270P - Apatinib added to taxanes and platinum neoadjuvant chemotherapy for patients with triple-negative and HER2-positive breast cancer: A multicenter, randomized, phase II, open-label trial

Background

Triple-negative and epidermal growth factor receptor 2 (HER2)-positive breast cancer represent the aggressive molecular subtypes. Neoadjuvant therapy plays an important role in improving the disease prognosis. Apatinib, a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor 2 (VEGFR2), combined with taxanes have demonstrated a promising anti-tumour activity in patients with metastatic breast cancer. Here, we performed a multicenter, randomized, phase II, open-label trial for patients with stage IIb-IIIc breast cancer, aiming determining whether the addition of apatinib to neoadjuvant chemotherapy increase the rate of pathological complete response (pCR).

Methods

Patients were randomly assigned into neoadjuvant chemotherapy with TP (docetaxel 75 mg/m² or nab-paclitaxel 260 mg/m² or paclitaxel liposome 175 mg/m² day 1, and carboplatin AUC=6 or cisplatin 75 mg/m² or lobaplatin 30 mg/m² day 1), or apatinib (500mg day 1-21) added to TP treatment. Cycles were repeated every 3 weeks with totally 6 cycles. Trastuzumab was combined with neoadjuvant therapy in patients with HER2-positive breast cancer.

Results

51 patients underwent radical surgery after neoadjuvant therapy. Compared with TP along (42.9%, 12/28), the addition of apatinib to TP neoadjuvant chemotherapy (Apa+TP) significantly increased the pCR rate (73.9%, 17/23) in patients with stage IIb-IIIc triple-negative and HER2-positive breast cancer (P=0.026). When separating patients into triple-negative (72.7% (8/11) vs. 50% (3/6), P=0.600) and HER2-positve (75% (9/12) vs. 40.9% (9/22), P=0.080) subtypes, the effect of apatinib on pCR was also improved compared with control group. The most common Grade 3-4 adverse events (AE) included hypertension (13.0% vs. 0%, P=0.170), hand-foot syndrome (4.3% vs. 0%, P=0.921), erythra (4.3% vs. 0%, P=0.921). No significant differences of AE were found between Apa+TP and control group.

Conclusions

Apatinib added to TP neoadjuvant chemotherapy significantly increased the pCR rate, suggesting an applicable strategy for triple-negative/HER2-positive breast cancer.

Clinical trial identification

NCT03580395.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

China Anti-Cancer Association Research Grant.

Disclosure

All authors have declared no conflicts of interest.