Portal de Periódicos da CAPES

Pivotal ERIVANCE basal cell carcinoma (BCC) study: 12-month update of efficacy and safety of vismodegib in advanced BCC

2015; Elsevier BV; Volume: 72; Issue: 6 Linguagem: Inglês

10.1016/j.jaad.2015.03.021

1097-6787

Aleksandar Sekulić, Michael R. Migden, Karl D. Lewis, John D. Hainsworth, James Solomon, Simon Yoo, Sarah T. Arron, Philip Friedlander, Ellen S. Marmur, Charles M. Rudin, Anne Lynn S. Chang, Luc Dirix, Jeannie Hou, Huibin Yue, Axel Hauschild,

Genetic and rare skin diseases.

Background Primary analysis from the pivotal ERIVANCE BCC study resulted in approval of vismodegib, a Hedgehog pathway inhibitor indicated for treatment of adults with metastatic or locally advanced basal cell carcinoma (BCC) that has recurred after surgery or for patients who are not candidates for surgery or radiation. Objective An efficacy and safety analysis was conducted 12 months after primary analysis. Methods This was a multinational, multicenter, nonrandomized, 2-cohort study in patients with measurable and histologically confirmed locally advanced or metastatic BCC taking oral vismodegib (150 mg/d). Primary outcome measure was objective response rate (complete and partial responses) assessed by independent review facility. Results After 12 months of additional follow-up, median duration of exposure to vismodegib was 12.9 months. Objective response rate increased from 30.3% to 33.3% in patients with metastatic disease, and from 42.9% to 47.6% in patients with the locally advanced form. Median duration of response in patients with locally advanced BCC increased from 7.6 to 9.5 months. No new safety signals emerged with extended treatment duration. Limitations Limitations include low prevalence of advanced BCC and challenges of designing a study with heterogenous manifestations. Conclusion The 12-month update of the study confirms the efficacy and safety of vismodegib in management of advanced BCC.