423P - A real-world study on the clinical value of apatinib-based regimens in metastatic triple-negative breast cancer

Background

Apatinib is an oral, highly potent tyrosine-kinase inhibitor targeting VEGFR2. The published studies have shown probable efficacy and safety. However, the recommended dose of apatinib (500mg/day) is associated with difficult-to-tolerate adverse reactions. To this end, we aim to investigate whether low-dose apatinib (250mg/day) in combination with chemotherapy could benefit metastatic triple-negative breast cancer (mTNBC) in the real-world setting.

Methods

Patients with mTNBC who were treated at Fujian Medical University Cancer Hospital from October 2011 to January 2023 were screened. Patients included in this study were divided into two groups, low-dose apatinib (250mg/day) and/or palliative chemotherapy. Descriptive statistics were used to summarize adverse reactions and demographic data. Progression-free survival (PFS) and overall survival (OS) were estimated by the Kaplan-Meier method. Secondary outcomes included objective response rate (ORR), disease control rate (DCR), and safety profiles.

Results

A total of 163 patients were included in this study and retrospectively analyzed. The Apatinib-based group (n = 56) showed significant benefits in terms of progression-free survival (PFS) and overall survival (OS) comparing with the chemotherapy-based treatment group (n = 107), with median PFS of 8.5 months (95% CI, 6.6-12.8) versus 2.8 months (95% CI, 2.4-4.4) (HR = 0.33, 95% CI, 0.22-0.50, P ＜ 0.001) and OS of 21.1 months (95% CI, 15.5-NR) versus 10.5 months (95% CI, 9.1-12.8) (HR = 0.28, 95% CI, 0.17-0.47, P ＜ 0.001). The overall response rate (ORR) and the disease control rate (DCR) were 53.6% versus 26.2% (P < .001) and 85.7% versus 44.9% (P < .001), respectively. The second- and later-line subgroup showed significant benefits. The grade 3/4 toxicity of apatinib plus chemotherapy was mainly manifested as neutropenia (8.8%) and hypertension (5.9%). No treatment-related serious adverse events or deaths were reported.

Conclusions

Low-dose apatinib plus chemotherapy showed better survival benefits than chemotherapy alone, with significantly improved non-hematological toxicity and increased patient tolerability for mTNBC. Much more investigation is warranted and necessary for further exploration.

Clinical trial identification

NCT05019690.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

National Clinical Key Specialty Construction Program, Natural science foundation of Fujian province, Grant/Award Number: 2021J01440; Fujian Provincial Clinical Research Center for Cancer Radiotherapy and Immunotherapy, Grant/Award Number:2020Y2012.

Disclosure

All authors have declared no conflicts of interest.