Efficacy, rate of tumor response, and safety of a short course (12-24 weeks) of oral vismodegib in various histologic subtypes (infiltrative, nodular, and superficial) of high-risk or locally advanced basal cell carcinoma, in an open-label, prospective case series clinical trial

Fosko, Scott W.; Chu, Melinda B.; Armbrecht, Eric S.; Galperin, Tim; Potts, Geoffrey F.; Mattox, Adam R.; Kurta, Anastasia O.; Polito, Kristen; Slutsky, Jordan B.; Burkemper, Nicole M.; Hurley, M. Yadira

doi:10.1016/j.jaad.2019.12.002

Cited by 17 publications

(21 citation statements)

References 15 publications

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“…20 Vismodegib efficacy in different histologic subtypes of highrisk or laBCC was examined in a phase 2b, single-center, prospective case series in 27 patients with a total of 65 BCCs. 21 To order reprints or e-prints of JDD articles please contact sales@jddonline.com Examined lesions were 45% nodular, 37% infiltrative, and 15% superficial. Histological clearance after 12 weeks of treatment with vismodegib 150 mg QD was 45% in nodular, 75% in infiltrative, and 50% in superficial BCCs.…”

Section: Clinical Efficacymentioning

confidence: 99%

“…Clinical clearance at 24 weeks was 83% for nodular, 92% in infiltrative, and 90% for superficial BCCs. 21 Another case series examined histologic changes in BCCs during vismodegib treatment and concluded vismodegib can promote a shift toward metatypical or squamous differentiation in patients with PR, and keratinization in patients with CR and PR. 22 Relapse following complete response Two retrospective studies examined relapse after discontinuation of vismodegib treatment in patients who achieved CR.…”

Section: Clinical Efficacymentioning

confidence: 99%

“…22 Relapse following complete response Two retrospective studies examined relapse after discontinuation of vismodegib treatment in patients who achieved CR. 23,24 In the first study, 116 patients with laBCC, including those previously enrolled in STEVIE and MIKIE, reported a median (95% confidence interval [CI]) relapse-free survival of 18 (13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24) months after CR and end of vismodegib treatment. 23 After 36 months of follow-up, the relapse-free rate was 35%.…”

Section: Clinical Efficacymentioning

confidence: 99%

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A Review of Hedgehog Inhibitors Sonidegib and Vismodegib for Treatment of Advanced Basal Cell Carcinoma

Migden¹,

Farberg²,

Dummer³

et al. 2021

JDD

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Basal cell carcinoma (BCC) is the most common malignancy in fair-skinned populations. Most cases are successfully treated with surgery, but in advanced BCC-including locally advanced BCC and metastatic BCC-surgery is likely to result in substantial morbidity or unlikely to be effective. In those patients, the systemic Hedgehog inhibitors (HHIs) sonidegib and vismodegib are the only approved pharmacologic treatment option. Although a number of clinical studies highlight the similarities and differences between the two HHIs, no head-to-head clinical comparison is available. Results from the pivotal BOLT and ERIVANCE clinical studies for sonidegib and vismodegib, respectively, demonstrate similar efficacy measured by objective response rate, complete response rate, and histologic tumor subtype. Safety results for both studies are comparable with similar common adverse events reported for muscle spasms, alopecia, and dysgeusia. A notable difference between sonidegib and vismodegib is their respective pharmacokinetic profiles with sonidegib reaching peak concentration in plasma within 2-4 hours of dosing and steady state in plasma achieved by week 17 of treatment, while vismodegib reaches peak plasma concentration approximately 2 days after a single dose and steady state within 21 days of repeated dosing. This review compares efficacy, safety, and pharmacokinetics of sonidegib and vismodegib based on published literature to date.

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Section: Clinical Efficacymentioning

confidence: 99%

Section: Clinical Efficacymentioning

confidence: 99%

Section: Clinical Efficacymentioning

confidence: 99%

See 1 more Smart Citation

A Review of Hedgehog Inhibitors Sonidegib and Vismodegib for Treatment of Advanced Basal Cell Carcinoma

Migden¹,

Farberg²,

Dummer³

et al. 2021

JDD

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“…16 This drug has therefore become the standard treatment for patients with laBCC and mBCC. 17,18 In the ERIVANCE BCC trial, vismodegib showed ORRs of 45% and 60% in 33 patients with mBCC and 63 with laBCC, respectively. 16 The adverse events reported were muscle spasms, alopecia, dysgeusia, decrease in weight, fatigue, nausea, decrease in appetite, and diarrhea.…”

Section: Discussionmentioning

confidence: 99%

“…Vismodegib has proven efficacy and safety and is associated with response rates of 48.5% in mBCC and 60.3% in laBCC 16 . This drug has therefore become the standard treatment for patients with laBCC and mBCC 17,18 . In the ERIVANCE BCC trial, vismodegib showed ORRs of 45% and 60% in 33 patients with mBCC and 63 with laBCC, respectively 16 .…”

Section: Discussionmentioning

confidence: 99%

Efficacy of Vismodegib in pigmented basal cell carcinoma: Appearances are deceiving

Raimondo

Mazzeo

Prete

et al. 2020

Dermatologic Therapy

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Basal cell carcinoma (BCC) is the most common skin cancer in humans. Pigmented basal cell carcinoma (pBCC) is a rare variant of BCC. Vismodegib, was the first drug to be approved for the treatment of locally advanced (laBCCs) or metastatic basal cell carcinoma. The aim of this study was to evaluate the efficacy of Vismodegib in patients with pBCCs. We retrospectively analyzed patients receiving Vismodegib as treatment for laBCCs presenting also various pBCCs. After 6 months of treatment, we performed excisional biopsies of pBCCs, that apparently at clinical and dermoscopic assessment did not respond to therapy. A total of nine patients were assessed. After 6 months of treatment, locally advanced target BCCs showed complete remission in four out of nine patients (44.4%), four patients (44.4%) were considered in partial remission and one patient (11%) showed no response to treatment. On the contrary, all the pBCCs showed both clinically and dermoscopically resistance to treatment. Therefore, clinically persistent pBCCs were surgically removed in three patients. Histology showed a complete elimination of the neoplastic cells together with features of previous regression. Our findings indicate that the efficacy of Vismodegib is higher than that documented by clinical or even dermatoscopic observation alone.

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Signaling pathways in the regulation of cancer stem cells and associated targeted therapy

Wang

2022

MedComm

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Cancer stem cells (CSCs) are defined as a subpopulation of malignant tumor cells with selective capacities for tumor initiation, self‐renewal, metastasis, and unlimited growth into bulks, which are believed as a major cause of progressive tumor phenotypes, including recurrence, metastasis, and treatment failure. A number of signaling pathways are involved in the maintenance of stem cell properties and survival of CSCs, including well‐established intrinsic pathways, such as the Notch, Wnt, and Hedgehog signaling, and extrinsic pathways, such as the vascular microenvironment and tumor‐associated immune cells. There is also intricate crosstalk between these signal cascades and other oncogenic pathways. Thus, targeting pathway molecules that regulate CSCs provides a new option for the treatment of therapy‐resistant or ‐refractory tumors. These treatments include small molecule inhibitors, monoclonal antibodies that target key signaling in CSCs, as well as CSC‐directed immunotherapies that harness the immune systems to target CSCs. This review aims to provide an overview of the regulating networks and their immune interactions involved in CSC development. We also address the update on the development of CSC‐directed therapeutics, with a special focus on those with application approval or under clinical evaluation.

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Efficacy, rate of tumor response, and safety of a short course (12-24 weeks) of oral vismodegib in various histologic subtypes (infiltrative, nodular, and superficial) of high-risk or locally advanced basal cell carcinoma, in an open-label, prospective case series clinical trial

Cited by 17 publications

References 15 publications

A Review of Hedgehog Inhibitors Sonidegib and Vismodegib for Treatment of Advanced Basal Cell Carcinoma

A Review of Hedgehog Inhibitors Sonidegib and Vismodegib for Treatment of Advanced Basal Cell Carcinoma

Efficacy of Vismodegib in pigmented basal cell carcinoma: Appearances are deceiving

Signaling pathways in the regulation of cancer stem cells and associated targeted therapy

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