administration of the first dose. Cardiotoxicity occurs in a small proportion of patients receiving trastuzumab, particularly when coadministered with anthracyclines, and cardiac assessment is recommended for all patients at baseline and at 3-monthly intervals. In modelled cost-effectiveness analyses based on data from clinical trials in patients with HER2-positive early breast cancer, adjuvant trastuzumab was predicted to be cost effective from a healthcare payer or societal perspective in several countries. Incremental costs per QALY or life-year gained with trastuzumab administered subsequent to or concurrent with chemotherapy compared with chemotherapy alone were consistently within accepted local thresholds for cost effectiveness. Sensitivity analyses demonstrated that these results remained generally robust to plausible changes in key model assumptions. In conclusion, in patients with HER2-positive early breast cancer, the addition of adjuvant trastuzumab is clinically effective in improving disease-free survival. Available pharmacoeconomic data from several countries, despite some inherent limitations, support the use of adjuvant trastuzumab for 1 year as a cost-effective treatment relative to chemotherapy alone in this patient population.     

华蟾素注射液联合化疗治疗晚期乳腺癌临床分析

目的观察华蟾素注射液联合化疗治疗晚期乳腺癌的临床疗效。方法将42例晚期乳腺癌患者随机分为两组,治疗组20例患者给予华蟾素注射液联合化疗,对照组22例患者仅应用化疗,观察近期疗效、毒副反应发生率和治疗后生活质量的改善。结果华蟾素治疗组较对照组的近期疗效提高,差异无统计学意义;毒副反应减低,生活质量有所改善,两组相比差异有统计学意义。结论华蟾素注射液联合化疗用于治疗晚期乳腺癌有较好疗效,值得临床推广。     

曲妥珠单抗辅助化疗治疗HER2阳性乳腺癌有效性和安全性的Meta分析

目的 系统评价曲妥珠单抗辅助化疗治疗HER2阳性乳腺癌的有效性和安全性。方法 计算机检索国内外1996-2013年发表的曲妥珠单抗辅助化疗治疗HER2 阳性乳腺癌的前瞻性随机对照研究,对符合纳入标准的研究以Jadad评分标准进行文献质量评价,并使用Review Manager 5.3进行Meta分析。结果 共纳入4项III 期临床随机对照试验(其中有两项试验为合并分析)。Meta分析结果显示,与单纯化疗相比,曲妥珠单抗联合化疗治疗HER2 阳性乳腺癌可以显著延长患者的无病生存期DFS(HR=0.63,95%CI [0.50,0.81],P<0.001)和总生存期OS(HR=0.69,95%CI [0.56,0.86],P=0.001)。在安全性方面,曲妥珠单抗联合化疗组心脏事件(RR=5.09,95% CI [3.23,8.03],P<0.00001)及充血性心力衰竭(RR=5.32,95% CI [2.28,12.44],P=0.0001)发生率显著高于单纯化疗组,而在心脏事件导致的死亡方面,两组没有显著差异。 结论 曲妥珠单抗联合化疗治疗HER2阳性乳腺癌的疗效显著优于单纯化疗,但心脏事件也显著增加。     

多西他赛为主的联合方案一线治疗晚期乳腺癌的临床观察

目的：观察多西他赛联合表阿霉素或顺铂一线治疗晚期乳腺癌的疗效和安全性。方法：62例晚期乳腺癌患者,将既往用蒽环类药物辅助化疗后转移的29例患者及3例不宜用蒽环类药物且未接受过辅助化疗的患者,予多西他赛联合顺铂（TP方案）化疗;将既往用CMF方案辅助化疗后转移的17例患者及13例既往未接受过辅助化疗的患者,予多西他赛联合表阿霉素（TE方案）化疗。TE组药物剂量多西他赛75mg.（m^2）^-1,表阿霉素60mg·（m^2）^-1,d1;TP组药物剂量为多西他赛75mg·（m^2）-1,d1,顺铂25mg·（m^2）^-1,d1～3,21天为1周期,2个周期末评价近期疗效及安全性。结果：62例患者均可评价疗效,其中CR7例,PR29例,SD17例,PD9例,总有效率为58.1%,TE组和TP组有效率分别为60.0%和56.3%（P=0.963）,临床受益率分别为86.7%和84.4%（P=0.897）,TTP分别为10.2个月和9.0个月（P=0.713）。不良反应主要是骨髓抑制、脱发、消化道反应,但均可耐受,无化疗相关死亡。结论：多西他赛联合表阿霉素或顺铂方案一线治疗晚期乳腺癌有较好的疗效,不良反应可以耐受,且TE和TP方案的疗效及安全性相当。     

Role of trastuzumab in adjuvant therapy for locally invasive breast cancer.

PURPOSE: The role of trastuzumab in adjuvant therapy for locally invasive breast cancer is discussed. SUMMARY: Trastuzumab is a humanized monoclonal antibody that binds to the extracellular domain of human epidermal growth factor receptor-2 (HER2). Currently, trastuzumab is indicated for use in HER2-positive patients with metastatic breast cancer. Because trastuzumab specifically targets a receptor that is overexpressed in tumor cells, it is less likely to cause the cytotoxic adverse effects of traditional chemotherapy. Cardiotoxicity has been a major concern, however. Several trials were started to evaluate trastuzumab in the adjuvant setting in patients diagnosed with early-stage breast cancer. The interim results of these trials have shown a promising effect of adjuvant therapy with trastuzumab in improving overall survival, disease-free survival, relapse-free survival, and distant-disease-free survival. CONCLUSION: The use of trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer can lead to increased survival. The appropriateness of trastuzumab therapy should be considered based on HER2 status, cost, and risk of toxicity.     

曲妥珠单抗引起过敏样反应

1例52岁女性患者,因乳腺癌术后辅助化疗给予曲妥珠单抗220mg加入0.9%氯化钠注射液250ml静脉滴注,滴速为50滴/min。输入约30min时,患者出现寒战、胸闷、口唇发麻、呼吸困难,心率165次/min,血压199/99mm Hg。立即停止输液,行对症治疗。50min后上述症状消失,心率及血压恢复正常。21d后再次化疗,曲妥珠单抗110mg加入0.9%氯化钠注射液250ml静脉滴注,滴速30滴/min。5min后,患者再次出现过敏样症状。停药10min后症状消失。