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曲妥珠单抗-美坦新偶联物治疗 Her2 阳性转移性乳腺癌的疗效和安全性:真实世界经验。

Efficacy and Safety of Trastuzumab Emtansine in Her2 Positive Metastatic Breast Cancer: Real-World Experience.

机构信息

Department of Medical Oncology, Dr. Ersin Arslan Education and Research Hospital, Gaziantep, Turkey.

Department of Medical Oncology, Faculty of Medicine, Cukurova University, Adana, Turkey.

出版信息

Cancer Invest. 2021 Jul-Aug;39(6-7):473-481. doi: 10.1080/07357907.2021.1933011. Epub 2021 Jun 7.

DOI:10.1080/07357907.2021.1933011
PMID:34014777
Abstract

AIM

The aim of this study is to evaluate the efficacy and toxicity of trastuzumab emtansine (T-DM1) in cases with metastatic breast cancer (mBC) in different lines of treatment.

METHOD

Retrospective analysis of T-DM1 results of human epidermal growth factor receptor 2 (Her2) positive 414 cases with mBC from 31 centers in Turkey.

FINDINGS

Except 2, all of the cases were female with a median age of 47. T-DM1 had been used as second-line therapy in 37.7% of the cases and the median number of T-DM1 cycles was 9. Progression-free survival (PFS) and overall survival (OS) times were different according to the line of treatment. The median OS was found as 43, 41, 46, 23 and 17 months for 1st, 2nd, 3rd, 4th and 5th line, respectively ( = 0.032) while the median PFS was found as 37, 12, 8, 8 and 8 months, respectively ( = 0.0001). Treatment was well tolerated by the patients. The most common grade 3-4 adverse effects were thrombocytopenia (2.7%) and increased serum gamma-glutamyl transferase (2%).

DISCUSSION

The best of our knowledge this is the largest real-life experience about the safety and efficacy of T-DM1 use in cases with mBC after progression of Her2 targeted treatment. This study suggests and supports that T-DM1 is more effective in earlier lines of treatment and is a reliable option for mBC.

摘要

目的

本研究旨在评估曲妥珠单抗-美坦新偶联物(T-DM1)在不同治疗线数的转移性乳腺癌(mBC)患者中的疗效和毒性。

方法

对土耳其 31 个中心的 414 例 HER2 阳性 mBC 患者的 T-DM1 结果进行回顾性分析。

结果

除 2 例外,所有患者均为女性,中位年龄为 47 岁。T-DM1 曾作为二线治疗应用于 37.7%的病例,T-DM1 周期的中位数为 9 个。无进展生存期(PFS)和总生存期(OS)时间因治疗线数而异。1 线、2 线、3 线、4 线和 5 线治疗的中位 OS 分别为 43、41、46、23 和 17 个月(=0.032),中位 PFS 分别为 37、12、8、8 和 8 个月(=0.0001)。患者对治疗的耐受性良好。最常见的 3-4 级不良事件为血小板减少症(2.7%)和血清γ-谷氨酰转移酶升高(2%)。

讨论

据我们所知,这是最大规模的真实世界经验,涉及曲妥珠单抗-美坦新偶联物在 HER2 靶向治疗进展后的 mBC 患者中的安全性和疗效。本研究表明并支持 T-DM1 在早期治疗线中更有效,是 mBC 的可靠选择。

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