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曲妥珠单抗-美坦新偶联物治疗转移性 HER-2 阳性乳腺癌患者的预后因素。

Prognostic factors of ado-trastuzumab emtansine treatment in patients with metastatic HER-2 positive breast cancer.

机构信息

Department of Medical Oncology, Istanbul Kartal Dr. Lutfi Kirdar Education and Research Hospital, Istanbul, Turkey.

Department of Medical Oncology, Medeniyet Universitesi Goztepe Education and Research Hospital, Istanbul, Turkey.

出版信息

J Oncol Pharm Pract. 2021 Apr;27(3):547-554. doi: 10.1177/1078155220924088. Epub 2020 May 19.

DOI:10.1177/1078155220924088
PMID:32423326
Abstract

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.

摘要

背景

Ado-trastuzumab emtansine 是一种抗体药物偶联物,将细胞毒性药物 emtansine 的活性与曲妥珠单抗的人表皮生长因子受体 2 靶向抗肿瘤特性相结合。

目的

我们对接受曲妥珠单抗 emtansine 治疗的转移性乳腺癌患者进行了研究。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 emtansine 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。我们有 78 例转移性乳腺癌患者接受曲妥珠单抗 emtansine 治疗的临床数据,这些患者于 2016 年 5 月至 2019 年 5 月在 Kartal Dr Lutfi Kirdar 教育和研究医院肿瘤内科接受治疗。我们的目的是评估曲妥珠单抗 emtansine 治疗个体的生存率和缓解率,以及与生存相关的因素。我们分析的因素包括癌抗原 15-3 敏感性、东部合作肿瘤学组表现状态、是否存在内脏转移、是否存在颅脑转移以及与治疗相关的血小板减少症。

结果

在 78 例患者中,中位无进展生存期为 7.8 个月,总生存期为 21.1 个月。20 例患者有客观肿瘤反应。结果表明,曲妥珠单抗 emtansine 具有可耐受的安全性且可管理,与先前文献的结果一致。最常见的不良反应为贫血、血小板减少症、疲劳和碱性磷酸酶水平升高。东部合作肿瘤学组表现状态为 2 的患者无进展生存期和总生存期均较东部合作肿瘤学组表现状态<2 的患者差;癌抗原 15-3 敏感型乳腺癌患者的无进展生存期和总生存期更差。根据我们的发现,与治疗相关的血小板减少症是生存的一个显著预后因素。有血小板减少症的患者无进展生存期为 12 个月,而无血小板减少症的患者仅为 4.1 个月。同样,经历过血小板减少症的患者的总生存期要好得多,为 29.5 个月,而 11.8 个月。

结论

曲妥珠单抗 emtansine 延长了无进展生存期和总生存期,具有可管理的安全性。血小板减少症、东部合作肿瘤学组表现状态和癌抗原 15-3 与无进展生存期和/或总生存期相关。

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