Effects of sonidegib: A Synthesis of Findings from 17 Studies

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Original Abstract of the Article

Main Research Findings

Sonidegib is a Hedgehog pathway inhibitor approved to treat locally advanced basal cell carcinoma and, depending on regulatory approval, metastatic basal cell carcinoma. 1 Sonidegib has shown robust efficacy and continued tolerability through 42 months in patients with advanced basal cell carcinoma. 1 Sonidegib has also been investigated for its potential use in treating myeloid neoplasms, in combination with azacitidine. 13 Topical delivery of sonidegib has also shown promising results in preclinical studies, suggesting its potential to reduce adverse effects associated with systemic administration. 16 Sonidegib has also been found to be effective in treating advanced basal cell carcinoma in patients who have undergone liver transplantation. This drug is also a promising treatment option for patients with Gorlin syndrome, a rare genetic condition characterized by the early development of numerous cutaneous basal cell carcinomas (BCCs), with better tolerability and complete response compared to vismodegib. 5 Additionally, sonidegib has shown potential as a neoadjuvant treatment before surgery for locally advanced basal cell carcinoma of the face. 6

Benefits and Risks

Benefit Summary

Sonidegib is an effective treatment option for advanced basal cell carcinoma, particularly in patients who are not candidates for surgery or radiotherapy. 1 3 It has shown to be effective in treating advanced basal cell carcinoma in patients who have undergone liver transplantation. It is a promising treatment option for patients with Gorlin syndrome, with better tolerability and complete response compared to vismodegib. 5 Additionally, sonidegib has shown potential as a neoadjuvant treatment before surgery for locally advanced basal cell carcinoma of the face. 6

Risk Summary

Sonidegib is associated with potential side effects such as muscle aches, fatigue, weight gain, loss of appetite, and taste changes. 3 It is important to be aware of these potential side effects and to discuss them with your doctor. Sonidegib is not recommended for use during pregnancy or breastfeeding. 3

Comparison of Studies

Similarities between Studies

Several studies have shown that sonidegib is an effective treatment for locally advanced or metastatic basal cell carcinoma. 3 1 7 11 These studies have also highlighted the potential of sonidegib as a treatment for basal cell carcinoma, suggesting its effectiveness across different patient populations. 14 4

Differences between Studies

The dosage and mode of administration of sonidegib can vary depending on the study. 3 1 7 11 Additionally, the side effects reported in different studies vary. 3 The effectiveness of sonidegib as a neoadjuvant treatment before surgery for locally advanced basal cell carcinoma of the face needs further investigation. 6

Consistency and Inconsistencies of Results

There is consistent evidence from multiple studies that sonidegib is effective in treating advanced basal cell carcinoma. 3 1 7 11 However, the specific side effects and optimal dosage and administration methods for sonidegib require further study. 3 Furthermore, research on the effectiveness of sonidegib as a neoadjuvant treatment and its use in patients with liver transplantation is still ongoing. 6

Practical Implications and Precautions

Sonidegib is a promising treatment option for advanced basal cell carcinoma, but it is important to be aware of the potential side effects. 3 It's crucial to discuss any potential concerns and to follow your doctor's instructions for proper usage and management of any side effects. Sonidegib should not be used during pregnancy or breastfeeding. 3

Limitations of Current Research

Further research is needed to fully understand the potential side effects of sonidegib. 3 More studies are required to confirm the effectiveness of sonidegib as a neoadjuvant treatment and its use in patients with liver transplantation. 6 Further research is also needed to determine the optimal dosage and administration method for sonidegib. 3 1 7 11

Future Research Directions

Future research should focus on further investigating the side effects of sonidegib. 3 Research is needed to confirm the effectiveness of sonidegib as a neoadjuvant treatment and its use in patients with liver transplantation. 6 Additional research is required to determine the optimal dosage and administration method for sonidegib. 3 1 7 11

Conclusion

Sonidegib is a promising treatment for locally advanced or metastatic basal cell carcinoma, offering a viable alternative for patients who are not suitable for surgery or radiotherapy. 3 1 While sonidegib shows promise, it is essential to remain vigilant about potential side effects and to consult with your doctor for proper usage and management of any side effects. This drug should not be used during pregnancy or breastfeeding. 3 Further research is needed to better understand sonidegib's safety profile and to optimize its administration. 3 1 7 11

Literature analysis of 17 papers
Positive Content
17
Neutral Content
0
Negative Content
0
Article Type
0
1
1
6
15
2.

Effects of Mild to Severe Hepatic Impairment on the Pharmacokinetics of Sonidegib: A Multicenter, Open-Label, Parallel-Group Study.

Author: HorsmansYves, ZhouJocelyn, LiudmilaMateva, GolorGeorge, ShiboletOren, QuinlanMichelle, EmotteCorinne, BossHildegard, CastroHenry, SellamiDalila, PrestonRichard A

This study assessed the pharmacokinetics (PKs) and safety of sonidegib, a Hedgehog signaling pathway inhibitor, in subjects with varying degrees of hepatic impairment. The study aims to provide dose recommendations for patients with hepatic impairment based on PKs and safety data.

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

Language : English

3.

Pharmacokinetics and pharmacodynamics of Hedgehog pathway inhibitors used in the treatment of advanced or treatment-refractory basal cell carcinoma.

Author: LearJohn T, MorrisLinda M, NessDylan B, LewisLionel D

BCC treatment

Sonidegib and vismodegib are the only FDA and EMA-approved small-molecule Hedgehog pathway inhibitors (HHIs) for treating advanced or refractory basal cell carcinoma (BCC). There are no head-to-head clinical trials comparing these two HHIs for 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

5.

Tolerance of sonidegib after intolerance of vismodegib-Experience in two patients with nevoid basal cell carcinoma syndrome (Gorlin syndrome).

Author: VenturiFederico, TraneLuciana, SilvestriFlavia, ZuccaroBiancamaria, MagnaterraElisabetta, De GiorgiVincenzo

Improved tolerability
Tumor regression
Adverse effects

The study reported two cases of Nevoid basal cell carcinoma syndrome (NBCCS) treated with hedgehog inhibitors (HHIs). Both patients had previously been treated with Vismodegib but discontinued due to adverse effects. They were then treated with Sonidegib, which demonstrated better tolerability and a complete response.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.

Language : English

7.

Multicenter Retrospective Andalusian Study of the Use of Sonidegib for the Treatment of Local Advanced Basal Cell Carcinoma in Real Clinical Practice.

Author: Ruiz-VillaverdeRicardo, Herrera-AcostaEnrique, Ruiz de CasasAndres, Villegas-RomeroIsabel M, Moreno-SuárezFátima G, Vílchez-MárquezFrancisco, Galán-GutiérrezManuel, Vázquez-BayoMaria Carmen, Cases-MéridaSandra, Almazán-FernándezFrancisco M

LA-BCC treatment

Locally advanced basal cell carcinoma (LA-BCC), a type of skin cancer, is difficult to treat with surgery or radiation. This article discusses the use of sonidegib, a drug approved for the treatment of LA-BCC that is not amenable to curative surgery or radiotherapy.

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

Language : English

9.

Efficacy and safety of sonidegib for the management of basal cell carcinoma: a drug safety evaluation.

Author: VillaniAlessia, ScalvenziMassimiliano, MicaliGiuseppe, LacarrubbaFrancesco, GencoLucia, RuggieroAngelo, FornaroLuigi, GuerrasioGianluca, PotestioLuca

laBCC treatment

This article discusses the use of sonidegib, a Hedgehog (HH) pathway inhibitor, for the treatment of locally advanced basal cell carcinoma (laBCC) in patients who are not amenable to surgery or radiation therapy. Sonidegib offers a valuable treatment option for patients with difficult-to-treat BCCs.

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.

Clinical Characteristics of an Italian Patient Population with Advanced BCC and Real-Life Evaluation of Hedgehog Pathway Inhibitor Safety and Effectiveness.

Author: ManninoMaria, PiccerilloAlfredo, FabbrociniGabriella, QuaglinoPietro, ArgenzianoGiuseppe, DikaEmi, AsciertoPaolo Antonio, PellacaniGiovanni, LongoCaterina, FargnoliMaria Concetta, BianchiLuca, Calzavara-PintonPiergiacomo, ZalaudekIris, FavaPaolo, ScalvenziMassimiliano, BocchinoEnrico, Di StefaniAlessandro, PerisKetty,

Effective treatment
Safe treatment
Therapy-related AEs

Hedgehog pathway inhibitors (HHIs) are effective and safe for the treatment of advanced basal cell carcinoma (aBCC). In a multicenter observational study of 178 patients, objective response rates were 76.7% (95% CI: 82.3-68.7) for locally advanced aBCC (laBCC) and 33.3% (95% CI: 88.2-1.7) for metastatic BCC (mBCC). Most therapy-related adverse events (AEs) were mild-moderate in severity.

Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

11.

Sonidegib as a Locally Advanced Basal Cell Carcinoma Therapy in Real-life Clinical Setting: A National Multicentre Study.

Author: Moreno-ArronesO M, Béa-ArdebolS, Mayo-MartinezF, Pérez-PastorG, Torres-NavarroI, Bonfill-OrtíM, DezaG, Ruiz-SalasV, MasferrerE, FealC, Turrión-MerinoL, TollA, YébenesM, Galiano-MejíasS, JakaA, Ferrandiz-PulidoC, FlorezA, Hernández-HernándezN, Fernández-de-MisaR, Rios-BucetaL, SanmartinO

Acceptable safety
Good effectiveness

This study investigated the real-life efficacy and safety profile of sonidegib in patients with basal cell carcinoma (BCC). 81.7% of the patients showed clinical improvement, with 52.4% partial response and 29.3% complete response. 68.3% of the patients experienced at least one adverse effect.

Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

12.

Sonidegib as a Locally Advanced Basal Cell Carcinoma Therapy in Real-life Clinical Setting: A National Multicentre Study.

Author: Moreno-ArronesO M, Béa-ArdebolS, Mayo-MartinezF, Pérez-PastorG, Torres-NavarroI, Bonfill-OrtíM, DezaG, Ruiz-SalasV, MasferrerE, FealC, Turrión-MerinoL, TollA, YébenesM, Galiano-MejíasS, JakaA, Ferrandiz-PulidoC, FlorezA, Hernández-HernándezN, Fernández-de-MisaR, Rios-BucetaL, SanmartinO

Acceptable safety profile
Effective sonidegib

This retrospective multicentric study described the use of sonidegib in 82 patients with aggressive basal cell carcinoma. The study found that 81.7% of patients showed clinical improvement, with a median treatment duration of 6 months and a median follow-up duration of 34.2 months. Prior vismodegib treatment and recurrent primary BCC were associated with a poorer response to sonidegib. The study concluded that sonidegib shows good effectiveness and acceptable safety in real-world clinical practice.

Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

13.

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

14.

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

15.

Biphenyls in Clusiaceae: Isolation, structure diversity, synthesis and bioactivity.

Author: WangYouyi, HuangQing, ZhangLi, ZhengChangwu, XuHongxi

Biphenyl compounds
Clusiaceae plants
Medicinal potential

This review explores the chemistry and biological activity of biphenyl compounds in Clusiaceae plants. These compounds have shown significant potential as medicinal agents with a wide range of biological effects, including antioxidant, anti-proliferative, and anti-inflammatory properties.

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.

Topical Delivery of Hedgehog Inhibitors: Current Status and Perspectives.

Author: PedersenKristian Kåber, Høyer-HansenMaria Helena, LitmanThomas, HædersdalMerete, OlesenUffe Høgh

Improved delivery
Reduced adverse effects

This review evaluates the current status of topical hedgehog inhibitor delivery for treating basal cell carcinomas, highlighting the need for improved delivery techniques to achieve sufficient skin uptake, biological response, and tumor clearance.

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

17.

Current approaches and strategies to identify Hedgehog signaling pathway inhibitors for cancer therapy.

Author: FengZifan, ZhuShanshan, LiWenrui, YaoMaojun, SongHualong, WangRu-Bing

Cancer therapy
Adverse effects
Resistance

This review explores various approaches for developing Hedgehog pathway inhibitors, including library screening, natural product-oriented approaches, and in silico tools. It highlights the need for new inhibitors due to limitations of current drugs.

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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