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North Wales Cancer Network Guidelines for the use of colony stimulating factor (G-CSF) in adult patients with solid tumours 1. Background Recombinant human granulocyte colony stimulating factor (rhG-CSF) stimulates the production of neutrophils. It may reduce the duration of chemotherapy-induced neutropenia and reduce the incidence of associated sepsis. There is no evidence that it improves overall survival. Treatment with recombinant growth factors should only be prescribed by those experienced in their use. Filgrastim (unglycosylated rhG-CSF) and lenogastrim (glycosylated rhG-CSF) have similar actions. Pegfilgastrim is a polyethylene glycol-conjugated (“pegylated”) derivative of filgastrim. Pegylation increases the duration of filgastrim activity. 2. Indications 2.1 Primary prophylactic G-CSF administration The use of G-CSF for primary prophylaxis is not routinely recommended unless the expected risk of febrile neutropenia (FN) is ≥ 20% Primary prophylaxis may be justified in patients at higher risk of infectious complications due to special circumstances. E.g. 2.2 Elderly patients (aged 65 and over) Pre-existing neutropenia Extensive prior chemotherapy Precious irradiation to pelvis or other areas containing large amounts of bone marrow. A history of recurrent febrile neutropenia while receiving earlier chemotherapy or similar or lesser dose-intensity. Conditions that potentially enhance the risk of serious infection. (poor performance status, active infection, decreased immune function). Secondary prophylactic G-CSF administration Secondary prophylaxis is used to maintain dose intensity, particularly in lymphoma and adjuvant breast cancer treatment following an episode of sepsis or to prevent treatment delays. In the absence of clinical data, or other compelling reasons to maintain chemotherapy doseintensity, dose reductions should be considered following episodes of febrile neutropenia or prolonged neutropenia with previous cycles, rather than secondary prophylaxis with growth factors, particularly if chemotherapy is not being given with curative intent. 2.3 Afebrile patients Growth factors should not be routinely used for afebrile neutropenic patients. 2.4 Febrile patients G_CSF should not be routinely used as an adjunct to antibiotic therapy in the treatment of uncomplicated fever and neutropenia but should be considered in patients with poor prognostic factors e.g: Pneumonia Multi-organ dysfunction Hypotension Invasive fungal infection Profound neutropenia ANC < 0.1 x 109/L) Age > 65 or those with post treatment lymphopenia 2.5 G-CSF for patients receiving concurrent chemotherapy and irradiation G-CSF should be avoided in patients receiving concomitant chemotherapy and radiotherapy, particularly involving the mediastinum (ASCO guidelines in JCO 2000, and update in JCO 2006). In the absence of chemotherapy, in patients receiving radiotherapy to large areas, the therapeutic use of G-CSF may be considered if prolonged delays to secondary for neutropenia are expected. Step 1 Assess frequency of FN associated with planned chemotherapy regimen FN risk ≥ 20% FN risk 10-20% FN risk < 10% Step 2 Assess factors that increase the frequency/risk of FN High risk Age > 65 years Increased risk (level I and II evidence) Advanced disease History of prior FN No antibiotic prophylaxis, no G-CSF use Other factors (level III and IV evidence) Poor performance and /or nutritional status Female gender Haemoglobin <12g/dL Liver, renal or cardiovascular disease Step 3 Define the patient’s overall FN risk for planned chemotherapy regimen Overall FN risk ≥20% Prophylactic G-CSF recommended Overall FN risk < 20% G-CSF use not indicated EORTC guidelines for the use of G-CSF to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphomas and solid tumours European Journal of Cancer 42 (2006) 2433 - 2453 3. Preparations Filgrastim: Cytotoxic induced neutropenia – Dose is 0.5 million units (5 micrograms) per kg daily by subcutaneous injection started not less than 24 hours after cytotoxic chemotherapy, continued until the neutrophil count has recovered to the normal range. Lenograstim: Cytotoxic induced neutropenia – Dose is 19.2 million units (150 micrograms) per m2 daily, by subcutaneous injection, started not less than 24 hours after cytotoxic chemotherapy, continued until the neutrophil count has recovered to the normal range. Pegfilgrastim: Prevention of cytotoxic induced neutropenia – Dose 6mg (0.6ml) once only for each chemotherapy cycle, starting 24 hours after chemotherapy. Normally only considered in patients requiring extended protection from neutropenia, for instance if previous chemotherapy has resulted in extended use of G-CSF support, or for certain lung and lymphoma chemotherapy regimens known to cause prolonged neutropenic episodes. 4. Cautions Recombinant human growth factors are to be used with caution in patients with premalignant or malignant myeloid conditions. Full blood counts including differential white cell and platelet counts should be monitored. Treatment should be discontinued in patients who develop signs of pulmonary infiltration Spleen size should be monitored as splenic rupture following the administration of G-CSF has been reported. Recombinant human growth factors are not recommended in pregnancy or breastfeeding. 5. Side-effects Include gastro-intestinal disturbances, anorexia, headache, asthenia, fever, muscular-skeletal pain, bone pain, rash, alopecia, injection site reactions and leocytosis. Less frequent side effects include chest pain, hypersensitivity reactions and arthralgia. There have been reports of pulmonary infiltrates leading to acute respiratory distress syndrome. 6. References Ozer H.et al. 2000 update of recommendations for the use haemopoietic colony stimulating factors: evidence- based clinical practice guidelines. Journal of Clinical Oncology, 2000; 18: 3558-3585 Smith TJ. et al. 2006 update of recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline. Journal of Clinical Oncology, 2006; 24 (19): 31873205 Aapro MS. et al. EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphomas and solid tumours. 2006; 42: 2433-2453 British National Formulary no 53 (March 2007) 7. Approval Agreed by Haematology MDT: 27.09.07 To be reviewed by: 27.09.10 or sooner as required