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Systemic Anti-Cancer Therapy Regimen Library

BR NON-Metastatic - cARBOplatin Q3W and PACLItaxel Q1W followed by AC [DOXOrubicin and CYCLOPHOSPHamide] dose dense

Treatment Overview

This regimen consists of two parts: cARBOplatin Q3W and PACLItaxel Q1W followed by AC [DOXOrubicin and CYCLOPHOSPHamide] dose dense.


This regimen contains a medicine where one or more biosimilars may exist. Any biosimilars used have been reviewed by the regulator (Medsafe) and relevant specialists were consulted nationally. Where regulators, in consultation with relevant specialists, 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.

Cycles 1 to 4 - 21 days - cARBOplatin Q3W and PACLItaxel Q1W

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 on days 8 and 15. If dexamethasone is omitted, the clinician may consider ondansetron 8 mg orally ONE hour prior to PACLItaxel infusion on days 8 and 15 for antiemetic cover.


Cycle specific Supportive Care Factors:

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

Emetogenicity: HIGH - cARBOplatin day 1; LOW days 8 and 15.

Growth factor support: Recommended for primary prophylaxis.

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

Cycles 5 to 8 - 14 days - AC [DOXOrubicin and CYCLOPHOSPHamide] dose dense

Cycle length:
14

Cycle specific Supportive Care Factors:

Emetogenicity: HIGH.

Growth factor support: Recommended for primary prophylaxis.

Cycle details

Cycles 1 to 4 - 21 days - cARBOplatin Q3W and PACLItaxel Q1W

Medication Dose Route Days Max Duration
aprepitant 125 mg oral administration 1
aprepitant 80 mg oral administration 2, 3
dexamethasone * 8 mg oral administration 1, 2, 3,
8, 15
loratadine * 10 mg oral administration 1, 8, 15
famotidine * 20 mg oral administration 1, 8, 15
ondansetron 8 mg oral administration 1
PACLItaxel * 80 mg/m² intravenous 1, 8, 15 60 minutes
cARBOplatin * 6 AUC (area under the curve) intravenous 1 60 minutes
ondansetron 8 mg oral administration 1
filgrastim 5 microgram/kg subcutaneous injection 2 to 6
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 on days 8 and 15. If dexamethasone is omitted, the clinician may consider ondansetron 8 mg orally ONE hour prior to PACLItaxel infusion on days 8 and 15 for antiemetic cover.


Cycle specific Supportive Care Factors:

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

Emetogenicity: HIGH - cARBOplatin day 1; LOW days 8 and 15.

Growth factor support: Recommended for primary prophylaxis.

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

Cycles 5 to 8 - 14 days - AC [DOXOrubicin and CYCLOPHOSPHamide] dose dense

Medication Dose Route Days Max Duration
olanzapine * 5 mg oral administration 1 to 4
aprepitant 125 mg oral administration 1
aprepitant 80 mg oral administration 2, 3
dexamethasone * 12 mg oral administration 1
dexamethasone * 8 mg oral administration 2, 3, 4
ondansetron 8 mg oral administration 1
DOXOrubicin 60 mg/m² intravenous 1 15 minutes
CYCLOPHOSPHamide 600 mg/m² intravenous 1 60 minutes
ondansetron 8 mg oral administration 1
pegFILGRASTIM 6 mg subcutaneous injection 2
cycliZINE 50 mg Three times daily oral administration 1

Cycle specific Supportive Care Factors:

Emetogenicity: HIGH.

Growth factor support: Recommended for primary prophylaxis.

Full details

Cycles 1 to 4 - 21 days - cARBOplatin Q3W and PACLItaxel Q1W

Day: 1

Medication Dose Route Max duration Details
aprepitant 125 mg oral administration
Instructions:
ONE hour prior to chemotherapy.
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.
ondansetron 8 mg oral administration
Instructions:
ONE hour prior to chemotherapy.
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.
cARBOplatin * 6 AUC (area under the curve) intravenous 60 minutes
Instructions:
Hypersensitivity risk increases with number of cycles of cARBOplatin.
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
aprepitant 80 mg oral administration
Instructions:
ONCE daily in the morning.
dexamethasone * 8 mg oral administration
Instructions:
ONCE daily in the morning with food.
filgrastim 5 microgram/kg subcutaneous injection
Instructions:
Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

Day: 3

Medication Dose Route Max duration Details
aprepitant 80 mg oral administration
Instructions:
ONCE daily in the morning.
dexamethasone * 8 mg oral administration
Instructions:
ONCE daily in the morning with food.
filgrastim 5 microgram/kg subcutaneous injection
Instructions:
Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

Day: 4

Medication Dose Route Max duration Details
filgrastim 5 microgram/kg subcutaneous injection
Instructions:
Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

Day: 5

Medication Dose Route Max duration Details
filgrastim 5 microgram/kg subcutaneous injection
Instructions:
Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

Day: 6

Medication Dose Route Max duration Details
filgrastim 5 microgram/kg subcutaneous injection
Instructions:
Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

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 5 to 8 - 14 days - AC [DOXOrubicin and CYCLOPHOSPHamide] dose dense

Day: 1

Medication Dose Route Max duration Details
olanzapine * 5 mg oral administration
Instructions:
ONE hour prior to chemotherapy. This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake. Some centres may choose to omit pre-chemotherapy dose or advise patient to take the night before chemotherapy if patient has to drive to appointment.
aprepitant 125 mg oral administration
Instructions:
ONE hour prior to chemotherapy.
dexamethasone * 12 mg oral administration
Instructions:
ONE hour prior to chemotherapy with food.
ondansetron 8 mg oral administration
Instructions:
ONE hour prior to chemotherapy.
DOXOrubicin 60 mg/m² intravenous 15 minutes
Instructions:
Warning vesicant—ensure vein is patent prior to administration, administer vesicant as per institutional policy and monitor for signs of extravasation throughout administration.
CYCLOPHOSPHamide 600 mg/m² intravenous 60 minutes
ondansetron 8 mg oral administration
Instructions:
EIGHT hours after chemotherapy OR before bed.
cycliZINE 50 mg Three times daily oral administration
Instructions:
When required for nausea and/or vomiting. Warning: may cause drowsiness. Consider starting dose at 25 mg and increasing as tolerated/required. The choice of rescue antiemetic may be substituted to reflect institutional policy or individual patient characteristics. Note that domperidone is not recommended in combination with olanzapine and ondansetron due to potential risk of QT prolongation.

Day: 2

Medication Dose Route Max duration Details
olanzapine * 5 mg oral administration
Instructions:
ONCE daily. This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
aprepitant 80 mg oral administration
Instructions:
ONCE daily in the morning.
dexamethasone * 8 mg oral administration
Instructions:
ONCE daily in the morning with food.
pegFILGRASTIM 6 mg subcutaneous injection

Day: 3

Medication Dose Route Max duration Details
olanzapine * 5 mg oral administration
Instructions:
ONCE daily. This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
aprepitant 80 mg oral administration
Instructions:
ONCE daily in the morning.
dexamethasone * 8 mg oral administration
Instructions:
ONCE daily in the morning with food.

Day: 4

Medication Dose Route Max duration Details
olanzapine * 5 mg oral administration
Instructions:
ONCE daily. This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
dexamethasone * 8 mg oral administration
Instructions:
ONCE daily in the morning with food.

Supportive Care Factors

Factor Value
Diarrhoea risk: Variable
Emetogenicity: Variable
Growth factor support: Recommended for primary prophylaxis
Hypersensitivity / Infusion related reaction risk: Variable

References

1. Sikov, W. M., D. A. Berry, C. M. Perou, et al. 2015. "Impact of the addition of carboplatin and/or bevacizumab to neoadjuvant once-per-week paclitaxel followed by dose-dense doxorubicin and cyclophosphamide on pathologic complete response rates in stage II to III triple-negative breast cancer: CALGB 40603 (Alliance)." J Clin Oncol 33(1):13-21., PMID: 25092775

2. Senkus, E., S. Kyriakides, S. Ohno, et al. 2015. “Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up.” Ann Oncol 26 Suppl 5:v8-30, PMID: 26314782

3. Sparano, J. A. 2015. "Defining a role and predicting benefit from platinum-based therapy in breast cancer: an evolving story." J Clin Oncol 33(1):1-3., PMID: 25332246

4. 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)

5. 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

6. Castells, M.C., Matulonis, U.A., and Horton, TM. Infusion reactions to systemic chemotherapy. Savarese DMF and Feldweg AM, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com/contents/infusion-reactions-to-systemic-chemotherapy (Accessed 26 March 2021).

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

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.