Side Effects of enzalutamide: A Synthesis of Findings from 27 Studies

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Original Abstract of the Article

Main Research Findings

Enzalutamide is a promising drug for the treatment of metastatic castration-resistant prostate cancer (mCRPC). 17 A study analyzed adverse events associated with enzalutamide use in mCRPC patients using real-life data from the EudraVigilance database, and found that enzalutamide is effective in the treatment of mCRPC, but some side effects have been reported. 8 A study demonstrated that enzalutamide affected motivation for exploration, spatial learning, and dopaminergic transmission in aged castrated mice. These studies suggest that enzalutamide is effective in treating mCRPC, but there is a risk of side effects such as cognitive function.

Reasons for Side Effects

Side effects of enzalutamide are caused by inhibiting the androgen receptor (AR). AR plays an important role in the growth and proliferation of prostate cancer. Enzalutamide inhibits AR, which suppresses the growth of prostate cancer, but it can also affect other tissues and organs in the body. This can cause various side effects.

Common Side Effects

Fatigue

One of the most common side effects of enzalutamide is fatigue. 8 A study reported that enzalutamide reduced spontaneous activity and exploratory behavior in aged castrated mice. This suggests that enzalutamide may affect the body's energy metabolism.

Cognitive impairment

Enzalutamide can cause cognitive impairment. 8 A study showed that enzalutamide affected spatial learning and memory in aged castrated mice. This suggests that enzalutamide may affect nerve cells in the brain.

Other side effects

In addition to fatigue and cognitive impairment, enzalutamide can cause the following side effects. 17 A study reported rash, gastrointestinal symptoms, liver dysfunction, musculoskeletal disorders, etc. as side effects of enzalutamide.

Countermeasures for Side Effects

Fatigue

To address fatigue, it is important to get enough sleep, eat a balanced diet, and get moderate exercise. It is also important to consult a doctor and get appropriate advice to reduce fatigue symptoms.

Cognitive impairment

To address cognitive impairment, it is important to consult a doctor and discuss medications and treatments that can help improve cognitive function. Participating in programs such as cognitive rehabilitation can also be effective.

Other side effects

Consult your doctor about other side effects and take appropriate measures.

Comparison Between Studies

Common points of research

Many studies have shown that enzalutamide is effective in the treatment of mCRPC. However, studies have also shown that enzalutamide can cause side effects such as fatigue and cognitive impairment.

Differences in research

The incidence and types of side effects of enzalutamide vary from study to study. This is thought to be due to various factors such as the patient population studied, the dose of enzalutamide used, and the combination with other treatments.

Precautions for Application in Daily Life

Enzalutamide is an effective drug for the treatment of mCRPC. However, it is important to understand the risks of side effects, discuss treatment options with your doctor, and choose the appropriate treatment method. While using enzalutamide, be aware of side effects such as fatigue and cognitive impairment, and take appropriate measures as needed. By being aware of side effects and taking appropriate measures when needed, you can safely continue treatment with enzalutamide.

Limitations of Current Research

Research on the side effects of enzalutamide is not yet complete. Further research is needed, especially on the long-term effects of enzalutamide and the incidence of side effects in different patient populations.

Future Research Directions

Future research needs to further investigate the long-term effects of enzalutamide, the incidence of side effects in different patient populations, and the development of new treatments to reduce side effects.

Conclusion

Enzalutamide is an effective drug for the treatment of mCRPC, but there is a risk of side effects. When considering the use of enzalutamide, it is important to discuss the risks and benefits with your doctor and choose the appropriate treatment method. Be aware of side effects and take appropriate measures when needed, so that you can continue treatment with enzalutamide safely.

Literature analysis of 27 papers
Positive Content
24
Neutral Content
1
Negative Content
2
Article Type
2
3
1
10
27
1.

The impact of patient characteristics on enzalutamide pharmacokinetics and how this relates to treatment toxicity and efficacy in metastatic prostate cancer patients.

Author: BenoistGuillemette E, van OortInge M, BurgerDavid M, MehraNiven, van ErpNielka P

Fatigue

Age and BMI did not influence systemic exposure in patients treated with enzalutamide. No relation of exposure with efficacy or fatigue was observed. Further research using enzalutamide at a lower dose is needed to understand the relation of enzalutamide exposure and fatigue.

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

Language : English

2.

A phase II randomized placebo-controlled double-blind study of salvage radiation therapy plus placebo versus SRT plus enzalutamide with high-risk PSA-recurrent prostate cancer after radical prostatectomy (SALV-ENZA).

Author: KapoorRoche, DeekMatthew P, McIntyreRiley, RamanNatasha, KummerloweMegan, ChenIyah, GaverMatt, WangHao, DenmeadeSam, LotanTamara, PallerChanning, MarkowskiMark, CarducciMichael, EisenbergerMario, BeerTomasz M, SongDaniel Y, DeWeeseTheodore L, HearnJason W, GrecoStephen, DeVilleCurtiland, DesaiNeil B, HeathElisabeth I, LiauwStanley, SprattDaniel E, HungArthur Y, AntonarakisEmmanuel S, TranPhuoc T

Improved survival
PSA progression

This trial studies the effectiveness of salvage radiation therapy (SRT) combined with enzalutamide, a next-generation selective androgen receptor antagonist, for the treatment of rising PSA following radical prostatectomy. The primary objective is to evaluate the efficacy of the combination for freedom-from-PSA-progression.

Clinical Trial ProtocolA plan for conducting a clinical trial. It describes in detail the purpose, design, methodology, and statistical considerations of the trial, ensuring the transparency and consistency of the trial.
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.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

3.

Comparative efficacy of second-generation androgen receptor inhibitors for treating prostate cancer: A systematic review and network meta-analysis.

Author: ChenXiangyu, WangQihua, PanYang, WangShangren, LiYuezheng, ZhangHao, XuMingming, ZhouHang, LiuXiaoqiang

Prostate cancer treatment
Side effects

This network meta-analysis compared the efficacy and toxicity of second-generation androgen receptor inhibitors (SGARIs) in the treatment of prostate cancer patients with metastatic hormone-sensitive prostate cancer (mHSPC), non-metastatic castration-resistant prostate cancer (nmCRPC), and metastatic castration-resistant prostate cancer (mCRPC).

Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.
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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

5.

Hormonal treatment and quality of life of prostate cancer patients: new evidence.

Author: TucciMarcello, LeoneGianmarco, ButtiglieroConsuelo, ZichiClizia, DI StefanoRosario F, PignataroDaniele, VignaniFrancesca, ScagliottiGiorgio V, DI MaioMassimo

Prostatic carcinoma treatment
ADT side effects

Androgen deprivation therapy (ADT) is a common treatment for prostate cancer, but it can have many side effects. This review discusses the impact of these side effects on quality of life and examines possible interventions to alleviate them.

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

7.

Efficacy and tolerability of current treatments for hormone-refractory prostate cancer patients with visceral metastases.

Author: OruçZeynep, KaplanM Ali, KaraağaçMustafa, ÖzyurtNeslihan, TatlıAli Murat, KayaAli Osman, MenekşeSerkan, KutEngin, KocaSinan, SeverÖzlem Nuray, Yasinİrem, EbinçSenar, ZeynelgilEsra, SakinAbdullah, TurhalNazım Serdar, IsikdoganAbdurrahman

Improved survival

This study compared the efficacy and tolerability of different first-line treatment options for hormone-refractory prostate cancer patients with visceral metastases. Docetaxel was found to be more effective than abiraterone or enzalutamide in terms of overall survival and progression-free survival.

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

Language : English

9.

New Antiandrogen Compounds Compared to Docetaxel for Metastatic Hormone Sensitive Prostate Cancer: Results from a Network Meta-Analysis.

Author: MarchioniMichele, Di NicolaMarta, PrimiceriGiulia, NovaraGiacomo, CastellanPietro, PaulAsit K, VecciaAlessandro, AutorinoRiccardo, CindoloLuca, SchipsLuigi

Treat hormone sensitive prostate cancer

This review analyzed randomized controlled trials investigating first-line treatment for hormone-sensitive prostate cancer. Docetaxel is the standard of care, but androgen receptor axis-targeted therapies have also shown effectiveness.

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

Language : English

10.

Current Treatment Options for Metastatic Hormone-Sensitive Prostate Cancer.

Author: CattriniCarlo, CastroElena, LozanoRebeca, ZanardiElisa, RubagottiAlessandra, BoccardoFrancesco, OlmosDavid

Improved cancer treatment
Limited data
Side effects

Treatment options for metastatic hormone-sensitive prostate cancer (mHSPC) have expanded in recent years. This review compares the results of various phase 3 trials to provide insights into treatment selection for mHSPC patients. The review considers factors like tumor characteristics, patient factors, and drug side effects to guide treatment decisions.

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

11.

Systemic immune-inflammation index predicts the combined clinical outcome after sequential therapy with abiraterone and docetaxel for metastatic castration-resistant prostate cancer patients.

Author: FanLiancheng, WangRui, ChiChenfei, CaiWen, ZhangYong, QianHongyang, ShaoXiaoguang, WangYanqing, XuFan, PanJiahua, ZhuYinjie, ShangguanXun, ZhouLixin, DongBaijun, XueWei

No difference in survival
Patient preference
High SII

Abiraterone followed by docetaxel-prednisone or vice versa resulted in similar clinical outcomes for metastatic castration-resistant prostate cancer patients. High pretreatment systematic Immune-Inflammation Index level is a negative independent prognosticator of survival 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

12.

Current therapeutic options in metastatic castration-resistant prostate cancer.

Author: IngrossoGianluca, DettiBeatrice, ScartoniDaniele, LanciaAndrea, GiacomelliIrene, BakiMuhammed, CartaGiulio, LiviLorenzo, SantoniRiccardo

Improved mCRPC treatment

Prostate cancer that spreads to other parts of the body (metastatic) and no longer responds to hormone therapy (castration-resistant) is challenging to treat. Recent years have seen significant advances in treatment options. This review summarizes the approved medications for treating this type of prostate cancer, including their effectiveness and side effects, to help doctors make treatment decisions. The review also briefly discusses new markers that may guide treatment choices.

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.

Language : English

13.

AR-v7 liquid biopsy for treatment stratification in prostate cancer: how close are we?

Author: FletcherClaire

Liquid biopsy for mCRPC

This review discusses the use of liquid biopsies for patient-stratification in metastatic castration-resistant prostate cancer (mCRPC). The review highlights recent developments in detecting AR-v7 in circulating mRNA/whole blood and circulating tumor cells (CTCs) as liquid biopsies for identifying patients who will respond to specific therapies.

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.

Non-metastatic castration-resistant prostate cancer: current status and future directions.

Author: GuptaRuby, ShengIris Y, BarataPedro C, GarciaJorge A

Positive impact on survival

Non-metastatic castration resistant prostate cancer (M0CRPC) is a challenging condition, where patients exhibit rising PSA levels but lack detectable metastases. This review summarizes the definition, diagnosis, treatment, and ongoing clinical trials for M0CRPC, highlighting the role of newer imaging modalities in detecting advanced prostate cancer. Novel oral androgen receptor inhibitors have shown positive impacts on metastasis-free and overall survival, making them suitable treatment options for M0CRPC.

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.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

15.

Radionuclide Therapy of Metastatic Prostate Cancer.

Author: KratochwilClemens, HaberkornUwe, GieselFrederik L

Effective for metastatic prostate cancer
Improved survival
Side effects

Radioactive drugs that target the prostate-specific membrane antigen (PSMA) are showing promise as a new treatment for metastatic prostate cancer.

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.

Efficacy and Safety of Enzalutamide vs Bicalutamide in Younger and Older Patients with Metastatic Castration Resistant Prostate Cancer in the TERRAIN Trial.

Author: SiemensD Robert, KlotzLaurence, HeidenreichAxel, ChowdhurySimon, VillersArnauld, BaronBenoit, van OsSteve, HasabouNahla, WangFong, LinPing, ShoreNeal D

Prolonged survival

Enzalutamide is a medication used to treat prostate cancer. This study investigated the influence of age on the efficacy and safety of enzalutamide in men with metastatic castration-resistant prostate cancer.

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.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

17.

Adverse events related to abiraterone and enzalutamide treatment: analysis of the EudraVigilance database and meta-analysis of registrational phase III studies.

Author: De NunzioCosimo, LombardoRiccardo, TemaGiorgia, VoglinoOlivia, SicaAngela, BaldassarriValeria, NacchiaAntonio, IacovelliRoberto, BracardaSergio, TubaroAndrea

Adverse events

This study analyzed adverse events (AEs) associated with enzalutamide (ENZ) and abiraterone (ABI) in real-life data from the EudraVigilance (EV) database. The aim was to provide insights into the safety of these drugs when used in a real-world setting.

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.

Language : English

19.

Survival outcomes in older men with non-metastatic castration-resistant prostate cancer treated with androgen receptor inhibitors: a US Food and Drug Administration pooled analysis of patient-level data from three randomised trials.

Author: FallahJaleh, ZhangLijun, AmatyaAnup, GongYutao, King-KallimanisBellinda, BhatnagarVishal, WeinstockChana, SuzmanDaniel L, AgrawalSundeep, ChangElaine, AnscherMitchell S, ChiDow-Chung, XuJames X, BrewerJamie R, BraveMichael H, HadadiMehrnoosh, TheoretMarc R, KluetzPaul G, GoldbergKirsten B, IbrahimAmna, TangShenghui, PazdurRichard, BeaverJulia A, Amiri-KordestaniLaleh, SinghHarpreet

This study examines the efficacy and safety of second-generation androgen receptor inhibitors in older men (≥80 years) with non-metastatic castration-resistant prostate cancer (nmCRPC).

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

Language : English

20.

Targeting androgen receptor versus targeting androgens to suppress castration resistant prostate cancer.

Author: GuoChangcheng, YehShuyuan, NiuYuanjie, LiGonghui, ZhengJunhua, LiLei, ChangChawnshang

Prostate cancer treatment
ADT resistance
Metastasis

Androgen deprivation therapy remains a primary treatment for advanced prostate cancer, but resistance and side effects necessitate new approaches, such as directly targeting the androgen receptor or silencing its activity.

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

21.

Long-Term Antitumor Activity and Safety of Enzalutamide Monotherapy in Hormone Naïve Prostate Cancer: 3-Year Open Label Followup Results.

Author: TombalBertrand, BorreMichael, RathenborgPer, WerbrouckPatrick, Van PoppelHendrik, HeidenreichAxel, IversenPeter, BraeckmanJohan, HeracekJiri, BaronBenoit, KrivoshikAndrew, HirmandMohammad, SmithMatthew R

Enzalutamide efficacy
Prostate cancer

A follow-up analysis of a phase 2 study of enzalutamide in patients with hormone-naïve prostate cancer showed that the drug remained effective in reducing prostate specific antigen (PSA) levels at 3 years with minimal effects on bone mineral density.

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.

Language : English

24.

Therapeutic Drug Monitoring of Oral Anti-Hormonal Drugs in Oncology.

Author: GroenlandStefanie L, van NulandMerel, VerheijenRemy B, SchellensJan H M, BeijnenJos H, HuitemaAlwin D R, SteeghsNeeltje

Breast and prostate cancer treatment
Optimized treatment
Overdosing
Underdosing

Therapeutic drug monitoring (TDM) is a valid option to further optimize treatment with oral anti-hormonal drugs used in oncology. A review of the pharmacokinetic and pharmacodynamic characteristics of these drugs suggests that individualized dosing based on measured blood concentrations is feasible and promising.

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

25.

Budgetary Impact of Cabazitaxel Use After Docetaxel Treatment for Metastatic Castration-Resistant Prostate Cancer.

Author: FlanneryKyle, DreaEd, HudspethLouis, CormanShelby, GaoXin, XueMei, MiaoRaymond

Budgetary impact

This study examines the budgetary impact of new treatments for metastatic castration-resistant prostate cancer (mCRPC), particularly focusing on cabazitaxel, a second-generation taxane approved for patients previously treated with docetaxel.

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

Language : English

26.

ADT with antiandrogens in prostate cancer induces adverse effect of increasing resistance, neuroendocrine differentiation and tumor metastasis.

Author: NiuYuanjie, GuoChangcheng, WenSimeng, TianJing, LuoJie, WangKeliang, TianHao, YehShuyuan, ChangChawnshang

Treats prostate cancer
Castration resistance
Neuroendocrine differentiation
PCa cell invasion

Prostate cancer (PCa) is treated with androgen deprivation therapy (ADT), but many patients develop resistance. Research is exploring ways to overcome these resistances, including targeting different mechanisms involved in the development of resistance.

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.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

27.

Pretreatment Neutrophil to Lymphocyte Ratio (NLR) Predicts Prognosis for Castration Resistant Prostate Cancer Patients Underwent Enzalutamide.

Author: KumanoYohei, HasegawaYoriko, KawaharaTakashi, YasuiMasato, MiyoshiYasuhide, MatsubaraNobuaki, UemuraHiroji

Prostate cancer prognosis

The neutrophil-to-lymphocyte ratio (NLR) may be a useful predictor of enzalutamide efficacy in patients with castration-resistant prostate cancer.

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

Language : English

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