Routine clinical use of nab-paclitaxel for advanced / metastatic breast cancer in Germany: Final results of the prospective observational study NABUCCO.

Abstract

e12555 Background: nab-Paclitaxel ( nab-P) is approved for treatment of metastatic breast cancer (MBC) on a 3-week schedule based on results from the pivotal trial in which nab-P 260 mg/m2 showed a significant increase of progression-free survival compared with solvent-based paclitaxel. However, numerous studies suggest a weekly schedule might be a more effective and less toxic option (Gradishar 2011). Data beyond clinical trials is limited. Here we report on prospective non-interventional real-world effectiveness and safety data. Methods: The NABUCCO study was designed to collect data on routine treatment of 700 patients (pts) with MBC in Germany. Primary objective was time to progression (TTP), secondary objectives were overall response rate (ORR), overall survival (OS), dosage scheme of nab-P and safety parameters. Descriptive statistics were used to analyze the data. TTP and OS were calculated using the Kaplan-Meier method. Results: Between 4/2012 and 4/2015 697 evaluable pts at 128 sites had been enrolled. Baseline characteristics: Median age 62.3 years (range 29.2-89.3), age ≥ 70 years n = 200 (28.7%), ECOG PS ≥ 2 n = 49 (7.0%), visceral metastases n = 511 (73.3%). The majority of pts received nab-P as 1st-line (n = 280, 40.2%) or 2nd-line (n = 169, 24.2%) chemotherapy. 194 pts (27.8%) received a 3-week schedule, 491 pts (70.4%) a weekly schedule, 12 pts (1.7%) other. In the overall population, median TTP was 5.9 months (95% CI 5.6-6.4), median OS 15.5 months (95 % CI 14.2-17.3). For pts ≥ 70 years median TTP was 6.9 months (95 % CI 5.7-8.5), median OS 14.8 months (95 % CI 12.6-18.8). In the 3-week group median TTP was 5.7 months (95 % CI 5.2-6.9), median OS 15.1 months (95 % CI 12.3-17.5). In the weekly group median TTP was 6.0 months (95 % CI 5.6-6.5), median OS 16.3 months (95 % CI 14.4-18.5). 34.3% of pts developed adverse events grade 3/4 including leukopenia (7.9%), peripheral sensory neuropathy (4.3%) and infections (4.2%). Further subgroup analyses will be presented. Conclusions: nab-P is an effective and safe therapy for pts with MBC in a real world setting. It is as effective in older women as it is in their younger counterparts. A weekly schedule could be a reasonable option.