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Systemic Anti-Cancer Therapy Regimen Library

BR Metastatic - DOCEtaxel, pERTUZumab and trastuzumab

Treatment Overview

PERTUZumab and trastuzumab may continue after DOCEtaxel has been discontinued until disease progression or toxicity.


This regimen contains a biological anti-cancer medicine where one or more biosimilars may exist. These have been reviewed by the regulator (Medsafe) and by haematologists and/or oncologists nationally. Where haematologists and/or oncologists have agreed that there are no clinically significant differences in either safety or effectiveness between a biosimilar and originator product, these drugs may be used interchangeably. If a prescriber thinks there is a difference, then a specific brand will be named when prescribing.

Cycle 1 - 21 days - Loading Dose

Cycle length:
21

Some centres may wish to replace the three oral doses of dexamethasone 8 mg premedication with a single intravenous dose of dexamethasone 20 mg prior to DOCEtaxel infusion.

Cycle 2 (and all further cycles) - 21 days - Maintenance Dose

Cycle length:
21

Some centres may wish to replace the three oral doses of dexamethasone 8 mg premedication with a single intravenous dose of dexamethasone 20 mg prior to DOCEtaxel infusion.

If the initial loading dose of pERTUZumab is well tolerated, subsequent doses may be administered over 30 minutes.

If the initial loading dose of trastuzumab is well tolerated, subsequent doses may be administered over 30 minutes.

Cycle details

Cycle 1 - 21 days - Loading Dose

Medication Dose Route Days Max Duration
dexamethasone * 8 mg Twice daily oral administration 0, 1, 2
pERTUZumab 840 mg intravenous 1 60 minutes
trastuzumab * 8 mg/kg intravenous 1 90 minutes
DOCEtaxel * 75 mg/m² intravenous 1 60 minutes
domperidone 10 mg Three times daily oral administration 1
loperamide 2 mg oral administration 1

Some centres may wish to replace the three oral doses of dexamethasone 8 mg premedication with a single intravenous dose of dexamethasone 20 mg prior to DOCEtaxel infusion.

Cycle 2 (and all further cycles) - 21 days - Maintenance Dose

Medication Dose Route Days Max Duration
dexamethasone * 8 mg Twice daily oral administration 0, 1, 2
pERTUZumab 420 mg intravenous 1 60 minutes
trastuzumab * 6 mg/kg intravenous 1 90 minutes
DOCEtaxel * 75 mg/m² intravenous 1 60 minutes
domperidone 10 mg Three times daily oral administration 1
loperamide 2 mg oral administration 1

Some centres may wish to replace the three oral doses of dexamethasone 8 mg premedication with a single intravenous dose of dexamethasone 20 mg prior to DOCEtaxel infusion.

If the initial loading dose of pERTUZumab is well tolerated, subsequent doses may be administered over 30 minutes.

If the initial loading dose of trastuzumab is well tolerated, subsequent doses may be administered over 30 minutes.

Full details

Cycle 1 - 21 days - Loading Dose

Day: 0

Medication Dose Route Max duration Details
dexamethasone * 8 mg Twice daily oral administration
Instructions:
Take with food.

Day: 1

Medication Dose Route Max duration Details
dexamethasone * 8 mg Twice daily oral administration
Instructions:
Take with food.
pERTUZumab 840 mg intravenous 60 minutes
Instructions:
An observation period of 60 minutes post-infusion is recommended prior to administration of further systemic anti-cancer treatment.
trastuzumab * 8 mg/kg intravenous 90 minutes
DOCEtaxel * 75 mg/m² intravenous 60 minutes
Instructions:
Prepare solution in PVC-free bag and administer via polyethylene lined administration set. Please carry out graded challenge as per institutional policy.
domperidone 10 mg Three times daily oral administration
Instructions:
When required for nausea and/or vomiting. The choice of rescue antiemetic may be substituted to reflect institutional policy or individual patient characteristics.
loperamide 2 mg oral administration
Instructions:
Take TWO capsules (=4 mg) at onset of loose bowel motions and a further ONE capsule (=2 mg) for every loose bowel motion (maximum of EIGHT capsules in 24 hours), or use as directed by oncologist or haematologist.

Day: 2

Medication Dose Route Max duration Details
dexamethasone * 8 mg Twice daily oral administration
Instructions:
Take with food.

Cycle 2 (and all further cycles) - 21 days - Maintenance Dose

Day: 0

Medication Dose Route Max duration Details
dexamethasone * 8 mg Twice daily oral administration
Instructions:
Take with food.

Day: 1

Medication Dose Route Max duration Details
dexamethasone * 8 mg Twice daily oral administration
Instructions:
Take with food.
pERTUZumab 420 mg intravenous 60 minutes
Instructions:
If the initial loading dose is well tolerated, subsequent doses may be administered over 30 minutes. An observation period of 30 minutes (or 60 minutes if previous reaction) post-infusion is recommended prior to administration of further systemic anti-cancer treatment.
trastuzumab * 6 mg/kg intravenous 90 minutes
Instructions:
If the initial loading dose of trastuzumab is well tolerated, subsequent doses may be administered over 30 minutes.
DOCEtaxel * 75 mg/m² intravenous 60 minutes
Instructions:
Prepare solution in PVC-free bag and administer via polyethylene lined administration set. Please carry out graded challenge as per institutional policy.
domperidone 10 mg Three times daily oral administration
Instructions:
When required for nausea and/or vomiting. The choice of rescue antiemetic may be substituted to reflect institutional policy or individual patient characteristics.
loperamide 2 mg oral administration
Instructions:
Take TWO capsules (=4 mg) at onset of loose bowel motions and a further ONE capsule (=2 mg) for every loose bowel motion (maximum of EIGHT capsules in 24 hours), or use as directed by oncologist or haematologist.

Day: 2

Medication Dose Route Max duration Details
dexamethasone * 8 mg Twice daily oral administration
Instructions:
Take with food.

Supportive Care Factors

Factor Value
Diarrhoea risk: Anti-diarrhoeals are usually prescribed with this treatment
Emetogenicity: Low
Hypersensitivity / Infusion related reaction risk: High - routine premedication recommended

References

1. Baselga, J., J. Cortes, S. B. Kim, et al. 2012. "Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer." N Engl J Med 366(2):109-119., PMID: 22149875

2. Swain, S. M., J. Baselga, S. B. Kim, et al. 2015. “Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer.” N Engl J Med 372(8):724-734, PMID: 25693012

3. Swain, S. M., J. Baselga, D. Miles, et al. 2014. "Incidence of central nervous system metastases in patients with HER2-positive metastatic breast cancer treated with pertuzumab, trastuzumab, and docetaxel: results from the randomized phase III study CLEOPATRA." Ann Oncol 25(6):1116-1121, PMID: 24685829

4. Swain, S. M., S. B. Kim, J. Cortes, et al. 2013. "Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA study): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 study." Lancet Oncol 14(6):461-471, PMID: 23602601

5. Pfizer New Zealand Limited. DBL Docetaxel New Zealand Data Sheet 07 August 2020. https://www.medsafe.govt.nz/profs/Datasheet/d/dbldocetaxelinj.pdf (Accessed 26 November 2020)

6. Roche Products (New Zealand) Limited. Herceptin (trastuzumab) New Zealand Data Sheet. https://www.medsafe.govt.nz/profs/Datasheet/h/Herceptininf.pdf (Accessed 16 February 2021)

7. Roche Products (New Zealand) Limited. Perjeta (pertuzumab) New Zealand Data Sheet. https://www.medsafe.govt.nz/profs/Datasheet/p/perjetainf.pdf (Accessed 12 April 2021)

8. Chouhan JD, Herrington JD. Single premedication dose of dexamethasone 20 mg IV before docetaxel administration. J Oncol Pharm Pract. 2011 Sep;17(3):155-9. doi: 10.1177/1078155210367950. Epub 2010 May 6., PMID: 20447949

9. Rogers, E. S., E. Witton, J. Stewart, and D. Porter. "Efficacy and safety of a single dose of dexamethasone pre docetaxel treatment: The Auckland experience." Annals of Oncology 25 (2014): iv537.

10. Boulanger J, Boursiquot JN, Cournoyer G, et al. Management of hypersensitivity to platinum- and taxane-based chemotherapy: cepo review and clinical recommendations. Curr Oncol. 2014;21(4):e630-e641. PubMed ID 25089112

11. Tabernero J, Vyas M, Giuliani R, Arnold D, Cardoso F, Casali PG, Cervantes A, Eggermont AMM, Eniu A, Jassem J, Pentheroudakis G, Peters S, Rauh S, Zielinski CC, Stahel RA, Voest E, Douillard JY, McGregor K, Ciardiello F. Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers. ESMO Open. 2017 Jan 16;1(6):e000142. doi: 10.1136/esmoopen-2016-000142. , PMID: 28848668

12. Lyman GH, Balaban E, Diaz M, Ferris A, Tsao A, Voest E, Zon R, Francisco M, Green S, Sherwood S, Harvey RD, Schilsky RL. American Society of Clinical Oncology Statement: Biosimilars in Oncology. J Clin Oncol. 2018 Apr 20;36(12):1260-1265. doi: 10.1200/JCO.2017.77.4893. Epub 2018 Feb 14. , PMID: 29443651

* The medicines, doses, combinations, and schedule in this treatment regimen have been carefully reviewed against international best practice guidelines by specialists in medical oncology around New Zealand and this advice has been accepted for publication by Te Aho o Te Kahu (the Cancer Control Agency). Sometimes medicines that are used in routine clinical practice have not been through a formal review process by the NZ Medicines Regulator Medsafe and are therefore considered unapproved or off-label. These medicines are legally able to be prescribed through sections 25 and 29 of the Medicines Act and by obtaining informed consent from patients. All treatment regimens listed on this website have been through robust peer review and are considered an accepted standard of care, whether prescribed through sections 25 or 29 or carrying formal Medsafe Approval.

s29: This symbol indicates that some formulations of the associated medicine are legally only able to be prescribed under section 29 of the Medicines Act. You can see which formulations are section 29 by hovering over the s29 symbol. You can access full medication details from the New Zealand Formulary by clicking on the medication name. Each clinician retains full responsibility for ensuring they have complied with all relevant obligations and requirements of section 29 including obtaining informed patient consent prior to prescribing the applicable medicine.