1.1 Cetuximab in combination with 5-fluorouracil (5-FU), folinic acid and oxaliplatin (FOLFOX), within its licensed indication, is recommended for the first-line treatment of metastatic colorectal cancer only when all of the following criteria are met:
The primary colorectal tumour has been resected or is potentially operable.
The metastatic disease is confined to the liver and is unresectable.
The patient is fit enough to undergo surgery to resect the primary colorectal tumour and to undergo liver surgery if the metastases become resectable after treatment with cetuximab.
The manufacturer rebates 16% of the amount of cetuximab used on a per patient basis.
1.2 Cetuximab in combination with 5-FU, folinic acid and irinotecan (FOLFIRI), within its licensed indication, is recommended for the first-line treatment of metastatic colorectal cancer only when all of the following criteria are met:
The primary colorectal tumour has been resected or is potentially operable.
The metastatic disease is confined to the liver and is unresectable.
The patient is fit enough to undergo surgery to resect the primary colorectal tumour and to undergo liver surgery if the metastases become resectable after treatment with cetuximab.
The patient is unable to tolerate or has contraindications to oxaliplatin.
1.3 Patients who meet the criteria in 1.1 and 1.2 should receive treatment with cetuximab for no more than 16 weeks. At 16 weeks, treatment with cetuximab should stop and the patient should be assessed for resection of liver metastases.
1.4 People with metastatic colorectal cancer with metastatic disease confined to the liver who receive cetuximab should have their treatment managed only by multidisciplinary teams that involve highly specialised liver surgical services.