Skin Cancer – Research Article
Mesti T.a,b· Sever M.a· Ocvirk J.a,baDepartment for Solid Tumors, Institute of Oncology Ljubljana, Ljubljana, Slovenia
bMedical Faculty, University of Ljubljana, Ljubljana, Slovenia
Log in to MyKarger to check if you already have access to this content.
Buy FullText & PDF Unlimited re-access via MyKarger Unrestricted printing, no saving restrictions for personal use read more
CHF 38.00 *
EUR 35.00 *
USD 39.00 *
Buy a Karger Article Bundle (KAB) and profit from a discount!
If you would like to redeem your KAB credit, please log in.
Save over 20% compared to the individual article price. Access via DeepDyve Unlimited fulltext viewing Of this article Organize, annotate And mark up articles Printing And downloading restrictions apply Subscribe Access to all articles of the subscribed year(s) guaranteed for 5 years Unlimited re-access via Subscriber Login or MyKarger Unrestricted printing, no saving restrictions for personal use read more Select* The final prices may differ from the prices shown due to specifics of VAT rules.
Article / Publication DetailsFirst-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
AbstractBackground: 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 DetailsFirst-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
Copyright / Drug Dosage / Disclaimer Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
留言 (0)