Abstract
Aim
Pegfilgrastim (Neulasta®) has proven efficacy as supportive therapy in a variety of chemotherapy regimens, but has not been studied in dose intensive, rapidly cycling regimens such as hyper-CVAD. We examined whether pegfilgrastim leads to similar kinetics of neutrophil recovery as daily G-CSF.
Methods
Using retrospective analysis, patients receiving pegfilgrastim were matched with controls (G-CSF) for cycle of chemotherapy, prior chemotherapy, dose of cytarabine received, age (<60 or >60), diagnosis (ALL or NHL) and bone marrow involvement. The primary endpoint was duration of grade IV neutropenia (ANC <500/ul). Secondary endpoints included time to neutrophil recovery, incidence of febrile neutropenia, positive blood cultures and delay in subsequent chemotherapy.
Results
Between 01/1999 – 06/2005 we identified 124 pegfilgrastim supported cycles in 43 patients. Cases were successfully matched to 124 G-CSF supported cycles from 38 controls. There were no significant differences between cases and controls with regards to prior chemotherapy, age, sex, cytarabine dose, diagnosis or bone marrow involvement. The median duration of grade IV neutropenia was 4 days in both groups (p =0.55).
| . | Pegfilgrastim (95% CI) . | G-CSF controls (95% CI) . | P value . |
|---|---|---|---|
| Grade IV neutropenia | |||
| - All cycles | 4 days (0–11) | 4 days (0–10) | 0.55 |
| - A cycles | 2 days (0–7) | 2 days (0–6) | 0.65 |
| - B cycles | 6 days (2–12) | 6 days (0–10) | 0.70 |
| Time to ANC >500/ul | 13 days (10–19) | 14 days (8–18) | 0.75 |
| Time to ANC >2000/ul | 14 days (11–29) | 14.5 days (9–22) | 0.27 |
| Febrile Neutropenia | 29% | 38% | 0.16 |
| Positive Blood Cultures | 11% | 12% | 0.85 |
| Delay in next cycle | 44% | 47% | 0.75 |
| . | Pegfilgrastim (95% CI) . | G-CSF controls (95% CI) . | P value . |
|---|---|---|---|
| Grade IV neutropenia | |||
| - All cycles | 4 days (0–11) | 4 days (0–10) | 0.55 |
| - A cycles | 2 days (0–7) | 2 days (0–6) | 0.65 |
| - B cycles | 6 days (2–12) | 6 days (0–10) | 0.70 |
| Time to ANC >500/ul | 13 days (10–19) | 14 days (8–18) | 0.75 |
| Time to ANC >2000/ul | 14 days (11–29) | 14.5 days (9–22) | 0.27 |
| Febrile Neutropenia | 29% | 38% | 0.16 |
| Positive Blood Cultures | 11% | 12% | 0.85 |
| Delay in next cycle | 44% | 47% | 0.75 |
Conclusions
A single dose of pegfilgrastim is as effective as daily G-CSF for supporting the hyper-CVAD chemotherapy regimen.
Author notes
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