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Non small cell lung cancer metastatic DOCEtaxel weekly

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The supportive therapies (e.g. antiemetics, premedications, 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 to 4

Day 1, 8, 15
Dexamethasone 8 mg (PO) ONCE a day with or after food in the morning of chemotherapy
DOCEtaxel 35 mg/m2 (IV infusion) in 250 mL to 500 mL sodium chloride 0.9% over 60 minutes
Frequency:
28 days 
Cycles:
4 unless otherwise indicated

The supportive therapies (e.g. antiemetics, premedications, 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 to 4

Day 1, 8, 15
Dexamethasone 8 mg (PO) ONCE a day with or after food in the morning of chemotherapy
DOCEtaxel 35 mg/m2 (IV infusion) in 250 mL to 500 mL sodium chloride 0.9% over 60 minutes
Frequency:
28 days 
Cycles:
4 unless otherwise indicated
  • Locally advanced, recurrent or metastatic non small cell lung cancer
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 docetaxel
Premedication

The product information states that premedication is required for this treatment.
Please refer to the treatment schedule for the suggested premedication regimen.
This may be substituted to reflect institutional policy.

Read more about premedication for prophylaxis of taxane hypersensitivity reactions
Emetogenicity LOW

Suggested default antiemetics have been added to the treatment schedule, and may be substituted to reflect institutional policy.

Ensure that patients also have sufficient antiemetics for breakthrough emesis:

Metoclopramide 10 mg three times a day when necessary (maximum of 30 mg/24 hours, up to 5 days) OR

Prochlorperazine 10 mg PO or 12.5 mg IV every 6 hours when necessary.

Read more about preventing antineoplastic induced nausea and vomiting
Peripheral neuropathy

Assess prior to each treatment. If a patient experiences grade 2 or greater peripheral neuropathy, a dose reduction, delay, or omission of treatment may be required; review by medical officer before commencing treatment.

Read more about peripheral neuropathy

Link to chemotherapy-induced peripheral neuropathy screening tool
Blood tests

FBC, EUC and LFTs at baseline and prior to each treatment.
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, including BCG, MMR, zoster and varicella vaccines, are contraindicated in cancer patients receiving immunosuppressive therapy and/or who have poorly controlled malignant disease.

Refer to the recommended schedule of vaccination for immunocompromised patients, as outlined in the Australian Immunisation Handbook.
Effects of cancer treatment on fertility

Cancer treatment can have harmful effects on fertility and this should be discussed with all patients of reproductive age prior to commencing treatment.

Read more about the effect of cancer treatment on fertility
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 antineoplastic 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 and reference committee consensus. Non-haematological gradings are based on Common Terminology Criteria for Adverse Events (CTCAE) unless otherwise specified. Renal and hepatic dose modifications have been standardised where possible. For more information see dosing considerations & disclaimer.

Note: All dose reductions are calculated as a percentage of the starting dose

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 reduce docetaxel by 25% for subsequent cycles
Febrile neutropenia Delay treatment until recovery and reduce docetaxel by 25% 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
less than 50 Delay treatment until recovery and reduce docetaxel by 25% for subsequent cycles
Renal impairment
No dose modifications necessary
Hepatic impairment
Hepatic dysfunction
Minimal Reduce docetaxel by 25%
Mild Reduce docetaxel by 50%
Moderate/Severe Omit docetaxel
Peripheral neuropathy
Grade 2 which is present at the start of the next cycle Reduce docetaxel by 25%; if persistent, reduce docetaxel by 50%
Grade 3 or Grade 4 Omit docetaxel
Mucositis and stomatitis
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 docetaxel by 25%
3rd occurrence: Reduce docetaxel by 50%
4th occurrence: Omit docetaxel
Grade 3 or Grade 4 Delay treatment until toxicity has resolved to Grade 1 or less and reduce the dose for subsequent cycles as follows:
1st occurrence: Reduce docetaxel by 50%
2nd occurrence: Omit docetaxel

References & Disclaimer

Docetaxel
  Interaction Clinical management
CYP3A4 and P-gp inhibitors (e.g. amiodarone, aprepitant, azole-antifungals, ritonavir, lapatinib, nilotinib, sorafenib, macrolides, ciclosporin, grapefruit juice etc.) Increased toxicity of docetaxel possible due to reduced clearance Avoid combination or monitor for docetaxel toxicity
CYP3A4 inducers (e.g. carbamazepine, phenytoin, phenobarbitone, rifampicin, St John’s wort etc.) Reduced efficacy of docetaxel possible due to increased clearance Avoid combination or monitor for decreased clinical response to docetaxel
General
  Interaction Clinical management
Warfarin Antineoplastic agents may alter the anticoagulant effect of warfarin Monitor INR regularly and adjust warfarin dosage as appropriate; consider alternative anticoagulant (e.g. LMWH or unfractionated heparin)
Direct oral anticoagulants (DOACs) e.g. apixaban, rivaroxaban, dabigatran

Interaction with both CYP3A4 and P-gp inhibitors /inducers.

DOAC and antineoplastic levels may both be altered, possibly leading to loss of efficacy or toxicity (i.e. increased bleeding).

Apixaban: avoid concurrent use with strong CYP3A4 and P‑gp inhibitors. If treating VTE, avoid use with strong CYP3A4 and P‑gp inducers. 

Rivaroxaban: avoid concurrent use with strong CYP3A4 and P‑gp  inhibitors.

Dabigatran: avoid combination with strong P‑gp inducers and inhibitors.

If concurrent use is unavoidable, monitor closely for efficacy/toxicity of both drugs.
Digoxin Antineoplastic agents can damage the lining of the intestine; affecting the absorption of digoxin Monitor digoxin serum levels; adjust digoxin dosage as appropriate
Antiepileptics Both altered antiepileptic and antineoplastic levels may occur, possibly leading to loss of efficacy or toxicity Where concurrent use of an enzyme-inducing antiepileptic cannot be avoided, monitor antiepileptic serum levels for toxicity, as well as seizure frequency for efficacy; adjust dosage as appropriate.
Also monitor closely for efficacy of the antineoplastic therapy
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
Vaccines Diminished response to vaccines and increased risk of infection with live vaccines Live vaccines (e.g. BCG, MMR, zoster and varicella) are contraindicated in patients on immunosuppressive therapy. Use with caution in patients on non-immunosuppressive therapy.
For more information; refer to the recommended schedule of vaccination for cancer patients, as outlined in the Australian Immunisation Handbook

Day 1, 8 and 15

Approximate treatment time: 90 minutes

General patient assessment prior to each day of treatment.

Peripheral neuropathy assessment tool

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

Prime IV line(s).

Insert IV cannula or access port or CVC.

Pre treatment medication

Verify premedication taken or administer as prescribed.

Administer antiemetics if required

Docetaxel

Prior to administration:
  • assess patient for fluid retention or weight gain prior to each cycle
    • notify medical officer of any signs of fluid retention or unexplained weight gain.

The medicines information reference publications stipulate the use of non-PVC containing bags and administration sets. However, this is not consistently recommended in the product information, therefore the decision should be at the discretion of the administering unit.

Administer docetaxel  (irritant with vesicant properties):
  • via IV infusion over 60 minutes
  • observe for hypersensitivity reactions
  • flush with ~ 100 mL of sodium chloride 0.9%.

Stop infusion at first sign of reaction:

  • if symptoms are mild and resolve when infusion is stopped, consider recommencing infusion after review by medical officer at a slower rate.
  • for severe reactions seek medical assistance immediately and do not restart infusion.

Remove IV cannula and/or deaccess port or CVC.

Continue safe handling precautions until 7 days after completion of drug(s)

Discharge Information

Antiemetics
  • Antiemetics as prescribed.
Premedication
  • Premedication for next cycle of chemotherapy.
Patient information
  • Ensure patient receives 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)
Hypersensitivity reaction

Anaphylaxis and infusion related reactions can occur with taxanes.

Read more about premedication for prophylaxis of taxane hypersensitivity reactions
Nausea and vomiting

Read more about prevention of treatment induced nausea and vomiting
Taste and smell alteration

Read more about taste and smell changes

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 neutropenia
Thrombocytopenia

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

Read more about thrombocytopenia
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
Oral mucositis

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

Read more about oral mucositis
Fatigue

Read more about fatigue
Skin rash

Antineoplastic agents 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
Ocular changes

Symptoms may include eye pain, blurred vision, blepharitis, uveitis, optic neuritis, tear duct stenosis, conjunctivitis, hyperlacrimation, watery or dry eyes and photophobia. 
Palmar-plantar erythrodysaesthesia (PPE) - hand-foot syndrome (HFS)

Bilateral erythema, tenderness, pain, swelling, tingling, numbness, pruritus, dry rash, or moist desquamation and ulceration of the palms and soles. It is also known as hand-foot syndrome (HFS). Symptoms appear to be dose dependent and palms are affected more than soles.

Read more about hand-foot syndrome associated with chemotherapy
Peripheral neuropathy

Typically symmetrical sensory neuropathy, affecting the fingers and toes, sometimes progressing to the hands and feet.  It is associated with several classes of antineoplastic agents. These include taxanes, platinum-based compounds, vinca alkaloids and some drugs used to treat multiple myeloma.

Read more about peripheral neuropathy
Fluid retention syndrome

Fluid retention, including peripheral oedema and weight gain, may occur with docetaxel treatment. The main risk factor for development is cumulative docetaxel dose. Pre-medication with dexamethasone may be used. Fluid retention will slowly resolve after cessation of treatment.

Read more about fluid retention syndrome associated with docetaxel

Late (onset weeks to months)
Anaemia

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

Read more about anaemia
Alopecia - partial

Hair thinning and/or patchy hair loss. Patients can also experience mild to moderate discomfort of the hair follicles, and rarely pain as the hair is falling out.

Read more about alopecia
Nail changes

Hyperpigmentation, paronychia, onycholysis, splinter haemorrhage, pyogenic granuloma formation, subungal haematoma and subungal hyperkeratosis are some of the nail changes associated with antineoplastic treatment.   

Read more about nail toxicities

An Italian randomised study by Gridelli compared weekly docetaxel with the more standard third weekly docetaxel.  The dose used weekly was 33.3 mg/m2 and the Q3 weekly dose was 75 mg/m2.  Most experience has been with a weekly dose of 35 mg/m2.  In this study 220 patients < 75 years were studied.  Quality of life data indicated no difference in the global quality of life scores but there was a difference in favour of the weekly schedule for pain, cough and hair loss.  Response rates and survival were similar.  The three weekly docetaxel was more toxic for leukopenia, neutropenia, febrile neutropenia and hair loss; any grade 3 & 4 haematological toxicity was significantly more frequent in the standard arm (25 versus 6%).r

The study by Baker was a pharmacological study in a small number of patients and concluded that the pharmacokinetics were similar for the weekly and three weekly regimens.r

The results of the Gridelli study were confirmed in a trial by Schuette which compared docetaxel 75 mg/m2 every 3 weeks versus docetaxel 35 mg/m2 weekly for 3 weeks out of 4. Response rates were 12.6% and 10.5%, and median survival 6.3 months and 9.2 months (p=0.07) respectively for the q 3-weekly and weekly schedules. There were significantly lower incidence of grade 3 / 4 anaemia and neutropenia in the weekly arm. This study confirms the equivalent efficacy between the 2 schedules but with reduced toxicity for weekly treatment.r

Efficacy

Survival:r

© Br J Cancer 2004

Toxicity

Adverse eventr Docetaxel 3 weekly Grade 3-4 (%) Docetaxel weekly Grade 3-4 (%) p-value
Anaemia 3 0 0.12
Leukopenia 10 2 0.02
Neutropenia 19 2 <0.0001
Febrile neutropenia 5 0 0.03
Allergy 2 1 0.62
Fatigue 7 6 0.78
Diarrhoea 3 3 0.99

Toxicityr

Schuette showed an increase in nail toxicities with weekly docetaxel and reduced grade 3-4 neutropenia.

© J Clin Oncol 2005

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Version 4

Date Summary of changes
23/07/2007 Patient information updated, new clinical instructions added.
16/12/2008 Review.
28/08/2009 Review, new dose modifications and transferred to eviQ.
02/07/2010 Haematological dose modifications updated ( 20% changed to 25% dose reduction).
12/10/2010 Dose modifications updated: "consider reducing" changed to " reduce".
21/01/2010 New format to allow for export of protocol information.
Protocol version number changed to V.2.
Antiemetics and premedications added to the treatment schedule.
Additional Clinical Information, Key Prescribing table and Key Administration table combined into new section titled Clinical Considerations.
Drug specific information placed behind the drug name link.
14/12/2012 Protocol reviewed at Medical Oncology Reference Committee meeting. CPG link added. No new evidence. Next review in 2 years.
02/09/2014 PHC view removed.
12/09/2014 Protocol reviewed by Medical Oncology Reference Committee. No changes. Next review 2 years.
18/02/2016 Discussed with Medical Oncology Reference Committee Chairs, for review every 5 years. Next review 3 years.
31/05/2017

Transferred to new eviQ website. Version number change to V.3.

Hepatitis B screening changed to NOT recommended.
10/05/2018 Haematological dose modifications updated as per consensus of the expert clinician group. Version number changed to V.4. 

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. Use is subject to eviQ’s disclaimer available at www.eviQ.org.au

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https://www.eviq.org.au/p/224

15 Oct 2019