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Clinical Trial
. 2023 Dec 31;24(1):2265055.
doi: 10.1080/15384047.2023.2265055. Epub 2023 Oct 13.

Phase II study of apatinib plus exemestane in estrogen receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer

Aihua Tan  1 , Li Nong  1 , Hongxue Wang  1 , Yuxian Jia  1 , Wuning Zhong  1 , Fanghui Qin  1 , Han Wang  1 , Jing Tang  1 , Yan Liu  1 , Yongkui Lu  1
Affiliations
Clinical Trial

Phase II study of apatinib plus exemestane in estrogen receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer

Aihua Tan et al. Cancer Biol Ther. .

Abstract

Purpose: Apatinib is a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor (VEGFR)-2. This study was conducted to assess the efficacy and safety of apatinib combined with exemestane in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC).

Methods: This single-center, single-arm phase II study enrolled patients with ER+/HER2- MBC progressed on previous letrozole or anastrozole. Stratified analysis was performed according to the number of chemotherapy regimens for metastatic disease. The primary endpoint was progression free survival (PFS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), clinical benefit rate (CBR), overall survival (OS) and toxicity. Patients received apatinib at a starting dose of 500 mg/d and exemestane 25 mg/d on days 1-28 of each 4-week cycle.

Results: Thirty patients were enrolled with median four prior anticancer therapies. Eighty percent of patients received chemotherapy for metastatic disease. The median PFS (mPFS) and OS were 5.6 (95%CI: 4.3-6.9) months and 15.7 (95% CI: 9.7-21.7) months, respectively. The ORR, DCR, and CBR were 21.4%, 71.4%, and 46.4%, respectively. Patients with 0-1 line chemotherapy for MBC showed a slightly longer mPFS compared to those with ≥2 lines chemotherapy (mPFS: 6.4 months vs 4.8 months, P = .090). Most of the AEs were grade 1/2. One patient (3.3%) who suffered bone marrow metastases experienced grade 4 thrombocytopenia, and 14 experienced grade 3 AEs. Fifty percent of patients were given reduced dose for apatinib.

Conclusions: Apatinib plus exemestane exhibited objective efficacy in patients with ER+/HER2- MBC who have failed multiple lines of treatment. The AEs of apatinib required close monitoring and most of patients were well tolerated.

Keywords: Apatinib; endocrine resistance; exemestane; metastatic breast cancer (MBC).

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Conflict of interest statement

No potential conflict of interest was reported by the authors.

Figures

Figure 1.
Figure 1.
Flowchart of the participants through the trial (CONSORT diagram).
Figure 2.
Figure 2.
Best overall response. PR, partial response; SD, stable disease; PD, progression disease.
Figure 3.
Figure 3.
Kaplan-–Meier estimates. (a) the overall PFS; (b) the OS. PFS, progression-free survival; OS, overall survival; mPFS, median PFS.
Figure 4.
Figure 4.
The stratified analysis. (a) the mPFS of patients with 0–1 line or ≥ 2 lines chemotherapy for MBC; (b) the OS of patients with 0–1 line or ≥ 2 lines chemotherapy for MBC. PFS, progression-free survival; OS, overall survival; mPFS, median PFS; MBC, metastatic breast cancer.
See this image and copyright information in PMC

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