Abstract

In this pilot study, we describe our experience with vismodegib in the treatment of basal cell carcinoma (BCC) and evaluate the feasibility of a tailored toxicity-driven administration of vismodegib in patients with multiple or locally advanced BCC. We retrospectively analyzed the clinical charts of 17 consecutive patients with BCC who were treated with vismodegib. Therapy was started at the usual dosage of 150 mg per day per person, continuously; a rescheduled dosage of 150 mg per day for 4 weeks with a subsequent stop of 2 weeks was allowed during the treatment according to the standard practice of our institution. During treatment, 14 patients with responsive disease presented an adverse event (100% cramps and 20% dysgeusia), therefore, requiring a change in the treatment plan. Overall, in eight out of 17 patients (47% of the overall population), it was possible to re-schedule the treatment by postponing therapy for 2 weeks every 4 weeks. These patients were all still alive at the time of the present analysis and were showing complete response. Adverse events resolved during the first interruption of therapy. The intermittent vismodegib schedule assessed in this pilot series could be beneficial in improving duration of treatment, allowing to maintain a long-term treatment response, even in an elderly and fragile population. Based on these preliminary findings, dedicated studies may be planned to further evaluate an intermittent schedule of vismodegib administration.

Highlights

  • Basal cell carcinoma (BCC) remains the most frequently diagnosed cancer worldwide, and its incidence is continuing to increase [1, 2]

  • We describe our experience with vismodegib in the treatment of BCC and we evaluate the feasibility of a tailored toxicity-driven administration of vismodegib in patients with multiple or locally advanced BCC

  • Vismodegib is widely used for the treatment of advanced BCC, further research has been advocated on its effectiveness and treatment schedules in clinical practice [12, 13]

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Summary

INTRODUCTION

Basal cell carcinoma (BCC) remains the most frequently diagnosed cancer worldwide, and its incidence is continuing to increase [1, 2]. Adverse events (AEs) are not uncommon with the chronic use of vismodegib, especially at the gastrointestinal and musculoskeletal level, and often lead to early interruption of treatment [16,17,18] This has important clinical consequences because vismodegib, in some cases, does not eradicate the disease, and the tumor may, regrow when therapy is definitively interrupted. Reformulation of vismodegib schedule, without interrupting therapy, appears to be a potentially intriguing strategy In this pilot study, we describe our experience with vismodegib in the treatment of BCC and we evaluate the feasibility of a tailored toxicity-driven administration of vismodegib in patients with multiple or locally advanced BCC. No comparisons were performed due to the explorative descriptive nature of the study

RESULTS
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DATA AVAILABILITY STATEMENT
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