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Hedgehog Inhibitors Beyond Clinical Complete Response in Basal Cell Carcinoma: Should I Stop or Should I Go?
Alfieri, Salvatore; Romanò, Rebecca; Marceglia, Sara; De Giorgi, Vincenzo; Peris, Ketty; Sollena, Pietro; Piccerillo, Alfredo; Moro, Ruggero; Gualdi, Giulio; Ascierto, Paolo Antonio; Palla, Marco; Paone, Miriam; Eibenschutz, Laura; Spagnolo, Francesco; Queirolo, Paola; Filippini, Daria Maria; Cavalieri, Stefano; Resteghini, Carlo; Bergamini, Cristiana; Manocchio, Antonello; Licitra, Lisa; Bossi, Paolo.
Afiliación
  • Alfieri S; Head and Neck Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.
  • Romanò R; Head and Neck Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.
  • Marceglia S; Department of Engineering and Architecture, University of Trieste, Trieste, Italy.
  • De Giorgi V; Section of Dermatology, Department of Health Sciences, University of Florence, Firenze, Italy.
  • Peris K; UOC di Dermatologia, Dipartimento di Scienze Mediche e Chirurgiche Addominali ed Endocrino Metaboliche, Fondazione Policlinico Universitario A Gemelli - IRCCS, Roma, Italy.
  • Sollena P; Dermatologia, Dipartimento di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Roma, Italy.
  • Piccerillo A; UOC di Dermatologia, Dipartimento di Scienze Mediche e Chirurgiche Addominali ed Endocrino Metaboliche, Fondazione Policlinico Universitario A Gemelli - IRCCS, Roma, Italy.
  • Moro R; UOC di Dermatologia, Dipartimento di Scienze Mediche e Chirurgiche Addominali ed Endocrino Metaboliche, Fondazione Policlinico Universitario A Gemelli - IRCCS, Roma, Italy.
  • Gualdi G; Dermatologia, Dipartimento di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Roma, Italy.
  • Ascierto PA; Escuela de Doctorado, Universidad Católica de Valencia San Vicente Martir, Valencia, Spain.
  • Palla M; Dermatologic Clinic, Department of Medicine and Aging Science, Università G d'Annunzio, Chieti-Pescara, Italy.
  • Paone M; Unit of Melanoma Cancer Immunotherapy and Innovative Therapy, National Tumour Institute IRCCS Fondazione G. Pascale, Napoli, Italy.
  • Eibenschutz L; Unit of Melanoma Cancer Immunotherapy and Innovative Therapy, National Tumour Institute IRCCS Fondazione G. Pascale, Napoli, Italy.
  • Spagnolo F; Unit of Melanoma Cancer Immunotherapy and Innovative Therapy, National Tumour Institute IRCCS Fondazione G. Pascale, Napoli, Italy.
  • Queirolo P; Dermatologia Oncologica e Prevenzione, Istituto San Gallicano IRCCS, Roma, Italy.
  • Filippini DM; Medical Oncology 2, IRCCS Ospedale Policlinico San Martino, Genova, Italy.
  • Cavalieri S; Department of Surgical Sciences and Integrated Diagnostics (DISC), Plastic Surgery Division, University of Genova, Genova, Italy.
  • Resteghini C; Istituto Europeo di Oncologia - IRCCS, Milan, Italy.
  • Bergamini C; Head and Neck Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.
  • Manocchio A; Department of Oncology and Hemato-oncology, University of Milan, Milano, Italy.
  • Licitra L; Head and Neck Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.
  • Bossi P; Head and Neck Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.
Oncologist ; 29(5): e699-e707, 2024 May 03.
Article en En | MEDLINE | ID: mdl-38127280
ABSTRACT

INTRODUCTION:

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. MATERIALS AND

METHODS:

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's correlation coefficient (P < .05) and Bayesian statistics (BF10).

RESULTS:

Sixty-eight BCC patients with a median (m) age of 75.5 years (39-100) were included. Most patients were male (N = 43, 63%), without Gorlin syndrome (N = 56, 82%) and with head and neck area as primary site (N = 51, 75%). After cCR, out of 68 patients, 90% (N = 61/68) discontinued vismodegib 82% (N = 50/61) due to toxicity (R1), and 18% (N = 11/61) due to recurrence (R2). Conversely, 10% (N = 7/68) continued vismodegib until last follow-up. In the whole population (N = 68), cCR was achieved with a mDTCR of 180.50 days. DFS showed a significant correlation with DTS (P < .01, BF10 = 39.2) and TTD (P < .01, BF10 = 35566), while it was not correlated to DTCR (BF10 < 0.1). The analysis of R1 subgroup (N = 50) confirmed these results. DFS correlated with DTS in all recurrent patients (N = 38, r = 0.44, P < .01) and in the recurrent patients who stopped vismodegib for toxicity (N = 26, r = 0.665, P < .01). DFS was longer when vismodegib was maintained for >2 months after cCR (mDFS > 2 months, N = 54 vs. ≤ 2 months, N = 14 470 vs. 175 d, P < .01).

CONCLUSIONS:

Our retrospective results suggest that HHIs should be continued after cCR to improve DFS in BCC.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Piridinas / Neoplasias Cutáneas / Carcinoma Basocelular / Proteínas Hedgehog / Anilidas Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Oncologist Asunto de la revista: NEOPLASIAS Año: 2024 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Piridinas / Neoplasias Cutáneas / Carcinoma Basocelular / Proteínas Hedgehog / Anilidas Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Oncologist Asunto de la revista: NEOPLASIAS Año: 2024 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Reino Unido