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

Abstract

Introduction: Locally advanced basal cell carcinoma (LA-BCC) is defined as that BCC in which there is radiological confirmation of invasion of certain neighboring structures in depth and also, usually, a BCC that is of a sufficient size and invasion (although there is no radiological demonstration of deep invasion) in which surgery and radiotherapy are not adequate, are insufficient or are contraindicated to achieve the cure of the tumor, either due to characteristics of the tumor itself or of the patient. Sonidegib is indicated for the treatment of adult patients with locally advanced basal cell carcinoma that is not amenable to curative surgery or radiotherapy. Material and methods: This is a retrospective, multicenter and descriptive study in nine centers in Andalusia, Spain. Patients treated with sonidegib for >3 months for locally advanced BCC were included from 1 January 2021 to 1 January 2023. Epidemiological, efficacy and safety data were collected. Results: In the present study, a total of 38 patients were included, with a median age of 76.23 years (range 40–101). Prior treatment was surgery (31.57%; n = 25), radiotherapy (15.78%; n = 6), vismodegib (31.57%; n = 12). Eleven patients had not received prior treatment. LA-BCC were located in the cephalic pole, face or scalp. There was a total response in 9/38 patients (23.7%), partial response in 25/38 patients (65.8%) and no response in 4 patients (10.52%). In 6/34 patients, the dose was reduced to 200 mg every other day until it was discontinued due to adverse effects. The main adverse effects reported were dysgeusia (n = 8), asthenia (n = 8), = 6), muscle spasms (n = 6), alopecia (n = 4) and gastrointestinal intolerance (n = 4). Discussion: Sonidegib is the second iHh authorized for the treatment of adult patients with locally advanced BCC who are not amenable to curative surgery or radiotherapy, based on the results of the phase II clinical trial, BOLT. Sonidegib shows good effectiveness and an acceptable safety profile in routine clinical practice in the sample presented.

The top 100 most cited articles in the treatment of basal cell carcinoma over the last decade: A bibliometric analysis and review

“…[ 30 ] Sonidegib, approved by the FDA in 2015 for LaBCC or mBCC treatment, has proven effective, especially in the elderly demographic (>75 yr), with 86.85% of patients attaining disease control. [ 5 ] The BOLT study (ClinicalTrials.gov identifier: NCT01327053), a comprehensive 42-month phase II trial, substantiated the long-term disease control efficacy of Sonidegib in patients with both invasive and noninvasive BCC subtypes. Particularly, invasive BCC and lesion subtypes exhibited the highest objective response rates.…”

“…[ 1 ] Histologically, BCC presents various forms, including noninvasive nodular and superficial subtypes, as well as invasive and infiltrative manifestations typified by morpheiform, infiltrating, micronodular, and basosquamous subtypes. [ 5 ] Current guidelines advise the use of topical agents (imiquimod 5%, 5% fluorouracil) and destructive methods (curettage, electrocautery, cryotherapy, laser ablation) for low-risk superficial BCC. Conversely, Mohs micrographic surgery (MMS) is the preferred treatment for high-risk or recurrent BCC and cases involving critical anatomical areas.…”

Giant Morpheaform Basal Cell Carcinoma Mimicking Scarring Alopecia: Exception Prone to Neglect

“…Wider surgical excision with histologically confirmed tumor-free margins is recommended, whilst monotherapy with chemotherapy and radiotherapy are of limited efficacy [ 28 , 30 ]. Whilst during the pre-hedgehog inhibitor therapy era the overall cure rate of GBCC was 61.7% at an average follow-up of 2 years [ 28 ], currently, treatment with Hh inhibitors—both in adjuvant and neoadjuvant modalities—appears to offer promising results [ 31 , 32 , 33 ].…”

Diagnosis of Skin Cancer: From the Researcher Bench to the Patient’s Bedside

“…Ruiz-Villaverde et al conducted a real-world analysis using the Hedgehog signaling pathway inhibitor, sonidegib, in locally advanced basal cell carcinoma. They reported significant efficacy and an acceptable safety profile [ 28 ]. Russo et al’s publication describes a specialized algorithm for lower lip reconstruction following skin cancer excision [ 29 ].…”