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Final Effectiveness and Safety Results of NABUCCO: Real-World Data From a Noninterventional, Prospective, Multicenter Study in 697 Patients With Metastatic Breast Cancer Treated With nab-Paclitaxel

2018; Elsevier BV; Volume: 18; Issue: 6 Linguagem: Inglês

10.1016/j.clbc.2018.07.010

1938-0666

Norbert Marschner, Christoph Salat, Ulrike Söling, Richard M. Hansen, Sina Grebhardt, Johanna Harde, Arnd Nusch, Karin Potthoff,

Colorectal Cancer Treatments and Studies

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.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.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.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.