[Antitumor Molecular Mechanism of Trifluridine and Tipiracil Hydrochloride (TAS-102: TFTD)]
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Hiroyuki Kitao1, Kazuaki Matsuoka, Makoto Iimori
1Dept. of Molecular Oncology, Graduate School of Medical Sciences, Kyushu University.
Abstract:
Treatment options for patients with metastatic colorectal cancer (mCRC), who are refractory to standard chemotherapy, are limited. In a global multicenter randomized double-blind phase III study (RECOURSE study), TAS-102 (TFTD) administration significantly improved overall survival rate with favorable safety profile in mCRC patients refractory to standard chemotherapy (HR=0.68, p<0.001). TFTD was approved initially in Japan in March 2014 and is currently under review by health authorities in the United States and Europe. TFTD is expected to play an important role in salvage-line treatment for patients with mCRC. In this review, we present the history of its clinical development and the experimental data that elucidate the underlying molecular mechanism of action of TFTD and its key component, trifluridine.
Insights
Treatment with TAS-102 (trifluridine/tipiracil) significantly improves survival for patients with metastatic colorectal cancer (mCRC) resistant to chemotherapy. This drug offers a new option for difficult-to-treat mCRC cases.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Metastatic colorectal cancer (mCRC) patients refractory to standard chemotherapy have limited treatment options.
- TAS-102 (trifluridine/tipiracil) is an investigational drug showing promise in this patient population.
Purpose of the Study:
- To review the clinical development history of TAS-102 (TFTD).
- To elucidate the molecular mechanism of action of TAS-102 and its component trifluridine.
Main Methods:
- A global, multicenter, randomized, double-blind, phase III study (RECOURSE) was conducted.
- Patient outcomes, including overall survival and safety, were evaluated.
Main Results:
- TAS-102 (TFTD) significantly improved overall survival in mCRC patients refractory to standard chemotherapy (HR=0.68, p<0.001).
- The drug demonstrated a favorable safety profile.
Conclusions:
- TAS-102 (TFTD) is an important new treatment option for salvage-line therapy in mCRC.
- Regulatory reviews are underway in the US and Europe following its approval in Japan.
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