Guidelines for the use of G-CSF in the Department of Oncology

Transcription

1 Guidelines for the use of G-CSF in the Department of Oncology Full Title of Guideline: Author (include and role): Division & Speciality: Scope (Target audience, state if Trust wide): Review date (when this version goes out of date): Explicit definition of patient group to which it applies (e.g. inclusion and exclusion criteria, diagnosis): Changes from previous version (not applicable if this is a new guideline, enter below if extensive): Summary of evidence base this guideline has been created from: Guidelines for the use of G-CSF in the Department of Oncology Ian Purcell, Specialist Pharmacist, Oncology and Radiotherapy Ian.Purcell@nuh.nhs.uk Lisa Mazzei, Senior Clinical Pharmacist Lisa.Mazzei2@nuh.nhs.uk Oncology, CAS directorate. Oncology medical staff Oncology clinical areas (wards, chemotherapy clinic, research team) Pharmacy Specialist Receiving Unit, City Campus King s Mill Hospital 30 st September 2020 Adult and Teenage Oncology patients receiving cytotoxic chemotherapy under the care of an adult oncologist at City Campus. (Please note there are separate guidelines for the treatment of haematological malignancies.) Primary prophylaxis regimes updated to reflect current practice. Brands available in NUH reviewed. Dosing guidance updated. Guidelines for the use of G-CSF in the department of clinical oncology. V3.0. September Guidelines for the use of G-CSF in the department of clinical oncology. V2.0. February Guidelines for the use of G-CSF in the department of clinical oncology. V1.0. February 2006 NICE (2012). Neutropenic sepsis: prevention and management of neutropenic sepsis in cancer patients. September Crawford J et al. Hematopoietic growth factors: ESMO Clinical Practice Guidelines for the applications. Ann Oncol 2010, 21 (suppl 5): East Midlands Cancer Network Guideline for G-CSF use in adult patients. October 2009 Smith T J et al Update of Recommendations for the Use of White Blood Cell Growth Factors: An Evidence- Based Clinical Practice Guideline. J Clin Oncol 2006, 24(19): Ozer H et al. ASCO 2000 update of recommendations for the use of haematopoietic colony stimulating factors: Page 1 of 7

2 Evidence based, clinical practice guidelines. J Clin Oncol 2000, 18, (Oct 15 th ): Nemunaitis J. A comparative review of colony stimulating factors Drugs 1997 Nov; 54(5): Croockewit et al. A European perspective on haematopoietic growth factors in haemato-oncology: Report of an expert meeting of the EORTC. Eur J Cancer 1997, 33: Summary of product characteristics for individual medicines Recommended best practice based on clinical experience of guideline developers This guideline has been registered with the trust. However, clinical guidelines are guidelines only. The interpretation and application of clinical guidelines will remain the responsibility of the individual clinician. If in doubt contact a senior colleague or expert. Caution is advised when using guidelines after the review date or outside of the Trust. Page 2 of 7

3 There are currently four preparations of GCSF available for use in adult oncology patients at Nottingham University Hospitals NHS Trust, Nivestim, Zarzio, Accofil and Granocyte (lenograstim). This guideline relates to the use of Nivestim, Zarzio and Accofil. Granocyte (lenograstim) should only be used within oncology as part of a specific protocol for the mobilisation of stem cells; consult clinical haematology for prescribing advice. Note: Nivestim Zarzio and Accofil are therapeutically equivalent biosimilar filgrastim brands. Nivestim is the preferred brand of choice on the NUH formularly that is routinely used and stocked at NUH. If stock shortages of Nivestim occur Zarzio and Accofil would be used in the interim. Pharmacists will endorse TTO prescriptions as necessary if this occurs. It is essential that G-CSF prescribing is by brand to ensure that the correct preparation is selected and given. 1. LICENSED INDICATIONS RELEVANT TO ONCOLOGY i. Reduction in the duration of neutropenia and incidence of febrile neutropenia in patients receiving cytotoxic chemotherapy for malignancy. 2. INDICATIONS FOR PRESCRIBING GCSF IN THE DEPARTMENT OF CLINICAL ONCOLOGY i. According to an approved clinical trial protocol. ii. GCSF is only indicated for primary prophylaxis in regimens which have been approved via the chemotherapy strategy group (see below), or discussed on an individual basis with the head of service. For primary prophylaxis: in patients with SCLC (limited and extensive stage) in patients with small-cell cancer of any origin in adjuvant or neo-adjuvant breast cancer patients treated with the FEC-100, EC90 and docetaxel mg/m 2 chemotherapy regimens. in teratoma patients treated with the T-BEP, VbIP or CBOP-BEP chemotherapy regimens in NHL patients treated with CHOP chemotherapy in sarcoma patients treated with intensive chemotherapy regimens. Page 3 of 7

4 iii. For secondary prophylaxis in patients on chemotherapy protocols prescribed with the intention to cure (i.e. FEC or docetaxel in breast cancer and CHOP or MCOP in Non-Hodgkins Lymphoma), where this intention is compromised by the inability to deliver chemotherapy on schedule because of severe or prolonged neutropenia and/or severe neutropenic sepsis. iv. In the palliative setting, dose reduction of chemotherapy should be the primary therapeutic option as no published regimens to date have demonstrated disease-free or overall survival benefits when maintaining full dose chemotherapy with the aid of GCSF. However, GSCF may be used as secondary prophylaxis in these patients if there are persisting long delays or repeated episodes of febrile neutropenia, despite reductions in chemotherapy doses. v. GCSF is not licensed as adjunct therapy for the treatment of uncomplicated neutropenic sepsis and therefore should not be used in this setting. However, use may be appropriate for established neutropenic sepsis with at least two factors predictive of poor clinical outcome, such as neutrophil count less than 0.1 x 10 9 /L with fever for more than 10 days, uncontrolled primary disease, pneumonia, hypotension, multi-organ dysfunction and invasive fungal infection. The benefit of GCSF in these situations has not been proven to affect survival, but does reduce hospital stay. vi. Pegfilgrastim (Neulasta ) should not be prescribed in oncology patients unless as part of a clinical trial where it is supplied by the trial company or costs are re-imbursed, as it is not funded through NHS England. 3. CONTRA-INDICATION AND PRECAUTIONS i. Hypersensitivity to the product or constituents. ii. iii. GCSF should not be used to increase the dose intensity of established cytotoxic regimes (unless within a clinical trial protocol). It should be used to maintain dose intensity. DO NOT ADMINISTER GCSF within 24 hours of cytotoxics unless otherwise specified in the protocol (STOP GCSF at least 24 hours before, and start a minimum of 24 hours after chemotherapy). This includes days 8 and 15 bleomycin in BEP. There is preliminary evidence to suggest that the severity of neutropenia may be Page 4 of 7

5 increased if GCSF is given on the same day as cytotoxics. iv. GCSF does not increase platelet or erythrocyte counts. v. Primary prophylaxis with GCSF is not indicated during chemoradiotherapy to the chest due to an increased rate of bone marrow suppression which has been associated with an increased risk of complications and death. 4. PRESENTATIONS Preparation NIVESTIM Filgrastim Presentation Stocked 300 microgram/0.5ml Prefilled syringe (30MU) 480 microgram/0.5ml Prefilled syringe (48MU) Available but not routinely stocked ZARZIO * Filgrastim 300 micrograms/0.5ml Prefilled syringe (30MU) 480 microgram/0.5ml Pre-filled syringe (48MU) ACCOFIL * Filgrastim 480 microgram/0.5ml Pre-filled syringe (48MU) Prescribe using brand name, i.e. as Filgrastim (Nivestim ) to ensure the correct product is dispensed and administered. * These brands would only be used in the event of a supply problem with Nivestim. 5. DOSE AND ADMINISTRATION i. Refer to relevant clinical trial/chemotherapy protocol for dose, presentation and duration of therapy. ii. ALWAYS INDICATE ON THE PRESCRIPTION IF THE PATIENT IS IN A CLINICAL TRIAL (pharmaceutical company, research body or Page 5 of 7

6 in-house) with the words TRIAL SUPPLY, so that pharmacy dispense from trial stock. Otherwise normal stock is dispensed and charged to the directorate. iii. Treatment period is variable and should be considered protocol specific to cover the expected nadir. Treatment should not be started within 24 hours after the last dose of cytotoxic. iv. Nivestim - The usual dose is 5 microgram/kg/day subcutaneously, usually rounded up or down to 300 microgram daily for 5-10 days, depending on chemotherapy regimen. Patients above 70kg may require dosing at 5 microgram/kg/day; this should be discussed with the consultant. Patients who have a body surface area >1.8 m 2 may receive a dose of 480 micrograms at consultant request. v. Following termination of Nivestim circulating neutrophil counts decrease by 50% within 1-2 days and to normal levels within 1-7 days. 6. ADVERSE EFFECTS See summary of product characteristics for full details. The most common side effects are: i. Musculoskeletal pain (approximately 10% of patients, 3% severe). Paracetamol is usually effective. ii. Reaction at injection site. The site of injection should be changed each day. iii. Reversible elevation of liver enzymes, LDH, and serum uric acid. iv. Dysuria. v. Transient decrease in blood pressure. 7. STORAGE STORE ALL NIVESTIM and ZARZIO SYRINGES IN THE REFRIGERATOR (2-8 O C). Page 6 of 7

7 8. MISCELLANEOUS Patient information sheets are included in the injection packs. Page 7 of 7