Abstract
Background. Neutropenia is a common toxicity in patients (pts) with lymphoma (lymph) who receive myeloablative chemotherapy (CT). It frequently leads to CT delays and dose reductions, potentially compromising the clinical outcome. Granulocyte colonystimulating factors (G-CSFs) represented a major development in the prevention of this disorder. Current European and US guidelines (2006) recommend primary prophylaxis with G-CSF for patients at overall ≥20% risk of febrile neutropenia (FN) due to CT and patient-related factors.
Methods. A multicentre, prospective, observational study, in adult pts with lymph initiating a new CT regimen with at least 4 planned cycles, assessing the incidence of grade 3–4 neutropenia (G3–4N) [defined as absolute neutrophil count <1.0 × 109/L] over the first four cycles of CT regimens with high or intermediate FN risk (FN risk ≥20% or 10–20%, respectively).
Results. This interim analysis contains data from 270 consecutive lymph pts (300 pts per protocol) from 31 Spanish centres from November 2005 to November 2007. Pts were 53.3% male, median age 57.5 years (range: 19–85), 87.0% ECOG 0-1 and 60.9% III–IV stage (43.6% IV stage). 71.8% of lymph pts were treated with CHOP-based CT (83.0% R-CHOP). G-CSF was used in 83.9% of pts (76.8% primary prophylaxis (PP), 23.2% secondary prophylaxis (SP)). The G-CSF received was 49.1% filgrastim and 50.9% pegfilgrastim. Global incidence of G3-4N over the first four cycles was 39.9%. The G3-4N incidence was 39.6% in pts treated with pegfilgrastim while it was 52.3% in pts treated with filgrastim. Pts treated with PP had an FN incidence of 15.4% while the incidence was 22.0% in those receiving SP. Full dose on schedule (FDOS) [defined as ≤ 15% dose reduction and ≤ 3 days dose delay] was achieved in 65.1% of pts treated as PP and 60.8% of pts treated as SP.
Conclusion. This study of clinical practice suggests that current guideline recommendations on the use of G-CSF PP with CT are becoming widely adopted in Spain. In patients receiving CT with intermediate/high FN risk, G-CSF PP and pegfilgrastim prophylaxis seemed to reduce neutropenia events compared with SP and Filgrastim. PP also improved the delivery of CT at full dose on schedule.
Disclosures: Benedit:Amgen, S.A.: Employment, Equity Ownership. Garrido:Amgen, S.A.: Employment, Equity Ownership.
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