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Colony Stimulating Factor Guidelines for Adult Patients
 

The Pharmacy and Therapeutics Committee has approved guidelines for the use of colony stimulating factors (CSFs).  These guidelines, created in concert with representatives from Adult Oncology and Bone Marrow Transplantation, are based on recommendations from the American Society of Clinical Oncology.  The guidelines are designed to inform practitioners about best practices when it comes to the use of CSFs, as well as dosage, administration and monitoring. 

University of Kentucky Chandler Medical Center
Colony Stimulating Factor Guidelines For Adult Patients 

Goals of Therapy

The primary goal of using G-CSF (filgrastim, Neupogen^®) or GM-CSF (sargramostim, Leukine^®) is to decrease neutropenic infections and the resulting morbidity and mortality.  A secondary goal is to use the colony stimulating factors (CSFs) to minimize overall costs of therapy.

Indications

Standard Chemotherapy

• Primary CSF Administration  - CSF use in all patients (given with first cycle of chemotherapy) is appropriate if the patient has ³ 40% chance of febrile neutropenia.  This may include the following categories (G-CSF or GM-CSF): 

- Previously radiated Hodgkin’s disease
- Patients with previous pelvic radiation
- AIDS-related lymphoma
- AML induction after blasts <5%, in patient >55 years of age

• Secondary CSF Administration - CSF use is indicated in subsequent cycles of chemotherapy if a patient has a documented neutropenic fever with the previous cycle of chemotherapy and a chemotherapy dose reduction is not appropriate.  The administration of CSFs is not recommended to afebrile neutropenic patients due to an apparent lack of benefit (G-CSF or GM-CSF). Diseases where dose intensity has been shown to be important include:

- Non-Hodgkin’s or Hodgkin’s lymphoma
- Breast cancer
- Germ cell tumors
- AML or ALL consolidation

High-Dose Chemotherapy

• Effective in the mobilization of peripheral blood progenitor cells (G-CSF alone, or GM-CSF + G-CSF)

• Autologous progenitor cell transplant (GM-CSF or G-CSF)

• Allogeneic bone marrow transplant (GM-CSF or G-CSF)

• Engraftment failure or delayed engraftment (GM-CSF or G-CSF)

Non-Chemotherapy Related Neutropenic Uses (G-CSF or GM-CSF)

• Chronic neutropenia, including cyclic, idiopathic, and congenital neutropenia

• Drug-induced neutropenia, when alternate drug therapy is not appropriate

• Aplastic anemia, in selected cases, where the ANC <500 cells/microliter and there is a history of a previous infection requiring antibiotics

• Myelodysplastic syndrome, in selected cases, when blasts <25% and there is a history of a previous infection requiring antibiotics

Unproven Uses (Not Recommended)

• Treatment of established febrile neutropenia (I.D. consult required)

Inappropriate Uses (Not Recommended)

• Neutropenia associated with the AIDS disease process

• Non-neutropenic infections

• Burns

• Extensive surgery

• Chemotherapy dose intensification outside of a clinical trial protocol

Initiation, Dose, Route, and Duration of Therapy

• CSFs should not be given concurrently, i.e. on the same day, with chemotherapy or radiotherapy.

• Initiating therapy 72 hours after chemotherapy may provide optimal neutrophil recovery.

• G-CSF is typically dosed at 5 mcg/kg; however, doses as small as 2 mcg/kg may be appropriate in some instances and doses >10 mcg/kg are not warranted.

• GM-CSF is typically dosed at 250 mcg/m².  Larger doses are unwarranted and can increase toxicity.

• Round the dose to the nearest vial size.  This has been used to enhance patient convenience and reduce costs without clinical detriment.

- G-CSF - patients weighing < 80 kg receive a single 300 mcg dose and patients weighing ³ 80 kg receive a 480 mcg dose.

- GM-CSF - patients with a BSA ≤ 1.3 m² receive 250 mcg/dose and patients with a BSA >1.3 m² receive 500 mcg/dose.

• Both agents can be administered subcutaneously.  Intravenous administration may also be used for both agents in selected patients as clinically indicated.

• Therapy should be discontinued when the absolute neutrophil count (ANC) is >1000 cells/microliter after expected chemotherapy-induced nadir.  Neutrophil counts may drop after stopping G-CSF by as much as 50%; however, counts do not typically drop after discontinuing GM-CSF.

       Monitoring

• Inpatients should have a CBC with differential performed at least once every 48 hours beginning at the time of expected neutrophil nadir.  The CSF should be discontinued according to the criteria listed above.

• Outpatients should have a CBC with differential performed during neutrophil nadir when seen in clinic for another indication.  Patients receiving G- or GM-CSF do not need a scheduled appointment for the sole purpose of checking a CBC with differential unless there is a need based on other indications, such as transfusion requirements.

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Approved by P&T Committee: 5/00 | Posted on: 8/02 | For Internal University of Kentucky Chandler Medical Center Use Only

Comments to Kelly Smith, Pharm.D., Last Modified: August 13, 2006
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