Effectiveness and tolerability of nab-paclitaxel in younger vs. elderly patients with metastatic HR-positive/HER2-negative breast cancer – results from the non-interventional, prospective study NABUCCO

Abstract Background There are only scarce data on treatment of elderly patients with nab-paclitaxel for metastatic breast cancer, especially from the real-world setting. Here we present data from the non-interventional study NABUCCO with special focus on taxane-induced peripheral neuropathy (TIPN) in younger and elderly patients. Patients and Methods A total of 407 patients with HR-positive/HER2-negative metastatic breast cancer has been enrolled between April 2012 and April 2015 onto the prospective, multi-center, non-interventional study NABUCCO. Details on effectiveness, tolerability and safety of nab-paclitaxel were evaluated for younger ( Results Neither median time to progression (TTP, younger 6.0 months, 95% CI 5.5-7.1; elderly 6.9 months, 95% CI 5.5-8.6) nor median overall survival (younger 16.4 months, 95% CI 14.2-18.1; elderly 14.5 months, 95% CI 11.9-17.4) differed by age group, also not in view of prior treatments. A multivariate regression model revealed that age did not significantly influence the TTP. TIPN was reported by 49.0% younger (44.3% CTCAE grade 1/2, 4.7% grade 3/4) and 45.8% elderly patients (41.1% CTCAE grade 1/2, 4.7% grade 3/4). The cumulative nab-paclitaxel dose did not correlate with the severity/grading of TIPN. Conclusion Treatment with nab-paclitaxel in first- or further-line of metastatic HR-positive/HER2-negative breast cancer resulted in similar effectiveness and safety, irrespective of age. Therefore, nab-paclitaxel is a valid treatment option for elderly and partially heavily pretreated patients. However, incidence of TIPN is high, influencing the patients’ quality of life. A close monitoring and awareness for early TIPN symptoms is warranted.