Cetuximab in combination with FOLFOXIRI (5- irinotecan and oxaliplatin) chemotherapy [CET4]

For chemotherapy-naïve metastatic or locally advanced and inoperable colorectal cancer where the following criteria have been met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy with cetuximab in combination with FOLFIRINOX/FOLFOXIRI chemotherapy will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. This patient has RAS wild-type metastatic or locally advanced and inoperable colorectal cancer.
3. This patient has not received previous cytotoxic chemotherapy for metastatic disease unless there has been use of previous neoadjuvant combination cytotoxic chemotherapy for potentially resectable metastatic colorectal cancer. Please mark below whether the patient has had neoadjuvant chemotherapy or not:

• the patient has not had previous neoadjuvant cytotoxic chemotherapy for metastatic colorectal cancer or
• the patient has been treated with previous neoadjuvant cytotoxic chemotherapy for potentially resectable metastatic colorectal cancer

4. Cetuximab in this FOLFIRINOX/FOLFOXIRI combination is being used as either 1st line treatment for metastatic colorectal cancer or as 2nd line treatment if treated with 1st line pembrolizumab for MSI-H/dMMR disease. Please mark below in which line of therapy the patient is having cetuximab plus FOLFIRINOX/FOLFOXIRI chemotherapy:

• cetuximab + FOLFIRINOX/FOLFOXIRI is being used as 1st line treatment for metastatic colorectal cancer or
• cetuximab + FOLFIRINOX/FOLFOXIRI is being used as 2nd line treatment for metastatic colorectal cancer as the patient has MSI-H/dMMR disease and has been treated with 1st line pembrolizumab or 1st line nivolumab which was previously available as an Interim COVID option

5. The patient has not received prior treatment with cetuximab or panitumumab unless this was received as part of combination neoadjuvant chemotherapy for potentially resectable metastatic disease. Patients with potentially resectable metastatic disease who have received a neoadjuvant cetuximab/panitumumab-containing combination chemotherapy with the intention of resection if the metastases become resectable, and who do not progress while on treatment with cetuximab/panitumumab but who then become unsuitable for surgery or have unsuccessful surgery, may continue treatment with the same cetuximab/panitumumab-containing combination chemotherapy. Patients who have successful resection(s) after neoadjuvant cetuximab/panitumumab-containing combination chemotherapy for metastatic disease and who did not progress on such chemotherapy may receive cetuximab/panitumumab with subsequent first-line combination chemotherapy if they present later with progression of metastatic disease. Please mark below the patient’s treatment status in respect of previous cetuximab/panitumumab-containing neoadjuvant chemotherapy:

• the patient has not been treated with previous chemotherapy with either cetuximab or panitumumab-containing combination chemotherapy for metastatic disease or
• the only previous cetuximab/panitumumab-containing chemotherapy was with neoadjuvant treatment for potentially resectable disease which resulted in a lack of disease progression and the patient was then unable to proceed to surgery or had unsuccessful surgery or
• the only previous cetuximab/panitumumab-containing chemotherapy was with neoadjuvant treatment for potentially resectable disease which resulted in a lack of disease progression and the patient was then able to proceed to surgery but has since relapsed

6. The prescribing clinician is aware that if this patient has BRAF V600 mutation-positive disease, the patient will be ineligible for encorafenib plus cetuximab as a subsequent line of therapy if they receive a cetuximab/panitumumab- containing regimen now as first-line therapy.
7. The prescribing clinician is aware that from 1st December 2020 an NHS England Best Value framework is in operation for cetuximab and panitumumab in first line colorectal cancer. The choice of this cetuximab-containing regimen is therefore in line with the local application of the Best Value framework for these drugs within my organisation.
8. This patient will receive cetuximab in combination FOLFIRINOX/FOLFOXIRI (5-fluorouracil, irinotecan and oxaliplatin in combination) chemotherapy.
9. Cetuximab will be given as a 2-weekly regimen at a dose of 500mg/m2.
10. Trust policy regarding the use of unlicensed treatments has been followed as cetuximab is not licensed for 2-weekly administration.
11. Cetuximab in combination with FOLFIRINOX chemotherapy will be given until disease progression on this regimen and that cetuximab will be discontinued when this disease progression occurs. If the patient experiences excessive toxicity with irinotecan and/or oxaliplatin, cetuximab can be subsequently continued in combination with a fluoropyrimidine without irinotecan and/or oxaliplatin until disease progression and then will be discontinued. Note: continued use of cetuximab beyond 1st line therapy is not commissioned once disease progression has occurred with 1st line treatment.
12. When a treatment break of more than 6 weeks beyond the expected cycle length is needed, I will complete a treatment break form to restart treatment, including an indication as appropriate if the patient had an extended break because of COVID 19.
13. The use of cetuximab will be otherwise used as per its Summary of Product Characteristics (SPC).

NHS funded From: 27 June 2017

Additional information

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA439 (29 March 2017)

Current Form Version

Note

The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.

If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.