Skin Cancer – Research Article

Mesti T.a,b· Sever M.a· Ocvirk J.a,b

Author affiliations

aDepartment for Solid Tumors, Institute of Oncology Ljubljana, Ljubljana, Slovenia
bMedical Faculty, University of Ljubljana, Ljubljana, Slovenia

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Article / Publication Details

First-Page Preview

Received: March 15, 2022
Accepted: May 14, 2022
Published online: July 27, 2022

Number of Print Pages: 7
Number of Figures: 3
Number of Tables: 2

ISSN: 1018-8665 (Print)
eISSN: 1421-9832 (Online)

For additional information: https://www.karger.com/DRM

Abstract

Background: Vismodegib is a first-in-class inhibitor of the hedgehog pathway for treatment of locally advanced basal cell carcinoma (laBCC) and metastatic BCC. Objectives: The purpose of this study is to report outcomes of patients with laBCC, with basal cell carcinoma nevus syndrome (Gorlin Goltz syndrome [G-G Syn]) treated with vismodegib in routine clinical practice in Slovenia in 8.3-year period. Methods: In this retrospective cohort study, we analyzed baseline characteristics, outcomes, and treatment-related adverse events from locally advanced BCC. The patients were divided into two cohorts: 39 laBCC or multiple BCC patients and 7 patients with G-G Syn who were treated with vismodegib from November 2012 till January 2021. Results: During 100-month period, 46 patients were diagnosed with laBCC (26), multiple BCC (13), and G-G Syn (7), all inappropriate for surgery or radiotherapy. Baseline characteristics: median age was 72.8 years in laBCC + multiple BCC cohort and 47.4 years in G-G Syn cohort. The objective response rate was 80% in laBCC + multiple BCC and 86% in G-G Syn cohort. Disease control rate (DCR) was 95% in laBCC + multiple BCC and 100% in G-G Syn cohort. Median duration of treatment was 9.9 months (range: 1.5–43.1) in laBCC and multiple BCC cohort and 19.5 months (range: 3.6–94.1) in G-G Syn cohort. Majority of treatment-emergent adverse events (TEAEs) in laBCC or multiple BCC cohort were grade 1 or 2 (96%), only 4% of AEs were grade 3. Majority of TEAEs in G-G Syn cohort were also grade 1 or 2 (87%), 13% of AEs were grade 3. No grade 4 or 5 vismodegib-related AEs were reported. Conclusion: Vismodegib has shown meaningful efficacy with DCR from 95% to 100% in patients with laBCC, multiple BCC, and G-G Syn in Slovenia. TEAEs were successfully alleviated with multidisciplinary approach and early supportive care.

© 2022 S. Karger AG, Basel

References Griffin LL, Ali FR, Lear JT. Non-melanoma skin cancer. Clin Med. 2016;16(1):62–5. Mohan SV, Chang AL. Advanced basal cell carcinoma: epidemiology and therapeutic innovations. Curr Dermatol Rep. 2014;3(1):40–5. Fania L, Didona D, Morese R, Campana I, Coco V, Di Pietro FR, et al. Basal cell carcinoma: from pathophysiology to novel therapeutic approaches. Biomedicines. 2020 Oct 23;8(11):449. Sekulic A, Migden MR, Oro AE, Dirix L, Lewis KD, Hainsworth JD, et al. Efficacy and safety of vismodegib in advanced basal-cell carcinoma. N Engl J Med. 2012 Jun 7;366(23):2171–9. Sekulic A, Migden MR, Basset-Seguin N, Garbe C, Gesierich A, Lao CD, et al. Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: final update of the pivotal ERIVANCE BCC study. BMC Cancer. 2017 May 16;17(1):332. Basset-Séguin N, Hauschild A, Kunstfeld R, Grob J, Dréno B, Mortier L, et al. Vismodegib in patients with advanced basal cell carcinoma: primary analysis of STEVIE, an international, open-label trial. Eur J Cancer. 2017 Nov;86:334–48. Kunstfeld R, Hauschild A, Zloty D, Rogers G, Dreno B, Mitchell L, et al. MIKIE: a randomized, double-blind, regimen-controlled, phase II, multicenter study to assess the efficacy and safety of two different vismodegib regimens in patients with multiple basal cell carcinomas. Jco. 2014;32(Suppl 15):TPS9121. Dréno B, Kunstfeld R, Hauschild A, Fosko S, Zloty D, Labeille B, et al. Two intermittent vismodegib dosing regimens in patients with multiple basal-cell carcinomas (MIKIE): a randomised, regimen-controlled, double-blind, phase 2 trial. Lancet Oncol. 2017 Mar;18(3):404–12. Bernia E, Llombart B, Serra-Guillén C, Bancalari B, Nagore E, Requena C, et al. Experience with vismodegib in the treatment of advanced basal cell carcinoma at a cancer center. Actas Dermosifiliogr. 2018 Nov;109(9):813–20. Flohil SC, van der Leest RJ, Arends LR, de Vries E, Nijsten T. Risk of subsequent cutaneous malignancy in patients with prior keratinocyte carcinoma: a systematic review and meta-analysis. Eur J Cancer. 2013;49:2365. Article / Publication Details

First-Page Preview

Received: March 15, 2022
Accepted: May 14, 2022
Published online: July 27, 2022

Number of Print Pages: 7
Number of Figures: 3
Number of Tables: 2

ISSN: 1018-8665 (Print)
eISSN: 1421-9832 (Online)

For additional information: https://www.karger.com/DRM

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