Abstract
Basal cell carcinoma (BCC) is the most common malignancy and form of skin cancer worldwide; advanced BCC, either as locally advanced BCC (laBCC) or metastatic BCC (mBCC), can cause substantial tissue invasion and morbidity. Until the recent availability of the hedgehog pathway inhibitors (HHIs) sonidegib and vismodegib, treatment options for advanced BCC were limited. These agents demonstrate efficacy in patients with laBCC and mBCC; however, the adverse events (AEs) associated with these agents can lead to treatment interruption or discontinuation and reduced quality of life, all of which significantly impact long-term adherence to therapy, which might affect clinical outcome. Given that most AEs are class-related effects, switching HHIs does not appear to lead to a significantly different AE profile, underscoring the importance of maintaining patients on their first HHI. Interrupting treatment of sonidegib and vismodegib does not appear to undermine the efficacy of these agents and is therefore a practical option to manage AEs in order to maintain continued treatment and disease control.
Highlights
Basal cell carcinoma (BCC) is the most common malignancy and form of skin cancer worldwide [1, 2]
BCC infrequently results in death or metastasis; advanced BCC, either as locally advanced BCC or metastatic BCC, can cause substantial tissue invasion and morbidity [2, 3]
Despite the majority of adverse event (AE) reported in pivotal vismodegib and sonidegib trials being mild, AEs were a primary reason for early discontinuation and frequently represent a limiting factor in continuous treatment [35]; dose adjustments or different schemes to avoid discontinuation and increase patient compliance are often required [42, 43]
Summary
Basal cell carcinoma (BCC) is the most common malignancy and form of skin cancer worldwide [1, 2]. Despite the majority of AEs reported in pivotal vismodegib and sonidegib trials being mild (grade 1 or 2 in severity), AEs were a primary reason for early discontinuation and frequently represent a limiting factor in continuous treatment [35]; dose adjustments or different schemes to avoid discontinuation and increase patient compliance are often required [42, 43]. Vismodegib maintained efficacy in a post hoc analysis of data from ERIVANCE and STEVIE using a tumor growth inhibition model to evaluate the effect of 8-week treatment interruptions on efficacy in patients with laBCC and mBCC [45]. A recent subgroup analysis of BOLT indicated that the ORRs and durations of response in patients with dose reductions or delays were similar to those for the overall study group. Results for duration of response and PFS in the 200 mg group were similar to those in the overall group and in the subgroups of patients with or without dose reductions or delays [46]
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