{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T14:31:44Z","timestamp":1789050704472,"version":"build-2803163510"},"reference-count":40,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2023,12,21]],"date-time":"2023-12-21T00:00:00Z","timestamp":1703116800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,5,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>In advanced basal cell carcinoma (BCC), the issue of whether Hedgehog inhibitors (HHIs) should be stopped or not after clinical complete response (cCR) achievement remains an unmet clinical need.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Materials and Methods<\/jats:title>\n                  <jats:p>We conducted a retrospective, multicenter study across 7 Italian dermato-oncology units including patients with BCC who continued vismodegib after cCR between 2012 and 2019. We assessed the relationship between the duration of vismodegib intake (days to cCR [DTCR], days to stop after cCR [DTS], total treatment days [TTD]), and disease-free survival (DFS). Reasons to stop vismodegib were (R1) toxicity and (R2) disease recurrence. The relationship between DTCR, DTS, TTD, and DFS in the whole population and in R1 subgroup was assessed by Pearson\u2019s correlation coefficient (P\u2005&amp;lt;\u2005.05) and Bayesian statistics (BF10).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Sixty-eight BCC patients with a median (m) age of 75.5 years (39-100) were included. Most patients were male (N\u2005=\u200543, 63%), without Gorlin syndrome (N\u2005=\u200556, 82%) and with head and neck area as primary site (N\u2005=\u200551, 75%). After cCR, out of 68 patients, 90% (N = 61\/68) discontinued vismodegib: 82% (N\u2005=\u200550\/61) due to toxicity (R1), and 18% (N\u2005=\u200511\/61) due to recurrence (R2). Conversely, 10% (N\u2005=\u20057\/68) continued vismodegib until last follow-up. In the whole population (N\u2005=\u200568), cCR was achieved with a mDTCR of 180.50 days. DFS showed a significant correlation with DTS (P\u2005&amp;lt;\u2005.01, BF10\u2005=\u200539.2) and TTD (P\u2005&amp;lt;\u2005.01, BF10\u2005=\u200535566), while it was not correlated to DTCR (BF10\u2005&amp;lt;\u20050.1). The analysis of R1 subgroup (N\u2005=\u200550) confirmed these results. DFS correlated with DTS in all recurrent patients (N\u2005=\u200538, r\u2005=\u20050.44, P\u2005&amp;lt;\u2005.01) and in the recurrent patients who stopped vismodegib for toxicity (N\u2005=\u200526, r\u2005=\u20050.665, P\u2005&amp;lt;\u2005.01). DFS was longer when vismodegib was maintained for &amp;gt;2 months after cCR (mDFS\u2005&amp;gt;\u20052 months, N\u2005=\u200554 vs.\u2005\u2264\u20052 months, N\u2005=\u200514: 470 vs. 175 d, P\u2005&amp;lt;\u2005.01).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Our retrospective results suggest that HHIs should be continued after cCR to improve DFS in BCC.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/oncolo\/oyad319","type":"journal-article","created":{"date-parts":[[2023,12,21]],"date-time":"2023-12-21T16:58:29Z","timestamp":1703177909000},"page":"e699-e707","source":"Crossref","is-referenced-by-count":8,"title":["Hedgehog Inhibitors Beyond Clinical Complete Response in Basal Cell Carcinoma: Should I Stop or Should I Go?"],"prefix":"10.1093","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8485-2275","authenticated-orcid":false,"given":"Salvatore","family":"Alfieri","sequence":"first","affiliation":[{"name":"Head and Neck Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori , Milano , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca","family":"Roman\u00f2","sequence":"additional","affiliation":[{"name":"Head and Neck Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori , Milano , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Marceglia","sequence":"additional","affiliation":[{"name":"Department of Engineering and Architecture, University of Trieste , Trieste , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vincenzo","family":"De Giorgi","sequence":"additional","affiliation":[{"name":"Section of Dermatology, Department of Health Sciences, University of Florence , Firenze , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ketty","family":"Peris","sequence":"additional","affiliation":[{"name":"UOC di Dermatologia, Dipartimento di Scienze Mediche e Chirurgiche Addominali ed Endocrino Metaboliche, Fondazione Policlinico Universitario A Gemelli - IRCCS , Roma , Italy"},{"name":"Dermatologia, Dipartimento di Medicina e Chirurgia Traslazionale, Universit\u00e0 Cattolica del Sacro Cuore , Roma , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pietro","family":"Sollena","sequence":"additional","affiliation":[{"name":"UOC di Dermatologia, Dipartimento di Scienze Mediche e Chirurgiche Addominali ed Endocrino Metaboliche, Fondazione Policlinico Universitario A Gemelli - IRCCS , Roma , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alfredo","family":"Piccerillo","sequence":"additional","affiliation":[{"name":"UOC di Dermatologia, Dipartimento di Scienze Mediche e Chirurgiche Addominali ed Endocrino Metaboliche, Fondazione Policlinico Universitario A Gemelli - IRCCS , Roma , Italy"},{"name":"Dermatologia, Dipartimento di Medicina e Chirurgia Traslazionale, Universit\u00e0 Cattolica del Sacro Cuore , Roma , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruggero","family":"Moro","sequence":"additional","affiliation":[{"name":"Escuela de Doctorado, Universidad Cat\u00f3lica de Valencia San Vicente Martir , Valencia , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giulio","family":"Gualdi","sequence":"additional","affiliation":[{"name":"Dermatologic Clinic, Department of Medicine and Aging Science, Universit\u00e0 G d\u2019Annunzio , Chieti-Pescara , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo Antonio","family":"Ascierto","sequence":"additional","affiliation":[{"name":"Unit of Melanoma Cancer Immunotherapy and Innovative Therapy, National Tumour Institute IRCCS Fondazione G. Pascale , Napoli , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"Palla","sequence":"additional","affiliation":[{"name":"Unit of Melanoma Cancer Immunotherapy and Innovative Therapy, National Tumour Institute IRCCS Fondazione G. Pascale , Napoli , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miriam","family":"Paone","sequence":"additional","affiliation":[{"name":"Unit of Melanoma Cancer Immunotherapy and Innovative Therapy, National Tumour Institute IRCCS Fondazione G. Pascale , Napoli , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Eibenschutz","sequence":"additional","affiliation":[{"name":"Dermatologia Oncologica e Prevenzione, Istituto San Gallicano IRCCS , Roma , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Spagnolo","sequence":"additional","affiliation":[{"name":"Medical Oncology 2, IRCCS Ospedale Policlinico San Martino , Genova , Italy"},{"name":"Department of Surgical Sciences and Integrated Diagnostics (DISC), Plastic Surgery Division, University of Genova , Genova , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paola","family":"Queirolo","sequence":"additional","affiliation":[{"name":"Istituto Europeo di Oncologia - IRCCS , Milan , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daria Maria","family":"Filippini","sequence":"additional","affiliation":[{"name":"Head and Neck Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori , Milano , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefano","family":"Cavalieri","sequence":"additional","affiliation":[{"name":"Department of Oncology and Hemato-oncology, University of Milan , Milano , Italy"},{"name":"Head and Neck Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori , Milano , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlo","family":"Resteghini","sequence":"additional","affiliation":[{"name":"Head and Neck Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori , Milano , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristiana","family":"Bergamini","sequence":"additional","affiliation":[{"name":"Head and Neck Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori , Milano , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonello","family":"Manocchio","sequence":"additional","affiliation":[{"name":"Department of Oncology and Hemato-oncology, University of Milan , Milano , Italy"},{"name":"Head and Neck Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori , Milano , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa","family":"Licitra","sequence":"additional","affiliation":[{"name":"Department of Oncology and Hemato-oncology, University of Milan , Milano , Italy"},{"name":"Head and Neck Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori , Milano , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo","family":"Bossi","sequence":"additional","affiliation":[{"name":"Medical Oncology Unit, ASST Spedali Civili di Brescia , Brescia , Italy"},{"name":"Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia , Brescia , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2023,12,21]]},"reference":[{"key":"2024050313094237000_CIT0001","first-page":"13","article-title":"Basal cell carcinoma review","volume-title":"Hematol Oncol Clin North Am","author":"Kim","year":"2019"},{"key":"2024050313094237000_CIT0002","first-page":"975","article-title":"Cutaneous squamous-cell carcinoma","volume-title":"N Engl J Med","author":"Alam","year":"2001"},{"key":"2024050313094237000_CIT0003","first-page":"303","article-title":"Basal cell carcinoma epidemiology; pathophysiology; clinical and histological subtypes; and disease associations","volume-title":"J Am Acad Dermatol","author":"Cameron","year":"2019"},{"key":"2024050313094237000_CIT0004","first-page":"2262","article-title":"Basal-cell carcinoma","volume-title":"N Engl J 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Cancer","author":"Sekulic","year":"2017"},{"key":"2024050313094237000_CIT0019","first-page":"716","article-title":"Treatment with two different doses of sonidegib in patients with locally advanced or metastatic basal cell carcinoma (BOLT): a multicentre, randomised, double-blind phase 2 trial","volume-title":"Lancet Oncol","author":"Migden","year":"2015"},{"key":"2024050313094237000_CIT0020","first-page":"1369","article-title":"Long-term efficacy and safety of sonidegib in patients with advanced basal cell carcinoma: 42-month analysis of the phase II randomized, double-blind BOLT study","volume-title":"Br J Dermatol","author":"Dummer","year":"2020"},{"key":"2024050313094237000_CIT0021","first-page":"3275","article-title":"Follow-up of patients with complete remission of locally advanced basal cell carcinoma after vismodegib discontinuation: a multicenter French study of 116 patients","volume-title":"J Clin 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