Cetuximab in combination with fluoropyrimidine-based chemotherapy [CET5]

For chemotherapy-naive metastatic or locally advanced and inoperable colorectal cancer where all the following criteria are met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy will be prescribed by a consultant, or internally accredited oncology specialty trainee, specifically trained and assessed 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 fluoropyrimidine-based combination is being used as either 1st line treatment for metastatic colorectal cancer OR as 2nd line treatment if treated with 1st line immunotherapy for MSI-H/dMMR disease OR as 1st line standard of care treatment if the patient was previously enrolled in the ROSETTA CRC CA266-0003 clinical trial. Please mark below in which line of therapy the patient is having cetuximab plus a fluoropyrimidine-based combination chemotherapy:

• cetuximab + fluoropyrimidine-based chemotherapy is being used as 1st line treatment for metastatic colorectal cancer or
• cetuximab + fluoropyrimidine-based chemotherapy 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 immunotherapy or
• cetuximab + fluoropyrimidine-based chemotherapy is being used as 1st line standard of care treatment and the patient was previously enrolled in the ROSETTA CRC CA266-0003 clinical trial

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. Cetuximab will be given in combination with fluoropyrimidine-based combination chemotherapy and this combination will be

• Irinotecan based
• Oxaliplatin based
• Both irinotecan and oxaliplatin based (e.g. FOLFOXIRI)

8. Cetuximab will be given as a 2-weekly regimen at a dose of 500mg/m2.
9. Cetuximab in combination with fluoropyrimidine-based 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 alone until disease progression and then will be discontinued.

Note

Note: continued use of cetuximab beyond 1st line therapy is not commissioned once disease progression has occurred with 1st line treatment.

10. When a treatment break of more than 6 weeks beyond the expected cycle length is needed, a treatment break form will be completed to restart treatment, which MUST be approved before treatment with cetuximab is recommenced.
11. 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 1.397 of the CDF list, downloaded from NHS England’s website on 15 May 2026 at 18:00.

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.

Older Form Versions

There are previous versions of this form. These may not all be available on this site.