Clamp AR et al. – A limited pharmacovigilance study of long-term mortality patterns for non-Hodgkin's lymphoma (NHL) pts treated with granulocyte colony-stimulating factor (G-CSF) to maintain dose intensity lacks statistical power but reports long-term outcome data worthy of further investigation Methods
Study of long-term mortality patterns based on data from the first randomized controlled trial of G-CSF to maintain chemotherapy dose intensity in NHL pts
Pts: for 80 pts with aggressive NHL subtypes randomized to receive VAPEC-B chemotherapy or VAPEC-B+G-CSF
Review of data on 10-yr overall survival (OS), progression-free survival (PFS), freedom from progression (FFP), and incidence of second malignancies
Median follow-up: 15.7 yrs for surviving pts
Results
No significant differences for PFS or OS
Better 10-year FFP in G-CSF arm
Mortality: 11 deaths from causes unrelated to NHL or treatment in G-CSF arm vs 5 in controls
More deaths from second malignancies (4 vs 2) and cardiovascular causes (5 vs 0) in the G-CSF arm
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