Final results of the European @entity1358 XXXX (EU-ARCCS) expanded-access study: a large open-label study in diverse community settings.

@entity1 @entity101 @entity1910 @entity294 @entity2857 @entity1295 @entity1358 @entity3
BACKGROUND: The European @entity1358 @entity2857 (EU-ARCCS) expanded-access study provided @entity2857 to advanced @entity1358 ( @entity1358 ) @entity1 in whom previous systemic therapy had failed. The study assessed the safety and use of @entity2857 for the treatment of advanced @entity1358 in a large community-based @entity1 population across 11 countries in Europe. @entity1 AND METHODS: EU-ARCCS was a single-arm, open-label trial of @entity2857 in advanced @entity1358 @entity1 . End points included safety, time to progression, progression-free survival (PFS), and disease control rate (DCR). Subgroup analyses included age, Eastern Cooperative Oncology Group performance status, histology, prior therapy, and number and sites of @entity3 . RESULTS: About 1159 advanced @entity1358 @entity1 were enrolled. Most @entity1 (94%) experienced drug-related adverse events (AEs) of any grade, with the most common grade >= 3 AEs including hand-foot skin reaction (13%), @entity294 (7%), @entity1295 (7%), @entity101 (6%), and @entity1910 /desquamation (5%). The incidence of AEs in the subgroups was similar to that in the overall population. Median PFS was 6.6 months; DCR at >= 8 and >= 12 weeks was 85% and 78%, respectively. CONCLUSIONS: The @entity2857 safety profile in European community-based practice settings was similar to that reported in clinical trials. The heterogeneous advanced @entity1358 @entity1 population in EU-ARCCS permitted assessment of @entity2857 in important subpopulations of advanced @entity1358 @entity1 .
