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Published in: BMC Cancer 1/2023

Open Access 01-12-2023 | Breast Cancer | Research

Apatinib plus etoposide in pretreated patients with advanced triple-negative breast cancer: a phase II trial

Authors: Mengru Cao, Hailing Lu, Shi Yan, Hui Pang, Lichun Sun, Chunhong Li, Xuesong Chen, Wei Liu, Jing Hu, Jian Huang, Ying Xing, Ningzhi Zhang, Yingqi Chen, Ting He, Danni Zhao, Yuanyuan Sun, Lin Zhao, Xiaomeng Liu, Li Cai

Published in: BMC Cancer | Issue 1/2023

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Abstract

Background

Treatment options for pretreated triple-negative breast cancer (TNBC) are limited. This study aimed to evaluate the efficacy and safety of apatinib, an antiangiogenic agent, in combination of etoposide for pretreated patients with advanced TNBC.

Methods

In this single-arm phase II trial, patients with advanced TNBC who failed to at least one line of chemotherapy were enrolled. Eligible patients received oral apatinib 500 mg on day 1 to 21, plus oral etoposide 50 mg on day 1 to 14 of a 3-week cycle until disease progression or intolerable toxicities. Etoposide was administered up to six cycles. The primary endpoint was progression-free survival (PFS).

Results

From September 2018 to September 2021, 40 patients with advanced TNBC were enrolled. All patients received previous chemotherapy in the advanced setting, with the median previous lines of 2 (1–5). At the cut-off date on January 10, 2022, the median follow-up was 26.8 (1.6–52.0) months. The median PFS was 6.0 (95% confidence interval [CI]: 3.8–8.2) months, and the median overall survival was 24.5 (95%CI: 10.2–38.8) months. The objective response rate and disease control rate was 10.0% and 62.5%, respectively. The most common adverse events (AEs) were hypertension (65.0%), nausea (47.5%) and vomiting (42.5%). Four patients developed grade 3 AE, including two with hypertension and two with proteinuria.

Conclusions

Apatinib combined with oral etoposide was feasible in pretreated advanced TNBC, and was easy to administer.

Clinical trial registration

Chictr.org.cn, (registration number: ChiCTR1800018497, registration date: 20/09/2018)
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Metadata
Title
Apatinib plus etoposide in pretreated patients with advanced triple-negative breast cancer: a phase II trial
Authors
Mengru Cao
Hailing Lu
Shi Yan
Hui Pang
Lichun Sun
Chunhong Li
Xuesong Chen
Wei Liu
Jing Hu
Jian Huang
Ying Xing
Ningzhi Zhang
Yingqi Chen
Ting He
Danni Zhao
Yuanyuan Sun
Lin Zhao
Xiaomeng Liu
Li Cai
Publication date
01-12-2023
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2023
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-023-10768-8

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