Superior efficacy of a Cremophor-free albumin-bound paclitaxel compared with solvent-based paclitaxel in Chinese patients with metastatic breast cancer

Aim:   In a previous study, a 130-nm nanoparticle albumin-bound paclitaxel ( nab -paclitaxel) demonstrated improved efficacy and safety profile compared with solvent-based paclitaxel (sb-paclitaxel) in Caucasian patients with metastatic breast cancer (MBC). The aim of the present randomized study was to compare the response rates and safety profile of nab -paclitaxel with sb-paclitaxel in Chinese patients with MBC.
Methods:   In the present open-label, multicenter study, 210 patients with MBC were randomly assigned to receive nab -paclitaxel 260 mg/m² intravenously (i.v.) over 30 min every 3 weeks (q3w) with no premedication or sb-paclitaxel 175 mg/m² i.v. over 3 h q3w with standard premedication.
Results:   The overall response rate was 54 and 29% in patients treated with nab -paclitaxel and sb-paclitaxel, respectively ( P  < 0.001). nab -paclitaxel induced a higher response rate in patients who were <65 years old, patients who were receiving first-line therapy, patients who had no prior anthracycline therapy, patients who had ≤ or >3 metastatic lesions, and patients who had visceral disease. The progression-free survival (PFS) period was 7.6 months for nab -paclitaxel and 6.2 months for sb-paclitaxel ( P  = 0.118). Despite the 49% higher paclitaxel dose in patients receiving nab -paclitaxel compared with patients receiving sb-paclitaxel, the safety profile was similar in both treatment groups. The most common grades 3 and 4 adverse event (AE) in both arms was neutropenia. The most common grade 3 nonhematologic AE was peripheral neuropathy, and no grade 4 peripheral neuropathy was observed.
Conclusion:   Compared with sb-paclitaxel, nab -paclitaxel demonstrated superior efficacy, an acceptable safety profile, and a trend toward increased PFS in patients with MBC.