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Systemic Anti-Cancer Therapy Regimen Library

BR Adjuvant - TCy and trastuzumab [DOCEtaxel, CYCLOPHOSPHamide and trastuzumab]

Treatment Overview

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 specific Supportive Care Factors:

Diarrhoea risk: Anti-diarrhoeals are usually prescribed with this treatment.

Emetogenicity: MEDIUM.

Growth factor support: Recommended for primary prophylaxis.

Hypersensitivity / Infusion related reaction risk: HIGH - routine premedication recommended.

Cycles 2 to 6 - 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 trastuzumab is well tolerated, subsequent doses may be administered over 30 minutes.


Cycle specific Supportive Care Factors:

Diarrhoea risk: Anti-diarrhoeals are usually prescribed with this treatment.

Emetogenicity: MEDIUM.

Growth factor support: Recommended for primary prophylaxis.

Hypersensitivity / Infusion related reaction risk: HIGH - routine premedication recommended.

Cycles 7 to 17 - 21 days - Trastuzumab Q3W Continuation

Cycle length:
21

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


Cycle specific Supportive Care Factors:

Emetogenicity: MINIMAL.

Cycle details

Cycle 1 - 21 days - Loading Dose

Medication Dose Route Days Max Duration
dexamethasone * 8 mg Twice daily oral administration 0, 1, 2
ondansetron 8 mg oral administration 1
DOCEtaxel * 75 mg/m² intravenous 1 60 minutes
CYCLOPHOSPHamide 600 mg/m² intravenous 1 60 minutes
trastuzumab 8 mg/kg intravenous 1 90 minutes
ondansetron 8 mg oral administration 1
pegFILGRASTIM 6 mg subcutaneous injection 2
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 specific Supportive Care Factors:

Diarrhoea risk: Anti-diarrhoeals are usually prescribed with this treatment.

Emetogenicity: MEDIUM.

Growth factor support: Recommended for primary prophylaxis.

Hypersensitivity / Infusion related reaction risk: HIGH - routine premedication recommended.

Cycles 2 to 6 - 21 days - Maintenance Dose

Medication Dose Route Days Max Duration
dexamethasone * 8 mg Twice daily oral administration 0, 1, 2
ondansetron 8 mg oral administration 1
DOCEtaxel * 75 mg/m² intravenous 1 60 minutes
CYCLOPHOSPHamide 600 mg/m² intravenous 1 60 minutes
trastuzumab 6 mg/kg intravenous 1 90 minutes
ondansetron 8 mg oral administration 1
pegFILGRASTIM 6 mg subcutaneous injection 2
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 trastuzumab is well tolerated, subsequent doses may be administered over 30 minutes.


Cycle specific Supportive Care Factors:

Diarrhoea risk: Anti-diarrhoeals are usually prescribed with this treatment.

Emetogenicity: MEDIUM.

Growth factor support: Recommended for primary prophylaxis.

Hypersensitivity / Infusion related reaction risk: HIGH - routine premedication recommended.

Cycles 7 to 17 - 21 days - Trastuzumab Q3W Continuation

Medication Dose Route Days Max Duration
trastuzumab 6 mg/kg intravenous 1 90 minutes

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


Cycle specific Supportive Care Factors:

Emetogenicity: MINIMAL.

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.
ondansetron 8 mg oral administration
Instructions:
ONE hour prior to chemotherapy.
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.
CYCLOPHOSPHamide 600 mg/m² intravenous 60 minutes
trastuzumab 8 mg/kg intravenous 90 minutes
ondansetron 8 mg oral administration
Instructions:
EIGHT hours after chemotherapy OR before bed.
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.
pegFILGRASTIM 6 mg subcutaneous injection

Cycles 2 to 6 - 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.
ondansetron 8 mg oral administration
Instructions:
ONE hour prior to chemotherapy.
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.
CYCLOPHOSPHamide 600 mg/m² intravenous 60 minutes
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.
ondansetron 8 mg oral administration
Instructions:
EIGHT hours after chemotherapy OR before bed.
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.
pegFILGRASTIM 6 mg subcutaneous injection

Cycles 7 to 17 - 21 days - Trastuzumab Q3W Continuation

Day: 1

Medication Dose Route Max duration Details
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.

Supportive Care Factors

Factor Value
Diarrhoea risk: Variable
Emetogenicity: Variable
Growth factor support: Variable
Hypersensitivity / Infusion related reaction risk: Variable

References

1. Jones, S. E., M. A. Savin, F. A. Holmes, et al. 2006. "Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer." J Clin Oncol. 24(34):5381-5387, PMID: 17135639

2. Jones, S., F. A. Holmes, J. O'Shaughnessy, et al. 2009. "Docetaxel With Cyclophosphamide Is Associated With an Overall Survival Benefit Compared With Doxorubicin and Cyclophosphamide: 7-Year Follow-Up of US Oncology Research Trial 9735." J Clin Oncol 27(8):1177-1183, PMID: 19204201

3. Takabatake, D., N. Taira, F. Hara, et al. 2009. "Feasibility study of docetaxel with cyclophosphamide as adjuvant chemotherapy for Japanese breast cancer patients." Jpn J Clin Oncol 39(8):478-483.

4. Slamon, D., W. Eiermann, N. Robert, et al. 2011. "Adjuvant trastuzumab in HER2-positive breast cancer." N Engl J Med 365(14):1273-1283., PMID: 21991949

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. 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., PMID: 25089112

8. 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.

9. 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

10. 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

11. 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.