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比较曲妥珠单抗-美坦新偶联物在既往接受曲妥珠单抗和帕妥珠单抗联合治疗与仅接受曲妥珠单抗治疗的人表皮生长因子受体 2 阳性转移性乳腺癌日本患者中的疗效。

Comparison of the efficacy of trastuzumab emtansine between patients with metastatic human epidermal growth factor receptor 2-positive breast cancers previously treated with combination trastuzumab and pertuzumab and with trastuzumab only in Japanese population.

机构信息

Department of Breast and Medical Oncology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.

Department of Breast Medical Oncology, National Center for Global Health and Medicine, 1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan.

出版信息

Breast Cancer. 2019 Jul;26(4):492-498. doi: 10.1007/s12282-019-00949-4. Epub 2019 Feb 8.

Abstract

BACKGROUND

Trastuzumab emtansine (T-DM1) has been approved since 2013 for patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) who had received trastuzumab (Tmab) and taxane. However, no clinical trial has evaluated the efficacy of T-DM1 in those who have previously received pertuzumab (Pmab). This study aimed to compare the efficacy of T-DM1 between patients who had received Tmab and Pmab and those who had received Tmab only in Japanese population.

METHODS

We identified all patients with HER2-positive MBC who received T-DM1 between April 1, 2014 and February 28, 2017 in our institution. The patients were divided into the Tmab group (i.e., those who received only Tmab before T-DM1 treatment) and the Tmab/Pmab group (i.e., those who received Tmab and Pmab before T-DM1 treatment), and progression-free survival (PFS) and best response were compared between the two groups.

RESULTS

A total of 42 patients were enrolled for outcome analysis. The median follow-up period was 4.8 months, and the median number of prior chemotherapy regimens for metastatic disease before T-DM1 was 1 (range 1-2) in the Tmab/Pmab group and 2 (range 0-6) in the Tmab group. The median PFS was 2.8 months in the Tmab/Pmab group (95% confidence interval [CI] 1.7-4.8 months) and 7.8 months in the Tmab group (95% CI 5.5-15.9 months) (p = 0.0030). The best response was lower in the Tmab/Pmab group (11.1% vs. 25.0%).

CONCLUSIONS

Patients with HER2-positive MBC who received Tmab and Pmab treatment before T-DM1 have fewer benefits from T-DM1.

摘要

背景

曲妥珠单抗-美坦新偶联物(T-DM1)自 2013 年以来已被批准用于接受曲妥珠单抗(Tmab)和紫杉烷治疗的人表皮生长因子受体 2(HER2)阳性转移性乳腺癌(MBC)患者。然而,尚无临床试验评估 T-DM1 在先前接受过帕妥珠单抗(Pmab)治疗的患者中的疗效。本研究旨在比较 T-DM1 在接受过 Tmab 和 Pmab 治疗的患者与仅接受过 Tmab 治疗的患者中的疗效。

方法

我们在我院确定了所有在 2014 年 4 月 1 日至 2017 年 2 月 28 日期间接受 T-DM1 治疗的 HER2 阳性 MBC 患者。将患者分为 Tmab 组(仅在 T-DM1 治疗前接受 Tmab)和 Tmab/Pmab 组(在 T-DM1 治疗前接受 Tmab 和 Pmab),并比较两组之间的无进展生存期(PFS)和最佳反应。

结果

共有 42 例患者入组进行结局分析。中位随访时间为 4.8 个月,在 Tmab/Pmab 组中,T-DM1 治疗前转移性疾病的中位化疗方案数为 1(范围 1-2),在 Tmab 组中为 2(范围 0-6)。在 Tmab/Pmab 组中,PFS 的中位数为 2.8 个月(95%置信区间 [CI] 1.7-4.8 个月),在 Tmab 组中为 7.8 个月(95% CI 5.5-15.9 个月)(p=0.0030)。T-DM1 治疗前接受 Tmab 和 Pmab 治疗的患者的最佳反应率较低(11.1%比 25.0%)。

结论

接受过 Tmab 和 Pmab 治疗的 HER2 阳性 MBC 患者从 T-DM1 中获益较少。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7be2/6570684/a33f5fa7325b/12282_2019_949_Fig1_HTML.jpg

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