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An oral chemotherapy pill for bowel cancer that has stopped responding to everything else; with bevacizumab it extends life by about three months.
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.
Trifluridine misincorporation into DNA causes strand dysfunction; tipiracil inhibits thymidine phosphorylase to maintain exposure.
1.Tipiracil blocks the enzyme that would destroy trifluridine, keeping blood levels up
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
Source: www.accessdata.fda.gov/drugsatfda_docs/label/2023/207981s012lbl.pdf. Doses are for orientation; the current label governs.
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. Plans require prior fluoropyrimidine, oxaliplatin and irinotecan for colorectal use.
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
Sources: NICE TA405 · SMC advice: trifluridine-tipiracil. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
RECOURSE
SUNLIGHT combination
| Region | Year | Indication |
|---|---|---|
| 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 · Lonsurf marketing authorisation issued 25 April 2016. |
| England (NICE) | 2016 | Previously treated metastatic colorectal cancer · TA405, published 24 August 2016, recommends it within its marketing authorisation with the patient access scheme discount. |
| England (NICE) | 2024 | Metastatic colorectal cancer after two lines of treatment, with bevacizumab · TA1008, published 25 September 2024, recommends the combination within its marketing authorisation subject to the commercial arrangement. |
| Adverse event |
|---|
| Neutropenia |
| Anaemia |
| Nausea, fatigue |
Most common grade 3-4 event; febrile neutropenia uncommon. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
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Patients with metastatic colorectal cancer carrying a KRAS G12C mutation (about 3-4% of cases) who have exhausted standard chemotherapy now have a targeted option that works far better than trifluridine-tipiracil or regorafenib. The higher sotorasib dose is clearly superior, and the EGFR antibody is essential because KRAS inhibition alone has little effect in bowel cancer. Responses are still modest and short-lived compared with EGFR or ALK inhibitors in lung cancer.
Trifluridine-tipiracil with bevacizumab is the refractory-line standard, and a reminder that combining two drugs already on the shelf can beat anything new in the same line.
Trifluridine-tipiracil became the other refractory-line standard alongside regorafenib, and the backbone that SUNLIGHT later improved on by adding bevacizumab.
Query for this drug: (TITLE:"Trifluridine/tipiracil" OR ABSTRACT:"Trifluridine/tipiracil" OR TITLE:"Lonsurf" OR ABSTRACT:"Lonsurf" OR TITLE:"TAS-102" OR ABSTRACT:"TAS-102") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Trifluridine/tipiracil, not a curated reading list.
Shares A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Colorectal Cancer, ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors, Injection of SHR-A1811 Versus Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, , Tae Won Kim.
Shares TATE and Pembrolizumab (MK3475) in mCRC and NSCLC, Injection of SHR-A1811 Versus Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, , Teclison, 5-Fluorouracil/Leucovorin (5FU/LV) in Combination With Regorafenib in Patients With Metastatic Colorectal Cancer.
Shares Second-line Standard Treatment Sequential TAS-102 and Bevacizumab Combined With Local Treatment in Advanced Colorectal Cancer, TAS-102 Combined With Bevacizumab for Second-line Maintenance Treatment of Advanced Colorectal Cancer, The Efficacy and Safety of TAS-102(Suyuan) Combined With Bevacizumab as First-line Therapy in Patients With Advanced Colorectal Cancer, BETWEEN: Biweekly Bevacizumab + Trifluridine/Tipiracil to Reduce Grade 3-4 Neutropenia in mCRC Patients.
Shares RECOURSE, Otsuka Pharmaceutical, Randomized trial of TAS-102 for refractory metastatic colorectal cancer (RECOURSE), Trifluridine-tipiracil and bevacizumab in refractory metastatic colorectal cancer (SUNLIGHT).
Shares Tae Won Kim, Takeda, KRAS G12C-mutant colorectal cancer, 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.
Shares Safety of Trifluridine/Tipiracil in Patients With Dihydropyrimidine Dehydrogenase Deficiency Diagnosed With Metastatic Colorectal or Gastroesophageal Cancer, Colorectal cancer drugs in England: what NICE has recommended, CodeBreaK 300: sotorasib plus panitumumab in chemotherapy-refractory KRAS G12C colorectal cancer, Colorectal cancer (KEGG map).
Shares Randomized trial of TAS-102 for refractory metastatic colorectal cancer (RECOURSE), Trifluridine-tipiracil and bevacizumab in refractory metastatic colorectal cancer (SUNLIGHT), BRAF V600E-mutant colorectal cancer, Colorectal cancer.
Shares Randomized trial of TAS-102 for refractory metastatic colorectal cancer (RECOURSE), Trifluridine-tipiracil and bevacizumab in refractory metastatic colorectal cancer (SUNLIGHT), 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, Gastric & gastro-oesophageal junction cancer.