Effects of trifluridine and tipiracil: A Synthesis of Findings from 16 Studies

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Original Abstract of the Article

Major Research Findings

Trifluridine/tipiracil has shown promise as a treatment option for various cancers, including advanced gastric cancer, gastroesophageal junction adenocarcinoma, and colorectal cancer, often used as a third- or later-line treatment. 10 , 13 , 7 , 11 , 1 . It may also be effective for treating advanced biliary tract carcinoma. 14 . In combination with bevacizumab, it has demonstrated clinical benefit for metastatic colorectal cancer refractory to standard therapy. 4 . Additionally, its combination with ramucirumab has shown promising results for treating advanced gastric cancer or gastroesophageal junction adenocarcinoma as a third- or later-line treatment. 10 . However, it can also lead to severe neutropenia, particularly in patients with impaired kidney function. 6 . The safety of trifluridine/tipiracil after previous anti-PD-1 therapy for advanced gastric cancer has also been investigated. 13 . In colorectal cancer, the combination of trifluridine/tipiracil with 5-FU might offer synergistic effects. 3 . While severe neutropenia is associated with trifluridine/tipiracil treatment for metastatic colorectal cancer, the effect of this neutropenia on long-term survival is unclear. 5 , 16 .

Benefits and Risks

Benefit Summary

Trifluridine/tipiracil has shown promise as a treatment option for various cancers, including advanced gastric cancer, gastroesophageal junction adenocarcinoma, and colorectal cancer, often used as a third- or later-line treatment. 10 , 13 , 7 , 11 , 1 . It may also be effective for treating advanced biliary tract carcinoma. 14 . In combination with bevacizumab, it has demonstrated clinical benefit for metastatic colorectal cancer refractory to standard therapy. 4 . Additionally, its combination with ramucirumab has shown promising results for treating advanced gastric cancer or gastroesophageal junction adenocarcinoma as a third- or later-line treatment. 10 .

Risk Summary

Trifluridine/tipiracil can lead to severe neutropenia, especially in patients with impaired kidney function. 6 . While severe neutropenia is associated with trifluridine/tipiracil treatment for metastatic colorectal cancer, the effect of this neutropenia on long-term survival is unclear. 5 , 16 .

Comparison Across Studies

Commonalities

Multiple studies have assessed the efficacy and safety of trifluridine/tipiracil in treating various cancers, often as a third- or later-line treatment option for advanced gastric cancer, gastroesophageal junction adenocarcinoma, and colorectal cancer. 10 , 13 , 7 , 11 , 1 . They consistently highlight the potential for severe neutropenia as a side effect. 6 , 5 , 16 .

Differences

Studies vary in their focus on the specific combination of trifluridine/tipiracil with other drugs and the types of cancers targeted. For instance, 4 investigates its combination with bevacizumab for metastatic colorectal cancer, while 10 examines its combination with ramucirumab for advanced gastric cancer or gastroesophageal junction adenocarcinoma. Furthermore, 14 explores the efficacy of trifluridine/tipiracil monotherapy for advanced biliary tract carcinoma.

Consistency and Contradictions in Findings

Many studies highlight the potential of trifluridine/tipiracil as a promising treatment option, but also acknowledge the risks of side effects, including severe neutropenia. 10 , 13 , 7 , 11 , 1 , 6 , 5 , 16 . However, the impact of severe neutropenia on long-term survival remains uncertain. 5 , 16 .

Considerations for Real-World Application

While trifluridine/tipiracil shows potential as a treatment option for various cancers, its use should be carefully considered due to potential side effects, especially severe neutropenia. 10 , 13 , 7 , 11 , 1 , 6 , 5 , 16 . Patients should consult with their doctor to weigh the potential benefits against the risks and make informed decisions regarding treatment. 10 , 13 , 7 , 11 , 1 , 6 , 5 , 16 .

Limitations of Current Research

While the studies discussed highlight the potential of trifluridine/tipiracil in treating various cancers, further research is necessary to understand its efficacy and safety in a wider range of scenarios. 10 , 13 , 7 , 11 , 1 , 6 , 5 , 16 .

Future Research Directions

Future research should focus on further investigating the efficacy and safety of trifluridine/tipiracil in combination with other therapies and in diverse cancer types, along with exploring optimal dosage and administration strategies. 10 , 13 , 7 , 11 , 1 , 6 , 5 , 16 .

Conclusion

Trifluridine/tipiracil shows potential as a treatment option for various cancers, including advanced gastric cancer, gastroesophageal junction adenocarcinoma, and colorectal cancer, often used as a third- or later-line treatment. 10 , 13 , 7 , 11 , 1 . It may also be effective for treating advanced biliary tract carcinoma. 14 . In combination with bevacizumab, it has demonstrated clinical benefit for metastatic colorectal cancer refractory to standard therapy. 4 . Additionally, its combination with ramucirumab has shown promising results for treating advanced gastric cancer or gastroesophageal junction adenocarcinoma as a third- or later-line treatment. 10 . However, it can also lead to severe neutropenia, particularly in patients with impaired kidney function. 6 . The safety of trifluridine/tipiracil after previous anti-PD-1 therapy for advanced gastric cancer has also been investigated. 13 . In colorectal cancer, the combination of trifluridine/tipiracil with 5-FU might offer synergistic effects. 3 . While severe neutropenia is associated with trifluridine/tipiracil treatment for metastatic colorectal cancer, the effect of this neutropenia on long-term survival is unclear. 5 , 16 . These studies suggest that trifluridine/tipiracil has the potential to become a valuable treatment option for patients with advanced cancers, but further research is essential to refine its application and understand its long-term impact. 10 , 13 , 7 , 11 , 1 , 6 , 5 , 16 .

Literature analysis of 16 papers
Positive Content
16
Neutral Content
0
Negative Content
0
Article Type
3
0
0
1
16
1.

Bevacizumab mitigates codon-specific effects of trifluridine/tipiracil on efficacy outcome parameters in metastatic colorectal cancer.

Author: DoleschalB, TaghizadehH, LentnerT, RiedlJ M, GranitzerJ, MorariuD, DeckerJ, AichbergerK J, WebersinkeG, KirchwegerP, PetzerA, RumpoldH

mCRC treatment

The study explored the efficacy of trifluridine/tipiracil (FTD/TPI) plus bevacizumab in patients with metastatic colorectal cancer (mCRC), considering the KRAS G12 mutation status. The results suggest that the combination may be effective regardless of the KRAS G12 mutation status.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

2.

Effects of prior therapies on outcomes with trifluridine/tipiracil in patients with metastatic gastric/gastroesophageal junction cancer in a randomized phase III trial (TAGS).

Author: ShitaraKohei, GeorgeBen, TaiebJulien, SundarRaghav, FakihMarwan G, MakrisLukas, BenhadjiKarim A, GhidiniMichele

Improved functioning
Progression-free survival
Survival benefit

This post hoc exploratory analysis of the TAGS trial assessed the impact of prior therapy type on the efficacy of trifluridine/tipiracil for metastatic gastric/gastroesophageal junction cancer. Trifluridine/tipiracil demonstrated survival benefits versus placebo regardless of prior treatment type, including patients who had received ramucirumab, paclitaxel, or irinotecan. The safety profile was consistent across subgroups.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

3.

Pharmacological effects of the simultaneous and sequential combinations of trifluridine/tipiracil (TAS-102) and 5-fluorouracil in fluoropyrimidine-sensitive colon cancer cells.

Author: OrlandiPaola, GentileDaniela, BanchiMarta, CucchiaraFederico, Di DesideroTeresa, CremoliniChiara, MorettoRoberto, FalconeAlfredo, BocciGuido

Cancer Treatment

This in vitro study investigated the synergistic effects of trifluridine/tipiracil (TAS-102) and 5-fluorouracil (5-FU) on colon cancer cell lines. The combination showed synergistic effects, particularly in wild-type cells, suggesting potential for future use in adjuvant or first-line treatment.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

4.

Trifluridine/Tipiracil Plus Bevacizumab for Vulnerable Patients With Pretreated Metastatic Colorectal Cancer: A Retrospective Study (WJOG14520G).

Author: KitoYosuke, KawakamiHisato, MitaniSeiichiro, NishinaShinichi, MatsumotoToshihiko, TsuzukiTakao, ShinoharaYudai, ShimokawaHozumi, KumanishiRyosuke, OhtaTakashi, KatsuyaHiroo, KawakamiTakeshi, NishinaTomohiro, HasegawaHiroko, AkiyoshiKohei, ChibaYasutaka, YamazakiKentaro, HironakaShuichi, MuroKei

FTD/TPI efficacy
Vulnerable patients
Neutropenia

Trifluridine/tipiracil (FTD/TPI) plus bevacizumab showed potential efficacy and an acceptable safety profile for vulnerable patients with pretreated metastatic colorectal cancer who were intolerant of intensive therapy.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

6.

Renal impairment as a risk factor for trifluridine/tipiracil-induced adverse events in metastatic colorectal cancer patients from the REGOTAS study.

Author: ShiroyamaMamiko, FukuokaShota, MasuishiToshiki, TakashimaAtsuo, KumekawaYosuke, KajiwaraTakeshi, YamazakiKentaro, ShimadaYasuhiro, EsakiTaito, MakiyamaAkitaka, MoriwakiToshikazu

Clinical benefit
Neutropenia risk

This real-world study found that patients with metastatic colorectal cancer (mCRC) and moderate/severe renal impairment who received trifluridine/tipiracil (FTD/TPI) therapy had a higher risk of developing severe neutropenia. However, FTD/TPI remains a viable treatment option due to its clinical benefit.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

8.

Effects and risk factors of TAS-102 in real-world patients with metastatic colorectal cancer, EROTAS-R study.

Author: YoshidaNaohisa, KuriuYoshiaki, IkedaJun, KudouMichihiro, KirishimaToshihiko, OkayamaTetsuya, MiyagawaKoji, TakagiTsuyoshi, NakanishiMasayoshi, DoiToshifumi, IshikawaTakeshi, ItohYoshito, OtsujiEigo

Disease control
Improved survival
TAS-102 side effects

TAS-102 + Bev showed a better OS and PFS compared to TAS-102 alone in real-world patients with metastatic CRC. The treatment was associated with a higher rate of grade 3 AE.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

9.

Real-world evidence of trifluridine/tipiracil plus bevacizumab in metastatic colorectal cancer using an administrative claims database in Japan.

Author: KagawaY, ShinozakiE, OkudeR, ToneT, KunitomiY, NakashimaM

CRC treatment

This real-world study evaluated the efficacy and safety of trifluridine/tipiracil (FTD/TPI) plus bevacizumab (BEV) for refractory metastatic colorectal cancer (mCRC). The study compared this combination with FTD/TPI or regorafenib monotherapy, providing valuable insights into real-world clinical outcomes.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

10.

Randomised phase II trial of trifluridine/tipiracil (FTD/TPI) plus ramucirumab (RAM) versus trifluridine/tipiracil for previously treated patients with advanced gastric or esophagogastric junction adenocarcinoma (RETRIEVE study, WJOG15822G).

Author: TakahashiNaoki, HaraHiroki, NagashimaKengo, HirataKenro, MasuishiToshiki, MatsumotoToshihiko, KawakamiHisato, YamazakiKentaro, HironakaShuichi, BokuNarikazu, MuroKei

Enhanced efficacy
Improved survival

This article discusses a randomized phase II trial evaluating the efficacy and safety of trifluridine/tipiracil (FTD/TPI) plus ramucirumab (RAM) compared to FTD/TPI monotherapy in patients with advanced gastric cancer and esophagogastric junction adenocarcinoma.

Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

11.

Ramucirumab beyond progression plus TAS-102 in patients with advanced or metastatic esophagogastric adenocarcinoma, after treatment failure on a ramucirumab-based therapy.

Author: GoetzeThorsten Oliver, SteinAlexander, LorenzenSylvie, HabibzadaTimorshah, GoekkurtEray, HerhausPeter, LooseMaria, SookthaiDisorn, BrulinTanita, IhrigKristina, PauligkClaudia, Al-BatranSalah-Eddin

EGA treatment
Ramucirumab efficacy
TAS-102 efficacy

This pilot trial explored the safety and efficacy of combining ramucirumab with TAS-102 in patients with advanced esophagogastric adenocarcinoma who had progressed on prior therapies. The combination showed a favorable safety profile with a lower incidence of adverse events compared to historical data. It also demonstrated efficacy in terms of tumor response and overall/progression-free survival, warranting further evaluation in a randomized trial.

Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

12.

Efficacy and safety of trifluridine/tipiracil (TAS-102) in patients with metastatic colorectal cancer: a systematic review and meta-analysis.

Author: HuangFengxiang, YangHaiyan, BaoWenguang, BinYehong, ZhouShengsheng, WangMan, LvXiaoping

Improved survival
Reduced tumor growth
Adverse events

TAS-102, a chemotherapy drug, improved overall survival (OS), progression-free survival (PFS), time to treatment failure (TTF), and disease control rate (DCR) in patients with metastatic colorectal cancer (mCRC). It was well-tolerated and did not increase the incidence of serious adverse events.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

14.

Phase II Trial of Trifluridine/Tipiracil Plus Irinotecan in Patients with Advanced, Refractory Biliary Tract Carcinoma.

Author: TellaSri Harsha, FosterNathan, QianShi, NguyenTran, BoradMitesh J, McWilliamsRobert R, AlbertsSteven R, Wee MaWen, ChakrabartiSakti, FruthBriant, WesslingJaclynn, HartgersMindy, WashburnLeslie, Fernandez-ZapicoMartin E, HogensonTara L, PitotHenry, JinZhaohui, MahipalAmit

Improved survival
Dose reduction
Hematologic toxicity
Therapy delay

The combination of trifluridine/tipiracil plus irinotecan showed a promising 16-week progression-free survival rate of 37% in patients with refractory, advanced unresectable biliary tract carcinoma (BTC).

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

15.

Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicentre, randomised, double-blind, phase 3 study.

Author: DasariArvind, LonardiSara, Garcia-CarboneroRocio, ElezElena, YoshinoTakayuki, SobreroAlberto, YaoJames, García-AlfonsoPilar, KocsisJudit, Cubillo GracianAntonio, Sartore-BianchiAndrea, SatohTaroh, RandrianViolaine, TomasekJiri, ChongGeoff, PaulsonAndrew Scott, MasuishiToshiki, JonesJeremy, CsősziTibor, CremoliniChiara, GhiringhelliFrancois, ShergillArdaman, HochsterHoward S, KraussJohn, BassamAli, DucreuxMichel, ElmeAnneli, FaugerasLaurence, KasperStefan, Van CutsemEric, ArnoldDirk, NandaShivani, YangZhao, SchelmanWilliam R, KaniaMarek, TaberneroJosep, EngCathy,

Colorectal cancer treatment

This study examines the efficacy and safety of fruquintinib, an oral inhibitor of vascular endothelial growth factor receptors (VEGFRs), in patients with heavily pretreated metastatic colorectal cancer. The study seeks to provide new treatment options for patients with advanced and refractory colorectal cancer.

Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

16.

Analysis of neutropenia as a predictive factor of the efficacy of trifluridine-tipiracil treatment.

Author: Domínguez SenínLoreto, Rodriguez GarcésMaría Yeray, Aviñó TarazonaVictoria, Amor UrbanoMaría, Santos-RubioMaria Dolores, Bayo CaleroJuan

Predictor of efficacy
Neutropenia

Grade 3-4 neutropenia is an independent predictor of treatment response and survival in patients undergoing routine treatment for metastatic colorectal cancer (mCRC) with trifluridine-tipiracil (TAS-102). This finding needs confirmation in a prospective study.

Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

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