169P - Anlotinib plus chemotherapy as neoadjuvant treatment of high-risk, early-stage triple-negative breast cancer: A prospective, single-arm, single-center, phase II clinical study

Background

Anlotinib is an oral multi-targeted tyrosine kinase inhibitor (TKI) that strongly inhibits VEGFR, PDGFR, FGFR, and c-kit. Combining anti-angiogenesis with chemotherapy yielded increased response rates in patients with early-stage triple-negative breast cancer (TNBC). This phase II study aims to evaluate the efficacy and safety of adding anlotinib to standard neoadjuvant chemotherapy in primary TNBC.

Methods

Patients aged 18 years or older with previously untreated stage ⅡB-IIIA histologically documented TNBC were assigned to receive chemotherapy plus oral anlotinib (12 mg qd, d1-14; 21 days per cycle; total 8 cycles). Chemotherapy comprised epirubicin at 90 mg/m² and cyclophosphamide at 600 mg/m2 followed by docetaxel at 100 mg/m², (21 days per cycle; both total 4 cycles), which was then followed by surgery. The primary endpoint was pathologic complete response (pCR; no invasive carcinoma in breast or axilla). Stratification was based on the clinical breast cancer stage.

Results

Between July 2019 and September 2020, 20 patients (female) with pathological stage ⅡB (85%), and IIIA (15%) were enrolled with a median age of 48.5 years (range: 32-72). Overall pCR rate was 50.0% (10/20，CI 95％：29.9％-70.1％). The pCR rate of pathological stage IIB patients was 52.9％ (CI 95％：31.0％-73.8％), which tends to be better than the pCR rate of 33.3% (CI 95%: 6.2%-79.2%) for patients with pathological stage IIIA. There were 21 kind of AEs observed, all including 76 grade 1 AEs and 21 grade 2 AEs; no grade 3 or higher AE was observed. The most common AEs included hand-foot syndrome (60% in total with 35% grade 2 and 25% grade 1), oral mucositis (55.0% in total with 35% grade 2 and 20.0% grade 1), fatigue (60.0%, all grade 1), hoarse voice (33.5%, all grade 1), nasal bleeding (25.0%, all grade 1), hypertension (25% with 5.0% grade 2) and diarrhea (25% with 5.0% grade 2). Neither unexpected safety signals nor treatment-related death occurred.

Conclusions

The addition of anlotinib to neoadjuvant chemotherapy showed manageable toxicity and promising antitumor activity for patients with high-risk, early-stage TNBC.

Clinical trial identification

ChiCTR2000038174, July 2019.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.