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An oral chemotherapy tablet that still works after fluorouracil has stopped working, because the active part is built into DNA rather than blocking an enzyme.
RECOURSE randomised 800 patients with refractory metastatic colorectal cancer 2:1 to trifluridine/tipiracil (TAS-102) or placebo. Median overall survival improved from 5.3 to 7.1 months (hazard ratio 0.68, 95% CI 0.58 to 0.81). Trifluridine is incorporated into DNA rather than inhibiting thymidylate synthase, which is why it retains activity after fluoropyrimidine failure, and tipiracil blocks its degradation. Neutropenia is the main toxicity. The FDA approved it in September 2015, the EU marketing authorisation for Lonsurf followed on 25 April 2016 and NICE recommended it in England in August 2016 (TA405). SUNLIGHT later showed that adding bevacizumab is better still.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
800 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Trifluridine/tipiracil | - | 7.1 months | 0.68 (0.58 to 0.81) | - | link |
| Placebo | - | 5.3 months |
Shares Taiho Pharmaceutical (Otsuka), SUNLIGHT, Servier, Trifluridine/tipiracil.
Shares Trifluridine/tipiracil, Cytotoxic chemotherapy, Colorectal cancer.
Shares Servier, Trifluridine/tipiracil, Cytotoxic chemotherapy.
Shares SUNLIGHT, Trifluridine/tipiracil, Colorectal cancer.
Shares Taiho Pharmaceutical (Otsuka), Trifluridine/tipiracil, Cytotoxic chemotherapy, Colorectal cancer.
Shares Trifluridine/tipiracil, Cytotoxic chemotherapy, Colorectal cancer.
Shares Trifluridine/tipiracil, Cytotoxic chemotherapy, Colorectal cancer.