BACKGROUND Ado-trastuzumab emtansine is an antibody-drug conjugate that combines the cytotoxic activity of emtansine with human epidermal growth factor receptor 2-targeted antitumor features of trastuzumab. OBJECTIVE We conducted a study of metastatic breast cancer patients treated with trastuzumab emtansine. By evaluating progression-free survival, overall survival, and response rates, we aimed to find prognostic factors of trastuzumab emtansine treatment. METHODS Our study is a single-center, retrospective, observational study. We have clinical data from 78 patients treated with trastuzumab emtansine for metastatic breast cancer, from May 2016 through May 2019, at Kartal Dr Lutfi Kirdar Education and Research Hospital, Medical Oncology Department. Our objective is to assess the survival and response rates in trastuzumab emtansine-treated individuals and the factors associated with survival. The factors we analyzed were cancer antigen 15-3 sensitivity, Eastern Cooperative Oncology Group-Performance Status, presence or absence of visceral metastases, presence or absence of cranial metastases, and treatment-associated thrombocytopenia. RESULTS Among 78 patients, median progression-free survival was 7.8 months, and overall survival was 21.1 months. Twenty of the patients had an objective tumor response. The results showed that trastuzumab emtansine was tolerable with a manageable safety profile and consistent with the results of the previous literature. Mostly seen adverse events were anemia, thrombocytopenia, fatigue, and increased levels of alkaline phosphatase. Patients with Eastern Cooperative Oncology Group-Performance Status = 2 had worse progression-free survival and overall survival compared to ones with Eastern Cooperative Oncology Group-Performance Status < 2; progression-free survival and overall survival are worse in cancer antigen 15-3-sensitive breast cancer patients. According to our findings, treatment-associated thrombocytopenia was a significant prognostic factor for survival. Patients with thrombocytopenia had 12 months progression-free survival, whereas patients without thrombocytopenia had only 4.1 months progression-free survival. In like manner, overall survival was much better in the thrombocytopenia-experienced patients as 29.5 versus 11.8 months. CONCLUSIONS Trastuzumab emtansine prolongs progression-free survival and overall survival with a manageable safety profile. Thrombocytopenia, Eastern Cooperative Oncology Group-Performance Status, and cancer antigen 15-3 are correlated with progression-free survival and/or overall survival.

中文翻译：

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ado-trastuzumab氨丹宁治疗转移性HER-2阳性乳腺癌患者的预后因素。

背景技术Ado-曲妥珠单抗Emtansine是一种抗体-药物偶联物，结合了Emtansine的细胞毒活性和人类表皮生长因子受体2靶向的曲妥珠单抗的抗肿瘤特性。目的我们进行了曲妥珠单抗氨丹宁治疗的转移性乳腺癌患者的研究。通过评估无进展生存期，总生存期和缓解率，我们旨在寻找曲妥珠单抗氨丹宁治疗的预后因素。方法我们的研究是一项单中心，回顾性，观察性研究。我们从2016年5月至2019年5月在医学肿瘤学系Kartal Dr.Lutfi Kirdar教育和研究医院收集了78例接受曲妥珠单抗氨丹宁治疗转移性乳腺癌的患者的临床数据。我们的目标是评估曲妥珠单抗经坦坦碱治疗的患者的生存率和缓解率以及与生存有关的因素。我们分析的因素是癌症抗原15-3敏感性，东部合作肿瘤小组表现状态，是否存在内脏转移，是否存在颅骨转移以及与治疗相关的血小板减少症。结果78例患者中位无进展生存期为7.8个月，总生存期为21.1个月。20名患者发生了客观的肿瘤反应。结果表明曲妥珠单抗氨丹宁具有可控的安全性，并且与先前文献的结果一致。最常见的不良事件是贫血，血小板减少，疲劳和碱性磷酸酶水平升高。与东部合作肿瘤小组表现状态<2的患者相比，东部合作肿瘤小组表现状态= 2的患者的无进展生存期和总体生存率更差；对癌症抗原15-3敏感的乳腺癌患者，无进展生存期和总体生存期更差。根据我们的发现，与治疗相关的血小板减少症是生存的重要预后因素。血小板减少症患者的无进展生存期为12个月，而没有血小板减少症的患者的无进展生存期仅为4.1个月。同样，患有血小板减少症的患者的总生存期要好得多，分别为29.5和11.8个月。结论曲妥珠单抗氨丹宁可延长无进展生存期和总体生存期，并具有可控的安全性。