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/m 2 intravenously (i.v.) over 30 min every 3 weeks (q3w) with no premedication or sb‐paclitaxel 175 mg/m 2 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.