Background: One of the most effective chemotherapies for metastatic breast cancer (MBC) is nab-paclitaxel (nab-P), which is approved for treatment of MBC after failure of first-line therapy and when anthracyclines are not indicated. Randomized clinical trials have shown high efficacy and acceptable toxicity. Real-world data of nab-P in MBC, however, are still limited.
Patients and methods: The prospective multicenter noninterventional study NABUCCO collected data on the routine treatment of patients with MBC receiving nab-P in 128 sites across Germany. The primary objective was time to progression. Secondary objectives were overall response rate, overall survival, safety, and quality of life.
Results: Between April 2012 and April 2015, a total of 705 patients with MBC at 128 active sites had been enrolled. A total of 697 patients had evaluable data with a median follow-up of 17.7 months. Median time to progression was 5.9 months (95% confidence interval, 5.6-6.4), overall response rate was 37.2%, and median overall survival was 15.6 months (95% confidence interval, 14.2-17.2). The results were similar in patients aged < 65 versus ≥ 65 years as well as in patients who received nab-P on a weekly or a triweekly schedule. The most frequently reported grade 3/4 adverse events were leukopenia (55, 7.9%), peripheral sensory neuropathy (30, 4.3%), and infections (29, 4.2%). Patients reported no apparent treatment-related impact on global quality of life.
Conclusion: The results of the NABUCCO study confirm the clinical trial outcomes and the favorable safety profile of nab-P in patients with metastatic breast cancer in a real-world setting.
Keywords: Advanced and metastatic breast cancer; Albumin-bound paclitaxel; Disease progression; Observational study; Outpatients.
Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.