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

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Original Abstract of the Article

Major Research Findings

Sonidegib is a SMO inhibitor used to treat locally advanced or metastatic basal cell carcinoma (BCC). Multiple studies have shown that sonidegib inhibits SMO, thereby suppressing the Hedgehog signaling pathway and the growth of BCC. 2 , 20 , 1 , , 17 , 7 , 9 , 22

Reasons for Side Effects

Sonidegib inhibits the Hedgehog signaling pathway to suppress the growth of basal cell carcinoma. However, the Hedgehog signaling pathway also plays a critical role in the growth and development of normal cells. Therefore, sonidegib can affect cells other than BCC, potentially leading to side effects. 12

Common Side Effects

Muscle Cramps

Muscle cramps are one of the most common side effects of sonidegib. 20 , 3 , 17 , 5 , 22

Hair Loss

Sonidegib can cause hair loss. 20 , 3 , 17 , 5 , 22

Taste Disturbances

Sonidegib can cause taste disturbances. 20 , 3 , 17 , 16 , 5 , 22

Nausea

Sonidegib can cause nausea. 20 , 3 , 17 , 16 , 5 , 22

Fatigue

Sonidegib can cause fatigue. 20 , 3 , 17 , 22

Weight Loss

Sonidegib can cause weight loss. 20 , 3 , 17 , 16 , 5 , 22

Diarrhea

Sonidegib can cause diarrhea. 3 , 22

Anemia

Sonidegib can cause anemia. 23

Liver Dysfunction

Sonidegib can cause liver dysfunction. 12

Infertility

Sonidegib can cause infertility. 12

Side Effect Management

Muscle Cramps

Muscle cramps may improve by stopping sonidegib treatment or reducing the dosage. 20 , 5

Hair Loss

Hair loss may improve by stopping sonidegib treatment or reducing the dosage. 20

Taste Disturbances

Taste disturbances may improve by stopping sonidegib treatment or reducing the dosage. 16

Nausea

Nausea may improve with the administration of anti-emetics. 16

Fatigue

Fatigue may improve with adequate rest and sleep. 16

Weight Loss

Weight loss may improve by eating a nutritious diet. 16

Diarrhea

Diarrhea may improve with the administration of anti-diarrheals. 16

Comparison Between Studies

Commonalities

Multiple studies have shown that sonidegib is effective in treating basal cell carcinoma. They also commonly report that sonidegib can cause side effects such as muscle cramps, hair loss, taste disturbances, nausea, fatigue, weight loss, and diarrhea. 2 , 20 , 3 , , 17 , 16 , 5 , 9 , 22

Differences

The incidence and severity of sonidegib side effects may vary depending on the study. 20 , 3 , , 17 , 16 , 5 , 9 , 22

Practical Application Considerations

Sonidegib is an effective medication for treating basal cell carcinoma, but it can cause side effects. If you are taking sonidegib, follow your doctor's instructions and immediately consult your doctor if you experience any side effects. 20 , 3 , , 17 , 16 , 5 , 9 , 22

Current Research Limitations

There are still some unknowns about the long-term effects of sonidegib and the mechanisms by which side effects occur. Additionally, more research is needed to identify patients who may benefit from sonidegib and those at high risk for side effects. 20 , 1 , , 17 , 7 , 9 , 22

Future Research Directions

Future research is needed to investigate the long-term safety and efficacy of sonidegib, the mechanisms by which side effects occur, and to identify patients who may benefit from sonidegib and those at high risk for side effects. Developing medications and treatment methods to reduce sonidegib side effects is also a future challenge. 20 , 1 , , 17 , 7 , 9 , 22

Conclusion

Sonidegib is an effective medication for treating basal cell carcinoma, but it can cause side effects. If you are taking sonidegib, follow your doctor's instructions and immediately consult your doctor if you experience any side effects. Further research is needed to investigate the long-term safety and efficacy of sonidegib, the mechanisms by which side effects occur, and to identify patients who may benefit from sonidegib and those at high risk for side effects. 20 , 1 , , 17 , 7 , 9 , 22

Literature analysis of 27 papers
Positive Content
22
Neutral Content
3
Negative Content
2
Article Type
1
2
2
11
25
2.

Pharmacological evaluation of a series of smoothened antagonists in signaling pathways and after topical application in a depilated mouse model.

Author: LauresserguesEmilie, HeuslerPeter, LestienneFabrice, TroulierDavid, Rauly-LestienneIsabelle, TouretteAmélie, AilhaudMarie-Christine, CathalaClaudie, TardifStéphanie, Denais-LalièveDelphine, CalmettesMarie-Thérèse, DegryseAnne-Dominique, DumoulinAntoine, De VriesLuc, CussacDidier

Basal cell carcinoma treatment
Side effects

The Hedgehog (HH) pathway is a target for treatment of basal cell carcinoma (BCC). Vismodegib and sonidegib are oral medications approved for treatment of advanced BCC but they produce side effects. We compared a large series of SMO antagonists, including GDC-0449 and LDE-225, to assess their potency. We found that LEQ-506 and TAK-441 were effective and may be suitable for topical treatment of less invasive BCC with fewer side effects.

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

Language : English

3.

FDA Approval Summary: Sonidegib for Locally Advanced Basal Cell Carcinoma.

Author: CaseyDenise, DemkoSuzanne, ShordStacy, ZhaoHong, ChenHuanyu, HeKun, PutmanAlexander, HelmsWhitney, KeeganPatricia, PazdurRichard

Basal cell carcinoma treatment
Sonidegib efficacy
Alopecia
Dysgeusia
Muscle spasms
Nausea

Sonidegib (ODOMZO) was approved for treating locally advanced basal cell carcinoma (laBCC) based on a trial of 230 patients. The objective response rate (ORR) was 58% in the 200 mg group and 44% in the 800 mg group for patients with laBCC. The most common side effects were muscle spasms, alopecia, dysgeusia, nausea, fatigue, increased serum creatine kinase, decreased weight, and diarrhea.

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

4.

Systemic treatments for basal cell carcinoma (BCC): the advent of dermato-oncology in BCC.

Author: AliF R, LearJ T

BCC treatment
Alopecia
Fatigue
Myalgia
Taste disturbance
Weight loss

Vismodegib, a hedgehog pathway inhibitor, has recently been licensed by the U.S. Food and Drug Administration for treatment of advanced BCC. Side-effects are frequent and considerable and include myalgia, taste disturbance, alopecia, weight loss and fatigue.

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

5.

Treatment of periocular advanced basal cell carcinoma with Hedgehog pathway inhibitors: A single-center study and a new dedicated therapeutic protocol.

Author: De GiorgiVincenzo, TraneLuciana, PierettiGiulia, SantoroNicola, SilvestriFlavia, VenturiFederico, ScarfìFederica, MaioVincenza, SpinelliGiuseppe, ScocciantiSilvia, GuerriniLaura, MassiDaniela, MazziniCinzia, DoniLaura

BCC treatment
Adverse events

This observational study evaluated the outcomes of Hedgehog pathway inhibitors (vismodegib and sonidegib) treatment in patients with locally advanced periocular basal cell carcinoma, demonstrating their effectiveness and potential for a new type of therapeutic scheme.

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

Language : English

6.

Development of an adverse drug event network to predict drug toxicity.

Author: WuQier, TaboureauOlivier, AudouzeKarine

Drug-ADE prediction
Adverse drug reaction
Side effects

This study presents a network of drug-adverse drug event (ADE) associations. The network is based on a large database of drug-ADE associations and is used to predict potential ADEs for drugs.

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

Language : English

7.

Clinical Management of Locally Advanced Basal-Cell Carcinomas and Future Therapeutic Directions.

Author: NiebelDennis, SirokayJudith, HoffmannFriederike, FröhlichAnne, BieberThomas, LandsbergJennifer

BCC treatment
Side effects

Locally advanced basal-cell carcinomas (laBCCs), a therapeutic challenge, are being investigated for potential treatment with various new strategies including second-generation SMO inhibitors, immune-checkpoint inhibitors and oncolytic viruses.

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

Language : English

9.

Systemic Targeted Treatments for Basal Cell Carcinoma.

Author: SvobodaSteven A, JohnsonNathan M, PhillipsMariana A

BCC treatment
Surgical management
Adverse effects
Drug resistance
Recurrence

Vismodegib and sonidegib are two drugs that target the sonic hedgehog (SHH) pathway, which can cause certain types of skin cancer. These drugs are effective in treating basal cell carcinoma (BCC), but they can also cause side effects that may lead to treatment discontinuation.

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.

Targeting the Oncoprotein Smoothened by Small Molecules: Focus on Novel Acylguanidine Derivatives as Potent Smoothened Inhibitors.

Author: PietrobonoSilvia, SteccaBarbara

cancer treatment
drug resistance
side effects

This review discusses the current and rapidly expanding field of Smoothened (SMO) small-molecule inhibitors, focusing on acylguanidine derivatives, for cancer therapy. It covers the challenges of using SMO antagonists, including side effects, low selectivity, and drug resistance.

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.

[Regression of cutaneous basal cell and squamous cell carcinoma under pembrolizumab].

Author: DelaitreL, Martins-HéricherJ, TruchotE, DenisD, ProphetteB, MaillardH, Bénéton-BenhardN

Tumor regression
Side effects

Pembrolizumab, an anti-PD1 antibody, may be effective as a second-line therapy for advanced squamous cell carcinoma (SCC) and basal cell carcinoma (BCC). This case report describes a patient with advanced SCC and BCC who experienced regression under pembrolizumab treatment.

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 : French

13.

Emerging noninvasive treatments of nonmelanoma skin cancers.

Author: TongdeeEmily, PsomadakisCorinna Eleni, PakaPavan, MarghoobNadeem, MarkowitzOrit

NMSC treatment
Side effects

Nonmelanoma skin cancer is the most common type of skin cancer, and its incidence is increasing. New and potential treatments include topical sonidegib, cemiplimab, taladegib, posaconazole, radiation therapy, and laser therapies.

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

Language : English

15.

Efficacy, safety, and comparison of sonic hedgehog inhibitors in basal cell carcinomas: A systematic review and meta-analysis.

Author: XiePingxing, LefrançoisPhilippe

Improved survival
Treatment response
Discontinuation
Side effects

Sonic hedgehog inhibitors (SHHis) were found to be effective in treating basal cell carcinoma (BCC) with similar overall response rates for vismodegib and sonidegib. However, the complete response rate was higher for vismodegib. Side effects were common and similar across molecules.

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

Language : English

17.

Sonic Hedgehog Pathway Inhibition in the Treatment of Advanced Basal Cell Carcinoma.

Author: LeavittErica, LaskGary, MartinStephanie

Advanced BCC treatment
Alopecia
Dysgeusia
Muscle spasms
Nausea
Weight loss

This review discusses the use of Sonic hedgehog (Shh) pathway inhibitors for advanced basal cell carcinoma (BCC). Vismodegib and sonidegib are FDA-approved for advanced BCCs and have been used for prevention and as neoadjuvant 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

18.

Emerging drugs and combination strategies for basal cell carcinoma.

Author: DreierJil, DummerReinhard, FeldererLea, NägeliMirjam, GobbiSharon, KunstfeldRainer

BCC treatment
Acquired resistance

Smoothened inhibitors are a promising new treatment for basal cell carcinoma (BCC), but more long-term data are needed to understand their effectiveness and the optimal duration of treatment.

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

19.

Phase 1/1b study of azacitidine and hedgehog pathway inhibitor sonidegib in patients with myeloid neoplasms.

Author: TibesRaoul, KosiorekHeidi E, DueckAmylou C, PalmerJeanne, SproatLisa, BogenbergerJames, HashmiShahrukh, MesaRuben, HoganWilliam, LitzowMark R, Al-KaliAref

Myeloid neoplasm treatment

This review discusses the potential for hedgehog pathway inhibitors (HHis) in the treatment of myeloid neoplasms. HHis are already used to treat some cancers and may hold promise for treating these blood cancers.

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, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.

Language : English

21.

Defining locally advanced basal cell carcinoma and integrating smoothened inhibitors into clinical practice.

Author: KhooAndre B S, AliFaisal R, LearJohn T

laBCC treatment
Side effects

Vismodegib has shown improvement in response rates for patients with locally advanced basal cell carcinoma (laBCC) with a favorable safety profile. A new smoothened inhibitor, sonidegib, shows similar efficacy and safety.

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

22.

Efficacy and Safety of Sonic Hedgehog Inhibitors in Basal Cell Carcinomas: An Updated Systematic Review and Meta-analysis (2009-2022).

Author: NguyenAlex, XiePingxing, LitvinovIvan V, LefrançoisPhilippe

Effective treatment
Alopecia
Diarrhea
Dysgeusia
Increased creatine kinase
Muscle spasms
Nausea
Weight loss

Sonic hedgehog inhibitors (SSHis) are effective treatment options for advanced basal cell carcinoma (BCC). Common adverse effects include muscle spasms, dysgeusia, and alopecia.

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.

Language : English

23.

Sonidegib, a Novel Inhibitor of Suicidal Erythrocyte Death.

Author: Al Mamun BhuyanAbdulla, SahuItishri, CaoHang, LangFlorian

Anemia
Eryptosis

Sonidegib, a Hedgehog pathway disrupting drug used for basal cell carcinoma, may induce eryptosis, a form of suicidal erythrocyte death, potentially contributing to anemia as a side effect.

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

Language : English

24.

Safety and efficacy of combined radiotherapy, immunotherapy and targeted agents in elderly patients: A literature review.

Author: BelgioiaLiliana, DesideriIsacco, ErricoAngelo, FranzeseCiro, DaidoneAntonino, MarinoLorenza, FioreMichele, BorghettiPaolo, GretoDaniela, FiorentinoAlba,

TT/IT with RT safety
limited data

The combination of radiotherapy (RT) with targeted therapy/immunotherapy (TT/IT) seems safe in elderly patients, but more data are needed to assess safety and toxicity.

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.

Survivin as a therapeutic target in Sonic hedgehog-driven medulloblastoma.

Author: BrunS N, MarkantS L, EsparzaL A, GarciaG, TerryD, HuangJ-M, PavlyukovM S, LiX-N, GrantG A, CrawfordJ R, LevyM L, ConwayE M, SmithL H, NakanoI, BerezovA, GreeneM I, WangQ, Wechsler-ReyaR J

MB therapy enhancement

Medulloblastoma (MB) is a type of brain tumor that is especially aggressive in children. Survivin is a protein that promotes cell survival and is often found at high levels in MB cells. This study found that blocking Survivin in MB cells reduced tumor growth in both mice and human cell lines. This suggests that targeting Survivin may be a promising therapeutic approach for MB.

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

26.

Hedgehog Pathway Inhibitors: Clinical Implications and Resistance in the Treatment of Basal Cell Carcinoma.

Author: HabashySuzanne, JafriAliya, OsmanHiba O, ThomasNeena E, UdekweSomtochi, HeindlStacey E

BCC treatment
Resistance
Side effects

This paper explores the most common side effects, resistance, and different methods to overcome resistance to hedgehog pathway inhibitors, like vismodegib and sonidegib, used for treating basal cell carcinoma (BCC).

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

27.

Development of Randomized Trials in Adults with Medulloblastoma-The Example of EORTC 1634-BTG/NOA-23.

Author: HauPeter, FrappazDidier, HoveyElizabeth, McCabeMartin G, PajtlerKristian W, WiestlerBenedikt, SeidelClemens, CombsStephanie E, DirvenLinda, KleinMartin, AnazodoAntoinette, HattingenElke, HoferSilvia, PfisterStefan M, ZimmerClaus, KortmannRolf-Dieter, SunyachMarie-Pierre, TanguyRonan, EffeneyRachel, von DeimlingAndreas, SahmFelix, RutkowskiStefan, BerghoffAnna S, FranceschiEnrico, PinedaEstela, BeierDagmar, PeetersEllen, GorliaThierry, VanlanckerMaureen, BrombergJacoline E C, GautierJulien, ZieglerDavid S, PreusserMatthias, WickWolfgang, WellerMichael

Improved outcomes
Reduced radiotherapy toxicity

This study describes the EORTC 1634-BTG/NOA-23 trial, which will investigate the efficacy and safety of sonidegib (a smoothened inhibitor) in patients with medulloblastoma. The trial aims to improve treatment outcomes by reducing radiotherapy-related toxicity and increasing efficacy.

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

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