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

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Original Abstract of the Article

Major Research Findings

Mitotane is a drug used to treat adrenocortical carcinoma. Studies have shown that mitotane is effective for treating this type of cancer; however, serious side effects can occur. These studies indicate that mitotane treatment can suppress cortisol secretion and improve clinical symptoms and quality of life in patients with adrenocortical carcinoma; however, various side effects have been reported in the digestive system, nervous system, and endocrine system. 16

Researchers have also found that the severity and types of side effects vary depending on the dosage and duration of treatment. For example, a low dose of mitotane was shown to improve growth velocity and pubertal development in children with Cushing’s syndrome. 12 On the other hand, high doses of mitotane were associated with more serious adverse events in other studies. 20

Reasons for Side Effects

The side effects of mitotane are thought to be caused by its direct effects on adrenocortical cells, inhibiting the synthesis of steroid hormones such as cortisol, leading to adrenal insufficiency. 19 Additionally, mitotane can interact with the lipid membranes of cells, potentially causing various side effects. 19

Common Side Effects

Digestive System

Side effects of mitotane on the digestive system include loss of appetite, nausea, vomiting, and diarrhea. 14 17 15 3 12 27 7

Nervous System

Side effects on the nervous system include headaches, dizziness, fatigue, memory problems, and changes in consciousness. 14 6 12

Endocrine System

The endocrine system can be impacted by mitotane leading to adrenal insufficiency, hypothyroidism, hypogonadism, hyperprolactinemia, and Cushing's syndrome. 19 5 15 13 18 25 24 1

Others

Other side effects may include skin abnormalities, liver problems, kidney problems, and low white blood cell counts. 14 17 12 27 8 1

Countermeasures for Side Effects

Digestive System

To manage digestive side effects, dietary changes can be implemented by consuming easily digestible foods and eating in smaller portions. Medication such as antiemetics and antidiarrheals may also be prescribed. 15

Nervous System

Treatments for nervous system side effects will depend on the specific symptom. For headaches, painkillers may be used, and antiemetics may help with dizziness. In cases of severe memory impairment or changes in consciousness, mitotane treatment may be temporarily discontinued or the dose reduced. 6

Endocrine System

Hormone replacement therapy is used to manage side effects affecting the endocrine system. For example, hormone replacement therapies for adrenal insufficiency may include cortisol and aldosterone. Hypothyroidism can be addressed with thyroid hormone preparations. 1 Male hormones and female hormones may be prescribed to address hypogonadism. 24

Comparison Between Studies

Common Points of Studies

Many studies show that mitotane treatment can suppress cortisol secretion and improve clinical symptoms in patients with adrenocortical carcinoma. They also commonly suggest that mitotane can cause side effects.

Differences in Studies

The severity and types of mitotane side effects can vary depending on the study. These differences likely depend on factors such as the dosage and duration of mitotane used, as well as the age and condition of the participants. Additionally, differences in methods used to evaluate side effects can influence results.

Precautions for Application in Daily Life

Mitotane is an effective drug for the treatment of adrenocortical carcinoma; however, it can also cause serious side effects. It is important to follow your doctor's instructions and undergo regular blood tests and physical examinations while taking this medication. Consult your doctor immediately if you experience any adverse effects.

Limitations of Current Research

The amount of research on mitotane is limited. Specifically, there are a small number of studies focusing on the side effects of mitotane, making it difficult to generalize the results. The mechanisms of these side effects are not fully understood, requiring further study.

Future Research Directions

More research is needed to better understand the side effects of mitotane. It is critical to clarify the mechanisms of these side effects and develop new treatments to mitigate them. The development of biomarkers to predict these side effects would also be beneficial.

Conclusion

Mitotane is an effective treatment for adrenocortical carcinoma; however, it can cause serious side effects. It is crucial to follow your doctor's instructions and undergo regular blood tests and physical examinations while taking this medication. Further research is necessary to develop new treatments and biomarkers to minimize the risk of side effects.

Keywords
Benefit Keywords
Cell viability and proliferation
ER-alpha activation
2
Antitumor potential
Cytotoxic effect
3
Estrogen-secreting ACC diagnosis
4
ACC treatment
5
Adrenocortical carcinoma treatment
6
Enhanced intestinal absorption
Enhanced oral bioavailability
7
Anti-proliferative effect
Wnt/beta-catenin inhibition
10
BMI decrease
Growth velocity restoration
Pubertal development restoration
12
ACC treatment
13
ACC treatment
15
Cortisol normalization
16
Adrenocortical carcinoma treatment
17
Cortisol control
18
Effective treatment of adrenocortical carcinoma
19
Adrenocortical cancer treatment
20
Early detection
Retinal problem reversal
21
ACC treatment
22
Cushing's disease treatment
23
ACC treatment
24
Effective treatment
25
Cushing's disease treatment
26
Disease-free survival
Increased survival
27
Risk Keywords
Mitotane adrenal insufficiency
Mitotane dyslipidemia
Mitotane endocrine toxicity
Mitotane hypogonadism
Mitotane ovarian cysts
Mitotane thyroid dysfunction
1
Estrogenic-like side effects
Potential for adverse effects
2
Larger tumor size
Mitotane side effects
Rapid evolution
Recurrence
Severe prognosis
Worse prognosis
4
Gastrointestinal disorders
Pituitary inflammation
Skin disorders
Thyroid disorders
5
Functional limitations
Mental consequences
Physical complaints
Social consequences
8
ACC Risk
9
Side effects
11
Adrenal insufficiency
Hepatitis
Side effects
12
Adrenal insufficiency
Side effects
Toxicity
13
Dyspnea
14
Adrenal insufficiency
Hypothyroidism
Precocious puberty
15
Side effects
16
Limited data
18
Disturbed bilayer structure
Increased membrane permeability
19
Mitotane toxicity
20
Retinal side effects
21
Hypercortisolism
Uncontrolled CD
23
Adrenal insufficiency
Hypogonadism
24
Monitoring protocol
Side effects
25
Intolerance
Recurrence
26
Difficult to control
Side effects
27
Literature analysis of 27 papers
Positive Content
17
Neutral Content
4
Negative Content
6
Article Type
0
1
2
7
26
1.

Metabolic and Endocrine Toxicities of Mitotane: A Systematic Review.

Author: BianchiniMarta, PulianiGiulia, ChiefariAlfonsina, MormandoMarilda, LaurettaRosa, AppetecchiaMarialuisa

Mitotane adrenal insufficiency
Mitotane dyslipidemia
Mitotane endocrine toxicity
Mitotane hypogonadism
Mitotane ovarian cysts
Mitotane thyroid dysfunction

This systematic review collected evidence on the side effects of mitotane, a drug used to manage adrenocortical carcinoma (ACC), on the endocrine and metabolic systems. The review found that mitotane can cause adrenal insufficiency, thyroid dysfunction, dyslipidemia, and other endocrine and metabolic side effects.

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

2.

Estrogen-Like Effect of Mitotane Explained by Its Agonist Activity on Estrogen Receptor-α.

Author: RossiniElisa, GiacopuzziEdoardo, GangemiFabrizio, TamburelloMariangela, CosentiniDeborah, AbateAndrea, LaganàMarta, BerrutiAlfredo, GrisantiSalvatore, SigalaSandra

Cell viability and proliferation
ER-alpha activation
Estrogenic-like side effects
Potential for adverse effects

This study investigated the interaction between mitotane, a drug used to treat adrenocortical carcinoma, and estrogen receptor-α (ER-α). The study found that mitotane directly binds and activates ER-α, explaining the estrogenic-like side effects observed in patients.

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

Language : English

5.

The Role of Immunotherapy in the Treatment of Adrenocortical Carcinoma.

Author: KarwackaIzabela, ObołończykŁukasz, Kaniuka-JakubowskaSonia, SworczakKrzysztof

ACC treatment
Gastrointestinal disorders
Pituitary inflammation
Skin disorders
Thyroid disorders

This review examines the potential of immunotherapy, particularly immune checkpoint inhibitors, in treating adrenocortical carcinoma (ACC). While single-agent immunotherapy has shown modest activity, ongoing clinical trials are evaluating the role of combination therapies involving anti-PD-1 and anti-CTLA-4 antibodies, and anti-PD-1 antibodies combined with glucocorticoid receptor antagonists.

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.

A case report of neurological adverse events caused by short-term and low-dose treatment of mitotane: The role of therapeutic drug monitoring.

Author: LiuXin, FuQiang, TangYan, DengJian-Hua, MeiDan, ZhangBo

Adrenocortical carcinoma treatment

Mitotane is a drug used to treat adrenocortical carcinoma (ACC), a type of cancer that affects the adrenal glands. This study reviews the safety of low-dose mitotane in patients with ACC. The study found that low-dose mitotane has a good safety profile and is generally well tolerated.

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.

Adrenocortical carcinoma masquerading as pheochromocytoma: a histopathologic dilemma.

Author: ShettyImpana, FullerSarah, RaygadaMargarita, MerinoMaria J, ThomasB J, WidemannBrigitte C, ReillyKarlyne M, PacakKarel, Del RiveroJaydira

ACC Risk

Adrenocortical carcinoma (ACC) is a rare but aggressive cancer with a poor prognosis. This case report highlights the importance of precise molecular pathology and genetic analysis in diagnosing ACC, which can be easily misdiagnosed as pheochromocytoma.

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

Language : English

11.

Changes in total and acylated ghrelin levels during mitotane treatment in patients with adrenocortical carcinoma.

Author: KomarowskaHanna, RucińskiMarcin, FichnaMarta, BromińskaBarbara, IżyckiDariusz, CzarnywojtekAgata, RuchałaMarek

Side effects

Plasma ghrelin levels are elevated during mitotane treatment for adrenocortical carcinoma (ACC) and are associated with an increased risk of side effects.

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

Language : English

12.

Mitotane (op'DDD) restores growth and puberty in nine children with Cushing's disease.

Author: MotteEmmanuelle, RothenbuhlerAnya, GaillardStephan, LahlouNajiba, TeinturierCécile, CoutantRégis, LinglartAgnès

BMI decrease
Growth velocity restoration
Pubertal development restoration
Adrenal insufficiency
Hepatitis
Side effects

Low-dose mitotane can improve growth velocity, pubertal development, and BMI in children with Cushing's disease, but its side effects, including adrenal insufficiency and hepatitis, make it a challenging treatment option.

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

Language : English

13.

Role of Mitotane in Adrenocortical Carcinoma - Review and State of the art.

Author: ParagliolaRosa Maria, TorinoFrancesco, PapiGiampaolo, LocantorePietro, PontecorviAlfredo, CorselloSalvatore Maria

ACC treatment
Adrenal insufficiency
Side effects
Toxicity

Mitotane is the primary treatment for adrenocortical carcinoma (ACC) but has significant side effects, and a new trial is evaluating the effectiveness of adjuvant mitotane therapy in patients with low-intermediate risk of recurrence.

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.

Mitotane-induced dyspnoea: an unusual side effect.

Author: FarooqAli U, AmjadWaseem, KocharTanureet, AdhikariSubash

Dyspnea

A case report highlights dyspnoea as a rare adverse effect of mitotane, a drug used for treating adrenocortical carcinoma and Cushing's syndrome.

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

15.

Mitotane in the treatment of childhood adrenocortical carcinoma: a potent endocrine disruptor.

Author: OddiePhilip D, AlbertBenjamin B, HofmanPaul L, JefferiesCraig, LaughtonStephen, CarterPhilippa J

ACC treatment
Adrenal insufficiency
Hypothyroidism
Precocious puberty

Mitotane, a drug used for adrenocortical carcinoma (ACC), can cause various endocrine complications, including adrenal insufficiency, hypothyroidism, and, as shown in this case report, precocious puberty.

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

Language : English

16.

Effectiveness of medical treatment for Cushing's syndrome: a systematic review and meta-analysis.

Author: BroersenLeonie H A, JhaMeghna, BiermaszNienke R, PereiraAlberto M, DekkersOlaf M

Cortisol normalization
Side effects

Medical treatment induces cortisol normalization effectively in a large percentage of patients. Medical treatment for Cushing's disease patients is a reasonable option in case of contraindication for surgery, a recurrence, or in patients choosing not to have surgery.

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

17.

Oral and vulvo-vaginal lichenoid reactions due to mitotane (Lysodren): A case report.

Author: SchmouchkovitchArthur, HerryHéloïse, ThuillierPhilippe, KerlanVéronique, FleuretCamille, Le TouxGuy, BoisraméSylvie

Adrenocortical carcinoma treatment

This paper discusses the importance of pharmacovigilance (drug safety) for identifying, characterizing, preventing, or minimizing risks related to medicinal products. The authors emphasize the importance of reporting side effects to health professionals to improve the benefit/risk assessment of drugs.

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

18.

Updates on the role of adrenal steroidogenesis inhibitors in Cushing's syndrome: a focus on novel therapies.

Author: FleseriuMaria, CastinettiFrederic

Cortisol control
Limited data

This review aimed to better characterize the efficacy and safety profiles of adrenal steroidogenesis inhibitors for the treatment of endogenous Cushing's syndrome (CS), particularly Cushing's disease (CD).

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

19.

The adrenal specific toxicant mitotane directly interacts with lipid membranes and alters membrane properties depending on lipid composition.

Author: ScheidtHolger A, HaralampievIvan, TheisgenStephan, SchirbelAndreas, SbieraSilviu, HusterDaniel, KroissMatthias, MüllerPeter

Effective treatment of adrenocortical carcinoma
Disturbed bilayer structure
Increased membrane permeability

This study found that mitotane, a drug used to treat adrenocortical carcinoma, interacts with lipid membranes, causing disturbances in bilayer structure and increased membrane permeability. This may contribute to the drug's effects and side effects.

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

20.

Contribution of Therapeutic Monitoring in the Assessment of Toxic Adverse Effects of Mitotane: a Case Report.

Author: JebabliNadia, GaïesEmna, EljebariHanen, CharfiRim, LakhalMohamed, KlouzAnis, SalouageIssam, TrabelsiSameh

Adrenocortical cancer treatment
Mitotane toxicity

This case report describes toxic plasma levels of mitotane in a 47-year-old man with adrenocortical cancer, despite low doses.

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.
LetterA written message for communication and exchange of information between individuals.

Language : English

21.

Retinal toxicities of cancer therapy drugs: biologics, small molecule inhibitors, and chemotherapies.

Author: LiuCatherine Y, FrancisJasmine H, BrodieScott E, MarrBrian, PulidoJose S, MarmorMichael F, AbramsonDavid H

Early detection
Retinal problem reversal
Retinal side effects

Several cancer therapy drugs can cause retinal side effects, including biologics, small molecule inhibitors, and traditional chemotherapy agents. Early detection of these complications is crucial.

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

22.

Liposomal polychemotherapy improves adrenocortical carcinoma treatment in a preclinical rodent model.

Author: HantelConstanze, JungSara, MussackThomas, ReinckeMartin, BeuschleinFelix

ACC treatment

Liposomal drug delivery systems may offer a promising new approach for treating adrenocortical carcinoma (ACC). This study investigated the efficacy of different chemotherapy regimens, including conventional and liposomal formulations, in preclinical models. Liposomal variants showed significant antitumoral effects in vivo, suggesting their potential for improved treatment of ACC.

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

Language : English

23.

Medical treatment of Cushing's disease.

Author: FeeldersRichard A, HoflandLeo J

Cushing's disease treatment
Hypercortisolism
Uncontrolled CD

Cushing's disease (CD) is associated with serious morbidity and increased mortality when suboptimally treated. While surgery is the first-line treatment modality for CD, hypercortisolism persists or recurs in many patients, highlighting the need for effective medical therapy.

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

24.

Mitotane therapy in adrenocortical cancer induces CYP3A4 and inhibits 5α-reductase, explaining the need for personalized glucocorticoid and androgen replacement.

Author: ChortisVasileios, TaylorAngela E, SchneiderPetra, TomlinsonJeremy W, HughesBeverly A, O'NeilDonna M, LibéRossella, AllolioBruno, BertagnaXavier, BertheratJérôme, BeuschleinFelix, FassnachtMartin, KaravitakiNiki, MannelliMassimo, ManteroFranco, OpocherGiuseppe, PorfiriEmilio, QuinklerMarcus, SherlockMark, TerzoloMassimo, NightingalePeter, ShackletonCedric H L, StewartPaul M, HahnerStefanie, ArltWiebke

ACC treatment
Adrenal insufficiency
Hypogonadism

Mitotane is a medication used to treat metastatic adrenocortical carcinoma. It is considered an adrenolytic substance, which means it can affect the adrenal glands. While the exact effects on steroidogenesis are limited, mitotane treatment is known to cause adrenal insufficiency and male hypogonadism as common side effects.

Controlled Clinical TrialA clinical trial that evaluates the effectiveness of a treatment by comparing a group that receives the intervention with a group that receives a placebo or standard 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

26.

Efficiency and tolerance of mitotane in Cushing's disease in 76 patients from a single center.

Author: BaudryCamille, CosteJoël, Bou KhalilRoula, SilveraStéphane, GuignatLaurence, GuibourdencheJean, AbbasHalim, LegmannPaul, BertagnaXavier, BertheratJérôme

Cushing's disease treatment
Intolerance
Recurrence

Mitotane is an effective treatment for Cushing's disease (CD). In a study of 76 patients, mitotane achieved remission in 72% of patients after a median time of 6.7 months.

Evaluation StudyResearch that systematically evaluates the effectiveness of a particular program or policy. It measures its outcomes and provides important information for future decision-making.
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

27.

[Adrenocortical carcinomas: therapeutic advances in 2011].

Author: GrunenwaldS, CaronPh

Disease-free survival
Increased survival
Difficult to control
Side effects

Adrenocortical cancer is a rare aggressive malignancy with poor prognosis. Surgery is the only curative treatment, and mitotane therapy may improve survival.

English AbstractA summary of a research paper/publication written in English for a wider audience.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : French

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