Italian interim analysis of the multinational, post-authorisation safety study (NISSO) to assess the long-term safety of sonidegib in patients with locally advanced basal cell carcinoma: focus on time to onset of adverse events
Background: Sonidegib is an oral inhibitor of the hedgehog signalling pathway, approved by EMA in 2015, following the pivotal BOLT study, for the treatment of adult patients with locally advanced BCC (laBCC) not amenable to curative surgery or radiation therapy. This interim analysis presents Italian data from the post-authorization safety NISSO study.
Authors
- Vincenzo De Giorgi (ORCID: https://orcid.org/0000-0001-6531-7998)
- P.A. Ascierto
- L. Scarpato
- Alessia Villani (ORCID: https://orcid.org/0000-0001-6430-268X)
- P. Bossi
- Paola Savoia (ORCID: https://orcid.org/0000-0002-1636-8411)
- K. Peris
- Federica De Galitiis
- Lisa Francesca Licitra (ORCID: https://orcid.org/0000-0003-0623-4118)
- Maria Concetta Fargnoli (ORCID: https://orcid.org/0000-0002-7249-2556)
- Michele Guida (ORCID: https://orcid.org/0000-0001-8411-0319)
- Ignazio Stanganelli (ORCID: https://orcid.org/0000-0001-6575-8785)
- F. Spagnolo
- Adriana Alberti (ORCID: https://orcid.org/0000-0003-3372-9423)
- Massimiliano Scalvenzi (ORCID: https://orcid.org/0000-0002-9912-3611)
Institutions
- Università degli Studi del Piemonte Orientale “Amedeo Avogadro” (IT)
- Agostino Gemelli University Polyclinic (IT)
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IT)
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (IT)
- Istituto Dermopatico dell'Immacolata (IT)
- Federico II University Hospital (IT)
- Azienda Socio Sanitaria Territoriale Lariana (IT)
- Istituto Tumori Bari (IT)
- San Gallicano Hospital (IT)
- Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" (IT)
- Ospedale Policlinico San Martino (IT)
- Fondazione IRCCS Istituto Nazionale dei Tumori (IT)
- Piedmont University (US)
- IRCCS Humanitas Research Hospital (IT)
- University of Florence (IT)
- University of Naples Federico II (IT)
- University of Brescia (IT)
Publication Details
- Journal
- EJC Skin Cancer
- Published
- 2025-01-01
- DOI
- https://doi.org/10.1016/j.ejcskn.2025.100335
- Primary Topic
- Tumors and Oncological Cases
- Type
- article
- Field-Weighted Citation Impact
- 0.00