Add-on apatinib puts brakes on disease progression in advanced TNBC

The addition of apatinib to vinorelbine appears to prolong progression-free survival (PFS) in patients with advanced triple-negative breast cancer (TNBC) with failed first- or second-line treatment, as shown in the results of a phase II study.

The study included 65 patients (mean age 48 years) who were randomized to receive vinorelbine alone (n=32) or with apatinib (n=33) in 28-day cycles. All patients had invasive ductal carcinoma with metastatic disease. Visceral metastatic rates were 19 percent in vinorelbine monotherapy group and 27 percent in the add-on apatinib group. In addition, 15 percent and 19 percent of patients in the respective groups had metastases in ≥3 organs. Most patients had received prior anthracycline or paclitaxel-based adjuvant or neoadjuvant chemotherapy and platinum-based metastatic chemotherapy.

During a median follow-up of 22.3 months, the primary endpoint of PFS was significantly longer in the add-on apatinib group than in the vinorelbine monotherapy group (3.9 vs 2.0 months; hazard ratio [HR], 1.82, 95 percent confidence interval [CI], 1.06–3.11; p=0.026).

Median overall survival was 11.5 months with add-on apatinib vs 9.9 months with vinorelbine monotherapy, with the difference not reaching statistical significance (HR, 1.01, 95 percent CI, 0.51–1.97; p=0.985). The same was true for objective response rate (9.1 percent with add-on apatinib vs 6.3 percent with vinorelbine monotherapy; p=0.667).

The most frequent treatment-related haematologic grade 3–4 adverse events (AEs) in the add-on apatinib group were leukopenia, granulocytopenia, anaemia, and thrombocytopenia. There were no reports of treatment-related nonhaematologic grade 4 AEs or treatment-related deaths.