Guideline for the Use of Granulocyte Colony Stimulating Factor (G-CSF) for Adults in Oncology and Haematology

Transcription

1 (G-CSF) for Adults in Oncology and Haematology For Use in: By: Oncology and Haematology Inpatients and Outpatients Oncologists and Haematologists For: Division responsible for document: Key words: Name and job title of document author: Name and job title of document author s Line Manager: Supported by: Assessed and approved by the: Date of approval: 26/04/2017 Ratified by or reported as approved to (if applicable): Cancer patients, particularly those receiving chemotherapy Clinical Support Division Granulocyte Colony Stimulating Factor (G-CSF), Filgrastim,Lenograstim, Neutropenia, Peripheral Blood Stem Cell (PBSC) Matthew Small, Oncology/Haematology Pharmacist Carol Farrow, Clincial Director Pharmacy Services Nimish Shah - Consultant Haematologist Daniel Epurescu - Consultant Medical Oncologist Clinical Guidelines Assessment Panel (CGAP) If approved by committee or Governance Lead Chair s Action; tick here Clinical Standards Group and Effectiveness Sub-Board To be reviewed before: This document remains current 26/04/2020 after this date but will be under review To be reviewed by: Matthew Small Reference and / or Trust 1204 Docs ID No: Version No: 5 Dr Jenny Wimperis name removed and Dr Nimish Shah added. Secondary Prophylaxis section amended to include In patients who are at high risk of developing neutropenic sepsis. In Treatment of Description of changes: Neutropenia section G-CSF should not be used in patients with uncomplicated febrile neutropenia, afebrile neutropenia or on the days the patients are proceeding with chemotherapy removed. Compliance links: (is there (e.g. NICE, CQC) any NICE related to guidance) If Yes - does the strategy/policy deviate from the recommendations of NICE? If so why? This guideline has been approved by the Trust's Clinical Guidelines Assessment Panel as an aid to the diagnosis and management of relevant patients and clinical circumstances. Not every patient or situation fits neatly into a standard guideline scenario and the guideline must be interpreted and applied in practice in the light of prevailing clinical circumstances, the diagnostic and treatment options available and the professional judgement, knowledge and expertise of relevant clinicians. It is advised that the rationale for any departure from relevant guidance should be documented in the patient's case notes. The Trust's guidelines are made publicly available as part of the collective endeavour to continuously improve the quality of healthcare through sharing medical experience and knowledge. The Trust accepts no responsibility for any misunderstanding or misapplication of this document Date approved: 26/04/2017 Review date: 26/04/2020 Trust Docs ID: 1204 Page 1 of 5

2 Quick reference guideline Primary Prophylaxis G-CSF should only be considered for primary prophylaxis for: chemotherapy regimens with a high risk of developing febrile neutropenia (>20%) (table 1) where there the chemotherapy regimen intermediate risk (10-20%) (table 2) and there are patient related risk factors for developing febrile neutropenia (table 3). as part of the chemotherapy regimen (e.g. R CHOP -14) Table 1: NNUH chemotherapy regimens with a high risk of neutropenia (>20%) FEC-T* ESHAP Docetaxel (100mg/m 2 ) BEACOPP IVE +/-R *During docetaxel treatment stage only Table 2: NNUH chemotherapy regimens with an intermediate risk of neutropenia (10-20%) FEC Docetaxel (75mg/m 2 ) CMF AC CAV ECX Cabazitaxel CHOP-21 (+/- R) ABVD DA-EPOCH (+/-R) Carboplatin-Etoposide Topotecan BEP Docetaxel + Gemcitabine Table 3: Patient related risk factors for developing neutropenia Age (>65 years) Bone marrow involvement with tumour Preexisting neutropenia Recent surgery or infection/open wounds Poor performance status Poor renal or hepatic function (esp elevated bilirubin) Prior intensive chemotherapy or radiotherapy Previous episodes of febrile neutropenia Date approved: 26/04/2017 Review date: 26/04/2020 Trust Docs ID: 1204 Page 2 of 5

3 Secondary Prophylaxis G-CSF may be given where curative chemotherapy has required a dose reduction or delay due to neutropenia when febrile neutropenia has occurred following a cycle of curative chemotherapy. G-CSF treatment may only be considered for palliative chemotherapy when febrile neutropenia occurs following suitable dose reduction and treatment delay. In patients who are at high risk of developing neutropenic sepsis. Treatment of Neutropenia G-CSF may be considered to treat high-risk patients with febrile neutropenia and with poor prognostic factors including profound neutropenia (Absolute Neutrophil Count (ANC) < 0.1 x 10 9 /litre), invasive fungal infection, pneumonia, hypotension, uncontrolled primary disease, multi-organ dysfunction and protracted neutropenia for 5-7 days. Peripheral Blood Stem Cell Mobilisation G-CSF may be used for priming of stem cells prior to harvest according to the appropriate protocol. Dosage is 10mcg/kg/day when given as monotherapy or 5mcg/kg/day in combination with chemotherapy. Treatment of Specific Disease States G-CSF shall be used where indicated as part of an approved protocol for a specific malignant disease or as part of a clinical trial protocol. Administration Treatment may only be initiated by a consultant, registrar or staff grade in oncology or haematology. Dosing: G-CSF should start at least 24 hours after chemotherapy and stop at least 24 hours prior to next chemotherapy. While on G-CSF treatment WCC should be monitored regularly and should not be allowed to exceed 50 x 10 9 /l as this may cause hyperviscosity syndrome In primary and secondary prophylaxis. The specific day of commencement will be dependent on individual patient and type of chemotherapy regime. The usual duration of G-CSF therapy is 5-7 days but often 2-5 days is adequate. Date approved: 26/04/2017 Review date: 26/04/2020 Trust Docs ID: 1204 Page 3 of 5

4 In high risk patients with febrile neutropenia G-CSF should be administered until ANC > 0.5 x 10 9 /litre for at least 2 days or >1.0 x 10 9 /litre for 1 day. Timing: Route: The administration of G-CSF should be at 6 p.m. to allow review of neutrophil count. Once daily subcutaneous injection. If a specific dose per weight or surface area is indicated the dosage should be tailored to the nearest whole vial size of filgrastim (300 micrograms and 480micrograms) or lenograstim (263 micrograms or 105 micrograms). Otherwise a standard dose of filgrastim 300 micrograms or lenograstim 263 micrograms should be prescribed. The intravenous route is not routinely recommended and may result in greater toxicity with no better biological activity. However in patients with significant thrombocytopenia (platelets <10x 10 9 /1), where subcutaneous injections are contraindicated, G-CSF may be prescribed as a 30 minute intravenous infusion in 20mls of 5% dextrose (NOTE: over dilution is contraindicated). NB At present lenograstim is only authorised for patients receiving treatment as part of an approved clinical trial where it is named as the G-CSF of choice. Side-effects Bone pain, myalgia, flu-like symptoms. These may be severe enough (e.g. bone pain) to warrant early discontinuation of G-CSF. Discuss with Consultant in charge. Objective of Guideline The objective of these guidelines is to provide recommendations on the appropriate use of colony stimulating factors in various clinical situations where neutropenia is encountered in haematology and oncology. Rationale for the recommendations The guidelines were written to ensure consistent practice and rational use of colony stimulating factors throughout the directorate. The recommendations are derived from those given in guidelines issued by the American Society of Clinical Oncology (ASCO), the British Society of Haematology (BSH) and Royal Marsden Hospital, which are all evidence based. Local recommendations such as the length and timing of doses where taken both from the above guidelines and experience gained in current practice. Broad recommendations See quick reference section Clinical Audit Standards derived from guideline The use of G-CSF in oncology and haematology will be audited in accordance with these guidelines. Date approved: 26/04/2017 Review date: 26/04/2020 Trust Docs ID: 1204 Page 4 of 5

5 Summary of development and consultation process undertaken before registration and dissemination The guidelines were written by Matthew Small (Clinical Pharmacy Practitioner Oncology & Haematology) following consultation with two of the Trust Haematologists (Dr. Jennie Wimperis and Dr. Martin Auger) and Trust Medical Oncologist (Dr. Daniel Epurescu). The draft version was then sent to Dr. Tom Roques (Clinical Oncologist) for further comment. The proposed guidelines were then further sent to each of the remaining haematologists and oncologists for comment and presented at an oncology meeting. The guideline has been regularly reviewed and changes made as appropriate with current evidence. It has been discussed and agreed at Haematology and Oncology departmental meetings. Distribution list/ dissemination method Final version of guidelines to be circulated to all oncology & haematology consultants, associate specialists, staff grades and specialist Registrars. Copies also to be included in Mulbarton ward procedure files and on the electronic haematology file (k-drive). A copy of the guidelines will also be available on the Trust intranet. References/ source documents NCCN Clinical Practice Guidelines in Oncology: Myeloid Growth Factors Version Appro MS et al: 2010 update of EORTC guidelines for the use of granulocyte colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphoproliferative disorders and solid tumours; Eur J Cancer 47 ( ) Changes made Date Version Previous version number June 2013 April 2017 Page number/ Section updated Details V4 V3 Page 2 Primary prophylaxis expanded to include regimens with 20% risk of febrile neutropenia and regimens with 10-20% risk of febrile neutropenia if a patient related risk factor is present. Such regimens and risk factors listed in tables. Page 5 References updated V5 V4 Front page Dr Jenny Wimperis name removed and Dr Nimish Shah added. Page 3 Secondary Prophylaxis section amended to include In patients who are at high risk of developing neutropenic sepsis. In Treatment of Neutropenia section G- CSF should not be used in patients with uncomplicated febrile neutropenia, afebrile neutropenia or on the days the patients are proceeding with chemotherapy removed. Date approved: 26/04/2017 Review date: 26/04/2020 Trust Docs ID: 1204 Page 5 of 5