Abstract P1-15-02: Febrile neutropenia (FN) risk assessment and granulocyte colony-stimulating factor (G-CSF) guideline adherence in patients with breast cancer – results from a German prospective multicentre observational study (PROTECT)

Background: FN is a dose-limiting toxicity of chemotherapy which can affect patient (pt) outcomes. EORTC guidelines recommend G-CSF primary prophylaxis when the overall FN risk assessment is ≥20%. We evaluated risk assessment and guideline adherence (prophylaxis in high-risk pts) in clinical practice among breast cancer patients. Methods: Eligible pts were enrolled consecutively at centres selected based on experience and geographical spread. Key inclusion criteria were diagnosis of solid tumour or lymphoma, physician-assessed overall FN risk ≥10% (chemotherapy risk plus individual risk factors per EORTC guidelines), and planned primary (PPP) or secondary (PSP) prophylaxis with pegfilgrastim. Pegfilgrastim administered >3 days after chemotherapy completion was classified as therapeutic use. The primary objective was to describe the proportion of pts with an investigator-assessed overall FN risk of >20% or 10–20% receiving PPP or PSP. Secondary objectives included evaluating FN incidence and chemotherapy dose reductions/delays. Data from breast cancer patients only are reported, and prophylaxis in high-risk patients was determined to evaluate guideline adherence. Results: 1003 pts were enrolled from Nov 2007 to Sept 2010. Mean (±SD) age was 54.4 (±11.2) years, almost all pts (99%) were female. Treatment intent was deemed curative by the investigator in 91% of pts. The investigator-assessed FN risk was >20% in 505 (50%) pts and 10–20% in 414 (41%) pts. Despite eligibility criteria, 84 (8%) pts were assessed by investigators as Conclusion: Adherence to G-CSF guidelines, and reasons for differences between planned and administered prophylaxis warrants further investigation. Comparison of outcomes between prophylaxis groups should be interpreted with caution; however, FN incidence remained low with pegfilgrastim PP among breast cancer pts in German clinical practice. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P1-15-02.