Randomized, multicenter, open-label study of pegfilgrastim compared with daily filgrastim after chemotherapy for lymphoma

Julie M. Vose, M. Crump, H. Lazarus, C. Emmanouilides, D. Schenkein, J. Moore, S. Frankel, I. Flinn, W. Lovelace, J. Hackett, B. C. Liang

Research output: Contribution to journalArticle

161 Citations (Scopus)

Abstract

Purpose: The primary objective was to assess the duration of grade 4 neutropenia (neutrophil count < 0.5 × 109/L) after one cycle of chemotherapy with etoposide, methyl-prednisolone, cisplatin, and cytarabine in patients randomly assigned to receive one dose of pegfilgrastim or daily filgrastim after chemotherapy. Febrile neutropenia, neutrophil profiles, time to neutrophil recovery, pharmacokinetics, and safety were also assessed. Patients and Methods: An open-label, randomized, phase II study was designed to compare the effects of a single subcutaneous injection of pegfilgrastim (sustained-duration filgrastim) 100 μg/kg per chemotherapy cycle (n = 33) with daily subcutaneous injections of filgrastim 5 μg/kg (n = 33) in patients receiving salvage chemotherapy for relapsed or refractory Hodgkin's or non-Hodgkin's lymphoma. Results: The incidence of grade 4 neutropenia in the pegfilgrastim and filgrastim groups was 69% and 68%, respectively. In addition, the mean duration of grade 4 neutropenia was similar in both groups (2.8 and 2.4 days, respectively). The results for the two groups were also not significantly different for febrile neutropenia, neutrophil profile, time to neutrophil recovery, or toxicity profile. A single subcutaneous injection of pegfilgrastim 100 μg/kg produced a sustained serum concentration relative to daily subcutaneous injections of filgrastim. Filgrastim-treated patients received a median of 11 injections per cycle. Conclusion: Pegfilgrastim was safe and well tolerated in this patient population. A single injection of pegfilgrastim per chemotherapy cycle provided neutrophil support with safety and efficacy similar to that provided by daily injections of filgrastim. Once-per-cycle administration of pegfilgrastim simplifies the management of neutropenia and may have important clinical benefits for patients and healthcare providers.

Original languageEnglish (US)
Pages (from-to)514-519
Number of pages6
JournalJournal of Clinical Oncology
Volume21
Issue number3
DOIs
StatePublished - Feb 1 2003

Fingerprint

Lymphoma
Neutrophils
Drug Therapy
Subcutaneous Injections
Neutropenia
Febrile Neutropenia
Injections
Safety
Cytarabine
Etoposide
Prednisolone
Filgrastim
pegfilgrastim
Hodgkin Disease
Health Personnel
Non-Hodgkin's Lymphoma
Cisplatin
Pharmacokinetics
Incidence
Serum

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Randomized, multicenter, open-label study of pegfilgrastim compared with daily filgrastim after chemotherapy for lymphoma. / Vose, Julie M.; Crump, M.; Lazarus, H.; Emmanouilides, C.; Schenkein, D.; Moore, J.; Frankel, S.; Flinn, I.; Lovelace, W.; Hackett, J.; Liang, B. C.

In: Journal of Clinical Oncology, Vol. 21, No. 3, 01.02.2003, p. 514-519.

Research output: Contribution to journalArticle

Vose, JM, Crump, M, Lazarus, H, Emmanouilides, C, Schenkein, D, Moore, J, Frankel, S, Flinn, I, Lovelace, W, Hackett, J & Liang, BC 2003, 'Randomized, multicenter, open-label study of pegfilgrastim compared with daily filgrastim after chemotherapy for lymphoma', Journal of Clinical Oncology, vol. 21, no. 3, pp. 514-519. https://doi.org/10.1200/JCO.2003.03.040
Vose, Julie M. ; Crump, M. ; Lazarus, H. ; Emmanouilides, C. ; Schenkein, D. ; Moore, J. ; Frankel, S. ; Flinn, I. ; Lovelace, W. ; Hackett, J. ; Liang, B. C. / Randomized, multicenter, open-label study of pegfilgrastim compared with daily filgrastim after chemotherapy for lymphoma. In: Journal of Clinical Oncology. 2003 ; Vol. 21, No. 3. pp. 514-519.
@article{ba58dc29762e4bd19f4e27572f8f0394,
title = "Randomized, multicenter, open-label study of pegfilgrastim compared with daily filgrastim after chemotherapy for lymphoma",
abstract = "Purpose: The primary objective was to assess the duration of grade 4 neutropenia (neutrophil count < 0.5 × 109/L) after one cycle of chemotherapy with etoposide, methyl-prednisolone, cisplatin, and cytarabine in patients randomly assigned to receive one dose of pegfilgrastim or daily filgrastim after chemotherapy. Febrile neutropenia, neutrophil profiles, time to neutrophil recovery, pharmacokinetics, and safety were also assessed. Patients and Methods: An open-label, randomized, phase II study was designed to compare the effects of a single subcutaneous injection of pegfilgrastim (sustained-duration filgrastim) 100 μg/kg per chemotherapy cycle (n = 33) with daily subcutaneous injections of filgrastim 5 μg/kg (n = 33) in patients receiving salvage chemotherapy for relapsed or refractory Hodgkin's or non-Hodgkin's lymphoma. Results: The incidence of grade 4 neutropenia in the pegfilgrastim and filgrastim groups was 69{\%} and 68{\%}, respectively. In addition, the mean duration of grade 4 neutropenia was similar in both groups (2.8 and 2.4 days, respectively). The results for the two groups were also not significantly different for febrile neutropenia, neutrophil profile, time to neutrophil recovery, or toxicity profile. A single subcutaneous injection of pegfilgrastim 100 μg/kg produced a sustained serum concentration relative to daily subcutaneous injections of filgrastim. Filgrastim-treated patients received a median of 11 injections per cycle. Conclusion: Pegfilgrastim was safe and well tolerated in this patient population. A single injection of pegfilgrastim per chemotherapy cycle provided neutrophil support with safety and efficacy similar to that provided by daily injections of filgrastim. Once-per-cycle administration of pegfilgrastim simplifies the management of neutropenia and may have important clinical benefits for patients and healthcare providers.",
author = "Vose, {Julie M.} and M. Crump and H. Lazarus and C. Emmanouilides and D. Schenkein and J. Moore and S. Frankel and I. Flinn and W. Lovelace and J. Hackett and Liang, {B. C.}",
year = "2003",
month = "2",
day = "1",
doi = "10.1200/JCO.2003.03.040",
language = "English (US)",
volume = "21",
pages = "514--519",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "3",

}

TY - JOUR

T1 - Randomized, multicenter, open-label study of pegfilgrastim compared with daily filgrastim after chemotherapy for lymphoma

AU - Vose, Julie M.

AU - Crump, M.

AU - Lazarus, H.

AU - Emmanouilides, C.

AU - Schenkein, D.

AU - Moore, J.

AU - Frankel, S.

AU - Flinn, I.

AU - Lovelace, W.

AU - Hackett, J.

AU - Liang, B. C.

PY - 2003/2/1

Y1 - 2003/2/1

N2 - Purpose: The primary objective was to assess the duration of grade 4 neutropenia (neutrophil count < 0.5 × 109/L) after one cycle of chemotherapy with etoposide, methyl-prednisolone, cisplatin, and cytarabine in patients randomly assigned to receive one dose of pegfilgrastim or daily filgrastim after chemotherapy. Febrile neutropenia, neutrophil profiles, time to neutrophil recovery, pharmacokinetics, and safety were also assessed. Patients and Methods: An open-label, randomized, phase II study was designed to compare the effects of a single subcutaneous injection of pegfilgrastim (sustained-duration filgrastim) 100 μg/kg per chemotherapy cycle (n = 33) with daily subcutaneous injections of filgrastim 5 μg/kg (n = 33) in patients receiving salvage chemotherapy for relapsed or refractory Hodgkin's or non-Hodgkin's lymphoma. Results: The incidence of grade 4 neutropenia in the pegfilgrastim and filgrastim groups was 69% and 68%, respectively. In addition, the mean duration of grade 4 neutropenia was similar in both groups (2.8 and 2.4 days, respectively). The results for the two groups were also not significantly different for febrile neutropenia, neutrophil profile, time to neutrophil recovery, or toxicity profile. A single subcutaneous injection of pegfilgrastim 100 μg/kg produced a sustained serum concentration relative to daily subcutaneous injections of filgrastim. Filgrastim-treated patients received a median of 11 injections per cycle. Conclusion: Pegfilgrastim was safe and well tolerated in this patient population. A single injection of pegfilgrastim per chemotherapy cycle provided neutrophil support with safety and efficacy similar to that provided by daily injections of filgrastim. Once-per-cycle administration of pegfilgrastim simplifies the management of neutropenia and may have important clinical benefits for patients and healthcare providers.

AB - Purpose: The primary objective was to assess the duration of grade 4 neutropenia (neutrophil count < 0.5 × 109/L) after one cycle of chemotherapy with etoposide, methyl-prednisolone, cisplatin, and cytarabine in patients randomly assigned to receive one dose of pegfilgrastim or daily filgrastim after chemotherapy. Febrile neutropenia, neutrophil profiles, time to neutrophil recovery, pharmacokinetics, and safety were also assessed. Patients and Methods: An open-label, randomized, phase II study was designed to compare the effects of a single subcutaneous injection of pegfilgrastim (sustained-duration filgrastim) 100 μg/kg per chemotherapy cycle (n = 33) with daily subcutaneous injections of filgrastim 5 μg/kg (n = 33) in patients receiving salvage chemotherapy for relapsed or refractory Hodgkin's or non-Hodgkin's lymphoma. Results: The incidence of grade 4 neutropenia in the pegfilgrastim and filgrastim groups was 69% and 68%, respectively. In addition, the mean duration of grade 4 neutropenia was similar in both groups (2.8 and 2.4 days, respectively). The results for the two groups were also not significantly different for febrile neutropenia, neutrophil profile, time to neutrophil recovery, or toxicity profile. A single subcutaneous injection of pegfilgrastim 100 μg/kg produced a sustained serum concentration relative to daily subcutaneous injections of filgrastim. Filgrastim-treated patients received a median of 11 injections per cycle. Conclusion: Pegfilgrastim was safe and well tolerated in this patient population. A single injection of pegfilgrastim per chemotherapy cycle provided neutrophil support with safety and efficacy similar to that provided by daily injections of filgrastim. Once-per-cycle administration of pegfilgrastim simplifies the management of neutropenia and may have important clinical benefits for patients and healthcare providers.

UR - http://www.scopus.com/inward/record.url?scp=0037313173&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0037313173&partnerID=8YFLogxK

U2 - 10.1200/JCO.2003.03.040

DO - 10.1200/JCO.2003.03.040

M3 - Article

C2 - 12560443

AN - SCOPUS:0037313173

VL - 21

SP - 514

EP - 519

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 3

ER -