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)

Abstract

Abstract 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 <10% risk; reasons for inclusion of low-risk pts were not documented. Measured baseline patient risk factors were similar between PPP and PSP pts, and PPP and PSP pts were equally likely to receive chemotherapy with curative intent (92% vs 89%) and less likely to have received prior chemotherapy (11% vs 20%). 100 pts (10%) experienced FN, 43/680 (6%) in the PPP and 53/254 (21%) in the PSP group. 45 (4%) pts experienced FN-related dose reductions or dose delays, with 22/680 (3%) in the PPP group and 22/254 (9%) in the PSP group. In the subgroup of pts assessed as high FN risk, PPP was administered to fewer pts than planned and PSP to more pts than planned (Table). 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.