Journal Article
. 1998 Dec; 16(12):3874-9.
doi: 10.1200/JCO.1998.16.12.3874.

Low-dose versus standard-dose lenograstim prophylaxis after chemotherapy: a randomized, crossover comparison

G C Toner 1 J D Shapiro  C R Laidlaw  D Rischin  M J Millward  M Wolf  H Januszewicz  S V Mitchell  A C Curran  J P Matthews  J F Bishop  
Affiliations
  • PMID: 9850033
  •     6 citations

Abstract

Purpose: Granulocyte colony-stimulating factor (G-CSF) administered prophylactically after chemotherapy reduces the duration and severity of neutropenia. This randomized crossover study was designed to assess whether a lower dose of G-CSF is as effective as a standard dose of 5 microg/kg daily.

Patients And Methods: Patients who received standard-dose chemotherapy regimens expected to cause neutropenia received G-CSF (lenograstim) that started the day after chemotherapy for 14 days or until the absolute neutrophil count (ANC) recovered to greater than 10 x 10(9)/L. The lenograstim dose was randomly allocated to be 2 or 5 microg/kg daily in the first cycle of chemotherapy and crossed over to the alternate dose for the second cycle. The study was designed to accrue 40 assessable patients to provide a power of 80% to detect a difference in duration of neutropenia of 1 day. Fifty-two patients were randomized to treatment and 43 patients completed two cycles of identical chemotherapy.

Results: There was little neutropenia irrespective of the dose used. Twenty-three patients (53%) had no grade III or IV neutropenia and 30 patients (70%) had no grade IV neutropenia. Crossover trial methodology was used to assess the difference in outcome caused by the lower dose compared with the standard dose (estimated treatment effect). There was no significant difference in the measures of neutropenia, hospitalization, or other clinical outcomes. The 95% confidence interval (one-sided) for the additional duration of neutropenia caused by the lower dose of lenograstim was 0.43 days or less for grade III or IV neutropenia and 0.34 days or less for grade IV neutropenia.

Conclusion: Lenograstim 2 microg/kg provides similar protection to 5 microg/kg against neutropenia that complicates standard-dose chemotherapy. The use of a lower dose has important implications for the cost-effectiveness of prophylactic G-CSF therapy.

Lenograstim: an update of its pharmacological properties and use in chemotherapy-induced neutropenia and related clinical settings.
C J Dunn, K L Goa.
Drugs, 2000 Apr 25; 59(3). PMID: 10776839
Review.
Are prophylactic haematopoietic growth factors of value in the management of patients with aggressive non-Hodgkin's lymphoma?
A Hackshaw, J Sweetenham, A Knight.
Br J Cancer, 2004 Apr 01; 90(7). PMID: 15054445    Free PMC article.
Randomized trial of 2 dosages of prophylactic granulocyte-colony-stimulating factor after induction chemotherapy in pediatric acute myeloid leukemia.
Hiroto Inaba, Xueyuan Cao, +4 authors, Bassem I Razzouk.
Cancer, 2011 Mar 08; 117(6). PMID: 21381017    Free PMC article.
Lenograstim: a review of its use in chemotherapy-induced neutropenia, for acceleration of neutrophil recovery following haematopoietic stem cell transplantation and in peripheral blood stem cell mobilization.
Gillian M Keating.
Drugs, 2011 Apr 21; 71(6). PMID: 21504247
Review.
A way forward on the medically appropriate use of white cell growth factors.
Thomas J Smith, Bruce E Hillner.
J Clin Oncol, 2012 Mar 01; 30(14). PMID: 22370327    Free PMC article.
Review.
Austrian Arbeitsgemeinschaft für Gynäkologische Onkologie (AGO) guideline for prophylaxis with granulocyte colony-stimulating factors (G-CSF) in gynecologic malignancies, including breast cancer.
Edgar Petru, Alain Gustave Zeimet, +9 authors, Austrian Arbeitsgemeinschaft für Gynäkologische Onkologie (AGO).
Wien Klin Wochenschr, 2012 Jun 29; 124(11-12). PMID: 22739650