Side Effects of regorafenib: A Synthesis of Findings from 26 Studies

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Original Abstract of the Article

Main Research Findings

Regorafenib is a multikinase inhibitor used to treat various cancers, including metastatic colorectal cancer, hepatocellular carcinoma, and gastrointestinal stromal tumors. Regorafenib inhibits cancer cell growth and angiogenesis, slowing cancer progression. However, Regorafenib has strong side effects that can impact the patient's quality of life.

Side effects of Regorafenib have been reported differently in various studies. For example, a study in 12 indicated that hand-foot syndrome could occur with Regorafenib administration. Another study in 3 showed a potential for diarrhea to occur with Regorafenib administration. Further research in 24 showed a potential for myocardial infarction to occur with Regorafenib administration. According to a study in 1 , the effectiveness of Regorafenib, a multikinase inhibitor used to treat liver cancer, is dependent on the cellular redox state and could be negated by the consumption of antioxidants.

Reasons for Side Effects

Regorafenib's side effects are thought to be caused by inhibiting multiple kinases. Regorafenib inhibits kinases in normal cells as well as cancer cells, potentially leading to various side effects.

Common Side Effects

Hand-Foot Syndrome

Hand-foot syndrome can occur as a side effect of Regorafenib. Hand-foot syndrome causes pain, redness, swelling, and numbness in the hands and feet. Research in 12 shows that Regorafenib increases the risk of hand-foot syndrome.

Diarrhea

Diarrhea can occur as a side effect of Regorafenib. A study in 3 shows a potential for diarrhea to occur with Regorafenib administration.

Hypertension

Hypertension can occur as a side effect of Regorafenib. Hypertension increases the risk of heart disease and stroke, so caution is needed.

Hepatic Dysfunction

Hepatic dysfunction can occur as a side effect of Regorafenib. Hepatic dysfunction can cause symptoms such as jaundice, fatigue, and loss of appetite.

Taste Disturbances

Taste disturbances can occur as a side effect of Regorafenib. Taste disturbances can cause food to taste different or result in a loss of taste.

Rash

Rash can occur as a side effect of Regorafenib. Rash causes red spots or bumps to appear on the skin.

Hair Loss

Hair loss can occur as a side effect of Regorafenib. Hair loss causes hair to fall out.

Gastrointestinal Perforation

A case study reported in 10 highlighted a patient who developed gastrointestinal perforation during Regorafenib therapy. This suggests that clinicians should be cautious about the possibility of this complication, especially in patients who have previously received bevacizumab treatment.

Myocardial Infarction

A rare case of Regorafenib-induced ST-elevation myocardial infarction (STEMI) was reported in 24 . This highlights the potential for serious cardiac side effects from Regorafenib, even though it is considered a rare event.

Corneal Perforation

A case report in 23 documented a patient experiencing corneal perforation while undergoing Regorafenib therapy. This underlines the potential for Regorafenib to lead to rare but severe ophthalmologic complications.

Countermeasures for Side Effects

Hand-Foot Syndrome

If hand-foot syndrome symptoms occur, Regorafenib administration may need to be stopped or reduced. Applying cold compresses to the affected area or using moisturizers can help alleviate the symptoms.

Diarrhea

If diarrhea occurs, it is crucial to stay hydrated. Taking antidiarrheal medication can also be effective. If the symptoms do not improve, consult a doctor.

Hypertension

If hypertension occurs, consult a doctor. You may need to take medication for hypertension.

Hepatic Dysfunction

If hepatic dysfunction occurs, Regorafenib administration may need to be stopped. You may also need to take medication for hepatic dysfunction.

Taste Disturbances

If taste disturbances occur, consult a doctor. Taste disturbances may be caused by something other than Regorafenib.

Rash

If a rash occurs, consult a doctor. A rash may be caused by something other than Regorafenib.

Hair Loss

If hair loss occurs, consult a doctor. Hair loss may be caused by something other than Regorafenib.

Comparison Between Studies

Commonalities Among Studies

Multiple studies have indicated that Regorafenib has a potential to cause side effects such as hand-foot syndrome, diarrhea, and hypertension. These side effects are believed to be caused by the drug's ability to inhibit multiple kinases.

Differences Among Studies

The incidence and severity of Regorafenib's side effects vary between studies. This is likely due to differences in patient characteristics and Regorafenib dosage.

Precautions Regarding Real-Life Applications

While Regorafenib is an effective drug for cancer treatment, it has strong side effects that can impact the patient's quality of life. When taking Regorafenib, it is essential to discuss the risks and benefits with a doctor. If side effects occur, seek immediate medical attention. It is particularly important for patients with liver cancer to avoid uncontrolled intake of antioxidants, as they can negate the effectiveness of Regorafenib. Consult with your doctor to discuss the potential benefits and risks of antioxidant use during your treatment.

Limitations of Current Research

Research on Regorafenib's side effects is still inadequate. Further research is needed to understand how Regorafenib causes side effects and to develop methods for preventing and mitigating these effects.

Future Research Directions

Future research on Regorafenib's side effects should focus on the following:

  • Understanding the mechanisms by which Regorafenib causes side effects
  • Developing methods for preventing side effects
  • Developing methods for reducing side effects

Conclusion

Regorafenib is an effective cancer treatment drug, but it has strong side effects that can impact the patient's quality of life. When taking Regorafenib, it is essential to discuss the risks and benefits with a doctor. If side effects occur, seek immediate medical attention. Research on Regorafenib's side effects is still inadequate. Further research is needed to understand how Regorafenib causes side effects and to develop methods for preventing and mitigating these effects.

Literature analysis of 26 papers
Positive Content
19
Neutral Content
2
Negative Content
5
Article Type
1
1
0
4
21
2.

Higher Systemic Exposure to Unbound Active Metabolites of Regorafenib Is Associated With Short Progression-Free Survival in Colorectal Cancer Patients.

Author: KubotaYutaro, FujitaKen-Ichi, TakahashiTakehiro, SunakawaYu, IshidaHiroo, HamadaKazuyuki, IchikawaWataru, TsunodaTakuya, ShimadaKazuhiro, MasuoYusuke, KatoYukio, SasakiYasutsuna

Improved survival
Side effects
Treatment discontinuation

This study examined the pharmacokinetic basis for individualized dosing of regorafenib, an effective treatment for metastatic colorectal cancer. It found that patients with higher AUCu values of the active metabolites M-2 or M-5 on day 1 had shorter progression-free survival, likely due to treatment discontinuation caused by adverse events.

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

3.

Toxicity and early outcomes of regorafenib in multiply pre-treated metastatic colorectal adenocarcinoma-experience from a tertiary cancer centre in India.

Author: ZanwarSaurabh, OstwalVikas, GuptaSudeep, SirohiBhawna, ToshniwalAnup, ShettyNitin, BanavaliShripad

Effective treatment
Handfoot syndrome
Hepatotoxicity

Regorafenib is an effective treatment strategy for multiply pre-treated metastatic colorectal cancers but is associated with significant side effects, most commonly hand-foot syndrome and fatigue.

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

Language : English

4.

KDR Mutation as a Novel Predictive Biomarker of Exceptional Response to Regorafenib in Metastatic Colorectal Cancer.

Author: Loaiza-BonillaArturo, JensenChristopher E, ShroffStuti, FurthEmma, Bonilla-ReyesPaula A, DeikAndres F, MorrissetteJennifer

Exceptional response to regorafenib
Improved quality of life
Sustained tumor regression
Disease progression
Intolerable side effects to chemotherapy

This case report describes an 84-year-old woman with Stage IVb colon adenocarcinoma who experienced an exceptional response to low-dose regorafenib after her tumor was found to have a KDR p.R961W mutation.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.

Language : English

5.

Taste, smell and mouthfeel disturbances in patients with gastrointestinal stromal tumors treated with tyrosine-kinase inhibitors.

Author: van ElstJip M, IJzermanNikki S, MathijssenRon H J, SteeghsNeeltje, ReynersAnna K L, de HaanJacco J

mouthfeel disturbance
smell disturbance
taste disturbance

Taste, smell, and mouthfeel disturbances are important side effects of anti-cancer medication, but their prevalence and impact on daily life in patients with gastrointestinal stromal tumor (GIST) are largely unknown.

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

Language : English

7.

Regorafenib-Induced Hand-Foot Skin Reaction Is More Severe on the Feet Than on the Hands.

Author: NonomiyaYuma, YokokawaTakashi, KawakamiKazuyoshi, KobayashiKazuo, AoyamaTakeshi, TakiguchiTomomi, SugisakiTakahito, SuzukiKenichi, SuenagaMitsukuni, WakatsukiTakeru, YamaguchiKensei, SugimotoYoshikazu, HamaToshihiro

Hand-foot skin reaction

Regorafenib, a multikinase inhibitor for metastatic colorectal cancer, commonly causes hand-foot skin reaction (HFSR). This study found that grade 3 HFSR was more frequent on the feet than on the hands, with an earlier onset on the feet. No preexisting risk factor was identified, suggesting the need for early detection and treatment of regorafenib-induced HSFR, particularly on the feet.

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

Language : English

8.

Treatment-related serious adverse events and fatal adverse events with regorafenib in cancer patients: a meta-analysis of phase 3 randomized controlled trials.

Author: CaoMeihui, LiFeifei, WangYue, ZhangJingdong

Cancer treatment
FAEs
SAEs

This meta-analysis of four phase 3 randomized controlled trials examined the association between regorafenib, a multikinase inhibitor, and the risk of serious adverse events (SAEs) and fatal adverse events (FAEs) in cancer patients. The analysis revealed no evidence of an increased risk of SAEs or FAEs associated with regorafenib treatment.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

9.

Triggering of Suicidal Erythrocyte Death by Regorafenib.

Author: ZierleJens, BissingerRosi, BouguerraGhada, AbbèsSalem, LangFlorian

Malignancy treatment
Anemia

Regorafenib, a multikinase inhibitor for cancer treatment, can cause anemia. This study investigated whether regorafenib induces eryptosis, a form of programmed erythrocyte death, and found that it does. Further research is needed to understand the mechanisms underlying regorafenib-induced anemia and develop strategies to mitigate this side effect.

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.

Gastrointestinal perforation during regorafenib administration in a case with hepatic metastases of colon cancer.

Author: OgataKenichi, TakamoriHiroshi, UmezakiNaoki, YagiTaisuke, OgawaKatsuhiro, OzakiNobuyuki, HayashiHiromitsu, TanakaHideyuki, IkutaYoshiaki, DoiKoichi

Gastrointestinal perforation

This case report describes a 65-year-old woman who developed gastrointestinal perforation during regorafenib therapy, a third-line therapy for progressive caecal cancer. The patient had a history of prior treatment with bevacizumab.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

11.

Health-Related Quality of Life and Side Effects in Gastrointestinal Stromal Tumor (GIST) Patients Treated with Tyrosine Kinase Inhibitors: A Systematic Review of the Literature.

Author: van de WalDeborah, ElieMai, Le CesneAxel, FumagalliElena, den HollanderDide, JonesRobin L, MarquinaGloria, SteeghsNeeltje, van der GraafWinette T A, HussonOlga

Improved HRQoL
Increased survival
TKI side effects

Tyrosine kinase inhibitors (TKIs) have revolutionized the treatment of gastrointestinal stromal tumors (GISTs) and have significantly improved overall survival. However, TKIs can also have side effects. This review summarizes the available literature on health-related quality of life (HRQoL) issues and side effects of different TKIs used to treat GIST.

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.

Hepatotoxicity of Small Molecule Protein Kinase Inhibitors for Cancer.

Author: ViganòMauro, La MiliaMarta, GrassiniMaria Vittoria, PuglieseNicola, De GiorgioMassimo, FagiuoliStefano

Cancer treatment
Hepatotoxicity

Hepatotoxicity is a significant concern with protein kinase inhibitors (PKIs), used to treat cancer. This review discusses the risk and management of hepatotoxicity associated with approved PKIs, emphasizing the need for careful patient evaluation and monitoring.

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

16.

Associations of HLA-C*01:02 and HLA-B*46:01 with regorafenib-induced erythema multiforme in Japanese patients with metastatic colorectal cancer.

Author: FujitaKen-Ichi, MatsumotoNatsumi, MuraseRemi, TakeshimaKosuke, IshidaHiroo, KubotaYutaro

Improved survival
Erythema multiforme

This study examined the association between specific human leukocyte antigen (HLA) haplotypes and regorafenib-induced erythema multiforme (EM) in patients with metastatic colorectal cancer (mCRC). The study suggests a potential association between HLA-C*01:02 and HLA-B*46:01 haplotypes and regorafenib-induced EM, although further validation is needed.

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.

A phase Ib study of the combination regorafenib with PF-03446962 in patients with refractory metastatic colorectal cancer (REGAL-1 trial).

Author: ClarkeJeffrey Melson, BlobeGerard C, StricklerJohn H, UronisHope Elizabeth, ZafarS Yousuf, MorseMichael, DropkinEvan, HowardLeigh, O'NeillMargot, RushingChristel N, NiedzwieckiDonna, WatsonHollie, BolchEmily, ArrowoodChristy, LiuYingmiao, NixonAndrew B, HurwitzHerbert I

Colorectal cancer treatment

A phase I study evaluated the maximum tolerated dose (MTD) and recommended phase II dose (RPTD) of PF-03446962, a monoclonal antibody targeting activin receptor-like kinase 1 (ALK-1), in combination with regorafenib in patients with refractory metastatic colorectal cancer.

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, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

18.

Off-target effects and clinical outcome in metastatic colorectal cancer patients receiving regorafenib: The TRIBUTE analysis.

Author: GiampieriRiccardo, PreteMichela Del, ProchiloTiziana, PuzzoniMarco, PuscedduValeria, PaniFabiana, MaccaroniElena, MasciaRoberta, BaleaniMaria Giuditta, MeletaniTania, BerardiRossana, LanzilloAnna Maria, MariottiStefano, ZaniboniAlberto, CascinuStefano, ScartozziMario

Treats Colorectal Cancer
Off-Target Effects

This retrospective study analyzed the correlation between off-target effects of regorafenib, a multikinase inhibitor, and overall survival, progression-free survival, and disease control rate in patients with metastatic colorectal cancer. The study found that skin rash or hypothyroidism were significantly correlated with improved overall survival.

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

Language : English

20.

Inhibition of LPAR6 overcomes sorafenib resistance by switching glycolysis into oxidative phosphorylation in hepatocellular carcinoma.

Author: GnocchiDavide, KurzykAgata, MintroneAntonella, LentiniGiovanni, SabbàCarlo, MazzoccaAntonio

Sorafenib resistance

LPAR6 promotes sorafenib resistance in hepatocellular carcinoma (HCC) cells by shifting energy metabolism towards lactic acid fermentation. A selective LPAR6 antagonist, 9-xanthenyl acetate, can overcome this resistance.

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

Language : English

21.

Multicenter, randomized, double-blind phase 2 trial of FOLFIRI with regorafenib or placebo as second-line therapy for metastatic colorectal cancer.

Author: SanoffHanna K, GoldbergRichard M, IvanovaAnastasia, O'ReillySeamus, KasbariSamer S, KimRichard D, McDermottRay, MooreDominic T, ZamboniWilliam, GroganWilliam, CohnAllen Lee, Bekaii-SaabTanios S, LeonardGregory, RyanTheresa, OlowokureOlugbenga O, FernandoNishan H, McCaffreyJohn, El-RayesBassel F, HorganAnne M, SherrillGary Bradley, YacoubGeorge Hosni, O'NeilBert H

Regorafenib efficacy

Regorafenib, a multikinase inhibitor, was evaluated in combination with FOLFIRI (folinic acid, fluorouracil, and irinotecan) as a second-line treatment for metastatic colorectal cancer. The study aims to determine the efficacy of this combination therapy.

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.
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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

23.

[Corneal perforation with tyrosine kinase inhibitor chemotherapy: REGORAFENIB].

Author: LanfantL, TroneM C, GarcinT, GauthierA S, ThuretG, GainP

Metastatic cancer treatment
Ophthalmologic side effects

Regorafenib, a new multi-targeted tyrosine kinase inhibitor, may cause ophthalmologic side effects such as eyelash abnormalities, eyelid abnormalities, and corneal erosions.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : French

24.

A Rare Case of Regorafenib-Induced ST-Elevation Myocardial Infarction.

Author: KarkiSadichhya, DeenadayalanVaishali, ShresthaPrajwal, DhungelSamriddh, VijAviral

Cardiac side effects
Myocardial ischemia

This case report describes a rare adverse event of regorafenib, a multi-kinase inhibitor, which caused ST-elevation myocardial infarction (STEMI) in a patient with colon cancer.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.

Language : English

25.

The role of stereotactic body radiation therapy in oligometastatic colorectal cancer: Clinical case report of a long-responder patient treated with regorafenib beyond progression.

Author: RobertoMichela, FalconeRosa, MazzucaFederica, ArchibugiLivia, CastaldiNadia, BotticelliAndrea, OstiMattia Falchetto, MarchettiPaolo

mCRC treatment
Hand-foot syndrome

The study found that a 55-year-old man affected by mCRC, treated with regorafenib combined with stereotactic body radiotherapy (SBRT), showing a durable response.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

26.

[Investigation of Administration Technique of Regorafenib in Our Center].

Author: MatsudaChu, DannoKatsuki, MiyazakiSusumu, FujitaniKazumasa, KubotaMasaru, MotooriMasaaki, NakatsukaRie, NishimuraMasashige, KitagawaAkihiro, TakagiMari, IwaseKazuhiro

Improved safety
Increased survival time

This study examined the safety and efficacy of regorafenib, a multikinase inhibitor, in Japanese patients with metastatic colorectal cancer. The study found that starting with a lower dose of regorafenib and gradually increasing it improved patient safety and allowed for longer treatment duration, leading to improved overall survival.

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

Language : Japanese

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