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Vismodegib in neoadjuvant treatment of locally advanced basal cell carcinoma: First results of a multicenter, open-label, phase 2 trial (VISMONEO study).
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2018
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Surgical OncologyNeoadjuvant TreatmentSurgeryDermatologyBasal Cell CarcinomaOncologyBcc PatientsVismoneo StudyAnti-cancer AgentRadiation OncologyMolecular OncologyCancer ResearchSkin CancerHealth SciencesCancer TreatmentFirst ResultsNeoadjuvant VismodegibMedicineCancer TherapeuticsDermatological Surgery
9509 Background: Surgery is the main treatment of basal cell carcinoma. In locally advanced basal cell carcinoma (laBCC), surgery may cause functional or aesthetic damages. Neoadjuvant administration of vismodegib in laBCC may reduce tumor size, facilitate resection and potentially reduce functional and aesthetic consequences of surgery. VISMONEO was conducted to assess efficacy and safety of vismodegib in the neoadjuvant treatment of laBCC. Methods: VISMONEO (NCT02667574) is an open-label, non-comparative, multicenter, phase II study. Patients with at least one histologically confirmed BCC of the face, inoperable or operable with functional or major aesthetic sequelae risk were included. Oral vismodegib 150 mg once-daily was administered for a period of 4 to 10 months, before surgery. Surgery was done once the best response under vismodegib was observed. Primary endpoint was the percentage of BCC patients with tumor down-staging following surgical resection after neoadjuvant vismodegib. Downstaging was defined according to a six-stage surgical classification related to the aesthetic and functional risk of the surgery. Results: 55 patients with laBCC were included. Median age of the patients was 73.1 years. At inclusion, 4 were inoperable, 15 were operable with a major functional risk and 36 were operable with a minor functional risk or a major aesthetic risk. Mean size of target lesion was 47.3 mm (SD = 27,2mm). 44 patients had a procedure after vismodegib treatment (80.0%, 95%CI [67 to 90]). Of these 44 responders, 27 had a complete response proved by biopsy. Main adverse events were dysgeusia, muscle spasms, alopecia, fatigue and weight loss (20 % of patients with grade ≥ 3) Conclusions: Neoadjuvant vismodegib allows a downstaging of surgical procedure for laBCCs in functionally sensitive locations. Final data will assess quality of long-term local control. Clinical trial information: NCT02667574.