Adjuvant sunitinib (Su) for locally advanced esophageal cancer (LAEC): Results of a phase II trial.

4091 Background: Despite trimodality therapy the prognosis for LAEC is poor. Adjuvant anti-VEGF strategies are under study in many cancers. In this completed phase II trial we report tolerability and efficacy of Su, a multitargeted tyrosine kinase inhibitor, following chemoradiation and surgery for LAEC. Methods: Included were patients (pts) with LAEC of the thoracic esophagus (TE) or gastroesophageal junction (GEJ), stages IIa to III, and ECOG PS ≤1. Treatment pre-op was Irinotecan (65mg/m2) + Cisplatin (30mg/m2) on weeks 1,2,4,5,7,8 + concurrent EBRT (50Gy/25 fractions). Irinotecan was reduced to 50mg/m2 after 22 pts enrolled, due to neutropenia. Su 37.5 mg daily, with dose schedule modifications, started 4-13 weeks post op, for 1 year. Planned sample size: 36 pts on Su. Primary end-points were feasibility and efficacy (time to treatment failure, time to progressive disease, survival [OS]). Results: 70 pts were enroled from 11/06 - 12/10. Nine pts excluded with positive PET. Median age 60 yr (36-71), 80...