Trifluridine plus tipiracil in combination with bevacizumab [TRI3]

For patients with either metastatic or locally advanced and inoperable colorectal cancer who have received 2 or more prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies with without anti-VEGF agents and/or anti- EGFR-based agents where the following criteria have been met:

1. This application is both being made by and the first cycle of systemic anti-cancer therapy with trifluridine plus tipiracil in combination with bevacizumab will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. The patient has a histologically confirmed diagnosis of adenocarcinoma of the colon or rectum.
3. The patient has either metastatic disease or locally advanced and inoperable disease.
4. The patient has been previously treated for metastatic or locally advanced and inoperable disease with 2 or more prior anticancer regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies. Note: the regimens of either FOLFIRINOX or FOLFOXIRI can be counted as 2 chemotherapy regimens.
5. The patient has either been previously treated with anti-EGFR-containing chemotherapy or not. Please tick which option applies to this patient:

• yes, the patient has been previously treated with anti-EGFR-containing chemotherapy or
• no, the patient has not been previously treated with anti-EGFR-containing chemotherapy

6. The patient has either been previously treated with an anti-VEGF-containing chemotherapy or not. Please tick which option applies to this patient:

• yes, the patient has been previously treated with an anti-VEGF-containing chemotherapy or
• no, the patient has not been previously treated with an anti-VEGF-containing chemotherapy

7. The patient has either been previously treated with regorafenib or not. or Please tick which option applies to this patient:

• yes, the patient has been previously treated with regorafenib or
• no, the patient has not been previously treated with regorafenib

8. The patient has an ECOG performance status of 0 or 1.
9. The patient has not been previously treated with trifluridine plus tipiracil.
10. The bevacizumab will be commenced at the same time as trifluridine plus tipiracil and at a dose of 5mg/Kg administered at 2-weekly intervals.
11. Trifluridine plus tipiracil in combination with bevacizumab is to be continued until loss of clinical benefit or unacceptable toxicity or patient choice to stop treatment, whichever is the sooner.
12. If the trifluridine plus tipiracil has to be permanently discontinued then the bevacizumab will also be stopped at the same time.
13. A formal medical review as to whether treatment with trifluridine plus tipiracil in combination with bevacizumab should continue or not will be scheduled to occur no later than by the end of the 2nd (28-day) cycle of therapy.
14. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, a treatment break approval form will be completed to restart treatment.
15. Both trifluridine plus tipiracil and bevacizumab will be otherwise used as set out in their respective Summaries of Product Characteristics (SPCs).

NHS funded From: 24 December 2024

Additional information

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA1008 (25 September 2024)

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The data on this page was produced using version 1.341 of the CDF list, downloaded from an archive of NHS England’s website on 11 January 2025 at 21:05.

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