1. Home
  2. Medical oncology
  3. Urogenital
  4. Bladder and Urothelial

Bladder/Urothelial locally advanced or metastatic avelumab

Treatment must be initiated and supervised by specialist physicians experienced in the treatment of cancer using immunological agents. Before commencing immunotherapy treatment in any patient, clinicians should have an understanding of the immune-related adverse events (irAEs) associated with immunotherapy treatment and their management.

Check for clinical trials in this patient group. Link to Australian Clinical Trials opens in a new tab or window website

On this page
Expand all Collapse all Back to top

Cycle 1 and further cycles

Drug Dose Route Day
Avelumab 800 mg IV infusion 1

In the clinical trial, the avelumab maintenance was commenced 4 to 10 weeks after the last dose of chemotherapy. The avelumab dose was 10 mg/kg however the TGA registered dose is 800 mg.r 

Frequency:
14 days 
Cycles:
Continuous until disease progression or unacceptable toxicity
Notes:

In the first few months after the start of immunotherapy, some patients can experience transient tumour flare (termed "pseudo progression" or an immune response). This may manifest as growth of existing lesions or the development of new lesions prior to later tumour regression. While this is rare (~5%), continuing treatment and performing a second scan 4 to 6 weeks later to confirm progression may be considered, particularly if the patient remains well.

Radiation recall has been observed with PD-L1 inhibitors, consideration should be given to the timing when starting this treatment after a prolonged course of radiation therapy.

Drug status:

Avelumab is PBS authority opens in a new tab or window

Cost:
~ $5,220 "How this cost is calculated"

The cost displayed on the protocol is intended as rudimentary guide only for the Australian context.

The cost includes anti-cancer drugs only (not antiemetics, supportive medications or consumables), unless otherwise indicated.

Drug unit costs are taken directly from the Pharmaceutical Benefits Scheme (PBS) website (www.pbs.gov.au). These costs are reviewed and updated on eviQ at 6 monthly intervals. Anti-cancer drugs that are not included on the PBS do not have a cost included in eviQ protocols.

Where there are differing unit costs based on vial sizes and tablet strengths, the mean unit cost is used. The cost of oral continuous therapy is based on a 28 day month.

Where oral drugs are available on the PBS for both 30- and 60-day prescriptions, the unit cost for the 30-day supply is used.

The protocol cost is derived from drug dose calculations based upon a default body surface area (BSA) of 1.8 m2; weight of 75 kg; and creatinine clearance of 75 mL/min.

One off loading doses and ongoing maintenance doses are not included in protocol cost calculations.

The cost displayed is the actual drug cost and does not necessarily reflect the cost incurred by the patient as many anti-cancer drugs are reimbursed on the PBS.

The supportive therapies (e.g. antiemetics, premedications, growth factor support etc.), infusion times, diluents, volumes and routes of administration, if included, are listed as defaults. They may vary between institutions and can be substituted to reflect individual institutional policy.

Antiemetics if included in the treatment schedule are based upon recommendations from national and international guidelines. These are defaults only and may be substituted to reflect individual institutional policy. Select here for recommended doses of alternative antiemetics.

Cycle 1 and further cycles

Day 1
Paracetamol 1,000 mg (PO) 60 minutes before treatment*
Loratadine 10 mg (PO) 60 minutes before treatment*
Avelumab 800 mg (IV infusion) in 250 mL sodium chloride 0.9% over 60 minutes

* Observe for hypersensitivity reaction. Patients should be premedicated with an antihistamine and paracetamol prior to the first 4 infusions of avelumab due to the significant risk of infusion related reactions. Following the fourth infusion, premedication for subsequent doses should be administered at the discretion of the treating clinician.

Frequency:
14 days 
Cycles:
Continuous until disease progression or unacceptable toxicity

Cycle 1 and further cycles

Drug Dose Route Day
Avelumab 800 mg IV infusion 1

In the clinical trial, the avelumab maintenance was commenced 4 to 10 weeks after the last dose of chemotherapy. The avelumab dose was 10 mg/kg however the TGA registered dose is 800 mg.r 

Frequency:
14 days 
Cycles:
Continuous until disease progression or unacceptable toxicity
Notes:

In the first few months after the start of immunotherapy, some patients can experience transient tumour flare (termed "pseudo progression" or an immune response). This may manifest as growth of existing lesions or the development of new lesions prior to later tumour regression. While this is rare (~5%), continuing treatment and performing a second scan 4 to 6 weeks later to confirm progression may be considered, particularly if the patient remains well.

Radiation recall has been observed with PD-L1 inhibitors, consideration should be given to the timing when starting this treatment after a prolonged course of radiation therapy.

Drug status:

Avelumab is PBS authority opens in a new tab or window

Cost:
~ $5,220 "How this cost is calculated"

The cost displayed on the protocol is intended as rudimentary guide only for the Australian context.

The cost includes anti-cancer drugs only (not antiemetics, supportive medications or consumables), unless otherwise indicated.

Drug unit costs are taken directly from the Pharmaceutical Benefits Scheme (PBS) website (www.pbs.gov.au). These costs are reviewed and updated on eviQ at 6 monthly intervals. Anti-cancer drugs that are not included on the PBS do not have a cost included in eviQ protocols.

Where there are differing unit costs based on vial sizes and tablet strengths, the mean unit cost is used. The cost of oral continuous therapy is based on a 28 day month.

Where oral drugs are available on the PBS for both 30- and 60-day prescriptions, the unit cost for the 30-day supply is used.

The protocol cost is derived from drug dose calculations based upon a default body surface area (BSA) of 1.8 m2; weight of 75 kg; and creatinine clearance of 75 mL/min.

One off loading doses and ongoing maintenance doses are not included in protocol cost calculations.

The cost displayed is the actual drug cost and does not necessarily reflect the cost incurred by the patient as many anti-cancer drugs are reimbursed on the PBS.

The supportive therapies (e.g. antiemetics, premedications, growth factor support etc.), infusion times, diluents, volumes and routes of administration, if included, are listed as defaults. They may vary between institutions and can be substituted to reflect individual institutional policy.

Antiemetics if included in the treatment schedule are based upon recommendations from national and international guidelines. These are defaults only and may be substituted to reflect individual institutional policy. Select here for recommended doses of alternative antiemetics.

Cycle 1 and further cycles

Day 1
Paracetamol 1,000 mg (PO) 60 minutes before treatment*
Loratadine 10 mg (PO) 60 minutes before treatment*
Avelumab 800 mg (IV infusion) in 250 mL sodium chloride 0.9% over 60 minutes

* Observe for hypersensitivity reaction. Patients should be premedicated with an antihistamine and paracetamol prior to the first 4 infusions of avelumab due to the significant risk of infusion related reactions. Following the fourth infusion, premedication for subsequent doses should be administered at the discretion of the treating clinician.

Frequency:
14 days 
Cycles:
Continuous until disease progression or unacceptable toxicity

Indications:

  • First-line maintenance treatment of locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-based induction chemotherapy
    • ECOG 0-1.

Precautions:

If any of these conditions are present, clinical judgement should be used and individual cases discussed with an expert in the field as indicated:

  • significant autoimmune disease (e.g. myasthenia gravis, inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, autoimmune ocular disease)
  • organ transplantation
  • previous history of viral hepatitis
  • HIV/acquired immune deficiency syndrome (AIDS)
  • previous radiation to the lungs.
Venous access required

IV cannula (IVC) or central venous access device (CVAD) is required to administer this treatment.

Read more about central venous access device line selection
Hypersensitivity/infusion related reaction

High risk with avelumab. 

Severe infusion-related reactions have been reported. 

Read more about Hypersensitivity reaction
Premedication

Premedicate with appropriate antihistamine and paracetamol prior to the first four infusions of avelumab. Further premedication is at the discretion of the treating physician. Premedication should continue if previous mild/moderate infusion related reaction. 
Emetogenicity MINIMAL

No antiemetics should be routinely administered before treatment in patients without a history of nausea and vomiting. If patients experience nausea and/or vomiting, consider using the low antiemetic prophylaxis regimen.

Read more about preventing anti-cancer therapy induced nausea and vomiting
Immune-related adverse events (irAEs)

Immune-related adverse events (irAEs) can occur early and escalate quickly in patients receiving immune checkpoint inhibitors. irAEs can also occur after discontinuation of treatment. Fatalities have been reported. Management of irAEs is largely based on expert opinion and consensus guidelines.

Examples of irAEs with high risk of mortality include:

  • cardiac toxicity: myocarditis
  • musculoskeletal toxicity: myositis
  • neurological toxicity: encephalitis, Guillain-Barré syndrome, myelitis, myasthenia gravis
  • pulmonary toxicity: pneumonitis
  • skin toxicity: Stevens-Johnson syndrome, toxic epidermal necrolysis.

Examples of irAEs in order of frequency include:

  • Common
    • endocrinopathies: thyroid dysfunction
    • gastrointestinal toxicity: diarrhoea
    • musculoskeletal toxicity: arthralgia, myalgia
    • skin toxicity: rash, erythema, pruritus
  • Less common
    • endocrinopathies: hypophysitis, type I diabetes mellitus
    • gastrointestinal toxicity: colitis
    • musculoskeletal toxicity: inflammatory arthritis
    • ocular toxicity: dry eye
    • renal toxicity
    • skin toxicity: vitiligo
  • Rare
    • endocrinopathies: primary adrenal insufficiency
    • gastrointestinal toxicity: pancreatitis
    • haematological toxicity
    • musculoskeletal toxicity: vasculitis
    • ocular toxicity: uveitis, iritis.

Proactive monitoring, patient self-monitoring and early reporting of adverse events is critical. Treatment interruptions/discontinuation, consultation with specialist and administration of corticosteroids and/or supportive care is required to minimise the risk of death.

Read more about the management of immune-related adverse events (irAEs)
Baseline investigations

Consider ECG and troponin at baseline. There is no clear evidence regarding the efficacy/value of baseline ECG or troponin in patients receiving immune checkpoint inhibitor therapy. Some cancer specialists obtain baseline testing, and others continue this through the initial period of therapy. Consider urinalysis at baseline, particularly in patients with additional risk factors for developing immune-related acute kidney injury.
Blood tests

FBC, EUC, eGFR, LFTs, serum cortisol, TFTs and BSL at baseline.

Repeat FBC, EUC, eGFR, LFTs and BSL prior to each cycle. Check TFTs every 4-6 weeks during treatment and every 12 weeks as indicated after finalising treatment. Consider checking serum cortisol every 4-6 weeks during treatment and every 12 weeks as indicated after finalising treatment. Check lipase and amylase if symptomatic of pancreatitis.

In the absence of suspicion of immune-related adverse events less frequent monitoring may be applicable, according to institutional guidelines. Evidence for the frequency of routine blood testing with immunotherapies varies within published studies and guidelines.

Read more about immunotherapy blood test monitoring recommendations.
Hepatitis and HIV

Hepatitis screening is recommended in all patients who are to receive immune checkpoint inhibitors.

Immunotherapy is associated with inflammatory adverse reactions resulting from increased or excessive immune activity and patients are at risk of developing autoimmune hepatitis. It should be used with caution in patients who have a history of chronic hepatic infections (hepatitis B and C), detectable human immunodeficiency virus (HIV) viral load or acquired immune deficiency syndrome (AIDS).
Vaccinations

Live vaccines are not recommended for patients receiving this treatment. Caution is advised with inactivated vaccines, particularly the influenza vaccine.

For more information about vaccinations in people with cancer refer to the Australian Immunisation Handbook opens in a new tab or window.
Effects of cancer treatment on fertility

Studies to evaluate the effects of immune checkpoint inhibitor therapy on fertility have not been performed. Therefore, the effect on male and female fertility is unknown. Limited evidence supports that immune checkpoint inhibitor-related hypogonadism due to orchitis and hypophysitis can impact fertility. Immune checkpoint inhibitors can cause fetal harm when given to pregnant women. A pregnancy test should be considered in females of reproductive potential if sexually active. It is important that all patients of reproductive potential use effective contraception whilst on therapy and after treatment finishes. There is very limited evidence to provide guidance regarding contraception timelines. Some studies have demonstrated PD-1 receptor occupancy for greater than 9 months after anti-PD-1 therapy (Brahmer et al., 2010). As a result, some cancer specialists advise using contraception for at least six months or even as long as two years after treatment finishes.

Read more about the impact of cancer treatment on fertility opens in a new tab or window

Link to Brahmer et al., 2010 opens in a new tab or window
Evidence for dose modifications is limited, and the recommendations made on eviQ are intended as a guide only. They are generally conservative with an emphasis on safety. Any dose modification should be based on clinical judgement, and the individual patient’s situation including but not limited to treatment intent (curative vs palliative), the anti-cancer regimen (single versus combination therapy versus chemotherapy versus immunotherapy), biology of the cancer (site, size, mutations, metastases), other treatment related side effects, additional co-morbidities, performance status and patient preferences.Suggested dose modifications are based on clinical trial findings, product information, published guidelines and reference committee consensus . The dose reduction applies to each individual dose and not to the total number of days or duration of treatment cycle unless stated otherwise. Non-haematological gradings are based on Common Terminology Criteria for Adverse Events (CTCAE) opens in a new tab or window unless otherwise specified. Renal and hepatic dose modifications have been standardised where possible. For more information see dosing considerations & disclaimer.

Immune checkpoint inhibitor dose modifications 

  • Dose reduction is not recommended
  • No dose adjustment is required in the elderly or mild hepatic impairment. Immune checkpoint inhibitors have not been studied in patients with moderate to severe hepatic impairment.

Management of immune-related adverse events (irAEs)

Link to Management of immune-related adverse events (irAEs)

Kidney dosing recommendations 
eGFR (mL/min/1.73m2) Recommended dose
≥ 30 No dose modification necessary
< 30 There are limited clinical data in severe kidney dysfunction, use with caution
Consider if immune-related adverse event. See Management of immune-related adverse events (irAEs)

The drug interactions shown below are not an exhaustive list. For a more comprehensive list and for detailed information on specific drug interactions and clinical management, please refer to the specific drug product information and the following key resources: 

For more information see References & Disclaimer.

Avelumab
No formal pharmacokinetic drug interaction studies have been conducted with avelumab. Since avelumab is cleared from the circulation through catabolism, no metabolic drug-drug interactions are expected. 
  Interaction Clinical management
Immunosuppressants (inc. corticosteroids) Reduced efficacy of both immunosuppressants and avelumab possible due to pharmacodynamic interaction

It is recommended that patients requiring corticosteroids prior to treatment receive the lowest possible dose (preferably no greater than 10 mg prednisolone or equivalent steroid per day). Once started on avelumab the use of corticosteroids to treat immune related adverse events (irAEs) does not appear to impact the clinical response to avelumab. In patients requiring ongoing corticosteroids post management of an irAE, the dose should be as low as possible.

Monitor for signs of organ rejection in transplant recipients.

eviQ provides safe and effective instructions on how to administer cancer treatments. However, eviQ does not provide every treatment delivery option, and is unable to provide a comprehensive list of cancer treatment agents and their required IV line giving set/filter or address chemical compatibilities related to IV drug preparation and administration. There may be alternative methods of treatment administration, and alternative supportive treatments that are also appropriate. Please refer to the individual product information monographs via the TGA opens in a new tab or window and Australian Injectable Drugs Handbook opens in a new tab or window websites for further information.

eviQ is currently updating the way information is presented in the administration section, if you notice any discrepancies please let us know, via feedback@eviq.org.au.

Day 1

Approximate treatment time: 90 minutes

Any toxicity may require delay of treatment and review by medical officer before commencing treatment.

Check for adverse events during previous treatment. 

Immunotherapy patient assessment prior to each treatment.

Prime IV line(s).

Insert IV cannula or access TIVAD or CVAD.

Pre treatment medication

Verify premedication taken or administer as prescribed.

Avelumab

Administer avelumab:
  • low protein binding 0.2 micron in-line or add-on filter should be used
  • via IV infusion over 60 minutes
  • observe for infusion-related reactions 
  • at first signs of infusion-related reaction obtain medical officer review
  • flush with ~ 100 mL of sodium chloride 0.9%.
Mild infusion-related reaction:
  • decrease the rate of infusion by 50% and monitor closely 
  • give any further doses with close monitoring.
Moderate infusion-related reaction:
  • stop the infusion until symptoms are mild or have resolved
  • restart the infusion at 50% of the previous rate
  • observe the patient closely for the remainder of the infusion 
  • give any further doses with close monitoring and premedication
Severe infusion-related reaction:
  • stop the infusion
  • medical officer review 
  • permanently discontinue avelumab.

Remove IV cannula and/or deaccess TIVAD or CVAD. 

Discharge information

Antiemetics - as/if prescribed.

Patient information

Ensure patient receives protocol patient information sheet.

The side effects listed below are not a complete list of all possible side effects for this treatment. Side effects are categorised into the approximate onset of presentation and should only be used as a guide.

The most common side effects with this treatment are immune-related adverse events (irAEs). irAEs can escalate quickly and close monitoring of the patient is required. Symptoms should improve promptly after the introduction of immunosuppressive therapy. If this does not occur review the diagnosis and seek further specialist advice. Refer to the Management of immune related adverse events document for further information.

Immune related adverse events
Cardiotoxicity

Cardiotoxicity is a rare but serious side effect, which may manifest as asymptomatic reduction in left ventricular ejection fraction (LVEF), arrhythmia, cardiomyopathy, myocarditis, pericarditis, cardiac fibrosis, hypertension, cardiac ischaemia, congestive heart failure (CHF) and cardiac arrest.

Read more about Management of immune related adverse events.
Gastrointestinal toxicity

Colitis, diarrhoea or more bowel movements than usual; blood or mucous in stools; dark, tarry, sticky stools; abdominal pain or tenderness.

Upper gastrointestinal tract inflammation including gastritis, duodenitis and oesophagitis can occur less commonly. Symptoms include nausea, vomiting, dysphagia, odynophagia, haematemesis and abdominal pain.

Read more about Management of immune related adverse events
Haematological toxicity

Autoimmune haemolytic anaemia (AIHA), acquired thrombotic thrombocytopenic purpura (TTP), aplastic anaemia (AA), immune thrombocytopenia (ITP), acquired haemophilia (AH), haemolytic uremic syndrome (HUS) and lymphopenia are rare but potentially serious immune-related adverse events associated with immunotherapy treatment.

Read more about Management of immune related adverse events.
Hepatotoxicity

Transaminase and total bilirubin elevation, jaundice, severe nausea or vomiting, pain on the right side of the abdomen, drowsiness, dark urine, bleeding or bruising more easily than normal, anorexia.

Read more about Management of immune related adverse events.
Musculoskeletal toxicity

Inflammatory arthritis, temporal arteritis, arthralgia, myalgia, synovitis, vasculitis, polymyalgia-like syndrome and myositis.

Read more about Management of immune related adverse events.
Neurological toxicity

Aseptic meningitis, myasthenia gravis, Guillain-Barre syndrome, encephalitis, meningeal symptoms, optic neuritis, neuropathy and acute inflammatory demyelinating polyneuropathy are infrequent but potentially serious immune-related adverse events associated with immunotherapy treatment.

Read more about Management of immune related adverse events.
Ocular toxicity

Eye pain, blurred vision, Uveitis/iritis, episcleritis, blepharitis, optic neuritis, tear duct stenosis, conjunctivitis, hyperlacrimation, watery or dry eyes and photophobia. 

Read more about Management of immune related adverse events.
Other endocrinopathies

Type 1 diabetes mellitus, hypophysitis, hypopituitarism and adrenal insufficiency are infrequent but potentially serious immune-related adverse events associated with immunotherapy treatment.

Read more about Management of immune related adverse events
Pulmonary toxicity

Radiographic changes, dyspnoea, new or worsening cough, hypoxia, tachycardia, chest pain or fever.

Read more about Management of immune related adverse events.
Renal toxicity

Increase in serum creatinine, oliguria, haematuria, peripheral oedema and anorexia.

Read more about Management of immune related adverse events.
Skin toxicity

Rash including full thickness, pruritus, skin blisters, ulceration and necrosis. Radiation recall can occur at site of previous radiation therapy. Symptoms include vesiculation, desquamation and ulceration of the skin.

Read more about Management of immune related adverse events
Thyroid toxicity

Thyroid toxicity is common with immune checkpoint inhibitors. Hypothyroidism is most frequent however hyperthyroidism can also occur.

Read more about Management of immune related adverse events

Non-immune related adverse events
Infusion reaction

Infusion-related reactions were reported commonly during treatment with avelumab. Severe infusion-related reactions have been reported. All patients should receive premedication with an anti-histamine and paracetamol prior to the first 4 infusions of avelumab. Further premedication is at the discretion of the treating physician.
Nausea and vomiting

Read more about prevention of treatment induced nausea and vomiting
Anaemia

Abnormally low levels of red blood cells (RBCs) or haemoglobin in the blood. 

Read more about anaemia
Fatigue

Read more about fatigue
Anorexia

Loss of appetite accompanied by decreased food intake.

Read more about anorexia

The evidence supporting this protocol is provided by a phase 3 multicentre international randomised trial (JAVELIN Bladder 100) involving 700 patients comparing best supportive care (BSC) and maintenance avelumab with BSC alone, in patients with unresectable locally advanced or metastatic urothelial cell carcinoma, who had not progressed after 4-6 cycles of first-line platinum-based chemotherapy.r

Between May 2016 and June 2019, 350 patients were randomised to receive BSC and avelumab (10 mg/kg two weekly until progression or toxicity), commencing within 4 to 10 weeks of platinum-based chemotherapy and 350 patients were randomised to receive BSC alone.

The primary end point was overall survival (OS), which was assessed in the overall population, and in the PD-L1-positive. Secondary end points were progression-free survival (PFS), objective response (ORR), time to response, duration of response, disease control, and safety.

Maintenance avelumab plus BSC significantly prolonged OS, as compared with BSC alone, among patients with urothelial cell carcinoma who had disease that had not progressed with first-line chemotherapy.

Efficacy

After a median follow up of 19 months, the median OS in the overall population was 21.4 months in the avelumab group and 14.3 months in the BSC alone arm (HR 0.69; 95% CI 0.56-0.86; P=0.001). 1 year overall survival was 71.3% in the avelumab arm vs 58.4% in the BSC arm.r 

Avelumab significantly prolonged progression free survival with median PFS 3.7 months in the avelumab arm vs 2.0 months in the BSC arm (HR 0.62; 95% CI 0.52-0.75). 

ORR was 9.7% (6% complete response, 3.7% partial response) in the avelumab arm vs 1.4% with BSC alone. Disease control rate was 41.1% in the avelumab arm vs 27.4% in the BSC arm.r

Kaplan-meier estimates of OS in the overall populationr

© N Engl J Med 2020

Kaplan-meier estimates PFS in the overall populationr

© N Engl J Med 2020

There were no reported clinically significant differences in quality of life scores or patient reported outcomes between groups.r

Toxicity

All cause adverse events occurred in 98.0% of the group receiving avelumab compared with 77.7% in the control group, grade 3 or above adverse events incidence was 47.4% and 25.2% respectively. There were two treatment-related deaths (0.6%) in the avelumab arm which were attributed to the trial treatment (urosepsis/possible central venous catheter infection and ischemic/thrombosis-related events).r

Adverse events (safety population) r

© N Engl J Med 2020

[%id%]
[%title%]

Flinders Filters has partnered with eviQ to build reliable, robust search filters to retrieve core high level evidence on topics of significance to eviQ. The project goal is the provision of a sustainable model for evidence retrieval to ensure ongoing currency of content.

These search filters have been developed to retrieve the most up to date evidence from PubMed, in real time, using specifically designed search filters built to meet our needs.

Searches can be used when a protocol is scheduled for review or at any time you choose. Access the Pubmed search opens in a new tab or window.

Specific opens in a new tab or window Balanced opens in a new tab or window Sensitive opens in a new tab or window
restricted to retrieving randomised control trials and systematic reviews.

is the middle ground between sensitive and specific searches.

retrieves all clinically relevant evidence - generally a broader search on a given topic.

Access Flinders Filters opens in a new tab or window, a division of the Flinders Digital Health Research Centre at Flinders University to read more about research solutions to searching problems.

Troubleshooting

Occasionally the searches may not display correctly or take too long to load (and will eventually timeout). This may be caused by Internet Explorer being unable to handle long URL's. You can rectify this by using Firefox, Safari or Google chrome. It is always a good idea to clear the cache regularly to ensure you are getting the most up to date search.

Feedback

If you identify any new articles that you believe should be included in the content, please use the feedback button below to inform us of the name of the article(s). 

Version 4

Date Summary of changes
27/07/2023

Protocol updated with ADDIKD guideline recommendations. 

PDF of previous protocol.

Version number changed to V.4.
08/03/2024 Protocol reviewed electronically by Urogenital Medical Oncology Reference Committee. No updates required. Next review in 4 years. 
04/03/2024 Patient information side effects preamble updated to include examples of 'common, less common and rare' side effects following consensus at the immunotherapy and skin reference committee meeting held on 23rd of February 2024.

Version 3

Date Summary of changes
30/09/2022

Protocol reviewed electronically by medical oncology reference committee. Efficacy updated with quality of life information and reference.

Version number increased to V.3. Next review in 2 years.
04/10/2022 Drug status updated.

Version 2

Date Summary of changes
13/04/2022

Protocol updated based on the consensus gained at the immunotherapy reference committee meeting held on 4th of March 2022. The following changes have been made across all immune checkpoint inhibitor protocols:

  • Clinical information- general irAEs, hepatitis and HIV, and fertility blocks updated. Individual irAE-related blocks removed. New block (baseline investigations) added.
  • Patient information- pregnancy and breastfeeding block in general advice section updated.

Version number increased to V.2. 
20/09/2022 Blood tests in clinical information section updated to remove information about CTLA-4 containing regimens.

Version 1

Date Summary of changes
22/10/2021 New protocol discussed at Medical Oncology Reference Committee meeting.
30/11/2021 Protocol approved and published on eviQ. Review in 1 year.

The information contained in this protocol is based on the highest level of available evidence and consensus of the eviQ reference committee regarding their views of currently accepted approaches to treatment. Any clinician (medical oncologist, haematologist, radiation oncologist, medical physicist, radiation therapist, pharmacist or nurse) seeking to apply or consult this protocol is expected to use independent clinical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. While eviQ endeavours to link to reliable sources that provide accurate information, eviQ and the Cancer Institute NSW do not endorse or accept responsibility for the accuracy, currency, reliability or correctness of the content of linked external information sources. Use is subject to eviQ’s disclaimer available at www.eviQ.org.au

Send feedback for this page

First approved:
Last reviewed:
Review due:

The currency of this information is guaranteed only up until the date of printing, for any updates please check:

https://www.eviq.org.au/p/4037

18 Apr 2025