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

Abstract

The noninterventional study NABUCCO evaluated effectiveness and safety of nab-paclitaxel in 697 patients with metastatic breast cancer (MBC) treated in routine care. The results confirm the clinical trial outcomes, the favorable benefiterisk profile of nab-paclitaxel, and the sustained global quality of life in patients with MBC in a real-world setting. 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.

A Systematic Review and Meta-Analysis of Nab-Paclitaxel Mono-Chemotherapy for Metastatic Breast Cancer.

“…However, according to our analysis, no matter which nab-paclitaxel schedule (weekly, biweekly or triweekly) was chosen, the nab-paclitaxel efficacy outcomes were not affected. The recently published NABUCCO study also showed no differences in terms of clinical activity of nab-paclitaxel according to the schedule used [10]. This finding is of particular interest for the clinical practice.…”

“…Gradishar WJ also demonstrated better disease control for nab-paclitaxel qw 3/4 regimens (100 mg/m2 and 150 mg/m2) versus a q3w regimen as monotherapy, and nab-paclitaxel at 150 mg/m2 qw 3/4 resulted in a 33.8 months OS longer than historically achieved with single-agent taxanes therapy in MBC [16]. However, in the NABUCCO study, efficacy superiority with respect to better tumor control and longer survival outcomes had not been obtained in the weekly nab-paclitaxel group [10]. Irrespective of the survival outcomes, weekly nab-paclitaxel regimen seemed to increase paclitaxel-related toxicity.…”

“…We ultimately identified 22 independent studies published between March 2005 and March 2020 [9,10,12,13,16,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37]. A flow chart representing selection of studies is shown in Figure 1 Table 1.…”

“…Since Ibrahim NK firstly reported 300 mg/m2 nab-paclitaxel monotherapy in a triweekly style resulting in a 48% overall response rate (ORR) for 63 MBC patients in a phase II trial [9], various clinical trials and real-life studies tried to explore the safety and activity of nab-paclitaxel in treating MBC. Most recently, in the NABUCCO observational study Marschner N reported the nab-paclitaxel monotherapy could offer a 37.2% ORR, a 68.3% clinical benefit rate (CBR), a 5.9 months of median time to progression (TTP) and a 15.6 months of median overall survival (OS) with lower (5%) grade 3/4 treatment-related adverse events (TRAEs) in 697 MBC patients, [10]. Head-to-head clinical comparisons between nab-paclitaxel and conventional taxanes were not lacking, with two pivotal phase II/III clinical trials reported by Gradishar WJ [11,12], coincidentally demonstrated superior efficacy and safety of nab-paclitaxel compared with paclitaxel (175 mg/m2, q3w) or docetaxel (100 mg/m2, q3w), with a statistically higher ORR and clinically significant prolongation of progression-free survival (PFS) with shorter infusion schedules (30 minutes) and no premedication.…”

A systematic review and meta-analysis of nab-paclitaxel mono-chemotherapy for metastatic breast cancer

“…Since Ibrahim NK rstly reported 300 mg/m2 nab-paclitaxel monotherapy in a triweekly style resulting in a 48% overall response rate (ORR) for 63 MBC patients in a phase II trial [9], various clinical trials and real-life studies tried to explore the safety and activity of nab-paclitaxel in treating MBC. Most recently, in the NABUCCO observational study Marschner N reported the nab-paclitaxel monotherapy could offer a 37.2% ORR, a 68.3% clinical bene t rate (CBR), a 5.9 months of median time to progression (TTP) and a 15.6 months of median overall survival (OS) with lower (5%) grade 3/4 treatment-related adverse events (TRAEs) in 697 MBC patients [10]. Head-to-head clinical comparisons between nab-paclitaxel and conventional taxanes were not lacking, with two pivotal phase II/III clinical trials reported by Gradishar WJ [11,12], coincidentally demonstrated superior e cacy and safety of nab-paclitaxel compared with paclitaxel (175 mg/m2, q3w) or docetaxel (100 mg/m2, q3w), with a statistically higher ORR and clinically signi cant prolongation of progression-free survival (PFS) with shorter infusion schedules (30 minutes) and no premedication.…”