Randomized comparison of pegfilgrastim day 4 versus day 2 for the prevention of chemotherapy-induced leukocytopenia.

Abstract

BACKGROUND:

To study the effects of deferring pegfilgrastim until day 4 on the reduction of chemotherapy-induced leukocytopenia.

PATIENTS AND METHODS:

Patients of age 61-80 years with aggressive lymphoma were randomly assigned to receive 6 mg pegfilgrastim on day 2 or 4 of a 2-week chemotherapy regimen (R-CHOP-14).

RESULTS:

Two hundred and ninety-two and 313 chemotherapy cycles were evaluable in 103 patients. Post-nadir pegfilgrastim serum levels were higher after day 4 than after day 2 application. This was associated with an attenuated leukocyte nadir after day 4 pegfilgrastim and there were fewer days with leukocytes <2 × 10(3)/mm(3) compared with day 2 pegfilgrastim. Grade 3 and 4 leukocytopenias (70% versus 43.3%; P < 0.001) and grade 4-only leukocytopenias (47% versus 20.5%; P < 0.001) were more frequent after day 2 pegfilgrastim. There were more chemotherapy cycles with grade 3 and 4 infections after day 2 than day 4 pegfilgrastim (9.4% versus 6.0%; P = 0.118). Interventional antibiotics were given more often after day 2 than after day 4 pegfilgrastim (30.7% versus 21.9% of cycles; P = 0.008). There were five deaths during leukocytopenia after day 2 and none after day 4 pegfilgrastim (P = 0.027).

CONCLUSIONS:

Administration of pegfilgrastim on day 4 was more effective in reducing severe leukocytopenias and resulted in fewer deaths during leukocytopenia. Pegfilgrastim should be given on day 4 to better exploit its myeloprotective potential.

• Authors: C Zwick, F Hartmann, S Zeynalova, V Pöschel, C Nickenig, M Reiser, E Lengfelder, N Peter, G Schlimok, J Schubert, N Schmitz, M Loeffler, M Pfreundschuh, German High-Grade Non-Hodgkin Lymphoma Study Group
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 22 Issue 8 Pg. 1872-7 (Aug 2011) ISSN: 1569-8041 [Electronic] England
• PMID: 21292644 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Recombinant Proteins
• Granulocyte Colony-Stimulating Factor
• pegfilgrastim
• Polyethylene Glycols
• Vincristine
• Doxorubicin
• Cyclophosphamide
• Filgrastim
• Prednisone

Topics

• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, therapeutic use)
• Cyclophosphamide (administration & dosage, therapeutic use)
• Dose-Response Relationship, Drug
• Doxorubicin (administration & dosage, therapeutic use)
• Drug-Related Side Effects and Adverse Reactions
• Female
• Filgrastim
• Granulocyte Colony-Stimulating Factor (administration & dosage, adverse effects, blood)
• Humans
• Leukocyte Count
• Leukopenia (chemically induced, mortality, prevention & control)
• Lymphoma (drug therapy)
• Male
• Middle Aged
• Neoplasm Staging
• Polyethylene Glycols
• Prednisone (administration & dosage, therapeutic use)
• Recombinant Proteins (administration & dosage, adverse effects, blood)
• Vincristine (administration & dosage, therapeutic use)