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Systemic Anti-Cancer Therapy Regimen Library

UGI GAST AND OES Metastatic - mFOLFOX6 [oxaliplatin, foliNIc acid and fluorouracil] [low dose foliNIc acid] 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 - 14 days - Loading Dose

Cycle length:
14

Cycle 2 (and all further cycles) - 14 days - Maintenance Dose

Cycle length:
14

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

Cycle details

Cycle 1 - 14 days - Loading Dose

Medication Dose Route Days Max Duration
dexamethasone * 8 mg oral administration 1, 2, 3
ondansetron 8 mg oral administration 1
trastuzumab * 6 mg/kg intravenous 1 90 minutes
oxaliplatin * 85 mg/m² intravenous 1 120 minutes
foliNIc acid * 50 mg flat dosing intravenous 1 2 minutes
fluorouracil * 400 mg/m² intravenous 1 15 minutes
fluorouracil * 2400 mg/m² intravenous 1 46 hours Min: 46 hours
ondansetron 8 mg oral administration 1
domperidone 10 mg Three times daily oral administration 1
loperamide 2 mg oral administration 1

Cycle 2 (and all further cycles) - 14 days - Maintenance Dose

Medication Dose Route Days Max Duration
dexamethasone * 8 mg oral administration 1, 2, 3
ondansetron 8 mg oral administration 1
trastuzumab * 4 mg/kg intravenous 1 90 minutes
oxaliplatin * 85 mg/m² intravenous 1 120 minutes
foliNIc acid * 50 mg flat dosing intravenous 1 2 minutes
fluorouracil * 400 mg/m² intravenous 1 15 minutes
fluorouracil * 2400 mg/m² intravenous 1 46 hours Min: 46 hours
ondansetron 8 mg oral administration 1
domperidone 10 mg Three times daily oral administration 1
loperamide 2 mg oral administration 1

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

Full details

Cycle 1 - 14 days - Loading Dose

Day: 1

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:
ONE hour prior to chemotherapy with food.
ondansetron 8 mg oral administration
Instructions:
ONE hour prior to chemotherapy.
trastuzumab * 6 mg/kg intravenous 90 minutes
oxaliplatin * 85 mg/m² intravenous 120 minutes
Instructions:
Usual infusion time of two hours may be extended to up to 6 hours if needed to reduce likelihood and/or severity of adverse reactions. Hypersensitivity risk increases with number of cycles of oxaliplatin.
foliNIc acid * 50 mg flat dosing intravenous 2 minutes
fluorouracil * 400 mg/m² intravenous 15 minutes
fluorouracil * 2400 mg/m² intravenous 46 hours Min: 46 hours
Instructions:
Continuous infusion via pump over 46 hours.
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 oral administration
Instructions:
ONCE daily in the morning with food.

Day: 3

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:
ONCE daily in the morning with food.

Cycle 2 (and all further cycles) - 14 days - Maintenance Dose

Day: 1

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:
ONE hour prior to chemotherapy with food.
ondansetron 8 mg oral administration
Instructions:
ONE hour prior to chemotherapy.
trastuzumab * 4 mg/kg intravenous 90 minutes
Instructions:
If the initial loading dose of trastuzumab is well tolerated, subsequent doses may be administered over 30 minutes.
oxaliplatin * 85 mg/m² intravenous 120 minutes
Instructions:
Usual infusion time of two hours may be extended to up to 6 hours if needed to reduce likelihood and/or severity of adverse reactions. Hypersensitivity risk increases with number of cycles of oxaliplatin.
foliNIc acid * 50 mg flat dosing intravenous 2 minutes
fluorouracil * 400 mg/m² intravenous 15 minutes
fluorouracil * 2400 mg/m² intravenous 46 hours Min: 46 hours
Instructions:
Continuous infusion via pump over 46 hours.
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 oral administration
Instructions:
ONCE daily in the morning with food.

Day: 3

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:
ONCE daily in the morning with food.

Supportive Care Factors

Factor Value
Diarrhoea risk: Anti-diarrhoeals are usually prescribed with this treatment
Emetogenicity: Medium
Hypersensitivity / Infusion related reaction risk: Low - routine premedication not recommended

References

1. Soularue, É, R. Cohen, C. Tournigand, et al. 2015. "Efficacy and safety of trastuzumab in combination with oxaliplatin and fluorouracil-based chemotherapy for patients with HER2-positive metastatic gastric and gastro-oesophageal junction adenocarcinoma patients: a retrospective study." Bull Cancer 102(4):324-331., PMID: 25744576

2. Ter Veer, E., A. Creemers, L. de Waal, et al. 2018. "Comparing cytotoxic backbones for first-line trastuzumab-containing regimens in human epidermal growth factor receptor 2-positive advanced oesophagogastric cancer: A meta-analysis." Int J Cancer 143(2):438-448., PMID: 29451302

3. Pharmacy Retailing (NZ) limited t/a Healthcare Logistics. Oxaliplatin Accord New Zealand Data Sheet. https://www.medsafe.govt.nz/profs/Datasheet/o/oxaliccordinf.pdf (Accessed 16 February 2021).

4. 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).

5. Celltrion Healthcare New Zealand Limited. Herzuma New Zealand Data Sheet. https://www.medsafe.govt.nz/profs/Datasheet/h/herzumainf.pdf (Accessed 16 February 2021).

6. 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. , PMID: 28848668

7. 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. , PMID: 29443651

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. 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 (Accessed 26 March 2021).

* 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.