Comparing the Incidence of Febrile Neutropenia Resulting in Hospital Admission Between the Branded Docetaxel and the Generic Formulations

Abstract

Studies have raised concern about the safety of generic compared with branded drugs. Febrile neutropenia (FN) resulting in hospital admission was compared between the branded docetaxel (Taxotere®, Sanofi) and 2 generic formulations (docetaxel Ebewe and docetaxel Hospira) in patients with breast cancer. This was a retrospective study that included patients with breast cancer who received docetaxel between January 2012 and December 2014. Patients who had an admission diagnosis of FN and had received docetaxel within 14 days prior to admission were evaluated. The docetaxel brand and dose, patient characteristics, hospital length of stay, admission to the intensive care unit (ICU), and mortality were recorded. During the study period, 2904 cycles of docetaxel were given for 876 patients (1519 cycles of docetaxel Sanofi, 811 cycles of docetaxel Hospira, and 574 cycles of docetaxel Ebewe). Among the cycles given, 130 cycles were associated with FN that required hospital admission. The overall incidence of FN resulting in hospital admission was significantly higher in patients who had received docetaxel Hospira, compared with patients who had received docetaxel Sanofi (47[5.8%] cycles vs 53 [3.5%] cycles, P = .009), but there was no significant difference between docetaxel Ebewe and docetaxel Sanofi (30[5.2%] cycles vs 53 [3.5%] cycles, P = .069). All cases of FN resolved except for 1 patient who died in the ICU after receiving docetaxel Ebewe. There was a significant difference in the incidence of FN between docetaxel Sanofi and docetaxel Hospira, but all cases in both groups resolved completely.

Keywords: branded; breast cancer; docetaxel; febrile neutropenia; generic.