Sonidegib improved quality of life in patients with advanced basal cell carcinoma: results from the phase 2 Basal Cell Carcinoma Outcomes with LDE225 Treatment trial through 73 weeks
Description
Patients with locally advanced basal cell carcinoma (laBCC) or metastatic BCC (mBCC) require treatment options other than surgery and radiation, which can produce distressing scarring and disfigurement. Sonidegib is a Hedgehog pathway inhibitor approved to treat advanced BCC (aBCC; Switzerland and Australia) and laBCC (US and EU). Quality of life (QoL) assessments in patients with laBCC and mBCC were conducted during the Basal Cell Carcinoma Outcomes with LDE225 Treatment (BOLT) trial for sonidegib. BOLT was a multicenter, randomized, double-blind, phase 2 study evaluating efficacy and safety of sonidegib (200 and 800 mg) in patients with laBCC or mBCC not amenable to surgery or radiation. To asses QoL, patients completed the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) and associated Head and Neck Cancer Module 35 (H&N35). Mean changes from baseline over time in QLQ-C30 and H&N35 subscales most applicable to aBCC were assessed. Higher functioning subscale scores indicated positive change, while higher symptom subscale scores indicated negative change. Sixty-six patients with laBCC and 13 with mBCC received sonidegib 200 mg daily. Overall, 88.7% (QLQ-C30) and 90.0% (H&N35) of all patients had baseline and ≥1 postbaseline questionnaire assessment. Mean changes from baseline scores for QLQ-C30 and H&N35 subscales were generally modest, and positive and negative fluctuations appeared evenly distributed for most subscales. Treatment with sonidegib 200 mg daily appeared to maintain or improve QoL from baseline in most patients with aBCC through 73 weeks.