Abstract
BACKGROUND: Mutations in the BRAF gene have been implicated in several human cancers. The objective of this screening study was to identify patients with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma harboring activating BRAF(V600) mutations for enrollment in a vemurafenib clinical study. METHODS: Formalin-fixed, paraffin-embedded tumor samples were collected and sent to a central laboratory to identify activating BRAF(V600) mutations by bidirectional direct Sanger sequencing. RESULTS: Overall incidence of BRAF(V600E) mutation in evaluable patients (n=548) was 3% (95% confidence interval [CI], 1.7-4.7): 11% in colorectal tumors (n=75), 6% in biliary tract tumors (n=16), 3% in non-small cell lung cancers (n=71), 2% in other types of solid tumors (n=180), and 3% in multiple myeloma (n=31). There were no BRAF(V600) mutations in this cohort of patients with ovarian tumors (n=68), breast cancer (n=86), or prostate cancer (n=21). CONCLUSION: This multicenter, national screening study confirms previously reported incidences of BRAF(V600) mutations from single-center studies. Patients identified with BRAF(V600) mutations were potentially eligible for enrollment in the VE-BASKET study.