Tipiracil
| Evidence Level: L5 | Predicted Indications: 9 |
Table of Contents
Tipiracil: Cecum villous adenoma
One-Sentence Summary
Tipiracil is a thymidine phosphorylase inhibitor used together with trifluridine (the TAS-102 combination) in colorectal cancer treatment. The TxGNN model predicts it may be relevant to cecum villous adenoma, but no clinical trials and no publications directly support this prediction, so it rests on the model prediction alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Cecum villous adenoma |
| TxGNN Prediction Score | 0.9999 |
| Evidence Level | L5 |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on known information, tipiracil inhibits thymidine phosphorylase. In the trifluridine/tipiracil combination it slows the breakdown of trifluridine, a nucleoside-analogue antimetabolite that targets rapidly dividing cells.
A villous adenoma of the cecum is a premalignant lesion of the large bowel, so there is a loose anatomical and biological link to colorectal cancer. However, adenomas are normally managed by endoscopic resection, not systemic chemotherapy. The high score therefore appears to be a model-based association rather than a clinically grounded rationale, and nothing in the compiled data shows benefit in this condition.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available for cecum villous adenoma.
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 11507P | Lonsurf 15/6.14 | Tablet containing 15 mg trifluridine with 6.14 mg tipiracil (as hydrochloride) | Not specified in the data compiled for this report |
One valid ARTG entry is recorded, and it is a combination product (trifluridine with tipiracil). It is an oral tablet.
Cytotoxicity
Tipiracil is used only in combination with the cytotoxic nucleoside analogue trifluridine, so the cytotoxicity considerations below come from the combination.
| Item | Content |
|---|---|
| Cytotoxicity Classification | Conventional cytotoxic combination (trifluridine is the cytotoxic component; tipiracil is the thymidine phosphorylase inhibitor) |
| Myelosuppression Risk | Please refer to the Product Information (PI) warnings and precautions |
| Emetogenicity Classification | Please refer to the Product Information (PI) warnings and precautions |
| Monitoring Items | Full blood count, liver and renal function (confirm against the PI) |
| Handling Protection | Follow local cytotoxic drug handling requirements; refer to the PI |
Safety Considerations
- Drug Interactions: 14 interaction records were compiled. Thirteen are rated Moderate, including cimetidine, tafenoquine, ketoconazole, brigatinib, crizotinib, encorafenib, ethinylestradiol, lenvatinib, medroxyprogesterone acetate, megestrol acetate, ribociclib, rucaparib and vandetanib. One further record is a pharmacology entry for a SARS-CoV-2 non-structural protein target, which has no severity rating.
Please refer to the TGA-approved Product Information (PI) for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is supported only by the model score. There are no trials or publications on cecum villous adenoma, and the usual management of this lesion is endoscopic resection rather than systemic chemotherapy.
To proceed, the following is needed:
- Any clinical or preclinical evidence that tipiracil, alone or with trifluridine, has activity in this condition
- Mechanism of action data
- Warnings and contraindications from the TGA-approved Product Information
- A clinical rationale for systemic cytotoxic therapy over standard endoscopic management
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.