Kawalec Paweł, Łopuch Sylwia, Mikrut Alicja
Jagiellonian University Medical College, Faculty of Health Sciences, Institute of Public Health, Department of Drug Management, Krakow, Poland.
Jagiellonian University Medical College, Faculty of Health Sciences, Institute of Public Health, Department of Drug Management, Krakow, Poland.
Clin Breast Cancer. 2015 Apr;15(2):90-100.e1. doi: 10.1016/j.clbc.2014.10.006. Epub 2014 Oct 22.
Breast cancer is the most common cancer and the most frequent cause of death in women. Targeted therapies offer a possibility of effective and individualized therapy based on the molecular profile of the tumor. The aim of this systematic review was to evaluate the efficacy and safety of targeted agents added to chemotherapy or endocrine therapy in patients with previously untreated metastatic breast cancer (MBC) depending on their human epidermal growth factor receptor 2 (HER2) and hormone receptor (HR) status (positive or negative). The systematic literature search was performed in PubMed, EMBASE, and the Cochrane Library to identify randomized controlled trials (RCTs). Thirteen trials were included. The addition of trastuzumab, pertuzumab, bevacizumab, or lapatinib to chemotherapy significantly (P < .05) improved objective response rate (ORR), time to failure (TTF), and overall survival (OS) in patients with HER2-positive (HER2(+)) disease. Trastuzumab or lapatinib combined with endocrine therapy significantly (P < .05) improved ORR, time to progression (TTP), and progression-free survival (PFS) in patients with HER2(+) and HR(+) disease. In patients with HER2-negative (HER2(-)) cancer, bevacizumab or lapatinib added to chemotherapy significantly (P < .05), improved ORR but did not prolong PFS and OS (P > .05). In patients with HER2(-) and HR(-) disease, trastuzumab combined with chemotherapy did not significantly improve (P > .05) ORR or PFS. Targeted therapies also increased the overall risk of adverse events. So far, there is a lack of published results for everolimus and trastuzumab emtansine trials in patients with previously untreated MBC. The addition of targeted therapy to chemotherapy or endocrine therapy using HER2 and HR status significantly improved ORR, PFS, and OS in patients with previously untreated MBC.
乳腺癌是女性中最常见的癌症，也是最常见的死亡原因。靶向治疗为基于肿瘤分子特征的有效且个体化治疗提供了可能。本系统评价的目的是评估在既往未接受治疗的转移性乳腺癌（MBC）患者中，根据其人类表皮生长因子受体2（HER2）和激素受体（HR）状态（阳性或阴性），在化疗或内分泌治疗基础上加用靶向药物的疗效和安全性。在PubMed、EMBASE和Cochrane图书馆进行系统文献检索，以识别随机对照试验（RCT）。纳入了13项试验。在HER2阳性（HER2(+)）疾病患者中，在化疗基础上加用曲妥珠单抗、帕妥珠单抗、贝伐单抗或拉帕替尼可显著（P < 0.05）提高客观缓解率（ORR）、失败时间（TTF）和总生存期（OS）。曲妥珠单抗或拉帕替尼联合内分泌治疗可显著（P < 0.05）提高HER2(+)和HR(+)疾病患者的ORR、进展时间（TTP）和无进展生存期（PFS）。在HER2阴性（HER2(-)）癌症患者中，在化疗基础上加用贝伐单抗或拉帕替尼可显著（P < 0.05）提高ORR，但未延长PFS和OS（P > 0.05）。在HER2(-)和HR(-)疾病患者中，曲妥珠单抗联合化疗未显著（P > 0.05）提高ORR或PFS。靶向治疗也增加了不良事件的总体风险。到目前为止，在既往未接受治疗的MBC患者中，依维莫司和曲妥珠单抗 emtansine试验缺乏已发表的结果。根据HER2和HR状态在化疗或内分泌治疗基础上加用靶向治疗可显著改善既往未接受治疗的MBC患者的ORR、PFS和OS。
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