M. Reda (Dijon, France)
Centre Georges-François Leclerc (Dijon)Author Of 1 Presentation
- A. Schmitt (Dijon, France)
- M. Reda (Dijon, France)
- P. Macaire (Dijon, France)
- H. Bellio (Dijon, France)
- L. Uwer (Vandoeuvre les Nancy, CE, France)
- S. Ilie (Dijon, Se, France)
- V. Lorgis (Dijon, Ce, France)
- A. Hennequin (Dijon, France)
- S. Ladoire (Dijon, Ce, France)
- E. Rederstorff (Dijon, France)
- P. Fumoleau (Paris, Ce, France)
- N. Isambert (Dijon, Ce, France)
- N. Bonnin (Pierre Benite, CE, France)
- B. You (Pierre Benite, France)
- G. Freyer (Pierre Benite, CE, France)
- I. Desmoulins (Dijon, Ce, France)
147P - When a single G-CSF administration is better than longer duration: example in patients treated by eribulin
Abstract
Background
Granulocyte colony-stimulating factors (G-CSF) are commonly given to limit chemotherapy-induced neutropenia. However, for weekly chemotherapy such as eribulin, their administration schedules remain empirical. This pharmacokinetic/pharmacodynamic (PK/PD) study was conducted to establish the effect of different G-CSF regimens on neutropenia’s incidence for patients treated by eribulin, to propose an optimal G-CSF dosing schedule.
Methods
A semi-physiological population PK/PD neutropoiesis model was developed from absolute neutrophil counts (ANC) obtained in 87 cancer patients receiving eribulin for two cyccles. The structural model considered ANC dynamics, neutropenic effect of eribulin and the stimulating effect of G-CSF on neutrophils. Final model parameters were used to calculate the incidence of neutropenia following different G-CSF dosing schedules for 1’000 virtual subjects.
Results
The final model successfully described the ANC time-course for all patients. Simulations showed that a single G-CSF administration 48h after each eribulin injection reduced the risk of severe neutropenia from 29.7% to 5.2%. G-CSF administration after the 2nd eribulin injection was responsible for similar incidence of neutropenia compared to absence of administration.
Conclusions
The PK/PD model well described our population's ANC data. Simulations showed a single G-CSF administration 48 hours after the end of each chemotherapy seems to be the optimal schedule to reduce eribulin-induced neutropenia.
Clinical trial identification
Eudract 2015-001753-32, 2015/01/26.
Legal entity responsible for the study
Centre Georges-François Leclerc.
Funding
Eisai.
Disclosure
G. Freyer: Speaker Bureau/Expert testimony: Eisai. All other authors have declared no conflicts of interest.