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Though generic medications are commonly used, studies have raised the concern about their safety, compared to the branded drugs.
Objectives:
To compare febrile neutropenia (FN) resulting in hospital admission between the branded docetaxel (Taxotere®, Sanofi) and two generic formulations (docetaxel Ebewe and docetaxel Hospira) in breast cancer patients.
Study Design:
A retrospective study conducted at a 170-bed comprehensive cancer center.
Methods:
We utilized the pharmacy database and medical records to identify patients with breast cancer who had received docetaxel. Among those patients, we identified patients who had an admission diagnosis of FN and had received docetaxel within 14 days prior to their admission. We recorded the patients’ characteristics and outcomes, as well as the docetaxel brand, dose and cycle number. The incidence of FN was compared between the branded and the generic formulations using Chi-square tests.
Results:
During the study period, 2904 cycles of docetaxel were given for 814 patients (1519 cycles of Taxotere®, 811 cycles of docetaxel Hospira, and 574 cycles of docetaxel Ebewe). Among the cycles given, 130 cycles were associated with FN. The incidence of FN was significantly higher in the 100mg/m2 docetaxel Hospira group, compared to Taxotere® [35(8.3%) cycles vs. 36 (4.5%) cycles, P=0.006], but there was no significant difference between docetaxel Ebewe and Taxotere® [22 (6.6%) cycles vs. 36 (4.5%) cycles, P=0.136]. No significant difference was seen between the groups in the incidence of FN at the 75 mg/m2dose regimen. FN resolved in all except for two patients who died in the ICU. The mean hospital LOS for all cases of FN was 4.18 days ±2.14 (SD).
Conclusions:
There was a significant difference in the incidence of FN between Taxotere® and docetaxel Hospira in the 100mg/m2 dose regimen, but all cases in both groups resolved completely.