Sonidegib for the treatment of advanced basal cell carcinoma

Ramelyte, Egle; Amann, Valerie C; Dummer, Reinhard

doi:10.1080/14656566.2016.1225725

Cited by 14 publications

(7 citation statements)

References 36 publications

(41 reference statements)

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“…A 42-month analysis of the randomized BOLT study confirmed the long-term efficacy and safety of sonidegib; the objective response rate (ORR) observed for patients with locally advanced basal cell carcinoma (laBCC) was 56.1% (95% CI 43.3-68.3%) and 46.1% (95% CI 37.2-55.1) for the 200 mg and 800 mg groups, respectively.…”

Section: Key Summary Pointsmentioning

confidence: 87%

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Sonidegib: Safety and Efficacy in Treatment of Advanced Basal Cell Carcinoma

Villani

Fabbrocini

Costa

et al. 2020

Dermatol Ther (Heidelb)

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Hedgehog inhibitors are promising alternative treatments for patients with advanced basal cell carcinomas. Sonidegib (Odomzo Ò ), an oral smoothened (SMO) antagonist, is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC) who present recurrence following surgery or radiation therapy, or those who are not candidates for surgery or radiotherapy. Several studies and randomized controlled trials have been conducted to evaluate the efficacy, safety, and tolerability of this new molecule that has demonstrated a good response rate (44%). Grade 1-2 adverse events have also been repor-ted. Further studies of real-world experiences are needed to better understand the correct management of the drug, alternative dosing regimens, and differences with other hedgehog inhibitors. This article provides a complete overview of the pharmacology and pharmacokinetics of sonidegib and a report of the trials and studies conducted. The most frequent adverse events and their correct management are also discussed.

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Section: Key Summary Pointsmentioning

confidence: 87%

“…Side effects from SMO inhibitors are very common and can be significant. Adverse events frequently represent a limiting factor in continuous treatment, and dose adjustments or different schemes to avoid discontinuation and increase patients compliance are often required [45,46]. In the initial BOLT study, [22].…”

Section: Safety Tolerability and Adverse Eventsmentioning

confidence: 99%

Sonidegib: Safety and Efficacy in Treatment of Advanced Basal Cell Carcinoma

Villani

Fabbrocini

Costa

et al. 2020

Dermatol Ther (Heidelb)

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“…Vismodegib is the first FDA-approved SMO inhibitor [13], in 2012, for the treatment of basal cell carcinoma and has been subsequently studied against colon [14], pancreatic [15], and medulloblasto-ma tumors [16]. In patients suffering from resistance to treatment [17][18][19][20], sonidegib, the second inhibitor of SMO approved by the FDA in 2015 [21], is used [22][23][24]. Other possible inhibitors against SMO, subjected to research, and possibly used in resistance to vismodegib and sonidegib [25], are natural products such as chalcone 12 [26], analogs of vitamin D3 [27], or itraconazole, the new inhibitor that might act against mutated SMO [28].…”

Section: Resultsmentioning

confidence: 99%

Inhibition of the Sonic Hedgehog Pathway by Cyclopamine or GLI1 siRNA Reduces In Vivo Tumorigenesis of Human Medulloblastoma Cells Xenotransplanted to Immunodeficient Nude Mice

Rosa¹,

Sánchez²,

Enguita-Germán³

et al. 2019

Advances Transl Med Res

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Medulloblastoma is an aggressive tumor; grade IV of the WHO classification that develops in the cerebellum, mostly linked to infancy and adolescence. It can be classified histologically and molecularly in different subtypes. Morphologically it can be divided into classical, desmoplastic/nodular, anaplastic, and large cell medulloblastoma. Molecularly, there are four groups: Wnt, Shh (sonic hedgehog), group 3 (mainly linked to MYC amplification), and group 4 (for unclassified tumors). Our work tries to prove the inhibition of the Shh pathway in two medulloblastoma cell lines: DAOY, a desmoplastic cerebellar medulloblastoma cell line of the Shh molecular group; and D283 Med, derived from a metastasis to peritoneum, possibly corresponding to an aggressive group 3 medulloblastoma. Cyclopamine, an inhibitor of the SMO oncogenic protein, and GLI1 siRNA were used as inhibitory agents of the Shh pathway in the two cell lines. For the in vivo assay, for each cell line, each experimental group consisted of 6 mice injected subcutaneously with control cells on the right flank, and cells treated with cyclopamine or GLI1 siRNA on the left flank. In the cell lines studied, cyclopamine showed a high inhibitory growth of subcutaneous tumors in the D283 Med and DAOY lines. The siRNA treatment, however, was only effective in the D283 Med cell line.

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“…During the follow‐up of patients with advanced BCC treated with HPI, discussing treatment and informing about possible adverse events to expect is of key importance (Table ). Sonidegib should be taken at least 2 hours after a meal and at least 1 hour before the following meal . The absorption of vismodegib is not affected by food .…”

Section: Follow‐up Of Patients During Hpi Treatment For Adverse Eventsmentioning

confidence: 99%

A Practical Guide for the Follow-Up of Patients with Advanced Basal Cell Carcinoma During Treatment with Hedgehog Pathway Inhibitors

et al. 2019

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The Hedgehog pathway inhibitors (HPIs), vismodegib and sonidegib, are increasingly employed in the treatment of patients with advanced basal cell carcinoma (BCC). The aim of this review is to create a synthesis of available information in the literature regarding the follow‐up of patients with advanced BCC treated with HPIs and to provide the treating physician with a structured practical guide to standardize clinical practice. Several challenges during treatment are addressed: to optimally evaluate tumor responses, to differentiate between resistance (HPI rechallenge not possible) and recurrence (HPI rechallenge may be possible) in case of BCC regrowth, to readily assess for toxicity and tolerability issues, to provide patients with practical ways and behaviors to effectively cope with adverse events, and to improve patient adherence and quality of life. Implications for Practice This is a practical guide for clinical practice regarding the monitoring and follow‐up of patients with advanced basal cell carcinoma (BCC) during treatment with the Hedgehog pathway inhibitors (HPIs) vismodegib and sonidegib. This review aims to bridge the gap in knowledge of assessing tumor response for BCC with both an externally visible component and an infiltrating component measurable with imaging. Furthermore, it addresses the follow‐up for adverse events as a challenging multistep process involving practices aiming to readily assess new‐onset symptoms of HPI toxicity, perform total‐body skin examination, and improve patient adherence and quality of life.

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Sonidegib for the treatment of advanced basal cell carcinoma

Abstract: Introduction. Advanced and metastatic basal cell carcinomas (BCCs) are rare but still

Cited by 14 publications

References 36 publications

Sonidegib: Safety and Efficacy in Treatment of Advanced Basal Cell Carcinoma

Sonidegib: Safety and Efficacy in Treatment of Advanced Basal Cell Carcinoma

Inhibition of the Sonic Hedgehog Pathway by Cyclopamine or GLI1 siRNA Reduces In Vivo Tumorigenesis of Human Medulloblastoma Cells Xenotransplanted to Immunodeficient Nude Mice

A Practical Guide for the Follow-Up of Patients with Advanced Basal Cell Carcinoma During Treatment with Hedgehog Pathway Inhibitors

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