# Trifluridine/tipiracil

Source: https://onco.cc/drugs/trifluridine-tipiracil/  
OnCo record `trifluridine-tipiracil` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

An oral chemotherapy pill for bowel cancer that has stopped responding to everything else; with bevacizumab it extends life by about three months.

## Summary

Trifluridine is incorporated into DNA; tipiracil blocks its breakdown. RECOURSE (2015) showed OS 7.1 vs 5.3 months alone; SUNLIGHT (2023) showed 10.8 vs 7.5 months with bevacizumab. Also approved in gastric cancer (TAGS). Neutropenia is the main toxicity; works even after 5-FU resistance because of a different mechanism.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Brand: Lonsurf
- Code: TAS-102
- Modality: Cytotoxic chemotherapy (oral nucleoside)
- Mechanism: Trifluridine misincorporation into DNA causes strand dysfunction; tipiracil inhibits thymidine phosphorylase to maintain exposure.
- Approvals: US 2015: Refractory metastatic colorectal cancer; US 2019: Refractory metastatic gastric/GEJ cancer (TAGS); US 2023: Refractory mCRC with bevacizumab; EU 2016: Metastatic colorectal cancer after available therapies; England (NICE) 2016: Previously treated metastatic colorectal cancer; England (NICE) 2024: Metastatic colorectal cancer after two lines of treatment, with bevacizumab
- Dosing: Oral; 35 mg/m² twice daily on days 1-5 and 8-12 of a 28-day cycle

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Trifluridine/tipiracil
- FDA label: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207981s012lbl.pdf
- NICE TA405: trifluridine-tipiracil for previously treated metastatic colorectal cancer: https://www.nice.org.uk/guidance/ta405
- NICE TA1008: trifluridine-tipiracil with bevacizumab after 2 systemic treatments: https://www.nice.org.uk/guidance/ta1008
- EMA Lonsurf: https://www.ema.europa.eu/en/medicines/human/EPAR/lonsurf

## Connected records

- cancers: [BRAF V600E-mutant colorectal cancer](https://onco.cc/cancers/braf-v600e-colorectal/), [Colorectal cancer](https://onco.cc/cancers/colorectal/), [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/), [HER2-positive gastric cancer](https://onco.cc/cancers/gastric-her2-positive/), [KRAS G12C-mutant colorectal cancer](https://onco.cc/cancers/kras-g12c-colorectal/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- companies: [Otsuka Pharmaceutical](https://onco.cc/companies/otsuka/), [Servier](https://onco.cc/companies/servier/), [Takeda](https://onco.cc/companies/takeda/), [Teclison](https://onco.cc/companies/teclison/)
- trials: [- IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorec](https://onco.cc/trials/nct06856837/), [5-Fluorouracil/Leucovorin (5FU/LV) in Combination With Regorafenib in Patients With Metastatic Colorectal Cancer](https://onco.cc/trials/nct06887218/), [A Phase Ib/III Study of Suvemcitug Plus FTD/TPI in Participants With Refractory Metastatic Colorectal Cancer](https://onco.cc/trials/nct07361003/), [A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Colorectal Cancer](https://onco.cc/trials/nct06992258/), [A Study Comparing BL-M07D1 With Physician's Choice Therapy in Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Failed Prior Treatment With Oxaliplatin, F](https://onco.cc/trials/nct07730489/), [A Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezolizumab](https://onco.cc/trials/nct07280377/), [A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers](https://onco.cc/trials/nct04626635/), [ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors](https://onco.cc/trials/nct05405595/), [ALTAIR](https://onco.cc/trials/altair/), [BETWEEN: Biweekly Bevacizumab + Trifluridine/Tipiracil to Reduce Grade 3-4 Neutropenia in mCRC Patients](https://onco.cc/trials/nct07071844/), [CIRCULATE-Japan (GALAXY / VEGA / ALTAIR)](https://onco.cc/trials/circulate-japan/), [ctDNA-Guided Cetuximab or Bevacizumab Plus Trifluridine/Tipiracil in RAS/BRAF Wild-Type mCRC](https://onco.cc/trials/nct07012954/), [Efficacy, Safety and Exploratory Clinical Study of Bevacizumab Combined With Oxaliplatin and TAS-102 in First-line Treatment of Advanced Colorectal Cancer](https://onco.cc/trials/nct05364489/), [FOG-001 in Locally Advanced or Metastatic Solid Tumors](https://onco.cc/trials/nct05919264/), [GAIA-102 Intraperitoneal Administration in Patients With Advanced Gastrointestinal Cancer of Microsatellite Stable With Malignant Ascites](https://onco.cc/trials/nct05438459/), [Injection of SHR-A1811 Versus Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, ](https://onco.cc/trials/nct06199973/), [Nelmastobart in Combination With Trifluridine/ Tipiracil and Bevacizumab in Metastatic/ Recurrent Colorectal Cancer](https://onco.cc/trials/nct06873763/), [Neoadjuvant Radiotherapy for Rectal Adenocarcinoma With Capecitabine Versus TAS-102 (Neo-REACT): A Multi-center, Randomized, Phase III Trial](https://onco.cc/trials/nct06850090/), [Nimotuzumab Combined With Trifluridine/Tipiracil in the Treatment of Refractory Metastatic Colorectal Cancer](https://onco.cc/trials/nct06343116/), [Radiotherapy Combined QL1706, TAS-102 and Bevacizumab in mCRC](https://onco.cc/trials/nct07116577/), [RECOURSE](https://onco.cc/trials/recourse/), [ROMANCE: "Irinotecan Plus Cetuximab Rechallenge Versus Trifluridine/Tipiracil Plus Bevacizumab in Molecularly Selected Metastatic Colorectal Cancer"](https://onco.cc/trials/nct07381764/), [Safety of Trifluridine/Tipiracil in Patients With Dihydropyrimidine Dehydrogenase Deficiency Diagnosed With Metastatic Colorectal or Gastroesophageal Cancer](https://onco.cc/trials/nct06245356/), [Second-line Standard Treatment Sequential TAS-102 and Bevacizumab Combined With Local Treatment in Advanced Colorectal Cancer](https://onco.cc/trials/nct06856187/), [Second-line Treatment of Metastatic Colorectal Cancer](https://onco.cc/trials/nct06242067/), [SUNLIGHT](https://onco.cc/trials/sunlight/), [TAS-102 Combined With Bevacizumab for Second-line Maintenance Treatment of Advanced Colorectal Cancer](https://onco.cc/trials/nct06293014/), [TAS-102 With or Without Celecoxib in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy](https://onco.cc/trials/nct05343013/), [TATE and Pembrolizumab (MK3475) in mCRC and NSCLC](https://onco.cc/trials/nct04701476/), [The Efficacy and Safety of TAS-102(Suyuan) Combined With Bevacizumab as First-line Therapy in Patients With Advanced Colorectal Cancer](https://onco.cc/trials/nct06092242/), [Treating Locally Advanced Rectal Cancer With TAS-102 Chemotherapy Plus Neoadjuvant Radiotherapy](https://onco.cc/trials/nct05965531/), [Trifluridine/Tipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract Cancer](https://onco.cc/trials/nct07146646/)
- key papers: [CodeBreaK 300: sotorasib plus panitumumab in chemotherapy-refractory KRAS G12C colorectal cancer](https://onco.cc/key-papers/paper-codebreak-300-nejm-2023/), [Randomized trial of TAS-102 for refractory metastatic colorectal cancer (RECOURSE)](https://onco.cc/key-papers/paper-mayer-recourse-tas-102-nejm-2015/), [Trifluridine-tipiracil and bevacizumab in refractory metastatic colorectal cancer (SUNLIGHT)](https://onco.cc/key-papers/paper-prager-sunlight-trifluridine-tipiracil-bevacizumab-nejm-2023/)
- roadmaps: [Colorectal cancer roadmap: from the adenoma-carcinoma sequence and the first screening trials to total mesorectal excision, oxaliplatin, RAS testing, immunotherapy for mismatch repair-deficient disease, ctDNA-guided treatment and organ preservation](https://onco.cc/roadmaps/colorectal-roadmap/), [ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment](https://onco.cc/roadmaps/ctdna-tests/)
- terms: [Colorectal cancer drugs in England: what NICE has recommended](https://onco.cc/terms/colorectal-uk-drug-access/)
- people: [Tae Won Kim](https://onco.cc/people/kim-tae-won/)
- pathways: [Colorectal cancer (KEGG map)](https://onco.cc/pathways/colorectal-cancer-signalling/)

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