Identifying Locally Advanced Basal Cell Carcinoma Eligible for Treatment with Vismodegib: An Expert Panel Consensus

Peris, Ketty; Licitra, Lisa; Ascierto, Paolo A.; Corvò, Renzo; Simonacci, Marco; Picciotto, Franco; Gualdi, Giulio; Pellacani, Giovanni; Santoro, Armando

doi:10.2217/fon.14.281

Cited by 41 publications

(33 citation statements)

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“…Additionally, until recently, there was no consensus on the definition of laBCC. 10 The advent of HPIs has prompted the need for an expert consensus on the defining features of laBCC to aid physicians who are determining whether to initiate HPI treatment.…”

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Hedgehog Pathway Inhibitor Therapy for Locally Advanced and Metastatic Basal Cell Carcinoma

et al. 2016

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IMPORTANCE Hedgehog pathway inhibitors (HPIs) were made available by US Food and Drug Administration approval in 2012 for vismodegib and 2015 for sonidegib. Both target the Smoothened molecule and are indicated for locally advanced basal cell carcinoma (laBCC) and metastatic basal cell carcinoma (mBCC). OBJECTIVE To evaluate clinical experience with HPIs, including efficacy and adverse effects. DATA SOURCES We conducted a systematic review in concordance with the PRISMA guidelines of PubMed, the Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and EMBASE, using search terms "vismodegib," "sonidegib," "Erivedge," "Odomza," "basal cell carcinoma," and "BCC." STUDY SELECTION We included clinical trials, retrospective medical record reviews, and prospective case series that used HPIs for the treatment of laBCC or mBCC in human subjects. Individual case reports and limited, retrospective case series were excluded from our review. DATA EXTRACTION AND SYNTHESIS Data were extracted independently by 2 reviewers on a predesigned, standardized form. MAIN OUTCOMES AND MEASURES The following data were recorded: number of patients with laBCC or mBCC, dose and frequency of drug administration, median duration of treatment, clearance and recurrence rates, and adverse effects. RESULTS Eleven vismodegib articles (published between 2009 and 2015) met criteria for inclusion, and 8 articles were able to be pooled for analysis. The 8 pooled articles included 744 total patients with 704 patients clinically evaluable. Sonidegib did not yield enough publications for a formal analysis. Objective response to vismodegib for laBCC had a weighted average of 64.7% (95% CI, 63.7%-65.6%); complete response averaged 31.1% (95% CI, 30.4%-31.8%). Objective response for mBCC was 33.6% (95% CI, 33.1%-34.2%); complete response averaged 3.9% (95% CI, 3.3%-4.4%). Median duration of therapy was 35.8 weeks (95% CI, 35.1-36.5 weeks). CONCLUSIONS AND RELEVANCE In a systematic review of HPIs for laBCC and mBCC, vismodegib, but not sonidegib, had enough studies to warrant a pooled analysis. Vismodegib was identified to have a significant, consistent effect on the median duration of therapy of laBCC and mBCC. While mBCC responses are superior to any traditional approach, the response rate for laBCC might be considered in the context of other standard treatment options including surgery and radiation therapy.

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Hedgehog Pathway Inhibitor Therapy for Locally Advanced and Metastatic Basal Cell Carcinoma

et al. 2016

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“…Lek ten (w dawce 150 mg/d) wydłużał czas do progresji choroby, z obiektywnymi odpowiedziami wynoszącymi od 30% do 60%. Najczęstsze zdarzenia niepożądane podczas terapii wismodegibem (u > 30% chorych) obejmują skurcze mięśni, łysienie, zaburzenia smaku, zmniejszenie masy ciała, zmęczenie i nudności [14][15][16]. Kolejnym inhibitorem szlaku Hedgehog, który uzyskał już rejestrację w Stanach Zjednoczonych, jest sonidegib [14][15][16][17].…”

Section: Inhibitory śCieżki Hedgehogunclassified

“…W przypadku BCC lub SCC o zaawansowaniu regionalnym lub systemowym, u których wyczerpano możliwości terapeutyczne, należy rozważyć włączenie pacjentów do udziału w badaniach klinicznych [1,4,14,15,17,18]. Leczenie raków skóry: napromienianiem i/lub z zastosowaniem chemioterapii i leczenia celowanego powinno odbywać się w wysokoprofilowych ośrodkach.…”

Section: Badania Kliniczneunclassified

Zalecenia dotyczące leczenia chorych na raka podstawnokomórkowego i na raka kolczystokomórkowego przygotowane przez Sekcję Onkologiczną Polskiego Towarzystwa Dermatologicznego i sekcję Akademia Czerniaka Polskiego Towarzystwa Chirurgii Onkologicznej

Owczarek¹,

Rutkowski²,

Słowińska³

et al. 2016

Nowotwory. Journal of Oncology

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Basal cell carcinoma (BCC) as well as the squamous cell carcinoma (SCC) are the most frequent malignant neoplasms among Caucasian patients. Despite the fact, that they seldom metastasise and are not directly fatal, they constitute a significant clinical issue. Such cancers infiltrate surrounding tissues and destroy the surrounding structures, e.g., bones and cartilages. This results in such structures developing severe defects and significantly reduces the quality of life of the patients. Those with chronic immunosuppresion or a genetic predisposition to develop UV-induced skin cancer are at risk of dying, particularly if the cancer is aggressive. The Oncology Department of the Polish Dermatology Society (Polish: Sekcja Onkologiczna Polskiego Towarzystwa Dermatologicznego-PTD) as well as the Melanoma Academy Department of the Polish Society of Oncological Surgery (Polish: sekcja Akademia Czerniaka Polskiego Towarzystwa Chirurgii Onkologicznej-PTChO), basing on the current European guidelines, American recommendations of the National Comprehensive Cancer Network (revision 1.2015) and interventional reviews of publications elaborated by the Cochrane Skin Group, attempted to systemise the diagnostic and therapeutic procedures and o determine rules for primary and secondary prevention in patients suspected/diagnosed with a basal cell or squamous cell carcinoma. The paper presents recommendations regarding diagnosis and treatment of skin cancers, taking all related benefits and challenges into consideration, as well as recommendations for post treatment patients monitoring.

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“…More recently, targeted therapy with sonic hedgehog inhibitor has shown impressive results in clinically advanced or inoperable BCCs …”

Section: Introductionmentioning

confidence: 99%

When basal cell carcinomas became giant: an Italian multicenter study

et al. 2019

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Background Giant basal cell carcinoma (GBCC) is a basal cell carcinoma (BCC) enlarged in a diameter more than 5 cm. Since GBCCs are a highly infrequent entity and the occurrence rate is approximately 0.5-1% out of all BCC types, only anecdotal cases are reported, and causes and characteristics inducing development of this tumor are not defined.Objectives Evaluate causative factors and clinico-histological characteristics of GBCCs.Methods The study is a 6-month, hospital-based case series study performed in 12 Italian dermatologic centers.Results A total of 59 cases and 458 control BCCs were collected. No significant differences existed between the two groups if we take into account social or cultural factors. The average duration of GBCCs is considerably longer than controls. GBCCs are located on unexposed areas while BCCs are on areas not usually covered by clothes. Superficial histological subtype was more frequent in the BCCs group, while infiltrative in GBCCs.GBCCs showed significantly higher local invasiveness, and greater metastatic capacity.More than half of GBCCs had been previously treated with one or more treatments.Conclusions Patients with GBCCs appear to belong to two categories: (i) those who present with GBCC due to delay in accessing medical attention, and (ii) those who have BCCs previously treated with inappropriate strategies. Very few cases could be due to intrinsically aggressive, refractory, or recurrent (after appropriately treated) BCCs. Social and cultural conditions do not appear to be involved in the development of GBCCS. These observations may help clinicians in selecting correct therapeutic strategies in the treatment of BCCs, which give rise to GBCC.

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Identifying Locally Advanced Basal Cell Carcinoma Eligible for Treatment with Vismodegib: An Expert Panel Consensus

Cited by 41 publications

References 50 publications

Hedgehog Pathway Inhibitor Therapy for Locally Advanced and Metastatic Basal Cell Carcinoma

Hedgehog Pathway Inhibitor Therapy for Locally Advanced and Metastatic Basal Cell Carcinoma

Zalecenia dotyczące leczenia chorych na raka podstawnokomórkowego i na raka kolczystokomórkowego przygotowane przez Sekcję Onkologiczną Polskiego Towarzystwa Dermatologicznego i sekcję Akademia Czerniaka Polskiego Towarzystwa Chirurgii Onkologicznej

When basal cell carcinomas became giant: an Italian multicenter study

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