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Systemic Anti-Cancer Therapy Regimen Library

CRC Metastatic - mFOLFOX6 [oxaliplatin, foliNIc acid and fluorouracil] and CETUximab [Q2W] [high dose foliNIc acid]

Treatment Overview

Cycle 1 (and all further cycles) - 14 days

Cycle length:
14

Cycle details

Cycle 1 (and all further cycles) - 14 days

Medication Dose Route Days Max Duration
doxycycline * 100 mg Once daily oral administration 0
hydrocortisone * 1 % Once daily topical administration 0
cetostearyl alcohol + paraffin liquid + paraffin soft white 50 g Once daily topical administration 0
avobenzone + homosalate + octisalate + octocrilene + oxybenzone 50 g topical administration 0
ondansetron 8 mg oral administration 1
dexamethasone * 8 mg oral administration 1, 2, 3
loratadine * 10 mg oral administration 1
CETUximab * 500 mg/m² intravenous 1 120 minutes
oxaliplatin 85 mg/m² intravenous 1 120 minutes
foliNIc acid (as calcium folinate) 400 mg/m² intravenous 1 120 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

Full details

Cycle 1 (and all further cycles) - 14 days

Day: 0

Medication Dose Route Max duration Details
doxycycline * 100 mg Once daily oral administration
Instructions:
  • To prevent rash.
  • Commence taking the day before CETUximab and continue for 6 weeks or as per institutional policy. If no rash develops after 6 weeks, consider stopping.
  • Take each dose with food and a large glass of water. Swallow whole, do not crush or chew. Remain sitting upright or standing for at least 30 minutes afterwards. Do not take indigestion remedies, iron or calcium preparations within 2 hours of taking this medicine.
  • Protect yourself from too much natural or artificial sunlight while being treated with this medicine.
hydrocortisone * 1 % Once daily topical administration
Instructions:
  • To prevent rash.
  • Apply to the face, hands, feet, neck, back and chest at bedtime or as directed by your oncologist.
  • If no rash develops after 6 weeks, consider stopping.
cetostearyl alcohol + paraffin liquid + paraffin soft white 50 g Once daily topical administration
Instructions:
  • Apply as a moisturiser to the face, hands, feet, neck, back and chest each morning or as directed by your oncologist.
  • Whilst this is a subsidised preparation, other moisturisers may also be suitable.
  • Quantity is approximate only, prescriber discretion required.
avobenzone + homosalate + octisalate + octocrilene + oxybenzone 50 g topical administration
Instructions:
  • SPF 50+ Sunscreen—apply to skin 30 minutes before going outdoors as directed by your oncologist.
  • Certified condition for subsidy. Whilst this is the subsidised preparation, alternative SPF 50+ sunscreen preparations may also be suitable.
  • Quantity is approximate only, prescriber discretion required.

Day: 1

Medication Dose Route Max duration Details
ondansetron 8 mg oral administration
Instructions:
ONE hour prior to chemotherapy.
dexamethasone * 8 mg oral administration
Instructions:
ONE hour prior to CETUximab with food.
loratadine * 10 mg oral administration
Instructions:
ONE hour prior to CETUximab.
CETUximab * 500 mg/m² intravenous 120 minutes
Instructions:
  • Maximum rate of 10 mg/minute for initial dose; if initial dose is well tolerated, subsequent doses may be administered over 60 minutes.
  • An observation period of 60 minutes post-infusion is recommended prior to administration of further systemic anti-cancer treatment.
oxaliplatin 85 mg/m² intravenous 120 minutes
Instructions:

To run concurrently with foliNIc acid.

  • 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 when patients are re-challenged with oxaliplatin.
foliNIc acid (as calcium folinate) 400 mg/m² intravenous 120 minutes
Instructions:
To run concurrently with oxaliplatin.
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.

Dose and duration may be individualised at clinician’s discretion.

Day: 3

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

Dose and duration may be individualised at clinician’s discretion.

Supportive Care Factors

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

References

Venook, A.P., D. Niedzwiecki, H. Lenz et al. 2017. "Effect of first-line chemotherapy combined with cetuximab or bevacizumab on overall survival in patients with KRAS wild-type advanced or metastatic colorectal cancer". JAMA. 2017 june 20; 317(23): 2392-2401 , PMID: 28632865

Nott, L., M. Khattak, T. Price, et al. Cancer Council Australia Colorectal Cancer Guidelines Working Party. [Version URL: https://wiki.cancer.org.au/australiawiki/index.php?oldid=173114, cited 2018 Apr 16]. Available from https://wiki.cancer.org.au/australia/Guidelines:Colorectal_cancer/Systemic_therapy_molecular_pathology. In: Cancer Council Australia Colorectal Cancer Guidelines Working Party. Cl

Petrelli N, Douglass HO Jr, Herrera L, et al: The modulation of fluorouracil with leucovorin in metastatic colorectal carcinoma: A prospective randomized phase III trial—Gastrointestinal Tumor Study Group. J Clin Oncol 7::1419,1989-1426,, PMID: 2674331

de Gramont A, Bosset JF, Milan C, et al: Randomized trial comparing monthly low-dose leucovorin and fluorouracil bolus with bimonthly high-dose leucovorin and fluorouracil bolus plus continuous infusion for advanced colorectal cancer: a French intergroup study. J Clin Oncol 15::808,1997-815,, PMID: 9053508

Matsuda, A., T. Yamada, S. Jamjittrong, et al. 2020. "Comparison Between Biweekly and Weekly Cetuximab in Patients With Metastatic Colorectal Cancer: A Meta-analysis." Anticancer Res 40(6):3469-3476., PMID: 32487646

Healthcare Logistics Ltd. Erbitux New Zealand Data Sheet 4 September 2018. https://www.medsafe.govt.nz/profs/Datasheet/e/Erbituxinf.pdf (Accessed 26 November 2020)

Hofheinz RD, Deplanque G, Komatsu Y, et al. Recommendations for the Prophylactic Management of Skin Reactions Induced by Epidermal Growth Factor Receptor Inhibitors in Patients With Solid Tumors. Oncologist. 2016;21(12):1483-1491. doi:10.1634/theoncologist.2016-0051., PMID: 27449521

Lacouture ME, Anadkat MJ, Bensadoun RJ, Bryce J, Chan A, Epstein JB, Eaby-Sandy B, Murphy BA; MASCC Skin Toxicity Study Group. Clinical practice guidelines for the prevention and treatment of EGFR inhibitor-associated dermatologic toxicities. Support Care Cancer. 2011 Aug;19(8):1079-95., PMID: 21630130

Deplanque G, Gervais R, Vergnenegre A, Falchero L, Souquet PJ, Chavaillon JM, Taviot B, Fraboulet G, Saal H, Robert C, Chosidow O. Doxycycline for prevention of erlotinib-induced rash in patients with non-small-cell lung cancer (NSCLC) after failure of first-line chemotherapy: A randomized, open-label trial. Journal of the American Academy of Dermatology. 2016 Jun 1;74(6):1077-85., PMID: 26946985

Dika, E., & Patrizi, A. (2017). Prevention of erlotinib-induced folliculitis with doxycycline. Dermatologic therapy, 30(1), https://doi.org/10.1111/dth.12419., PMID: 27592506

* 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.