Open-label, randomized study of pegfilgrastim vs. daily filgrastim as an adjunct to chemotherapy in elderly patients with non-Hodgkin's lymphoma

Andrew Grigg*, Philippe Solal-celigny, Peter Hoskin, Kerry Taylor, Andrew McMillan, Roswitha Forstpointer, Pamela Bacon, Jennifer Renwick, Wolfgang Hiddemann, Didier Blaise, Bertrand Coiffier, Johannes Drach, Edward Fitzsimons, Mathias Freund, Michael Green, Barry Hancock, Ulrich Jaeger, Georg Maschmeyer

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review


Pegfilgrastim is composed of the protein filgrastim to which a 20-kDa polyethylene glycol (PEG) is covalently bound at the N-terminal residue resulting in decreased renal clearance and increased plasma half-life compared with filgrastim. This open-label, randomized, phase 2 study compared two doses of single administration pegfilgrastim (60 and 100 μg/kg) with daily doses of filgrastim (5 μg/kg/day) or no cytokine treatment after standard CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) chemotherapy for non-Hodgkin's lymphoma in 50 elderly patients. The primary endpoint was the duration of grade 4 (severe) neutropenia (absolute neutrophil count <0.5 × 109/l) in cycle 1. Duration of grade 4 neutropenia in cycle 1 was 2.2 (SD 1.2), 1.5 (SD 1.1), 0.8 (1.2) and 5.0 (2.0) days for patients who received pegfilgrastim 60 μg/kg, pegfilgrastim 100 μg/kg, filgrastim 5 μg/kg and no cytokine, respectively. The baseline characteristics of the pegfilgrastim and filgrastim groups were imbalanced with increased bone-marrow involvement and prior therapy in the former. When the treatment groups were balanced for these risk factors, duration of grade 4 neutropenia was comparable with 2.0 and 3.0 vs. 0.6 and 0.5 days for pegfilgrastim 100 μg/kg and filgrastim patients with and without these risk factors, respectively. The incidence of febrile neutropenia (defined as ANC < 0.5 × 109/l and temperature > 38.2°C) was low (10% of patients). Pegfilgrastim was well tolerated with a safety profile similar to daily filgrastim. Once per chemotherapy cycle administration of pegfilgrastim was comparable to filgrastim in this clinical setting.

Original languageEnglish
Pages (from-to)1503-1508
Number of pages6
JournalLeukemia and Lymphoma
Issue number9
StatePublished - 1 Sep 2003
Externally publishedYes


  • Elderly
  • Febrile neutropenia
  • Grade 4 neutropenia
  • Non-Hodgkin's lymphoma
  • Phase II clinical trial


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