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regimen-monograph
FOLFIRI+ENCO+PNTM
Cancer Type
Gastrointestinal,
Colorectal,
Small bowel and appendix
Intent
Palliative
Regimen Category
Evidence-informed
Funding Program
New Drug Funding Program
Panitumumab - In Combination with Encorafenib and Chemotherapy for Previously Untreated Metastatic Colorectal Cancer
Exceptional Access Program
Encorafenib - In combination with panitumumab and chemotherapy for previously untreated metastatic colorectal cancer, according to specific criteria
Drugs Used
A - Regimen Name
FOLFIRI+ENCO+PNTM Regimen
Folinic Acid (Leucovorin)-Fluorouracil-Irinotecan-Encorafenib-Panitumumab
Disease Site
Gastrointestinal
Colorectal
Small bowel and appendix
Small bowel and appendix
Intent
Palliative
Regimen Category
Evidence-informed :
Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR). Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.
This Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph. Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Rationale and Uses
Treatment for patients with previously untreated BRAF V600E-mutated metastatic colorectal, small bowel, or appendiceal cancer
(Refer to the NDFP eligibility form for detailed funding criteria.)
Supplementary Public Funding
PANitumumab
New Drug Funding Program (Panitumumab - In Combination with Encorafenib and Chemotherapy for Previously Untreated Metastatic Colorectal Cancer) (NDFP Website )
encorafenib
Exceptional Access Program (Encorafenib - In combination with panitumumab and chemotherapy for previously untreated metastatic colorectal cancer, according to specific criteria) (EAP Website )
B - Drug Regimen
| PANitumumab | 6 mg /kg | IV | Day 1 |
| irinotecan | 180 mg /m² | IV over 90 minutes | Day 1 |
| leucovorin | 400 mg /m² | IV over 120 minutes concurrently with irinotecan | Day 1 |
| fluorouracil | 400 mg /m² | IV bolus, after leucovorin | Day 1 |
|
THEN
|
|||
| fluorouracil | 2400 mg /m² | IV continuous infusion over 46 hours | Start on Day 1 |
| encorafenib | 300 mg | PO | Days 1 to 14 |
Irinotecan and Leucovorin may be infused at the same time by using a y-connector, but not in the same bag, then Fluorouracil.
C - Cycle Frequency
REPEAT EVERY 14 DAYS
Until disease progression or unacceptable toxicity
If encorafenib or panitumumab is discontinued due to unacceptable toxicity, the other drug (i.e., panitumumab or encorafenib) must also be discontinued.
D - Premedication and Supportive Measures
Antiemetic Regimen:
Moderate
No routine prophylaxis (encorafenib)
- Also refer to CCO Antiemetic Summary
Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.
Patients should be tested for DPD deficiency before starting treatment with fluorouracil. Refer to the DPD Deficiency Guidance for Clinicians for more information.
Premedications for irinotecan:
- Prophylactic atropine may be considered in patients who have experienced cholinergic symptoms.
- Unless contraindicated, atropine 0.25 to 1mg IV/Subcut may be given for cholinergic adverse effects (early diarrhea).
- Diarrhea (including abdominal cramps) may be severe and delayed with irinotecan; use loperamide 4mg at the onset of diarrhea, then 2mg every 2 hours until patient is diarrhea-free for 12 hours. During the night the patient may take 4mg of loperamide every 4 hours.
Other Supportive Care:
- Diarrhea can be severe with irinotecan, with either immediate or delayed onset. Patients must be instructed in the use of loperamide as treatment for diarrhea, and must have a supply of this drug upon starting irinotecan treatments.
- May advise patients to suck on ice chips during bolus injection of 5-FU, to reduce stomatitis.
- As sun exposure may exacerbate skin reactions associated with panitumumab, patients should be advised to use sunscreen, wear a hat and limit sun exposure.
- Consider pre-emptive therapy for EGFR inhibitor-related skin toxicity; the following was shown to be of benefit with panitumumab treatment, starting the day before treatment and continued until week 6. (Lacouture et al, 2010):
- Skin moisturizer applied to the face, hands, feet, neck, back and chest in the morning
- Sunscreen to exposed areas (SPF > 15, UVA and UVB) before going outdoors
- Hydrocortisone 1% cream to the face, hands, feet, neck, back and chest at bedtime
- Doxycycline (or minocycline) PO
- Refer to EGFR inhibitor-induced skin toxicity management guidelines for more information (e.g. Alberta Health Services, ESMO, NCCN, Melosky 2009).
J - Administrative Information
Approximate Patient Visit
4-5 hours
Pharmacy Workload (average time per visit)
37.403 minutes
Nursing Workload (average time per visit)
61.667 minutes
K - References
Burtness B, Anadkat M, Basti S, et al. NCCN Task Force Report: Management of dermatologic and other toxicities associated with EGFR inhibition in patients with cancer. J Natl Compr Canc Netw 2009;7 Suppl 1:S5-S24.
Douillard JY, Cunningham D, Roth AD et al. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomized trial. The Lancet 2000;355:1041-7.
Elez E, Yoshino T, Shen L, et al. Encorafenib, cetuximab, and mFOLFOX6 in BRAF-mutated colorectal cancer. N Engl J Med 2025;392(24):2425-37. doi: 10.1056/NEJMoa2501912.
Encorafenib drug monograph. Ontario Health (Cancer Care Ontario).
Fluorouracil drug monograph. Ontario Health (Cancer Care Ontario).
Irinotecan drug monograph. Ontario Health (Cancer Care Ontario).
Lacouture ME, Sibaud V, Gerber PA, et al. Prevention and management of dermatological toxicities related to anticancer agents: ESMO Clinical Practice Guidelines. Ann Oncol. 2021;32(2):157-170.
Lacouture, ME, Mitchell EP, Piperdi B et al. Skin toxicity evaluation protocol with panitumumab (STEPP), a phase II, open-label, randomized trial evaluating the impact of a pre-emptive skin treatment regimen on skin toxicities and quality of life in patients with metastatic colorectal cancer. J Clin Oncol 2010; 28: 1351-7.
Melosky B, Burkes R, Rayson D, et al. Management of skin rash during EGFR-targeted monoclonal antibody treatment for gastrointestinal malignancies: Canadian recommendations. Current Oncology 2009; 16(10): 14-24.
Panitumumab drug monograph. Ontario Health (Cancer Care Ontario).
Prevention and Treatment of Acneiform Rash in Patients Treated with EGFR Inhibitor Therapies. Alberta Health Services. November 2020.
Reimbursement recommendation: Encorafenib. Canada's Drug Agency, March 2026.
May 2026 new ST-QBP regimen
L - Other Notes
DPD Deficiency Testing and Guidance:
Patients should be tested for DPD deficiency before starting treatment with fluorouracil. Refer to the DPD Deficiency Guidance for Clinicians for more information.
In patients with unrecognized DPD deficiency, acute, life-threatening toxicity may occur; if acute grade 2-4 toxicity develops, treatment should be stopped immediately and permanent discontinuation considered based on clinical assessment of the toxicities.
Antidote for Fluorouracil Overdose:
Uridine triacetate is a prodrug of uridine and is a specific antidote for treating fluorouracil overdose or severe early onset toxicities. If available, consider administering as soon as possible (i.e. within 96 hours) for suspected overdose. If not available, treatment is symptomatic and supportive.
For usage approval and supply, contact Health Canada’s Special Access Program (SAP) (Phone: 613-941-2108. On-call service is available for emergencies).
The recommended dosing and administration for uridine triacetate in patients ≥18 years is:
- 10 grams (1 packet of coated granules) orally every 6 hours for 20 doses in total, without regards to meals.
- Granules should not be chewed. They should be mixed with 3 to 4 ounces of soft foods such as applesauce, pudding or yogurt.
- The dose should be ingested within 30 minutes of preparation, followed by at least 4 ounces of water.
- Refer to the prescribing information on dose preparation for NG-tube or G-tube use.
Additional resources on the management of fluorouracil infusion overdose:
- Management of Fluorouracil Infusion Overdose Guideline (Alberta Health Services)
- Management of Fluorouracil Infusion Overdose at the BCCA - Interim Guidance (BC Cancer Agency)
M - Disclaimer
Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph. Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.
Last Updated: July 21, 2026
