Drug updated on 3/28/2024
| Dosage Form | Tablet (oral; trifluridine/ tipiracil: 15 mg/6.14 mg, 20 mg/8.19 mg) |
| Drug Class | Antineoplastics |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
- For the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.
Summary
- Trifluridine and tipiracil (Lonsurf) is indicated for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
- It is also used in treating adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.
- A systematic review found trifluridine/tipiracil to be effective in heavily pretreated metastatic gastric cancer patients; however it was associated more frequently than regorafenib or SIRT with nausea/vomiting/diarrhea as adverse events.
- In comparison to other drugs like regorafenib,TAS-102,and fruquintinib for mCRC beyond second line treatment,Lonsurf showed no significant difference in overall survival(OS)and progression-free survival(PFS).
- The information provided comes from five Systematic Reviews / Meta-Analyses documents which were thoroughly reviewed during this analysis process.
- Despite its effectiveness across different patient populations, the drug has shown varying toxicity profiles among individuals hence necessitating careful consideration before prescription by health professionals due to potential side effects such as gastrointestinal issues among others.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Lonsurf (trifluridine and tipiracil) Prescribing Information. | 2019 | FDA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| The effect of trifluridine/tipiracil for patients with heavily pretreated metastatic gastric cancer. | 2021 | Medicine |
| Final clinical guidance report: trifluridine-tipiracil (Lonsurf) for gastric cancer. | 2020 | CADTH |
| Systematic review and network meta-analyses of third-line treatments for metastatic colorectal cancer. | 2020 | Journal of Cancer Research and Clinical Oncology |
| Comparison of efficacy and safety for patients with beyond second line treated metastatic colorectal cancer: a network meta-analysis of randomized controlled trials. | 2020 | Journal of Chemotherapy |
| Regorafenib, TAS-102, or fruquintinib for metastatic colorectal cancer: any difference in randomized trials? | 2020 | International Journal of Colorectal Disease |
| Final clinical guidance report: trifluridine-tipiracil (Lonsurf) for metastatic colorectal cancer (resubmission). | 2019 | CADTH |
| A systematic review of observational studies of trifluridine/tipiracil (TAS-102) for metastatic colorectal cancer. | 2019 | Acta Oncologica |
Economic Studies
| Document Title | Year | Source |
|---|---|---|
| Trifluridine-Tipiracil for Previously Treated Metastatic Colorectal Cancer: An Evidence Review Group Perspective of a NICE Single Technology Appraisal. | 2018 | PharmacoEconomics |