Abstract 247P
Background
Apatinib is an oral, highly potent tyrosine-kinase inhibitor targeting VEGFR2. Phase II trial of apatinib in triple-negative breast cancer that have failed at least three chemotherapy regimens have demonstrated apatinib dose of 500 mg rather than 750 mg is the recommended starting dose for the heavily pretreated metastatic triple-negative breast cancer (mTNBC) patients with measurable rate of partial response and PFS. This phase II trial aimed to investigate the efficacy and safety of apatinib combined with chemotherapy in patients with HER2-negative advanced breast cancer.
Methods
Patients with HER2-negative advanced breast cancer with less than two lines of systemic therapy were enrolled in this open-label, controlled, phase II trial. Patients with measurable disease were randomly assigned, in a 1:1 ratio, to receive oral apatinib (250 mg once daily) combined with chemotherapy (physician’s choice) or single-agent chemotherapy of the physician’s choice until disease progression or intolerable toxicity. The primary end point was progression-free survival.
Results
Between August 2017 and January 2021, of the 80 patients who underwent randomization, 40 were assigned to receive apatinib plus chemotherapy and 40 were assigned to receive standard therapy. Median PFS was significantly longer in the apatinib group than in the single chemotherapy group (182 days vs 63 days; P=0.043); the median PFS of TNBC subgroup(11 in apatinib group, 14 in chemotherapy group) was longer in the apatinib group than in the single chemotherapy group (167 days vs 63 days; P=0.637); the most common grade ≥3 treatment-emergent adverse events included hypertension (11.1%), neutropenia (22.2%), leukopenia (8.3%), hypokalemia( 8.3%) in the apatinib group; neutropenia (13.9%), leukopenia (8.3%), anemia (11.1%), aspartate transaminase (AST) increased (5.6%), alanine aminotransferase (ALT) increased (8.3%) in single chemotherapy group.
Conclusions
Apatinib combined with chemotherapy in treating advanced HER2-negative breast cancer showed encouraging efficacy with a manageable safety profile, even in patients with TNBC and HR+ patients and those with liver metastases.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Zhanhong Chen.
Funding
JiangsuHengrui Medicine Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.