Side Effects of trifluridine and tipiracil: A Synthesis of Findings from 21 Studies

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Original Abstract of the Article

Main Research Findings

Trifluridine/tipiracil (TAS-102) has shown efficacy in treating patients with metastatic colorectal cancer (mCRC) who have been previously treated with standard therapies. 19 This includes elderly patients and those who have received multiple prior treatments. 9 The combination of TAS-102 with other therapies, such as bevacizumab and oxaliplatin, is also being investigated. 2 8

Reasons for Side Effects

Trifluridine/tipiracil (TAS-102) is an anti-cancer drug that works by interfering with the DNA synthesis of cancer cells. This mechanism can lead to side effects that affect the bone marrow, gastrointestinal tract, and skin. 11 Additionally, TAS-102 can also inhibit vascular endothelial growth factor (VEGF), potentially leading to side effects like high blood pressure. 7

Common Side Effects

Myelosuppression

The most common side effect of TAS-102 is myelosuppression, which can lead to a decrease in white blood cells, red blood cells, and platelets, increasing the risk of infection, anemia, and bleeding. 19 12 2 10

Gastrointestinal Symptoms

Side effects of TAS-102 include nausea, vomiting, diarrhea, and loss of appetite. 19 16 10 These symptoms are likely caused by TAS-102 affecting the gastrointestinal system. 12

Skin Reactions

Side effects of TAS-102 can include erythema of the palms and soles, rash, and nail abnormalities. 12 These are likely caused by TAS-102 affecting the skin. 17

Hypertension

TAS-102 can cause hypertension as a side effect. 7 This is likely due to TAS-102 inhibiting vascular endothelial growth factor (VEGF). 12

Countermeasures for Side Effects

Myelosuppression

Countermeasures for myelosuppression include administering medications such as granulocyte colony-stimulating factor (G-CSF) if white blood cell counts decrease as determined by blood tests. 12 Maintaining good hygiene practices such as hand washing is also crucial to prevent infection. 17

Gastrointestinal Symptoms

Countermeasures for gastrointestinal symptoms include using antiemetics for nausea and vomiting, and antidiarrheals for diarrhea. 17 Loss of appetite can be addressed by using nutritional supplements. 17

Skin Reactions

Countermeasures for skin reactions include using topical steroid medications and moisturizers. 17 If symptoms are severe, it may be necessary to discontinue TAS-102 administration. 12

Hypertension

Countermeasures for hypertension include administering antihypertensive medications. 12 Dietary management such as salt restriction is also important. 12

Comparison Between Studies

Commonalities of Studies

Many studies have shown that TAS-102 is effective in treating patients with metastatic colorectal cancer that is resistant to standard therapies. TAS-102 has also been shown to be safe and effective in elderly patients and those who have been heavily pretreated.

Differences Between Studies

There are differences between studies regarding the type, frequency, and severity of side effects of TAS-102. This is likely due to differences in the patient population studied and the research design.

Points to Note Regarding Application in Real Life

TAS-102 can be an effective treatment for patients with metastatic colorectal cancer that is resistant to standard therapies. However, TAS-102 can cause a variety of side effects, including myelosuppression, gastrointestinal symptoms, and skin reactions. Therefore, it is important to fully understand the risks and benefits of TAS-102 and consult with your doctor before using it.

Limitations of Current Research

Research on TAS-102 is still ongoing. Further research is needed on the efficacy and safety of TAS-102.

Future Research Directions

To better understand the efficacy and safety of TAS-102, the following research is considered necessary:

  • Research to evaluate the efficacy and safety of various combination therapies with TAS-102
  • Development of new treatments to reduce the side effects of TAS-102
  • Development of new methods of administration to improve the efficacy of TAS-102

Conclusion

Trifluridine/tipiracil (TAS-102) can be an effective treatment for patients with metastatic colorectal cancer that is resistant to standard therapies. However, TAS-102 can cause a variety of side effects, including myelosuppression, gastrointestinal symptoms, and skin reactions. Therefore, it is important to fully understand the risks and benefits of TAS-102 and consult with your doctor before using it.

Literature analysis of 21 papers
Positive Content
19
Neutral Content
0
Negative Content
2
Article Type
2
0
0
4
20
1.

Double-blind crossover comparison of triazolam and lorazepam in the posthypnotic state.

Author: CohnJ B

Induces sleep
Daytime sleepiness
Side effects

Triazolam and lorazepam are both effective hypnotics, but lorazepam has more pronounced daytime carryover and side effects.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

5.

Regorafenib and trifluridine/tipiracil in real clinical practice.

Author: García-BelosoNerea, Romero-VentosaElena Yaiza, Gayoso-ReyMónica, López-LópezAida, Robles-TorresDavid, de CastroNoemí Martínez-López, Piñeiro-CorralesGuadalupe

Gastrointestinal disorders
Hematological adverse reactions

The effectiveness of regorafenib and trifluridine/tipiracil in treating advanced colorectal cancer in real-world clinical practice was lower than that reported in clinical trials. The toxicity profile mirrored that described in the literature.

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

Language : English

6.

Trifluridine induces HUVECs senescence by inhibiting mTOR-dependent autophagy.

Author: JiaHui-Jie, ZhouMin, VashisthManoj Kumar, XiaJing, HuaHui, DaiQian-Long, BaiShi-Rui, ZhaoQi, WangXiao-Bo, ShiYi-Ling

Anti-cancer effect
Cellular senescence

This study evaluated the potential of trifluridine to induce senescence in human umbilical vein endothelial cells. The findings suggest that trifluridine can induce cellular senescence by inhibiting autophagy and activating the mTOR signaling pathway.

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

7.

A Phase I dose-escalation study of third-line regorafenib with trifluridine/tipiracil in metastatic colorectal cancer.

Author: MoehlerMarkus, MichelMaurice, SteinAlexander, TrojanJoerg, MarquardtJens, TintelnotJoseph, WaidmannOliver, WeinmannArndt, WoernsMarcus-Alexander, SchroederHelge, MaenzMartin, FoersterFriedrich

Feasible and safe
Improved survival
Hypertension

This study determined a recommended Phase II dose of trifluridine/tipiracil (FTD/TPI) combined with regorafenib (REG) for treating refractory metastatic colorectal cancer. The recommended dose was found to be FTD/TPI 25 mg/m² b.i.d. + REG 120 mg/d. The combination was safe and showed promising efficacy signals.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

8.

A phase 1b expansion study of TAS-102 with oxaliplatin for refractory metastatic colorectal cancer.

Author: CecchiniMichael, KortmanskyJeremy S, CuiCan, WeiWei, ThumarJaykumar Ranchobdhai, UbohaNataliya V, HafezNavid, LacyJill, FischbachNeal A, SabbathKert D, GomezChristina M, SpornJonathan Reed, SteinStacey, HochsterHoward S

CRC treatment
Overall survival
Progression-free survival

This open-label phase 1b study evaluated the safety and efficacy of TAS-102 in combination with oxaliplatin (TAS-OX) in 41 patients with metastatic colorectal cancer previously treated with 5-fluorouracil, irinotecan, and oxaliplatin. The combination was safe with no unexpected toxicities. Although the objective response rate was not clinically meaningful, the study suggests potential benefit in terms of progression-free survival and overall survival in this heavily pretreated population.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

12.

Maximising clinical benefit with adequate patient management beyond the second line in mCRC.

Author: ArgilesGuillem, ArnoldDirk, PragerGerald, SobreroAlberto F, Van CutsemEric

Regorafenib efficacy
Trifluridine/tipiracil efficacy
Diarrhea
Fatigue
Hand-foot skin reaction
Hypertension
Neutropenia

Trifluridine/tipiracil and regorafenib are new treatment options for patients with metastatic colorectal cancer (mCRC). While both can extend survival, they have different side effect profiles. This review discusses factors to consider when choosing between these therapies, emphasizing the importance of managing side effects to improve patient quality of life.

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

13.

Intensive safety monitoring program of antineoplastic medicines: A pilot study in a Portuguese oncology hospital.

Author: MendesDiogo, RigueiroGraça, SilvaRui S, PenedonesAna, AlvesCarlos, SousaGabriela, Batel-MarquesFrancisco

Cancer drug safety
Gastrointestinal disorders
Hematologic disorders

This intensive safety monitoring program was feasible and allowed identifying serious and unexpected adverse drug reactions in cancer patients.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.

Language : English

14.

Efficacy and safety of trifluridine/tipiracil in third-line and beyond for the treatment of patients with metastatic colorectal cancer in routine clinical practice: patterns of use and prognostic nomogram.

Author: Fernandez MontesA, Vazquez RiveraF, Martinez LagoN, Covela RúaM, Cousillas CastiñeirasA, Gonzalez VillarroelP, de la Cámara GómezJ, Méndez MéndezJ C, Salgado FernándezM, Candamio FolgarS, Reboredo LópezM, Carmona CamposM, Gallardo MartínE, Jorge FernándezM, Pellón AugustoM L, París BouzasL, García GómezJ

mCRC treatment
Asthenia
Neutropenia

Trifluridine/tipiracil was effective and safe in chemorefractory mCRC patients in clinical practice.

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

Language : English

15.

Safety profile of trifluridine/tipiracil monotherapy in clinical practice: results of the German compassionate-use program for patients with metastatic colorectal cancer.

Author: KasperStefan, KisroJens, FuchsMartin, MüllerChristian, Schulz-AbeliusArmin, KarthausMeinolf, RafiyanMohammad-Reza, SteinAlexander

Treatment of metastatic colorectal cancer

Trifluridine/tipiracil (TAS-102, Lonsurf®) is a novel oral anti-tumor agent that is a new treatment option for metastatic colorectal cancer (mCRC) patients refractory or intolerant to standard therapies.

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

Language : English

16.

Safety of trifluridine/tipiracil in an open-label expanded-access program in elderly and younger patients with metastatic colorectal cancer.

Author: MayerRobert J, HochsterHoward S, CohenSteven J, WinklerRobert, MakrisLukas, GrotheyAxel

mCRC treatment
Side effects

Trifluridine/tipiracil (FTD/TPI) showed a safe and tolerable profile in US patients with metastatic colorectal cancer who progressed on standard therapies in an expanded-access program.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health 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

17.

Metastatic Colorectal Cancer: Management With Trifluridine/Tipiracil
.

Author: WhiteTeresa, LarsonHeidi, MinnellaAlexandra, HochsterHoward S

Treatment-related AE

Treatment-related adverse events are common in patients with metastatic colorectal cancer receiving chemotherapy, potentially affecting adherence to oral regimens like trifluridine/tipiracil.

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

19.

FDA Approval Summary: TAS-102.

Author: MarcusLeigh, LemerySteven J, KhasarSachia, WearneEmily, HelmsWhitney S, YuanWeishi, HeKun, CaoXianhua, YuJingyu, ZhaoHong, WangYaning, StephensOlen, EnglundErika, AgarwalRajiv, KeeganPatricia, PazdurRichard

Improved overall survival
Prolonged progression-free survival
Abdominal pain
Anemia
Decreased appetite
Diarrhea
Fatigue
Nausea
Neutropenia
Pyrexia
Thrombocytopenia
Vomiting

This article summarizes the results of a clinical trial evaluating the efficacy and safety of TAS-102 for treating metastatic colorectal cancer. TAS-102 demonstrated a statistically significant improvement in overall survival and progression-free survival compared to placebo. The most common side effects were anemia, neutropenia, and fatigue.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

20.

Efficacy and Safety of Regorafenib or TAS-102 in Patients with Metastatic Colorectal Cancer Refractory to Standard Therapies.

Author: SuedaToshinori, SakaiDaisuke, KudoToshihiro, SugiuraTakashi, TakahashiHidekazu, HaraguchiNaotsugu, NishimuraJunichi, HataTaishi, HayashiTaro, MizushimaTsunekazu, DokiYuichiro, MoriMasaki, SatohTaroh

Metastatic colorectal cancer treatment

Regorafenib and TAS-102 are novel antitumor agents for patients with metastatic colorectal cancer (mCRC) whose disease has progressed after standard therapies. Both drugs have been shown to prolong survival in patients with mCRC, but the appropriate choice of treatment remains to be established.

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

Language : English

21.

[Efficacy of TAS-102].

Author: KotaniDaisuke, FukuokaShota, YoshinoTakayuki

Colorectal cancer treatment

This article discusses the drug TAS-102, a chemotherapeutic agent for treating metastatic colorectal cancers. The article highlights the “drug lag” phenomenon in Japan, where drug approval is often delayed compared to other regions. TAS-102, initially halted in US trials, was approved in Japan first after showing positive results in phase I and II clinical trials. The article summarizes the efficacy and side effects of TAS-102 based on data from various clinical trials.

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 : Japanese

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