Side Effects of neratinib: A Synthesis of Findings from 16 Studies

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Original Abstract of the Article

Major Research Findings

Neratinib is a tyrosine kinase inhibitor used to treat HER2-positive breast cancer. It was approved by the FDA in 2017 for use in the extended adjuvant treatment of early-stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy. 9 Neratinib is thought to be effective in inhibiting tumor growth and increasing invasive disease-free survival. 9 However, Neratinib is associated with several side effects.

Reasons for Side Effects

Neratinib targets HER2, a protein that plays a crucial role in cell growth and survival. This protein is often overexpressed in cancer cells. Neratinib inhibits HER2 to slow cancer cell growth, but it also can affect normal cells, leading to various side effects. 5

Common Side Effects

Diarrhea

Diarrhea is a common side effect of neratinib, with a 40% incidence of grade 3 or 4 diarrhea. 9 This is the most common side effect leading to discontinuation of treatment. 9 It is thought to be caused by Neratinib affecting the cells in the digestive tract. 6 The severity of diarrhea can range from mild to severe, and severe cases can lead to dehydration.

Skin Side Effects

Neratinib can cause various side effects on the skin. 9 8 This includes rash, itching, dryness, and even nail abnormalities, acne, and facial rash. 8

Eye Side Effects

Neratinib can cause eye side effects, including decreased vision, eye pain, and eye swelling. 4 5 15 14 One study even reported a case of suspected macular toxicity presenting as macular telangiectasia type II, 4 which is a rare and potentially overlooked side effect of tyrosine kinase inhibitors (TKIs).

Gastrointestinal Side Effects

Neratinib can cause gastrointestinal side effects, including nausea, vomiting, and abdominal pain. 9 6 A case report described a patient who developed a duodenal ulcer while receiving neratinib. 6

Countermeasures for Side Effects

Countermeasures for Diarrhea

If diarrhea symptoms are mild, they may improve by staying hydrated and avoiding high-fiber foods. If the symptoms are severe, you may need to take antidiarrheal medication as directed by your doctor.

Countermeasures for Skin Side Effects

If you experience skin side effects, you can improve the symptoms by applying moisturizers and steroid ointments as directed by your doctor. It is also important to avoid exposure to ultraviolet rays by using sunscreen and wearing hats.

Countermeasures for Eye Side Effects

If you experience eye side effects, you should immediately see a doctor. Failure to receive appropriate treatment can lead to serious conditions such as vision impairment.

Countermeasures for Gastrointestinal Side Effects

If you experience gastrointestinal side effects, you can improve the symptoms by taking antiemetics and gastric acid suppressants as directed by your doctor. It is also important to eat easily digestible foods.

Comparison between Studies

Commonalities among Studies

Multiple studies have shown that neratinib is effective in treating HER2-positive breast cancer. However, it has also become clear that it can cause various side effects.

Differences among Studies

The frequency and severity of side effects from neratinib may vary depending on the study. This is believed to be due to differences in the age, health status, and dosage of the study participants.

Notes on Application to Real Life

Neratinib is an effective drug for treating HER2-positive breast cancer, but it can cause various side effects. Therefore, it is important to follow your doctor's instructions carefully when taking neratinib and be aware of the signs of side effects. If you experience side effects, consult your doctor immediately.

Limitations of Current Research

Research on the side effects of neratinib is still insufficient. In particular, much is still unknown about long-term side effects.

Future Directions for Research

Research is needed to further investigate the side effects of neratinib. In particular, it is important to research long-term side effects and methods to reduce side effects.

Conclusion

Neratinib is an effective drug for treating HER2-positive breast cancer, but it can cause various side effects. It is important to follow your doctor's instructions carefully when taking neratinib and be aware of the signs of side effects.

Literature analysis of 16 papers
Positive Content
14
Neutral Content
0
Negative Content
2
Article Type
4
0
1
5
14
1.

Nicotine gum use in the first year of the Lung Health Study.

Author: Bjornson-BensonW, NidesM, DolceJ, RandC, LindgrenP, O'HaraP, BuistA S

Quit smoking
Reduced side effects
Mild side effects

28.9% of participants in the Lung Health Study were using nicotine gum 12 months after entry. Among sustained nonsmokers, continuous gum users reported more mild side effects than those who used gum intermittently. Factors associated with nicotine dependence were related to the use and amount of gum use at 12 months.

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.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).

Language : English

2.

Effects of nicotine dose and administration method on withdrawal symptoms and side effects during short-term smoking abstinence.

Author: LeischowS J, ValenteS N, HillA L, OtteP S, AickinM, HoldenT, KligmanE, CookG

smoking cessation
insomnia

This study evaluated the effects of different nicotine replacement treatments on self-reported withdrawal symptoms and side effects during smoking cessation. The 24-hr patch was more effective than the 16-hr patch in reducing morning urge to smoke. Double-patch use resulted in greater insomnia.

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, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).

Language : English

5.

Tyrosine kinase inhibitors in breast cancer (Review).

Author: IancuGeorge, SerbanDragos, BadiuCristinel Dumitru, TanasescuCiprian, TudosieMihai Silviu, TudorCorneliu, CosteaDaniel Ovidiu, ZguraAnca, IancuRaluca, VasileDanut

Brain penetration
Oral administration
Reduced cardiotoxicity
Adverse side effects
Lack of specificity

Anti-EGFR therapy has shown promise in breast cancer treatment, but most researched agents lack specificity and have frequent side effects. Tyrosine kinase inhibitors (TKIs) have advantages, including reduced cardiotoxicity and oral administration. Lapatinib, neratinib, and pyrotinib are the only TKIs approved for limited indications in a subset of breast cancer patients. Future research should focus on identifying breast cancer subtypes and developing more targeted agents to improve treatment outcomes.

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

6.

Neratinib-Induced Duodenal Ulcer: A Case Report.

Author: MoftakharBahar, KharelPrakash, NiraulaSujan, GandhiShipra, FalksonCarla, DhakalAjay

GI side effects
duodenal ulcer

This case report describes a 37-year-old woman who developed a duodenal ulcer while receiving neratinib for HER2-positive breast cancer. The ulcer resolved upon discontinuing neratinib, emphasizing the importance of recognizing gastrointestinal (GI) side effects associated with neratinib use.

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

8.

Adverse cutaneous effects of neratinib.

Author: HamidRamiz N, AhnChristine S, HuangWilliam W

Skin changes

This case report highlights the potential cutaneous side effects associated with neratinib, a tyrosine kinase inhibitor approved for treating HER-2 positive breast cancer. The patient developed changes in the fingernails, acne, and facial rash, consistent with a neratinib-induced skin reaction. This finding emphasizes the need for further investigation into the potential dermatological effects of this novel drug.

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

9.

U.S. Food and Drug Administration Approval: Neratinib for the Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer.

Author: SinghHarpreet, WalkerAmanda J, Amiri-KordestaniLaleh, ChengJoyce, TangShenghui, BalcazarPamela, Barnett-RinggoldKimberly, PalmbyTodd R, CaoXianhua, ZhengNan, LiuQi, YuJingyu, PierceWilliam F, DanielsSelena R, SridharaRajeshwari, IbrahimAmna, KluetzPaul G, BlumenthalGideon M, BeaverJulia A, PazdurRichard

Breast cancer treatment
Abdominal pain
Decreased appetite
Diarrhea
Fatigue
Muscle spasms
Nausea
Rash
Stomatitis
Vomiting

This article summarizes the FDA approval of neratinib for the extended adjuvant treatment of early-stage HER2-overexpressed/amplified breast cancer. Neratinib was shown to improve invasive disease-free survival compared to placebo in a randomized, double-blind, placebo-controlled trial. However, neratinib is associated with a high incidence of diarrhea, which is the most common adverse event leading to treatment discontinuation.

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.

Language : English

12.

Escalating and de-escalating treatment in HER2-positive early breast cancer.

Author: JoensuuHeikki

Effective breast cancer treatment

This review examines current and emerging therapies for early HER2-positive breast cancer. While 12 months of adjuvant trastuzumab remains the standard, clinical trials are investigating shorter durations, dual HER2 inhibition, and longer treatment courses. Results from these trials are expected to inform future treatment guidelines.

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.

Neratinib Plus Paclitaxel vs Trastuzumab Plus Paclitaxel in Previously Untreated Metastatic ERBB2-Positive Breast Cancer: The NEfERT-T Randomized Clinical Trial.

Author: AwadaAhmad, ColomerRamon, InoueKenichi, BondarenkoIgor, BadweRajendra A, DemetriouGeorgia, LeeSoo-Chin, MehtaAjay O, KimSung-Bae, BachelotThomas, GoswamiChanchal, DeoSuryanarayan, BoseRon, WongAlvin, XuFeng, YaoBin, BryceRichard, CareyLisa A

Delayed CNS progression
Reduced CNS recurrence
Diarrhea
Leukopenia
Neutropenia

Neratinib plus paclitaxel was not superior to trastuzumab plus paclitaxel in terms of progression-free survival in first-line ERBB2-positive metastatic breast cancer.

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.

Language : English

14.

A systematic review of dual targeting in HER2-positive breast cancer.

Author: KümlerIben, TuxenMalgorzata K, NielsenDorte Lisbet

Breast cancer treatment
HER2-positive survival
Trastuzumab resistance

This review examines the efficacy and toxicity of dual targeting strategies in HER2-positive breast cancer, considering the development of therapeutic agents to potentiate the effect of trastuzumab or target cells that have become resistant to trastuzumab.

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.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

15.

Safety and efficacy of neratinib (HKI-272) plus vinorelbine in the treatment of patients with ErbB2-positive metastatic breast cancer pretreated with anti-HER2 therapy.

Author: AwadaA, DirixL, Manso SanchezL, XuB, LuuT, DiérasV, HershmanD L, AgrapartV, AnanthakrishnanR, StaroslawskaE

Antitumor activity
Diarrhea
Nausea
Neutropenia

Neratinib combined with vinorelbine demonstrated promising antitumor activity in patients with HER2-positive metastatic breast cancer. The most common side effects were diarrhea, neutropenia, and nausea.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
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

16.

Neratinib, an irreversible ErbB receptor tyrosine kinase inhibitor, in patients with advanced ErbB2-positive breast cancer.

Author: BursteinHarold J, SunYan, DirixLuc Y, JiangZefei, ParidaensRobert, TanAntoinette R, AwadaAhmad, RanadeAnantbhushan, JiaoShunchang, SchwartzGary, AbbasRichat, PowellChristine, TurnbullKathleen, VermetteJennifer, ZacharchukCharles, BadweRajendra

Breast cancer treatment

This open-label, multicenter, phase II trial evaluated the efficacy and safety of neratinib, a pan-ErbB receptor tyrosine kinase inhibitor, in patients with advanced ErbB2-positive breast cancer. Neratinib showed promising efficacy in both those with and those without prior trastuzumab treatment.

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.
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.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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