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Breast metastatic everolimus and exemestane

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Drug Dose Route
Everolimus 10 mg ONCE a day PO
Exemestane 25 mg ONCE a day PO

Continuous until disease progression or unacceptable toxicity

Notes:

This is a potentially toxic treatment and requires close monitoring of side effects.

Drug status:

Exemestane is a PBS restricted benefit opens in a new tab or window

Everolimus is PBS authority opens in a new tab or window

Everolimus is available as 5 mg and 10 mg tablets and exemestane as 25 mg tablets.

Cost:
~ $1,680 per month "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.

Continuous treatment
Everolimus 10 mg (PO) ONCE a day

with or without food
Exemestane 25 mg (PO) ONCE a day with or after food

Continuous until disease progression or unacceptable toxicity

Drug Dose Route
Everolimus 10 mg ONCE a day PO
Exemestane 25 mg ONCE a day PO

Continuous until disease progression or unacceptable toxicity

Notes:

This is a potentially toxic treatment and requires close monitoring of side effects.

Drug status:

Exemestane is a PBS restricted benefit opens in a new tab or window

Everolimus is PBS authority opens in a new tab or window

Everolimus is available as 5 mg and 10 mg tablets and exemestane as 25 mg tablets.

Cost:
~ $1,680 per month "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.

Continuous treatment
Everolimus 10 mg (PO) ONCE a day

with or without food
Exemestane 25 mg (PO) ONCE a day with or after food

Continuous until disease progression or unacceptable toxicity

Indication:

  • hormone-receptor positive, HER-2 negative advanced breast cancer in post-menopausal women after failure of treatment with letrozole or anastrozole

Exclusion:

  • history of hepatitis B or C, or human immunodeficiency virus (HIV) infection.
Caution with oral anti-cancer drugs

Select links for information on the safe prescribing, dispensing and administration of orally administered anti-cancer drugs. 

Read more about at COSA guidelines for the safe prescribing, dispensing and administration of systemic cancer therapy opens in a new tab or window and oral anti-cancer therapy opens in a new tab or window
Emetogenicity minimal or low

No routine prophylaxis required. If patients experience nausea and/or vomiting, consider using the low emetogenic risk regimen.

Read more about preventing anti-cancer therapy induced nausea and vomiting
Oral mucositis

Oral mucositis is a common side effect with this treatment and may manifest as mouth and tongue ulceration.

Early intervention may help to avoid dose alteration or interruption. Topical treatments (alcohol free) are recommended. Pre-emptive use of a steroid-based mouthwash has been shown to reduce the incidence and severity of oral mucositis in patients receiving everolimus.rr

Read more about oral mucositis and stomatitis
Infections

Patients may be immunosuppressed and should be carefully observed for the occurrence of infections, including opportunistic infections.
Pneumonitis

There have been cases of non-specific interstitial pneumonitis, including rare fatal reports, occurring in patients who have received this treatment.

Read more about pulmonary toxicity associated with anti-cancer drugs.
Wound healing

This treatment may impair wound healing and temporary interruption of treatment is recommended in patients undergoing major surgical procedures. Resume treatment based on clinical judgement of adequate wound healing.
Hyperglycaemia

Hyperglycaemia has been observed with this treatment. Close monitoring of blood sugar levels is recommended. Initiation of antidiabetic therapy may be required. In patients with pre-existing diabetes, dose adjustment of oral antidiabetic medications or insulin may be required.
Hyperlipidaemia

Hyperlipidaemia is a common adverse event. Dose adjustment or initiation of lipid-lowering agents may be required.
Tendon disorders

Tendonitis and tenosynovitis have been reported in patients receiving third generation aromatase inhibitors. Although rare, tendon rupture can also occur. Monitor patients for symptoms of tendonitis and tenosynovitis.
Blood tests

FBC, EUC, eGFR, LFTs, calcium, magnesium, phosphate and BSL at baseline and repeat monthly or as clinically indicated. Lipid studies every 6 to 8 weeks.
Hepatitis B screening and prophylaxis

Routine screening for HBsAg and anti-HBc is NOT usually recommended for patients receiving this treatment.

Read more about hepatitis B screening and prophylaxis in cancer patients requiring cytotoxic and/or immunosuppressive therapy
Vaccinations

Live vaccines are contraindicated in cancer patients receiving immunosuppressive therapy and/or who have poorly controlled malignant disease. Possible suboptimal response to inactivated vaccines.

For more information about vaccinations in people with cancer refer to the Australian Immunisation Handbook 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.

Note: Treatment was discontinued permanently in patients who required more than two dose reductions and in those who had treatment interruptions lasting more than 4 weeks.r

Haematological toxicity
ANC x 109/L (pre-treatment blood test)
1.0 to less than 1.5 Refer to local institutional guidelines; it is the view of the expert clinicians that treatment should continue if patient is clinically well
0.5 to less than 1.0 Delay treatment until recovery
less than 0.5 Delay treatment until recovery and consider reducing everolimus to 5 mg once a day for subsequent cycles
Febrile neutropenia Delay treatment until recovery and consider reducing everolimus to 5 mg once a day for subsequent cycles
Platelets x 109/L (pre-treatment blood test)
75 to less than 100 The general recommendation is to delay, however if the patient is clinically well it may be appropriate to continue treatment; refer to treating team and/or local institutional guidelines
50 to less than 75 Delay treatment until recovery
25 to less than 50 Delay treatment until recovery and consider reducing everolimus to 5 mg once a day for subsequent cycles
less than 25 Omit everolimus
Kidney dosing recommendations 
  • Suggested dose modifications are based on the International Consensus Guideline on Anticancer Drug Dosing in Kidney Dysfunction (ADDIKD).
  • Where one or more drugs in a protocol is recommended to be avoided, consider using a clinically appropriate alternative treatment protocol instead.
  • Before dose adjusting or omitting a drug, consider treatment intent.
  • In kidney replacement therapy consult a multidisciplinary team consisting of oncology/haematology with nephrology and/or clinical pharmacology for the management of dosing. 
  • For complete information on individual drug recommendations please review the individual drug monograph in the ADDIKD guideline.
eGFR
(mL/min/1.73m2)		 Everolimus Exemestane*
≥ 60

Full dose

No dose reduction required in kidney dysfunction.

 

 

 

 

 

 

 

 

 
45 - 59

Full dose

Increased risk of renal adverse events
30 - 44

Full dose

Increased risk of renal adverse events
15 - 29

Full dose

Increased risk of renal adverse events
< 15
(without kidney replacement therapy)

Consult a multidisciplinary team consisting of oncology/haematology with nephrology and/or clinical pharmacology for the management of dosing.
* This drug was not included in the ADDIKD guideline.
Hepatic impairment
Hepatic dysfunction
Mild No dose modifications necessary
Moderate Reduce everolimus to 5 mg once a day
Severe Omit everolimus
Mucositis and stomatitis
  • Pre-emptive use of a steroid-based mouthwash may help the patient avoid dose alteration or interruption
  • Manage with topical analgesic mouth treatments (e.g. benzocaine, lignocaine etc.) with or without topical corticosteroids (i.e. triamcinolone oral paste)
  • Avoid using agents containing alcohol, hydrogen peroxide, iodine and thyme derivatives
Grade 2 Delay treatment until toxicity has resolved to Grade 1 or less and reduce the dose for subsequent cycles as follows:
1st occurrence: No dose reduction
2nd occurrence: Reduce everolimus to 5 mg once a day
3rd occurrence: Reduce everolimus to 5 mg on alternate days
4th occurrence: Discontinue everolimus
Grade 3 Delay treatment until toxicity has resolved to Grade 1 or less and reduce the dose for subsequent cycles as follows:
1st occurrence: Reduce everolimus to 5 mg once a day 
2nd occurrence: Discontinue everolimus
Grade 4 Discontinue everolimus
Diarrhoea
Grade 2 Delay treatment until toxicity has resolved to Grade 1 or less and reduce the dose for subsequent cycles as follows:
1st occurrence: No dose reduction
2nd occurrence: Reduce everolimus to 5 mg once a day 
3rd occurrence: Reduce everolimus to 5 mg on alternate days
4th occurrence: Discontinue everolimus
Grade 3 Delay treatment until toxicity has resolved to Grade 1 or less and reduce the dose for subsequent cycles as follows:
1st occurrence: Reduce everolimus to 5 mg once a day 
2nd occurrence: Discontinue everolimus
Grade 4 Discontinue everolimus
Pneumonitis (non-infectious)
Grade 2 Delay treatment until toxicity has resolved to Grade 1 or less and reduce the dose for subsequent cycles as follows:
1st occurrence: Reduce everolimus to 5 mg once a day
2nd occurrence: Discontinue everolimus
Grade 3 or Grade 4 Discontinue everolimus

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.

Everolimus
  Interaction Clinical management
Nephrotoxic drugs (e.g. aminoglycosides, amphotericin, contrast dye, frusemide, NSAIDs) Additive nephrotoxicity Avoid combination or monitor kidney function closely
CYP3A4 and P-gp inhibitors (e.g. amiodarone, aprepitant, azole-antifungals, ritonavir, lapatinib, nilotinib, sorafenib, macrolides, ciclosporin, grapefruit juice etc.) Increased toxicity of everolimus possible due to reduced clearance Avoid combination or monitor for everolimus toxicity.

If concomitant use cannot be avoided, consider reducing everolimus dose based on careful monitoring of tolerability.
CYP3A4 and P-gp inducers (e.g. carbamazepine, phenytoin, phenobarbitone, rifampicin, St John's wort, dexamethasone etc.) Reduced efficacy of everolimus possible due to increased clearance Avoid combination or monitor for decreased clinical response to everolimus.

If concomitant use cannot be avoided, consider increasing everolimus dose based on careful monitoring of tolerability.
Potassium lowering drugs (e.g. thiazide diuretics, amphotericin) Additive risk of hypokalaemia with everolimus Avoid combination or monitor potassium level and for signs of hypokalaemia.
Exemestane
  Interaction Clinical management
Oestrogen containing therapies Negate the pharmacological action of exemestane Combination contraindicated (minimal use of topical oestrogen therapy for vulvo-vaginal complaints may be considered)
CYP3A4 inducers (e.g. carbamazepine, phenytoin, phenobarbitone, rifampicin, St John's wort etc.) Reduced efficacy of exemestane possible due to increased clearance Caution advised if combination used - monitor for decreased clinical response to exemestane
General
  Interaction Clinical management
Antiplatelet agents and NSAIDs Increased risk of bleeding due to treatment related thrombocytopenia. Avoid or minimise combination.
If combination deemed essential, (e.g. low dose aspirin for ischaemic heart disease) monitor for signs of bleeding.
Serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs e.g. paroxetine) and serotonin noradrenaline reuptake inhibitors (SNRIs e.g. venlafaxine) Increased risk of serotonin syndrome with concurrent use of 5-HT3 receptor antagonists (e.g. palonosetron, ondansetron, granisetron, tropisetron, dolasetron, etc.) Avoid combination.
If combination is clinically warranted, monitor for signs and symptoms of serotonin syndrome (e.g. confusion, agitation, tachycardia, hyperreflexia).
For more information link to TGA Medicines Safety Update. opens in a new tab or window

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.

Administration

This is a continuous oral treatment

Pre treatment assessment

Any toxicity grade 2 or greater may require dose reduction, delay or omission of treatment and review by medical officer before commencing treatment.

Anti-cancer drug patient assessment tool prior to each day of treatment.

Pre treatment medication

Verify antiemetics taken or administer as prescribed.

Everolimus

Administer everolimus:
  • orally ONCE a day, at the same time every day (preferably in the morning)
  • to be swallowed whole with a glass of water; do not break, crush or chew
  • may be taken with food or without food (advise to take consistently with regard to food)
  • if difficulty is experienced swallowing the tablet advise patient to:
    • place tablet in a glass with approx 30 mL water
    • stir or shake gently, the tablet will disperse in about 7 minutes
    • drink straight away
    • rinse glass with 30 mL and drink remaining residual drug.

Note: missed doses may be taken up to 6 hours after regularly scheduled time; if  more than 6 hours, resume at next regularly scheduled time.

Exemestane

Administer exemestane:
  • orally ONCE a day
  • to be swallowed whole with a glass of water; do not break, crush or chew
  • to be taken with or immediately after food
  • if nausea develops, take after food at night

Note: missed doses should not be replaced; if a dose is forgotten or vomited, normal dosing should be resumed at the next scheduled dose.

Post administration

Continue safe handling precautions (reproductive risk only) for 7 days after completion of drug(s).

Discharge information

Discharge medications

Everolimus and exemestane tablets - with written instructions on how to take them.

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.

Immediate (onset hours to days)
Nausea and vomiting

Read more about prevention of treatment induced nausea and vomiting
Headache

Early (onset days to weeks)
Neutropenia

Abnormally low levels of neutrophils in the blood. This increases the risk of infection. Any fever or suspicion of infection should be investigated immediately and managed aggressively. 

Read more about immediate management of neutropenic fever
Thrombocytopenia

A reduction in the normal levels of functional platelets, increasing the risk of abnormal bleeding.  

Read more about thrombocytopenia
Oral mucositis

Erythematous and ulcerative lesions of the gastrointestinal tract (GIT). It commonly develops following chemotherapy, radiation therapy to the head, neck or oesophagus, and high dose chemotherapy followed by a blood and marrow transplant (BMT).

Pre-emptive use of a steroid-based mouth wash has been shown to reduce the incidence and severity of oral mucositis and may help to avoid dose alteration or interruption in patients receiving this treatment.

Read more about oral mucositis
Anorexia

Loss of appetite accompanied by decreased food intake.

Read more about anorexia
Diarrhoea

Read more about treatment induced diarrhoea
Fatigue

Read more about fatigue
Hot flushes
Hyperglycaemia

High blood sugar, an excess of glucose in the blood stream.
Hyperlipidaemia and hypercholesterolaemia

Abnormally elevated levels of lipids and cholesterol in the blood.
Skin rash

Anti-cancer drugs can cause a number of changes in the skin with maculo-papular rash the most common type of drug-induced skin reaction. 

Read more about skin rash
Fluid retention and oedema

An excess amount of fluid around the cells, tissues or serous cavities of the body, leading to swelling.
Pulmonary toxicity

Pulmonary toxicity may include damage to the lungs, airways, pleura and pulmonary circulation. 

Read more about pulmonary toxicity associated with anti-cancer drugs
Hepatotoxicity

Anti-cancer drugs administered either alone or in combination with other drugs and/or radiation therapy may cause direct or indirect hepatotoxicity. Hepatic dysfunction can alter the metabolism of some drugs resulting in systemic toxicity.
Nephrotoxicity

Kidney dysfunction resulting from damage to the glomeruli, tubules or renal vasculature.

Late (onset weeks to months)
Anaemia

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

Read more about anaemia
Arthralgia and myalgia

Generalised joint pain or and/or stiffness and muscle aches, often worse upon waking or after long periods of inactivity. Can improve with movement. May be mild or severe, intermittent or constant and accompanied by inflammation. 

Read more about arthralgia and myalgia
Periorbital oedema

Accumulation of fluid in the tissue surrounding the eye sockets (orbits).
Mood changes
Tendonitis and tendon rupture

Uncommonly tendonitis, tenosynovitis, trigger finger and tendon rupture (rare) may occur.

The evidence supporting this protocol is provided by BOLERO-2, a phase III, double-blind, placebo-controlled, multicentre international randomised trial (2:1 ratio) involving 724 patients comparing everolimus (10 mg/day) and exemestane (25 mg/day) with exemestane alone in patients with hormone-receptor-positive advanced breast cancer who had recurrence or progression while receiving previous therapy with a nonsteroidal aromatase inhibitor in the adjuvant setting or to treat advanced disease.r

The primary end point was progression-free survival. Secondary end points were overall survival, overall response rate, and safety.

Everolimus combined with exemestane improved progression-free survival in patients with hormone-receptor-positive advanced breast cancer previously treated with nonsteroidal aromatase inhibitors. Response rates were also superior in patients treated with combination therapy. Overall survival results were immature at the time of interim analysis.r,r

Efficacy

Final progression-free survival analysis by central assessment revealed a PFS benefit of 6.9 months with combination therapy (11.0 months for everolimus in combination with exemestane versus 4.1 months for exemestane alone; HR 0.38 (95%CI 0.31-0.48); log-rank p < 0.0001). Everolimus and exemestane treatment substantially extended PFS benefits compared with exemestane alone regardless of baseline disease or prior therapy characteristics.r At the time of analysis, fewer deaths were reported with combination therapy than in patients treated with exemestane alone (25.4% vs 32.2%). A final analysis of overall survival is planned after 398 events. Improvements were also observed in overall response, objective response rate and clinical benefit rate.r

Kaplan-Meier estimates progression-free survival r

© Adv Ther 2013

Overall survival and tumour responser

© AdvTher 2013

Toxicity

Adverse events r

© New England Journal of Medicine 2012

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Version 6

Date Summary of changes
05/06/2024

Protocol assessed by eviQ medical oncology reference committee and deemed suitable to be reviewed as required. Flag added, review date removed and version number increased to V.6. Read more about as required review protocol status in this factsheet.

Version 5

Date Summary of changes
19/07/2023

Protocol updated with ADDIKD guideline recommendations. New kidney dosing recommendation table added to dose modification section.

PDF of previous protocol.

Version number changed to V.5.
05/12/2023

Protocol reviewed electronically by Medical Oncology Reference Committee. No changes. Next review 4 years.

Version 4

Date Summary of changes
21/12/2021 Changed antiemetic clinical information block to minimal or low, to align with new categories. See ID 7 Prevention of anti-cancer therapy induced nausea and vomiting (AINV) v5. Metoclopramide removed from treatment schedule. Version number changed to V.4.

Version 3

Date Summary of changes
09/05/2014 New protocol taken to Medical Oncology Reference Committee meeting.
16/06/2014 Approved and published on eviQ.
22/06/2015 Protocol reviewed electronically by Medical Oncology Reference committee. No changes and next review in 2 years.
31/05/2017 Transferred to new eviQ website. Protocol version number changed to V.2.
Hepatitis B screening changed to NOT recommended.
03/11/2017 Protocol reviewed at Medical Oncology Reference Committee meeting. 
Clinical information and side effects updated - pre-emptive use of steroid-based mouthwash added to mucositis information.
Review protocol in 2 years.
10/05/2018 Haematological dose modifications updated as per consensus of the expert clinician group. Version number changed to V.3.
23/09/2019 Protocol reviewed at Medical Oncology Reference Committee meeting on 30/08/2019. No changes. Next review in 2 years.
13/08/2021 Protocol reviewed electronically by Medical Oncology Reference Committee. Nil changes. Review in 2 years.

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

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First approved:
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Review due:
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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/1590

14 May 2025