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Systemic Anti-Cancer Therapy Regimen Library

CRC Metastatic - mFOLFIRI [irinotecan, foliNIc acid 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
atropine sulfate * 600 microgram intravenous 1 2 minutes
irinotecan 180 mg/m² intravenous 1 90 minutes
foliNIc acid (as calcium folinate) 400 mg/m² intravenous 1 90 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.
atropine sulfate * 600 microgram intravenous 2 minutes
Instructions:

Only if required for acute diarrhoea or cholinergic symptoms.

  • Alternatively, dose may be administered subcutaneously.
  • 600 microgram = 0.6 mg.
  • Some centres may wish to give a reduced dose of 300 microgram (= 0.3 mg) in line with institutional policy.
  • Dose may be repeated up to a maximum dose of 1200 microgram (= 1.2 mg).
irinotecan 180 mg/m² intravenous 90 minutes
Instructions:
To run concurrently with foliNIc acid.
foliNIc acid (as calcium folinate) 400 mg/m² intravenous 90 minutes
Instructions:
To run concurrently with irinotecan.
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

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

Van Cutsem, E., C. H. Kohne, E. Hitre, et al. 2009. "Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer." N Engl J Med 360(14):1408-1417. , PMID: 19339720

Van Cutsem, E., H. J. Lenz, C. H. Kohne, et al. 2015. "Fluorouracil, Leucovorin, and Irinotecan Plus Cetuximab Treatment and RAS Mutations in Colorectal Cancer." J Clin Oncol 33(7):692-700., PMID: 25605843

Heinemann, V., L. F. von Weikersthal, T. Decker, et al. 2014. "FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer (FIRE-3): a randomised, open-label, phase 3 trial." Lancet Oncol 15(10):1065-1075. , PMID: 25088940

Hubbard, J. M. and S. R. Alberts. 2013. "Alternate dosing of cetuximab for patients with metastatic colorectal cancer." Gastrointest Cancer Res 6(2):47-55., PMID: 23745159

Cheng, Ann-Lii, Gerardo Cornelio, Lin Shen, et al. 2013. "First-line Cetuximab with FOLFOX or FOLFIRI Every 2 Weeks In KRAS Wild-Type Metastatic Colorectal Cancer: phase II APEC Study." Annals of oncology 24 (suppl 4):iv34-iv35. Abstract No:PD-0028

Brodowicz, T., T. E. Ciuleanu, D. Radosavljevic, et al. 2013. "FOLFOX4 plus cetuximab administered weekly or every second week in the first-line treatment of patients with KRAS wild-type metastatic colorectal cancer: a randomized phase II CECOG study." Ann Oncol 24(7):1769-1777. , PMID: 23559149

Martin-Martorell, P., S. Rosello, E. Rodriguez-Braun, et al. 2008. "Biweekly cetuximab and irinotecan in advanced colorectal cancer patients progressing after at least one previous line of chemotherapy: results of a phase II single institution trial." Br J Cancer 99(3):455-458., PMID: 18665167

Tabernero, J., F. Ciardiello, F. Rivera, et al. 2010. "Cetuximab administered once every second week to patients with metastatic colorectal cancer: a two-part pharmacokinetic/pharmacodynamic phase I dose-escalation study." Ann Oncol 21(7):1537-1545. , PMID: 19940007

Pfeiffer, P., D. Nielsen, J. Bjerregaard, et al. 2008. "Biweekly cetuximab and irinotecan as third-line therapy in patients with advanced colorectal cancer after failure to irinotecan, oxaliplatin and 5-fluorouracil." Ann Oncol 19(6):1141-1145. , PMID: 18281264

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

Van Cutsem, E., C. H. Kohne, I. Lang, et al. 2011. "Cetuximab plus irinotecan, fluorouracil, and leucovorin as first-line treatment for metastatic colorectal cancer: updated analysis of overall survival according to tumor KRAS and BRAF mutation status." J Clin Oncol 29(15):2011-2019., PMID: 21502544

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

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.