Trifluridine and tipiracil

(Lonsurf®)

Lonsurf®

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Drug updated on 5/17/2024

Dosage FormTablet (oral; trifluridine/ tipiracil: 15 mg/6.14 mg, 20 mg/8.19 mg)
Drug ClassNucleoside metabolic inhibitor and thymidine phosphorylase inhibitor
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with metastatic colorectal cancer as a single agent or in combination with bevacizumab 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.
  • Indicated 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
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  • Trifluridine and tipiracil (Lonsurf) is indicated for the treatment of adult patients with metastatic colorectal cancer as a single agent or in combination with bevacizumab who have previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. It is also used to treat metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy.
  • Fifteen studies were reviewed, providing extensive analysis on the efficacy and safety of Lonsurf in treating metastatic colorectal cancer (mCRC) and metastatic gastric or gastroesophageal junction adenocarcinoma.
  • Lonsurf demonstrated a consistent improvement in overall survival (OS), progression-free survival (PFS), and disease control rate across subgroups, including patients with KRAS wild-type tumors. This highlights its broad efficacy irrespective of genetic mutation status.
  • Lonsurf combined with bevacizumab was particularly effective, showing increased median OS and PFS compared to Lonsurf monotherapy. Neutropenia was identified as the most common severe adverse event, followed by limited rates of discontinuation due to adverse events.
  • Elevated incidences of hematological adverse events such as neutropenia, leukopenia, and anemia were noted to be more prevalent when combined with other antineoplastic agents including bevacizumab.
  • The combination outperformed other treatments, offering significant OS benefit among regimens evaluated, indicating it as an optimal choice for this patient population.
  • Lonsurf showed the best intervention for PFS compared to Selective Internal Radiation Therapy using yttrium-90 and regorafenib, while all active treatments showed improvement in OS. SIRT had the longest OS without statistically significant differences.
  • Benefits extend to diverse patient subgroups, including those characterized by different KRAS mutation statuses, suggesting universal applicability across various patient demographics such as age, gender, and varying baseline performance statuses.

Product Monograph / Prescribing Information

Document TitleYearSource
Lonsurf (trifluridine and tipiracil) Prescribing Information.2023Taiho Oncology, Inc., Princeton, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy and safety of trifluridine/tipiracil (TAS-102) in patients with metastatic colorectal cancer: a systematic review and meta-analysis.2024Clinical & Translational Oncology
Efficacy and safety of trifluridine/tipiracil-containing combinations in colorectal cancer and other advanced solid tumors: a systematic review.2024Oncologist
Selective internal radiation therapy using y-90 resin microspheres for metastatic colorectal cancer: an updated systematic review and network meta-analysis.2024Advances in Therapy
Trifluridine/tipiracil with or without bevacizumab in metastatic colorectal cancer: results of a systematic review and meta-analysis.2023Therapeutic Advances in Medical Oncology
Comparison of the efficacy and safety of third-line treatments for metastatic colorectal cancer: a systematic review and network meta-analysis. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10552753/pdf/fonc-13-1269203.pdf 2023 Frontiers in Oncology2023Frontiers in Oncology
A systematic review and meta-analysis of trifluridine/tipiracil plus bevacizumab for the treatment of metastatic colorectal cancer: evidence from real-world series.2023Current Oncology
The effect of trifluridine/tipiracil for patients with heavily pretreated metastatic gastric cancer.2021Medicine
Comparison of efficacy and safety for patients with beyond second line treated metastatic colorectal cancer: a network meta-analysis of randomized controlled trials.2020Journal of Chemotherapy
Role of systemic treatment for advanced/metastatic gastric carcinoma in the third-line setting: a bayesian network analysis.2020Frontiers in Oncology
Systematic review and meta-analysis of multitargeted tyrosine kinase inhibitors in patients with intractable metastatic colorectal cancer.2020Technology in Cancer Research & Treatment
Systematic review and network meta-analyses of third-line treatments for metastatic colorectal cancer.2020Journal 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.2020Journal of Chemotherapy
Regorafenib, TAS-102, or fruquintinib for metastatic colorectal cancer: any difference in randomized trials?2020International Journal of Colorectal Disease
Comparison of regorafenib, fruquintinib, and tas-102 in previously treated patients with metastatic colorectal cancer: a systematic review and network meta-analysis of five clinical trials.2019Medical Science Monitor
A systematic review of observational studies of trifluridine/tipiracil (TAS-102) for metastatic colorectal cancer.2019Acta Oncologica

Clinical Practice Guidelines