Side Effects of apalutamide: A Synthesis of Findings from 19 Studies

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Original Abstract of the Article

Main Research Findings

Apalutamide has been evaluated in various clinical trials as an effective drug for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) and non-metastatic castration-resistant prostate cancer (nmCRPC). 5 、 10 、 11 、 14 Apalutamide is a type of androgen receptor inhibitor (ARi) that inhibits the growth of prostate cancer cells by inhibiting the binding of androgens to androgen receptors. 17 、 12 Apalutamide has been shown to delay the time to metastasis and prolong overall survival in patients with nmCRPC. 10 、 14 In patients with mHSPC, the combination of apalutamide and androgen deprivation therapy (ADT) significantly prolonged survival compared to ADT alone. 13 、 12

Reasons for Side Effects

Apalutamide inhibits the binding of androgens to androgen receptors, suppressing the growth of prostate cancer cells, but at the same time, it inhibits the action of androgens in various tissues of the body. Therefore, apalutamide may cause side effects related to androgen deficiency. 5 、 8 For example, apalutamide can cause side effects such as sexual dysfunction and osteoporosis due to the decrease in male hormones. 17 Also, apalutamide is metabolized in the liver, so it may affect liver function. 18

Common Side Effects

Skin Reactions

The most common side effect of apalutamide is skin reactions. 、 4 Skin rashes, itching, and erythema have been reported. 、 4 In severe cases, drug reaction with eosinophilia and systemic symptoms (DRESS) may occur. 3 DRESS is a serious skin reaction characterized by fever, rash, lymphadenopathy, and organ damage. 3

Fatigue

Apalutamide can cause fatigue. 10 Fatigue is thought to be caused by apalutamide's inhibition of androgen receptors, affecting the body's energy metabolism. 10

Gastrointestinal Symptoms

Apalutamide can cause gastrointestinal symptoms. 10 Constipation, diarrhea, nausea, and vomiting have been reported. 10

Nervous System Symptoms

Apalutamide can cause nervous system symptoms. 10 Headaches, dizziness, and numbness have been reported. 10

Liver Dysfunction

Apalutamide is metabolized in the liver, so it can cause liver dysfunction. 18 Elevated liver function test values have been reported. 18

Other Side Effects

In addition to the side effects above, apalutamide may also cause the following side effects. 10 、 5 、 8

  • Sexual dysfunction
  • Osteoporosis
  • Weight gain
  • Hypertension
  • Diabetes
  • Falls
  • Fractures

Side Effect Countermeasures

Skin Reactions

If you experience a skin reaction, stop using apalutamide and consult your doctor. 4 In severe cases, drug treatment with steroids may be required. 3

Fatigue

If you experience severe fatigue, consult your doctor. 10 Symptoms may improve by getting enough rest, paying attention to your diet, and reviewing your lifestyle habits. 10

Gastrointestinal Symptoms

If you experience gastrointestinal symptoms, consult your doctor. 10 Constipation can be improved by eating foods high in fiber and drinking plenty of fluids. 10 Diarrhea can be improved by taking laxatives or following a dietary plan. 10

Nervous System Symptoms

If you experience nervous system symptoms, consult your doctor. 10 Headaches can be improved by taking analgesics or getting enough rest. 10 If you experience severe dizziness, consult your doctor. 10

Liver Dysfunction

If you suspect liver dysfunction, consult your doctor. 18 Liver function tests will be performed and treatment will be given if necessary. 18

Comparison Between Studies

Commonalities in Studies

Many studies have shown that apalutamide delays the time to metastasis and prolongs overall survival in patients with nmCRPC. 10 、 14 Also, in patients with mHSPC, the combination of apalutamide and ADT significantly prolonged survival compared to ADT alone. 13 、 12

Differences in Studies

The effectiveness and frequency of side effects of apalutamide may vary depending on the study. 6 For example, the effects and side effects of apalutamide may differ depending on age and concomitant medications. 9 Also, results may differ due to differences in study design and evaluation methods. 16

Points to Note Regarding Application in Real Life

Apalutamide is an effective drug for the treatment of prostate cancer, but it also carries the risk of side effects. 10 、 5 When taking apalutamide, it is important to consult with your doctor and fully understand the risks and countermeasures of side effects before taking it. 9 In particular, elderly patients and patients taking multiple medications are at higher risk of side effects, so caution is required. 9 Also, apalutamide should not be used by pregnant women or breastfeeding women. 10 When taking apalutamide, follow your doctor's instructions and take it according to the dosage and method of administration. 10

Limitations of Current Research

Research on apalutamide is not yet sufficient. 16 Further research is needed on long-term safety and efficacy. 17 Also, further research is needed on the optimal use of apalutamide. 13

Future Research Directions

Research is needed to evaluate the long-term safety and efficacy of apalutamide. 17 Also, research is needed to identify the optimal use of apalutamide. 13 In addition, research is needed to reduce the side effects of apalutamide. 5 、 8

Conclusion

Apalutamide is an effective drug for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) and non-metastatic castration-resistant prostate cancer (nmCRPC). 10 、 11 However, apalutamide also carries the risk of side effects. 10 、 5 When taking apalutamide, it is important to consult with your doctor and fully understand the risks and countermeasures of side effects before taking it. 9

Literature analysis of 19 papers
Positive Content
15
Neutral Content
1
Negative Content
3
Article Type
5
2
3
7
17
1.

Measurement of side effects of drugs.

Author: HuskissonE C, WojtulewskiJ A

Check list interference

Using a check list to collect side effects in a clinical trial may interfere with the reporting of known and unknown symptoms.

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.

Language : English

2.

Anti-platelet effects of 100 mg alternate day oral aspirin: a randomized, double-blind, placebo-controlled trial of regular and enteric coated formulations in men and women.

Author: RidkerP M, HennekensC H, ToflerG H, LipinskaI, BuringJ E

Cardiovascular benefit
Reduced gastrointestinal symptoms

Further research is needed to determine the optimal dose of aspirin to produce a cardiovascular benefit while minimizing side effects, particularly in women.

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

4.

Apalutamide-induced lichenoid reaction in a patient with non-metastatic castrate-resistant prostate cancer.

Author: CremanteMalvina, PuglisiSilvia, GandiniAnnalice, GuadagnoAntonio, CatalanoFabio, DamassiAlessandra, MurianniVeronica, Llaja ObispoMiguel Angel, BannaGiuseppe Luigi, ButiSebastiano, RebuzziSara Elena, RescignoPasquale, FornariniGiuseppe

M0 CRPC treatment
mHSPC treatment
Skin reactions

This abstract describes apalutamide, an oral selective androgen receptor inhibitor approved for the treatment of prostate cancer. The abstract highlights skin reactions as a common side effect and adverse event of special interest.

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

5.

Adverse Events and Androgen Receptor Signaling Inhibitors in the Treatment of Prostate Cancer: A Systematic Review and Multivariate Network Meta-analysis.

Author: CaoBrent, KimMelissa, ReizineNatalie M, MoreiraDaniel M

Improved prostate cancer outcomes
Headache
Hypertension

A systematic review of 14 randomized controlled trials compared the adverse event profiles of four androgen receptor signaling inhibitor (ARSi) drugs (abiraterone, apalutamide, darolutamide, and enzalutamide) for prostate cancer. The review found that the side-effect profiles were similar except for a higher risk of hypertension and headache with enzalutamide. Close blood-pressure monitoring for enzalutamide is recommended.

Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
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.

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

8.

Immune checkpoint inhibitor- and phosphatidylinositol-3-kinase inhibitor-related diabetes induced by antineoplastic drugs: two case reports and a literature review.

Author: GaoYue, ZhongMingyao, GanLulu, XiangCheng, LiLing, YanYimin

Hyperglycemia

Immune checkpoint inhibitors (ICIs) and phosphatidylinositol-3-kinase inhibitors (PI3KIs) can cause diabetes as a side effect. This paper presents two case reports of diabetes induced by tremelimumab and apalutamide, respectively, and provides a comprehensive review of the literature on ICI- and PI3Ki-related diabetes.

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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

9.

Next-Generation Androgen Receptor-Signaling Inhibitors for Prostate Cancer: Considerations for Older Patients.

Author: FengZizhen, GraffJulie N

prostate cancer treatment
drug interactions
prostate cancer

This review discusses the mechanism of action, efficacy, and safety of next-generation hormonal therapies for prostate cancer, particularly in older patients, considering their unique challenges.

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

10.

How I do it: Apalutamide use in non-metastatic castrate resistant prostate cancer.

Author: MoulJudd W

Metastasis delay
Prostate cancer treatment
Side effects

Apalutamide, a new oral nonsteroidal antiandrogen, has been shown to delay the presence of metastases in patients with non-metastatic castrate-resistant prostate cancer by approximately two years.

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.

A Systematic Review and Network Meta-analysis of Novel Androgen Receptor Inhibitors in Non-metastatic Castration-resistant Prostate Cancer.

Author: HirdAmanda E, MageeDiana E, BhindiBimal, YeXiang Y, ChandrasekarThenappan, GoldbergHanan, KlotzLaurence, FleshnerNeil, SatkunasivamRaj, KlaassenZachary, WallisChristopher J D

nmCRPC treatment

This study used network meta-analysis to compare different non-steroidal anti-androgens (NSAAs) in men with high-risk non-metastatic castrate-resistant prostate cancer (nmCRPC). Subgroup analyses identified patients who may benefit more from NSAAs combined with androgen deprivation therapy.

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

Language : English

13.

[Combination therapy for metastatic hormone-sensitive prostate cancer: What? When? For whom?]

Author: ThomasC, OhlmannC-H

Increased survival
Prostate cancer treatment
Side effects

Novel combination therapies are the standard systemic treatment for metastatic hormone-sensitive prostate cancer. This article discusses the use of docetaxel, abiraterone, and apalutamide in combination therapy, highlighting the importance of individualizing treatment decisions based on patient characteristics.

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 : German

14.

Health-related Quality of Life at the SPARTAN Final Analysis of Apalutamide for Nonmetastatic Castration-resistant Prostate Cancer Patients Receiving Androgen Deprivation Therapy.

Author: OudardStéphane, HadaschikBoris, SaadFred, CellaDavid, BaschEthan, GraffJulie N, UemuraHiroji, DibajShiva, LiSusan, Brookman-MaySabine D, De PorrePeter, BevansKatherine B, TrudeauJeremiah J, SmallEric J, SmithMatthew R

Improved survival
Preserved HRQoL

This study evaluated health-related quality of life (HRQoL) in patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) receiving apalutamide or placebo in the SPARTAN trial. HRQoL was maintained in patients receiving apalutamide, but declined in patients receiving placebo. Apalutamide did not worsen patient-reported fatigue and was well tolerated. These findings, along with previous reports of improved survival and time to metastases, support the use of apalutamide for nmCRPC.

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

15.

Treatment of non-metastatic castration resistant prostate cancer in 2020: What is the best?

Author: HeideggerIsabel, BrandtMaximilian P, HeckMatthias M

Effective treatment
Side effects

Three new androgen receptor antagonists (enzalutamide, apalutamide, and darolutamide) have been approved by the Food and Drug Administration for the treatment of nonmetastatic castration-resistant prostate cancer. These drugs have shown good clinical efficacy with tolerable side effects in large phase III trials. This review discusses the use of these new treatment options, focusing on patient selection and the impact of new imaging modalities like prostate-specific membrane antigen-positron-emission tomography.

Historical ArticleA research paper that analyzes past events and developments using primary sources and examines them from a historical perspective.
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.

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

17.

The LACOG-0415 phase II trial: abiraterone acetate and ADT versus apalutamide versus abiraterone acetate and apalutamide in patients with advanced prostate cancer with non-castration testosterone levels.

Author: WerutskyGustavo, MalufFernando Cotait, CronembergerEduardo Henrique, Carrera SouzaVinicius, Dos Santos MartinsSuelen Patricia, PeixotoFábio, SmaletzOren, SchutzFábio, HerchenhornDaniel, SantosTelma, Mavignier CarcanoFlavio, Queiroz MunizDavid, Nunes FilhoPaulo R S, ZaffaroniFacundo, BarriosCarlos, FayAndré

Prostate cancer treatment
Side effects

This study explores the potential of abiraterone acetate with prednisone (AAP) and apalutamide, both alone and in combination, as hormonal therapies for advanced prostate cancer. The researchers hypothesize that these treatments may be effective in reducing castration-associated side effects, such as sexual dysfunction, osteoporosis, weight gain, and increased cardiovascular risk.

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

19.

Apalutamide plus abiraterone acetate and prednisone versus placebo plus abiraterone and prednisone in metastatic, castration-resistant prostate cancer (ACIS): a randomised, placebo-controlled, double-blind, multinational, phase 3 study.

Author: SaadFred, EfstathiouEleni, AttardGerhardt, FlaigThomas W, FrankeFabio, GoodmanOscar B, OudardStéphane, SteuberThomas, SuzukiHiroyoshi, WuDaphne, YeruvaKesav, De PorrePeter, Brookman-MaySabine, LiSusan, LiJinhui, ThomasShibu, BevansKatherine B, MundleSuneel D, McCarthySharon A, RathkopfDana E,

mCRPC treatment

A combination treatment of apalutamide plus abiraterone acetate, which each target a different mechanism of androgen signaling, is being investigated as a potential treatment for metastatic castration-resistant prostate cancer (mCRPC).

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.
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

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