The neoadjuvant administration of vismodegib in unresectable locally advanced basal cell carcinoma (laBCC) may reduce tumor size, facilitate resection and potentially preserve the functional and the aesthetic aspect of the affected area. VISMONEO is conducted to assess the efficacy and safety of vismodegib in the neoadjuvant treatment of laBCC.
VISMONEO is an open-label, non-comparative, multicenter, phase II study. Patients (pts) with at least one histologically confirmed lesion of laBCC and lesion with a diameter ≥ 3cm in zones at intermediate risk of tumor recurrence and a BCC with a diameter of ≥ 2 cm in the zones at higher risk of tumor recurrence are included. Oral vismodegib 150 mg once-daily is administered for a maximum of 10 months. A total of 55 expected pts will be followed for 3 years. The primary endpoint is the percentage of BCC pts with tumor down-staging following surgical resection after at least 4 months of vismodegib. Secondary endpoints include clinical benefits assessed by an independent panel of experts; medico-economic impact of this neoadjuvant strategy, safety (NCI-CTCAE, v4.0) and quality of life (Skindex-16 questionnaire).
Between November 2014 and June 2015, 55 pts have been included in 17 centers in France. Half of pts are men (51%), their mean age is 72 years (±SD 12) and 73% (n = 40) are > 65 years old; 58% (n = 32) have an ECOG performance status of 0, 35% (n = 19) ECOG1 and 7% (n = 4) ECOG ≥ 2. Disease is measurable in all pts and 3 (5.5%) pts have a Gorlin syndrome. BCC sites are mainly eye (35%; n = 19); ear (14%; n = 8); temporal (14%; n = 8); nose (13%; n = 7), forehead (11%; n = 6), cheek (5%; n = 3), scalp (4%; n = 2); and others (lips, parietal: 4%; n = 2). No previous radiotherapy for most pts 98% (n = 54). In December 2015, 8 pts were still under treatment and 47 completed the protocol (including pts still followed-up and pts resected with a less heavy surgery than planned and a complete response).
The characteristics of patients with laBCC treated with neoadjuvant vismodegib and surgical resection are consistent with the few resectable laBCC patients included in clinical trials. This phase II study is ongoing.
Clinical trial identification
Legal entity responsible for the study
N. Basset-Seguin: Roche, Galderma, Novartis, Leo, Pierre Fabre, Genentech. P. Saiag, S. Dalac-Rat: Roche, BMS, GSK, MSD, Novartis. D. Meddour: abbvie Algeria. M. Dib: Lille University Hospital. A. Mahmoudi: Roche. All other authors have declared no conflicts of interest.