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CHS19/156
Canberra Health ServicesClinical Procedure Immunotherapy Nursing Assessment of Toxicities (Adults Only)Contents
Contents....................................................................................................................................1
Purpose.....................................................................................................................................2
Alerts.........................................................................................................................................2
Scope........................................................................................................................................ 2
Section 1 – Immune Oncology Triage Tool................................................................................3
Background........................................................................................................................... 3
Using the Tool.......................................................................................................................3
No Hospitalisation Required.................................................................................................3
Hospitalisation Required.......................................................................................................3
Implementation...................................................................................................................... 17
Related Policies, Procedures, Guidelines and Legislation.......................................................17
References.............................................................................................................................. 17
Search Terms.......................................................................................................................... 19
Attachments............................................................................................................................19
Attachment A – Immunotherapy Triage Letter for ED/RAU/Walk in Centre.......................21
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Do not refer to a paper based copy of this policy document. The most current version can be found on the ACT Health Policy Register
CHS19/156
Purpose
To guide and support Canberra Health Services (CHS) nursing staff in the assessment, triage and treatment of patients with suspected immune-related adverse events who are currently receiving immunotherapy agents.
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Alerts
This procedure is a guide only. Medical and nursing staff will make all decisions during the assessment and triage of a patient based on best practice using their own clinical judgement and will not rely solely upon this procedure.
This procedure aims to provide a timely assessment and review of patients admitted to the Canberra Hospital
The Oncology or Haematology treating team must be consulted prior to commencing corticosteroids. Dosage of steroids and route of administration will be based on severity of toxicity and discretion of treating physician.
All patients with a suspected immune-related adverse event require close and careful monitoring.
Grade 3 and grade 4 immune-related adverse events may require hospitalisation and close monitoring
Immune related adverse events (irAEs), including severe irAEs, are more common with combination anti-programmed death 1 (PD1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA4) immunotherapies (e.g. ipilimumab/nivolumab). There should be a high suspicion for irAEs in patients presenting with symptoms on combination immunotherapy, and a low threshold for assessing these patients in the Rapid Assessment Unit (RAU) given the heightened risk for severe irAEs.
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Scope
This procedure applies to CHS, Canberra Region Cancer Centre (CRCC), RAU, and the Emergency Department (ED) and any Advanced Practice Nurse who triages patients with cancer including:
Nurse Practitioners, Advanced Practice Nurses and Registered Nurses who are working within their scope of practice and in accordance with CHS policies and procedures
Patients within scope:o Patients over the age of 18 yearso Haematology and Oncology patients.
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Section 1 – Immune Oncology Triage Tool
Background This tool has been designed as an appendix to the United Kingdom Oncology Nursing
Society (UK ONS) Oncology/Haematology Helpline Triage Tool noted below and currently in use in RAU at CHS.
The immune-oncology triage tool is designed to guide and support nursing staff to assess and triage patients with suspected immune-related adverse events who are currently receiving immunotherapy agents.
Using the Tool1. Patient will call or present to the ED or RAU with any symptoms or concerns. Patients
may present with the immunotherapy triage letter (see Attachment 1).2. The Advanced Practice Nurse or the Nurse Practitioner will proceed through the tool by
asking the patient the questions on the following topics: Diarrhoea/Gastrointestinal (GI) Skin/Mucosal Rheumatological/Musculoskeletal Endocrine Neurological Pulmonary Vision Mucosa Renal Hepatic
3. The patient’s answers are then graded by severity on a scale of 1-4 4. A decision regarding advice or further investigations and treatment is then made in
conjunction with the treating team.
No Hospitalisation RequiredBased on an agreed treatment plan with the patients’ treating team patients may receive: Advice over the phone and regular follow up phone calls Where further assessment and treatment is required, the patient will be informed to
present to the ED or RAU for assessment and treatment and be discharged the same day with regular follow up phone calls by the Cancer Specialist
Nurse or other members of the treating team.
Hospitalisation RequiredPatients will be admitted through the ED or RAU. In conjunction with the patient, the treating team will develop a plan of care and commence observation and treatment.
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Link to National Comprehensive Cancer Network (NCCN) Guidelines https://www.nccn.org/professionals/physician_gls/
Management of Immunotherapy-Related ToxicitiesToxicity 1 (mild) 2 (moderate) 3 (severe) 4 (life-threatening)Diarrhoea/ GIAre you experiencing: Any
diarrhoea? Increase in
bowel movements? If so, how many?
Watery stools?
Abdominal pain or cramping?
Any blood or mucous in stools?
Any nausea or vomiting?
2-4 stools above baseline assessment in 24 hrs Without symptoms of colitis*if any associated abdominal pain/ cramping or blood in stools WITH or WITHOUT diarrhoea proceed to grade 2 management
Advise patient to commence symptomatic treatment, loperamide and oral fluid replacement (Gastrolyte)
Stool culture to exclude infectious causes including microscopy, culture and sensitivity (MCS);
4-6 stools above baseline in 24 hrs Or Colitis: abdominal pain; blood or mucous in stoolPatient should attend ED or RAU for assessment
Stool culture to rule out infectious aetiologies including microscopy, culture and sensitivity (MCS); clostridium difficile toxin and faecal calprotectin (non-MBS item)
Contact treating team Commence oral
prednisolone Monitor daily with phone
calls, if no improvement in 2-3 days increase oral corticosteroids or consider other immunomodulatory agents (infliximab) in consultation with medical
At least 7 stools above baseline Or Colitis: severe abdominal pain
Contact treating team Commence high-dose IV
corticosteroids and if no response in 2 days treating team should consider other immunomodulatory agents (see NCCN guidelines)
Patient may require hospitalisation for supportive care
*Corticosteroids are contraindicated if GI perforation is present, which requires surgical review
Stool culture to rule out infectious aetiologies including microscopy, culture and sensitivity (MCS); clostridium difficile toxin and faecal calprotectin (non-MBS item)
Sigmoidoscopy/ Colonoscopy and
>7 stools above baseline in 24 hrs Or Colitis: life threatening diarrhoea, colitis or perforationUrgent intervention indicated
Hospitalisation indicated.
Manage as per grade 3, with urgent involvement of gastroenterologist
Additional immunosuppressive agents maybe required for steroid refractory cases, at the discretion of the treating oncologist.
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Toxicity 1 (mild) 2 (moderate) 3 (severe) 4 (life-threatening)clostridium difficile toxin
Follow up phone call in 24 AND 48hrs if persists for 3-5 days proceed to grade 2 management
oncology team (see NCCN guidelines) continued until symptoms resolve to grade 1 then tapered over 4 weeks.
biopsy may be indicated in consultation with gastroenterologist
Referral to dietician is recommended.
Once symptoms resolved to grade 1 steroid should be tapered over at least 4 weeks.
Skin Do you have
any new rashes?
Does your skin feel itchy (pruritis)?
Any blisters on skin; pain or tenderness over skin?
Any itch or rash/ lesions in mouth or genitals?
Any changes
Rash <10% of body surface area (BSA) Patients should be
advised to apply an emollient (QV, Cetaphil, Aveeno, Moo goo brands are available – patients will need to purchase these over the counter)
Administer oral antihistamine for pruritis and topical corticosteroids
Follow up phone call
Rash covering 10-30% of BSA
Full body assessment including oral mucosal assessment. If rash/ pruritis present in mouth, proceed to Grade 3 management
Symptomatic treatment with emollients, antihistamines and topical corticosteroids as per Grade 1.
Follow up phone call within 24hrs, if rash/ itch intolerable, patient should attend RAU for assessment
Rash covering >30% BSAAdvise patient to attend RAU
Commence corticosteroids (see NCCN Guidelines) tapered over 4 weeks once symptoms resolved to grade 1.
Consider Skin biopsy for rashes with blistering or full thickness dermal ulceration and dermatology consult
No formal definition – however life threatening if suspected Stevens-Johnson Syndrome or toxic epidermal necrolysis characterised by >30% BSA skin sloughing, erythema, epidermal detachment
Hospitalisation indicated with urgent referral to dermatologist
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Toxicity 1 (mild) 2 (moderate) 3 (severe) 4 (life-threatening)in pigmentation?
in 48hrs to check symptoms improving
and commencement of oral corticosteroids (see NCCN Guidelines) with 4 week taper.
Referral to dermatologist recommended
Urgent administration corticosteroids (see NCCN guidelines), tapered over 4 weeks once symptoms resolved to grade 1.
Endocrine Have you
noticed any change in sleeping pattern or fatigue level?
Any headaches?
Any changes in mood?
Any sweating? Have you felt
unusually thirsty?
Any confusion?
Have you felt dizzy or
Primary Adrenal Insufficiency:Symptoms may include: Chronic malaise Lassitude Fatigue that is worsened by exertion, improved with bed rest Generalised weakness not limited to particular muscle groups Anorexia Weight loss Hypotension, hyponatraemia, hyperkalaemia
Management: Patient to present to ED or RAU for assessment Adrenocorticotrophic Hormone (ACTH) and cortisol, check electrolytes if not already performed Referral to endocrine team
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Toxicity 1 (mild) 2 (moderate) 3 (severe) 4 (life-threatening)lightheaded?
Are you taking any steroids?
Symptomatic Hypothyroidism:Symptoms may include: Fatigue Weight gain Weakness Muscle cramps Course/ dry hair and skin Cold intolerance Constipation Depression
Management: Present to ED or RAU for assessment Contact treating team and commence thyroid replacement as needed* Advice from and referral to endocrinologist recommended
*Caution is needed: if patient has concomitant adrenal and thyroid insufficiency – replacement of thyroid hormones before adrenal hormones (cortisol) can precipitate an acute adrenal crisis.
Symptomatic Hyperthyroidism:Symptoms may include: Fatigue Insomnia Appetite change
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Toxicity 1 (mild) 2 (moderate) 3 (severe) 4 (life-threatening) Weight loss Heart palpitations Heat intolerance Nervousness/ mood changes Tremor Dyspnoea Hair thinning Increased bowel movements
Management: Present to ED or RAU for assessment Contact treating team and commence anti-thyroid medication as needed Referral to endocrinologist recommended
Symptomatic Diabetes:Symptoms may include: Excessive weakness Polydipsia Polyuria Blurred vision Abdominal pain Mood changes Weight loss Tachycardia Hypothermia Hypotensive
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Toxicity 1 (mild) 2 (moderate) 3 (severe) 4 (life-threatening)
Management: Present to ED or RAU for assessment Contact treating team, and initiate insulin replacement if needed, close monitoring of blood glucose levels Referral to endocrinologist recommended
Suspected Hypophysitis:Symptoms may include: Headache Visual disturbances Polydipsia Polyuria Low ACTH, Low testosterone*, low TSH*Testosterone level can decrease in illness irrespective of pituitary function
Management: Present to ED or RAU for assessment Pathology including TSH, FT3, FT4, ACTH, Cortisol, FSH, LH and prolactin for females and males; add testosterone for
males Contact treating team, management with either corticosteroids or hormone replacement will depend on area of
inflammation (steroid replacement should occur prior to thyroid hormone replacement). MRI pituitary may be indicated Hospitalisation may be indicated depending on severity of symptoms
Neurological Any
unsteadiness or loss of
Mild symptoms: Fatigue Dizziness Unsteadiness
Moderate Symptoms: Fatigue Dizziness Unsteadiness
Moderate to severe symptoms impacting on ADL’s Advise patient to attend ED or
RAU or present to nearest
Severe symptoms, advise as per grade 3.
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Toxicity 1 (mild) 2 (moderate) 3 (severe) 4 (life-threatening)balance?
Any dizziness? Noticed any
difficulty gripping or dropping things?
Any numbness or tingling in hands or feet?
Any confusion?
Any headaches?
Any visual changes?
Any weakness in limbs?
Memory impairment Confusion Sensory changes Headache With no change in
instrumental ADL’s
Advise patient to attend ED or RAU
Notify treating team follow up possible
differential diagnosis of progression of disease
Consider referral to neurologist
Memory impairment Confusion Sensory changes Headache Which impact on day to day
activities (instrumental ADL’s)
Advise patient to attend ED or RAU and notify treating team
Consider referral to neurologist
Commence oral corticosteroids (see NCCN Guidelines)
emergency department and notify treating team.
Hospitalisation indicated and urgent referral to neurologist
Commencement of IV corticosteroids (see NCCN Guidelines)
Pulmonary Have you
noticed a dry cough or worsening dry cough?
Any shortness of breath?
Asymptomatic: clinical or diagnostic findings only
Pulse oximetry (resting and with movement)
Reassess in 1-2
New or worsening symptoms of dry cough, dyspnoea with or without fever, chest pain. Advise patient to attend ED
or RAU for assessment Consider infectious
workup: nasal swab, sputum culture
Severe symptoms of dyspnoea and dry cough, feverLife-threatening consequences urgent intervention needed, hospitalisation indicated,
Supportive oxygen therapy initiated
Severe symptoms of dyspnoea and dry cough, feverLife-threatening consequences urgent intervention needed, hospitalisation indicated, as per grade
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Toxicity 1 (mild) 2 (moderate) 3 (severe) 4 (life-threatening) Any recent
radiotherapy that involved the lung field?
weeks Consider chest CT
with contrast
Contact treating team. If recent radiotherapy to lung, consider differential diagnosis of radiation induced pneumonitis.
High resolution CT chest Commencement of oral
corticosteroids (see NCCN Guidelines) tapering over 1 month once symptoms resolve to grade 1.
Consider Respiratory consult
*Patient will require follow up phone calls to ensure resolution of symptoms
Consider infectious workup: nasal swab, sputum culture
Contact treating team. If recent radiotherapy to lung, consider differential diagnosis of radiation induced pneumonitis. Commencement of IV corticosteroids (see NCCN Guidelines)
Consider Respiratory consult
Once symptoms return to baseline taper over at least 6 weeks to avoid rebound.
*Patient will require follow up phone calls post discharge to ensure continued improving symptoms
3
Vision Have you
noticed any changes in vision?
Any blurred vision?
Mild redness, pain, blurred vision, photophobia or other symptoms Advise patient to
attend ED or RAU for assessment, contact
Moderate symptoms of eye redness, pain, blurred vision, photophobia or other symptoms Advise patient to attend ED
or RAU for assessment, contact ophthalmologist
Moderate to severe symptoms as described in Grade 2. Patient at risk of permanent eye damage and blindness, urgent intervention indicated by ophthalmologist,
Severe symptoms as described in Grade 2. Patient at risk of permanent eye damage and blindness, urgent intervention indicated by
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Toxicity 1 (mild) 2 (moderate) 3 (severe) 4 (life-threatening) Any eye pain? ophthalmologist on-
call for assessment and guidance on use of topical steroid eye drops
Phone call follow up to ensure resolution of symptoms
on-call for assessment, consider topical steroid eye
drops Phone call follow up to
ensure resolution of symptoms
topical steroid eye drops and systemic steroids indicated under guidance of oncology/ haematology treating team and opthamologist,
hospisation indicated
ophthalmologist,
topical steroid eye drops and systemic steroids indicated,
hospitalisation indicated
Mucosa Have you
noticed a dry mouth?
Mild mucosal dryness. check patient’s oral
hydration, educate on oral hygiene, use of artificial saliva spray, frequent sips of water, regular non-alcohol based mouthwashes.
No action required. Monitor at each follow up
Moderate dryness . some difficulty with mastication and swallowing food.
Advise patient to attend ED or RAU for assessment.
Referral to speech pathology and dietician recommended.
Moderate to severe dry mouth.Manage as per Grade 2.
Renal Have you
noticed any change in urination?
Frequency? Pain?
Creatinine elevated 1.5-2.0x baselineProteinuria 1+
Urinalysis for casts and protein
Exclude other causes,
Creatinine elevated 2 to 3 x baselineProteinuria 2+
Advise pt to attend ED or RAU
Urinalysis for casts and
Creatinine elevated 3.0 to 6.0 x baseline
Advise pt to attend ED or RAU Urinalysis for casts and protein,
consider hydration status and nephrotoxic medications
Creatinine >6.0 x baseline
Manage as per Grade 3
Hospitalisation and dialysis indicated
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Toxicity 1 (mild) 2 (moderate) 3 (severe) 4 (life-threatening)consider hydration status and nephrotoxic medications
Notify treating team of change in creatinine,
Advise patient to promote oral hydration
weekly monitoring of creatinine and urine protein
protein, consider hydration status and nephrotoxic medications
Notify treating team Monitor creatinine every 2-
3 days Referral to nephrologist –
consider renal biopsy Commence oral
corticosteroids (see NCCN Guidelines)
Notify treating team Monitor creatinine daily commence IV corticosteroids
(see NCCN Guidelines) Referral to nephrologist –
consider renal biopsy
Urgent Nephrology consult
Hepatic*Usually asymptomatic, check when patient last had LFT’s
AST/ ALT >1 to 3 x ULN and/ or Total Bilirubin >1 to 1.5 x ULN Notify treating team Monitor LFT’s weekly,
if LFT’s deteriorate or patient is unwell proceed to grade 2
Rule out infection, viral etiology, disease-related hepatic dysfunction or drug induced dysfunction
AST/ ALT 3-5 x ULN, total bilirubin >1.5-3 x ULN Advise patient to attend
RAU Evaluate to exclude other
causes of hepatic injury Notify treating team If persists more than 3-5
days commence oral corticosteroids (see NCCN Guidelines)
Monitor LFT’s every 5 days, if persisting treat as grade 3.
AST/ ALT >5 X ULN, bilirubin >3 x ULN Advise patient to attend RAU or
closest ED immediately contact treating team and initiate
IV corticosteroids (see NCCN Guidelines)
Hospitalisation may be indicated Referral to Gastroenterologist/
Hepatologist
AST/ ALT >20 X ULN
Manage as per Grade 3Hospitalisation indicated
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Toxicity 1 (mild) 2 (moderate) 3 (severe) 4 (life-threatening) Assess dietary
supplement use, alcohol use and paracetamol use
Musculoskeletal
Arthralgia: Have you had
any joint pain or swelling, stiffness after inactivity?
Myalgias/ Myositis: Any pain or
tenderness in
Mild symptoms not affecting ADL’s Assess number of
joints involved, Advise to use NSAIDS,
heat packs to affected areas
Monitor with follow up phone call in 48hrs
Please refer to NCCN Guidelines for further information
Ask patient to attend ED or RAU for assessment
Consider monitoring serial aldolase/
Moderate symptoms affecting ADL’s Assess number of joints
involved Contact treating team as
patient may require oral corticosteroids until symptoms <grade 1 then taper over 4-6 weeks
Monitor with follow up phone call in 48hrs if no improvement, notify treating team and consider referral to rheumatology
Ask patient to attend ED or RAU for assessment
Monitor serial aldolase/ creatine kinase
Contact treating team as
Moderate to severe symptoms affecting ADL’s Assess number of joints involved Contact treating team Patient will require high dose
corticosteroids and regular analgesia
Rheumatology consultation advised if no improvement by week 2
Patient may require hospitalisation
Ask patient to attend ED or RAU for assessment
Contact treating team Monitor serial aldolase/ creatine
kinase until symptoms resolve
Severe symptoms affecting ADL’s Assess number of
joints involved Contact treating
team Patient will require
high dose corticosteroids and regular analgesia
Rheumatology consultation advised if no improvement by week 2
Patient may require hospitalisation
Ask patient to attend ED or RAU for assessment
Contact treating team
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Toxicity 1 (mild) 2 (moderate) 3 (severe) 4 (life-threatening)your muscles?
Any muscle weakness?
creatine kinase Advise patient to use
pain analgesia as required
Phone call follow up in 48hrs to assess symptoms
patient will require oral corticosteroids
Pain analgesia Phone call follow up in
48hrs to assess symptoms
Oral corticosteroids or IV equivalent
Consider muscle MRI and EMG Consider muscle biopsy Patient may require
hospitalisation Consider rheumatology or
neurology referral
Monitor serial aldolase/ creatine kinase until symptoms resolve
Oral corticosteroids or IV equivalent
Consider muscle MRI and EMG
Consider muscle biopsy
Patient may require hospitalisation
Consider rheumatology or neurology referral
Cardiovascular Any chest
pain? Does the
pain get worse on breathing in?
Any shortness of breath?
Any heart palpitations
Advise patient to attend emergency departmentSee NCCN Guidelines for detailed assessment and grading requirements
Will require cardiology consultationECG, Cardiac biomarkers including Creatine Kinase and troponinInflammatory biomarkers including ESR, CRP, WBC count,Cardiac MRIIf severe Grade 3 or 4 will require hospitalisation and high dose steroids
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Toxicity 1 (mild) 2 (moderate) 3 (severe) 4 (life-threatening)or feelings of racing heart?
Any low grade fever?
Any fatigue? Any swelling
in legs?
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Implementation
The procedure will be implemented through the following: Communication at Department meetings Tabled at Division of Cancer and Ambulatory Support (CAS) Clinical Governance
Committee Included in the CAS UpdatED Newsletter CHS Policy Alerts to all CHS staff.
Related Policies, Procedures, Guidelines and Legislation
Policies Consent and Treatment Medication Handling Policy
Procedures CHS Healthcare Associated Infections Clinical Procedure CHS Patient Identification and Procedure Matching Policy
GuidelinesNational Comprehensive Cancer Network (NCCN) Guidelines https://www.nccn.org/professionals/physician_gls/
Legislation Health Records (Privacy and Access) Act 1997 Human Rights Act 2004 Work Health and Safety Act 2011 Medication, Poisons and Therapeutic Goods Act (2008)
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References
1. Andrews, S., & Holden, R. (2012). Characteristics and management of immune-related adverse effects associated with ipilimumab, a new immunotherapy for metastatic melanoma. Cancer Management and Research, 4, 299-307. DOI: 10.2147/CMAR.S1873.
2. Bartell, H., Wolchok, J., Hodi, S., Liu, H., Wojtaszek, C., & Weber, J. (2015). Immuno-oncology safety education experience: key lessons from ipilimumab (IPI). From the 30th Annual Meeting and Associated Programs of the Society for Immunotherapy of Cancer (SITC 2015) National Harbor, MD, USA. 4-8 November 2015. Retrieved from Journal for Immunotherapy of Cancer, 3, (2), 384. Doi: 10.1186/2051-1426-3-S2-P384.
3. EviQ: Cancer Treatments Online. (2016). Management of immune-related adverse events (irAEs). Approved 6th December 2016, retrieved from http: //www.eviq.org.au
4. Cancer Research UK. (2015). How long a new drug takes to go through clinical trials. Retrieved from Cancer Research UK website: http://www.cancerresearchuk.org/about-
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cancer/find-a-clinical-trial/how-clinical-trials-are-planned-and-organised/how-long-it-takes-for-a-new-drug-to-go-through-clinical-trials
5. Caturegli , P., Newschaffer, C., Olivi, A., Pomper, M.G., Burger, P.C., & Rose, N.R. (2011). Autoimmune Hypophysitis. Endocrine Reviews, 26,(5), DOI: http://dx.doi.org/10.1210/er.2004-0011.
6. Eigentler, T.K., Hassel, J.C., Berking, C., Aberle, J., Bachmann, O., Grunwald, V…Gutzmer, R. (2016). Diagnosis, monitoring and management of immune-related adverse drug reactions of anti-PD-1 antibody therapy. Cancer Treatment Reviews, 45, 7-18. Doi: 10.1016/j.ctrv.2016.02.003
7. Haanen, J.B.A.G., Van Thienen, H., & Blank, C.U. (2015). Toxicity patterns with immunomodulating antibodies and their combinations. Seminars in Oncology, 42, (3), 423-428. Doi:10.1053/j.seminoncol.2015.02.011.
8. Haanen, J.B.A.G., Carbonnel, F., Robert, C., Kerr, K.M., Peters, S., Larkin, J., Jordan, K. (2017). Management of toxicities from immunotherapy: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Annals of Oncology, 28, (4), iv119-iv142. DOI: 10.1093/annonc/mdx225
9. Howell M; Lee R; Bowyer S; Fusi A; Lorigan P.(2015). Optimal management of immune-related toxicities associated with checkpoint inhibitors in lung cancer. Lung Cancer. 88(2):117-23.
10. Ivashko, I.N., & Kolesar, J.M. (2016). Pembrolizumab and nivolumab: PD-1 inhibitors for advanced melanoma. American Journal of Health-System Pharmacy, 73, (4), p 193-201. Doi: 10.2146/ajhp140768
11. Kannan, R., Madden, K., & Andrews, S. (2014). Primer on immune-oncology and immune response. Clinical Journal of Oncology Nursing, 18, (3), 311-317. Doi: 10.1188/14.CJON.311-317
12. Ledezma, B., & Heng, A. (2014). Real-world impact of education: treating patients with ipilimumab in a community practice setting. Cancer Management and Research, 6, 5-14. Doi: 10.2147/CMAR.S52543.
13. Lomax, A., Nielsen, T., Visintin, L., O’Carrigan, B., Honeyball, F., Shum, B., Saw, R.P.M., McNeil, C. 2017. Clinical Nurse Consultant Support: Management of patients with melanoma receiving immunotherapy and targeted therapy. Clinical Journal of Oncology Nursing. 21 (2), ppE93-E98. Doi: 10.1188/17.CJON.E93-E98.
14. Michot, J.M., Bigenwald, C., Champiat, S., Collins, M., Carbonnel, F., Postel-Vinay, S.Lambotte, O. (2015). Immune-related adverse events with immune checkpoint blockade: a comprehensive review. European Journal of Cancer, 54, 139-148. Doi: 10.1016/j.ejca.2015.11.016
15. National Cancer Institute. (2010). Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Retrieved from the National Institutes of Health website: https://search.nih.gov/search?utf8=%E2%9C%93&affiliate=nih&query=CTCAE&commit=Search
16. Pasquali, S., Kefford, R., Chiarion Sileni, V., Nitti, D., Rossi, C.R., Pilati, P & Mocellin, S. (2014). Systemic treatments for metastatic cutaneous melanoma (protocol), Cochrane Database of Systematic Reviews, 5, (CD011123). Doi: 10.1002/14651858.CD011123.
17. Redman, J.M., Gibney, G.T., & Atkins, M.B. (2016). Advances in immunotherapy for melanoma. BMC Medicine, 14, (20), 1-11. Doi: 10.1186/s12916-016-0571-0
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18. Reimschissel, E., Dela Cruz, B., Gonzales, M., Buitrago, J., Goodman, C. & Johnston, P.A. 2017. Immunotherapy Toxicities: A new electronic documentation template to improve patient care. Clinical Journal of Oncology Nursing. 21, (2), pp 41-44. Doi: 10.1188/17.CJON.S2.41-44.
19. Rubin, K. 2017. Advances in melanoma: The rationale for the Melanoma Nursing Initiative. Clinical Journal of Oncology Nursing. 21, (4), pp7-10. Doi: 10.1188/17.CJON.S4.7-10
20. Spain, L., Diem, S., & Larkin, J. (2015). Management of toxicities of immune checkpoint inhibitors. Cancer Treatment Reviews, 44, 51-60. Doi: 10.1016/j.ctrv.2016.02.001.
21. Thompson, J., Schneider, B., Brahma, J., Andrews, S., Armand, P., Davies, M…Wolchok, J. 2018 NCCN Guidelines Management of immunotherapy-related toxicities. Version 1 retrieved 21 march 2018 from http://www.nccn.org
22. Thompson, J., Schneider, B., Brahma, J., Andrews, S., Armand, P., Bhatia, S. 2019. Management of Immunotherapy Related Toxicities. Journal of the National Comprehensive Cancer Network. 17, (3), pp.255-289. Doi:10.6004/jnccn.2019.0013
23. Villadolid, J., & Amin, A. (2015). Immune checkpoint inhibitors in clinical practice: update on management of immune-related toxicities. Translational Lung Cancer Research, 4 (5), 560-575.
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Search Terms
Immunotherapy, Toxicities, Immunotherapy: Nursing Assessment of Toxicities, Immune-related adverse events, Rapid Assessment Unit.
Attachments
Attachment A – Immunotherapy Triage Letter for ED/RAU/Walk in Centre
Doc Number Version Issued Review Date Area Responsible PageCHS19/156 1 18/09/2019 01/08/2022 CAS 19 of 21
Do not refer to a paper based copy of this policy document. The most current version can be found on the ACT Health Policy Register
CHS19/156
Disclaimer: This document has been developed by Canberra Health Services specifically for its own use. Use of this document and any reliance on the information contained therein by any third party is at his or her own risk and Canberra Health Services assumes no responsibility whatsoever.
Policy Team ONLY to complete the following:Date Amended Section Amended Divisional Approval Final Approval 17/07/2019 Complete Review Cathie O’Neill, ED CAS CHS Policy Committee
This document supersedes the following: Document Number Document NameCHHS17/051 Immunotherapy Nursing Assessment of Toxicities (Adults Only)
Doc Number Version Issued Review Date Area Responsible PageCHS19/156 1 18/09/2019 01/08/2022 CAS 20 of 21
Do not refer to a paper based copy of this policy document. The most current version can be found on the ACT Health Policy Register
CHS19/156
Attachment A – Immunotherapy Triage Letter for ED/RAU/Walk in Centre
Attention: Treating Clinician in ED, RAU/ Walk-In Centre
The following patient …………………………………………………… is on Immunotherapy called …………………….
Immunotherapy is a type of cancer treatment that helps your immune system fight cancer. This is NOT Chemotherapy. Immunotherapies can cause inflammation in healthy tissue in any part of the body. Immune-related adverse events (irAE’s) above grade 3 can be life-threatening and fatal if untreated. Unlike chemotherapy, management for toxicities associated with immunotherapies often involve early initiation of corticosteroids depending on grade of irAE*.
If the patient has any of the following:Gastrointestinal Diarrhoea
Abdominal pain Fever Blood or mucous in stool
Liver AST or ALT 3-5 times > ULN Bilirubin >1.5 ULN
Endocrine Moderate to severe symptoms of fatigue, headache, changes in mental status, hypotension, abnormal TFT’s, increase in thirst or urine output, low cortisol
Pulmonary Dry cough, fine inspiratory crackles, dyspnoea
Skin Moderate to severe diffuse rash covering > 30% body surface area
Neurologic Moderate to severe neurological symptoms impacting on ADL’sRenal Decreased urinary output, elevated creatinineOcular Any eye redness, pain, blurred vision or photophobiaMusculoskeletal Severe joint, muscle pain affecting ADL’sCardiac Immune-mediated myocarditis is rare - testing for serum troponin and CK may
be required on discussion with the treating team
If you suspect any of the above please contact the patients’ treating team below:
Doc Number Version Issued Review Date Area Responsible PageCHS19/156 1 18/09/2019 01/08/2022 CAS 21 of 21
Do not refer to a paper based copy of this policy document. The most current version can be found on the ACT Health Policy Register
Surname:Given Name:DOB: Sex:Address:
Oncologist: …………………………………………………………………………………………………………………Cancer Specialist Nurse: ……………………………………………………………………………………………..After hours: Contact the Medical Oncology registrar on-call at the Canberra Hospital, via switch 9.