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Systemic Anti-Cancer Therapy Regimen Library

Home > BR NON-Metastatic - PACLItaxel Q1W, pERTUZumab and trastuzumab Q3W

BR NON-Metastatic - PACLItaxel Q1W, pERTUZumab and trastuzumab Q3W

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

If the initial infusion of PACLItaxel is well tolerated, the clinician may decide at their discretion to taper off and eventually omit dexamethasone premedication. If dexamethasone is omitted, the clinician may consider ondansetron 8 mg ONE hour prior to PACLItaxel infusion for antiemetic cover.

Cycles 2 to 4 - 21 days - Maintenance Dose

Cycle length:
21

If the initial infusion of PACLItaxel is well tolerated, the clinician may decide at their discretion to taper off and eventually omit dexamethasone premedication. If dexamethasone is omitted, the clinician may consider ondansetron 8 mg ONE hour prior to PACLItaxel infusion for antiemetic cover.

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 oral administration 1, 8, 15
loratadine * 10 mg oral administration 1, 8, 15
famotidine * 20 mg oral administration 1, 8, 15
pERTUZumab 840 mg intravenous 1 60 minutes
trastuzumab 8 mg/kg intravenous 1 90 minutes
PACLItaxel * 80 mg/m² intravenous 1, 8, 15 60 minutes
domperidone 10 mg Three times daily oral administration 1
loperamide 2 mg oral administration 1

If the initial infusion of PACLItaxel is well tolerated, the clinician may decide at their discretion to taper off and eventually omit dexamethasone premedication. If dexamethasone is omitted, the clinician may consider ondansetron 8 mg ONE hour prior to PACLItaxel infusion for antiemetic cover.

Cycles 2 to 4 - 21 days - Maintenance Dose

Medication Dose Route Days Max Duration
dexamethasone * 8 mg oral administration 1, 8, 15
loratadine * 10 mg oral administration 1, 8, 15
famotidine * 20 mg oral administration 1, 8, 15
pERTUZumab 420 mg intravenous 1 60 minutes
trastuzumab 6 mg/kg intravenous 1 90 minutes
PACLItaxel * 80 mg/m² intravenous 1, 8, 15 60 minutes
domperidone 10 mg Three times daily oral administration 1
loperamide 2 mg oral administration 1

If the initial infusion of PACLItaxel is well tolerated, the clinician may decide at their discretion to taper off and eventually omit dexamethasone premedication. If dexamethasone is omitted, the clinician may consider ondansetron 8 mg ONE hour prior to PACLItaxel infusion for antiemetic cover.

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: 1

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:
ONE hour prior to PACLItaxel infusion with food.
loratadine * 10 mg oral administration
Instructions:
ONE hour prior to PACLItaxel infusion.
famotidine * 20 mg oral administration
Instructions:
ONE hour prior to PACLItaxel infusion. Do not take indigestion remedies, iron or calcium preparations within 2 hours of taking this medicine.
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
PACLItaxel * 80 mg/m² intravenous 60 minutes
Instructions:
Prepare solution in PVC-free bag and administer via polyethylene lined administration set with an in-line filter of 0.22 microns or less in size. 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: 8

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:
ONE hour prior to PACLItaxel infusion with food.
loratadine * 10 mg oral administration
Instructions:
ONE hour prior to PACLItaxel infusion.
famotidine * 20 mg oral administration
Instructions:
ONE hour prior to PACLItaxel infusion. Do not take indigestion remedies, iron or calcium preparations within 2 hours of taking this medicine.
PACLItaxel * 80 mg/m² intravenous 60 minutes
Instructions:
Prepare solution in PVC-free bag and administer via polyethylene lined administration set with an in-line filter of 0.22 microns or less in size. Please carry out graded challenge as per institutional policy.

Day: 15

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:
ONE hour prior to PACLItaxel infusion with food.
loratadine * 10 mg oral administration
Instructions:
ONE hour prior to PACLItaxel infusion.
famotidine * 20 mg oral administration
Instructions:
ONE hour prior to PACLItaxel infusion. Do not take indigestion remedies, iron or calcium preparations within 2 hours of taking this medicine.
PACLItaxel * 80 mg/m² intravenous 60 minutes
Instructions:
Prepare solution in PVC-free bag and administer via polyethylene lined administration set with an in-line filter of 0.22 microns or less in size. Please carry out graded challenge as per institutional policy.

Cycles 2 to 4 - 21 days - Maintenance Dose

Day: 1

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:
ONE hour prior to PACLItaxel infusion with food.
loratadine * 10 mg oral administration
Instructions:
ONE hour prior to PACLItaxel infusion.
famotidine * 20 mg oral administration
Instructions:
ONE hour prior to PACLItaxel infusion. Do not take indigestion remedies, iron or calcium preparations within 2 hours of taking this medicine.
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.
PACLItaxel * 80 mg/m² intravenous 60 minutes
Instructions:
Prepare solution in PVC-free bag and administer via polyethylene lined administration set with an in-line filter of 0.22 microns or less in size. 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: 8

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:
ONE hour prior to PACLItaxel infusion with food.
loratadine * 10 mg oral administration
Instructions:
ONE hour prior to PACLItaxel infusion.
famotidine * 20 mg oral administration
Instructions:
ONE hour prior to PACLItaxel infusion. Do not take indigestion remedies, iron or calcium preparations within 2 hours of taking this medicine.
PACLItaxel * 80 mg/m² intravenous 60 minutes
Instructions:
Prepare solution in PVC-free bag and administer via polyethylene lined administration set with an in-line filter of 0.22 microns or less in size. Please carry out graded challenge as per institutional policy.

Day: 15

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:
ONE hour prior to PACLItaxel infusion with food.
loratadine * 10 mg oral administration
Instructions:
ONE hour prior to PACLItaxel infusion.
famotidine * 20 mg oral administration
Instructions:
ONE hour prior to PACLItaxel infusion. Do not take indigestion remedies, iron or calcium preparations within 2 hours of taking this medicine.
PACLItaxel * 80 mg/m² intravenous 60 minutes
Instructions:
Prepare solution in PVC-free bag and administer via polyethylene lined administration set with an in-line filter of 0.22 microns or less in size. Please carry out graded challenge as per institutional policy.

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. Nitz, U. A., O. Gluz, M. Christgen, et al. 2017. "De-escalation strategies in HER2-positive early breast cancer (EBC): final analysis of the WSG-ADAPT HER2+/HR- phase II trial: efficacy, safety, and predictive markers for 12 weeks of neoadjuvant dual blockade with trastuzumab and pertuzumab +/- weekly paclitaxel." Ann Oncol 28(11):2768-2772., PMID: 28945833

2. Dang, C., N. Iyengar, F. Datko, et al. 2015. "Phase II study of paclitaxel given once per week along with trastuzumab and pertuzumab in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer." J Clin Oncol 33(5):442-447, PMID: 25547504

3. Swain, S. M., M. S. Ewer, G. Viale, et al. 2018. "Pertuzumab, trastuzumab, and standard anthracycline- and taxane-based chemotherapy for the neoadjuvant treatment of patients with HER2-positive localized breast cancer (BERENICE): a phase II, open-label, multicenter, multinational cardiac safety study." Ann Oncol 29(3):646-653, PMID: 29253081

4. Bachelot, T., E. Ciruelos, A. Schneeweiss, et al. 2019. "Preliminary safety and efficacy of first-line pertuzumab combined with trastuzumab and taxane therapy for HER2-positive locally recurrent or metastatic breast cancer (PERUSE)." Ann Oncol 30(5):766-773., PMID: 30796821

5. Novartis New Zealand Ltd. Paclitaxel Ebewe New Zealand Data Sheet 16 April 2020. https://www.medsafe.govt.nz/profs/Datasheet/p/PaclitaxelEbeweinj.pdf (Accessed 26 November 2020)

6. 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)

7. 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)

8. 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

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. 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

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.