Immunotherapy - Nursing Assessment of Toxicities (Adults Only)



Canberra Hospital and Health Services

Clinical Procedure

Immunotherapy: Nursing Assessment of Toxicities (Adults Only)

|Contents |

Contents 1

Purpose 2

Alerts 2

Scope 2

Section 1 – Immune-Oncology Triage Tool 3

Implementation 12

Related Policies, Procedures, Guidelines and Legislation 12

References 12

Search Terms 14

|Purpose |

To guide and support 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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This Standard Operating Procedure (SOP) describes for staff the process to

|Scope |

|Alerts |

• This procedure is a guide only. Medical and nursing staff should make all decisions during the assessment and triage of a patient based on best practice using their own clinical judgement and should not rely solely upon this procedure. This procedure aims to provide a timely assessment and review of patients admitted to the Canberra Region Cancer Centre Rapid Assessment Unit.

• Treating team must be consulted prior to commencing steroid. Dosage of steroid should 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 require hospitalisation and close monitoring

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|Scope |

This procedure applies to Canberra Hospital, Canberra Region Cancer Centre Rapid Assessment Unit (RAU):

Nurse Practitioners, Advanced Practice Nurses and Registered Nurses who are working within their scope of practice and in accordance with the Rapid Assessment Unit Model of Care

• Patients over the age of 18 years

• Haematology and Oncology patients not receiving chemotherapy.

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|Section 1 – Immune-Oncology Triage Tool |

Background

• This tool has been designed as an appendix to the UKONS Oncology/ Haematology Helpline Triage Tool noted below and currently in use in Rapid Assessment Unit.

• 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 Tool

1. Patient will call the RAU with any symptoms or concerns. All queries of this nature should be directed to the Advanced Practice Nurse or the Nurse Practitioner.

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/ GI

• Skin

• Endocrine

• Neurological

• Pulmonary

• Vision

• Mucosa

• Renal

• Hepatic

3. The patients answers are then graded by severity on a scale of 1-4 and a decision regarding advice or further investigations and treatment is then made in conjunction with the treating team.

No Hospitalisation Required

Based on an agreed 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 in Rapid Assessment Unit the patient will be informed to present to the unit for assessment and treatment and be discharged the same day with regular follow up phone calls

Hospitalisation Required

Based on agreed plan with the patients’ treating team patients may be admitted to hospital to receive treatment and observation. Patients will be admitted through the Rapid Assessment Unit.

|Toxicity |Grade |

| |0 |1 (mild) |2 (moderate) |3 (severe) |4 (life-threatening) |

|Diarrhoea/ GI |None |

|Are 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? | |

| | |

|*Are you receiving combination | |

|Ipilimumab/ Nivolumab? (If yes and| |

|any of the above symptoms, pt to | |

|present to RAU for assessment). | |

| |Asymptomatic Hypothyroidism: |Symptomatic Hypothyroidism: |

| |Patient not displaying any symptoms however TSH |Symptoms may include: |

| |elevated, fT4 is low |Fatigue |

| |Continue close monitoring of patient, bloods 3 weekly |Weight gain |

| |including TSH, fT3/ fT4 and cortisol* |Weakness |

| |If TSH >10mu/L, Endocrine review recommended |Muscle cramps |

| |If TSH and FT4 low – consider central hypothyroidism – |Course/ dry hair and skin |

| |will need cortisol/ACTH |Cold intolerance |

| |Educate patient on symptoms and advise patient to |Constipation |

| |contact cancer specialist nurse or RAU if symptomatic |Depression |

| | | |

| |Patient not displaying any symptoms however tend to see |Management: |

| |a suppressed TSH beforehand then fT3 and fT4 elevated |Present to RAU for assessment |

| |Continue close monitoring of patient, bloods 3 weekly |Contact treating team and commence thyroid replacement as needed* |

| |including TSH, fT3/ fT4 and cortisol* |Advice from and referral to endocrinologist recommended |

| |Educate patient on symptoms and advise patient to | |

| |contact cancer specialist nurse or RAU if symptomatic |*Caution is needed: if patient has concomitant adrenal and thyroid insufficiency – replacement of thyroid hormones |

| |Referral to endocrinologist |before adrenal hormones (cortisol) can precipitate an acute adrenal crisis. |

| | | |

| |In patients with a suppressed TSH but normal FT3 & FT4 =|Symptomatic Hyperthyroidism: |

| |subclinical hyperthyroidism |Symptoms may include: |

| | |Fatigue |

| |*Check whether patient is on steroids as ACTH and |Insomnia |

| |cortisol result will be difficult to interpret. Cortisol|Appetite change |

| |should be taken before 10am. |Weight loss |

| | |Heart palpitations |

| |Asymptomatic Diabetes: |Heat intolerance |

| |Patient not displaying any symptoms however BGL |Nervousness/ mood changes |

| |consistently elevated >7.0 mmols on pathology. |Tremor |

| |Contact treating team |Dyspnoea |

| |Consider referral to endocrinology |Hair thinning |

| | |Increased bowel movements |

| | | |

| | |Management: |

| | |Present to 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 |

| | | |

| | |Management: |

| | |Present to 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 RAU for assessment |

| | |Pathology including TSH, FT3, FT4, ACTH, Cortisol, FSH, LH and prolactin for males and females |

| | |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 may be indicated |

| | |Hospitalisation may be indicated depending on severity of symptoms |

|Neurological |

|Any unsteadiness or loss of balance? |

|Any dizziness? |

|Noticed any difficulty gripping or dropping things? |

|Any numbness or tingling in hands or feet? |

|Any confusion? |

|Any headaches? |

The procedure will be implemented through the following:

0. Communication at Department meetings

0. Tabled and CACHS Clinical Governance Committee

0. Included in the CACHS UpdatED Newsletter

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|Related Policies, Procedures, Guidelines and Legislation |

Policies

• Consent and treatment

• Medication handling policy

Procedures

• CHHS Healthcare Associated Infections Clinical Procedure

• CHHS Patient Identification and Procedure Matching Policy

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: //.au

4. Cancer Research UK. (2015). How long a new drug takes to go through clinical trials. Retrieved from Cancer Research UK website:

5. Caturegli, P.,  Newschaffer, C.,   Olivi, A.,   Pomper, M.G., Burger, P.C., & Rose, N.R. (2011). Autoimmune Hypophysitis. Endocrine Reviews, 26,(5), DOI: .

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. 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.

9. 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

10. 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

11. 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.

12. 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

13. National Cancer Institute. (2010). Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Retrieved from the National Institutes of Health website:

14. 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.

15. 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

16. 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.

17. 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

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Disclaimer: This document has been developed by ACT Health, Canberra Hospital and Health Service 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 Health Directorate assumes no responsibility whatsoever.

|Date Amended |Section Amended |Approved By |

|Eg: 17 August 2014 |Section 1 |ED/CHHSPC Chair |

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