An open-label, multicenter phase II trial of sunitinib for patients with chemorefractory metastatic gastric cancer.

Abstract

e14503 Background: Since sunitinib is effective in metastatic renal cancer and GIST tumors, we evaluated tolerability and efficacy of sunitinib for the first time in highly pretreated caucasian patients (pts) with unresectable metastatic (met.) adenocarcinoma of stomach, esophagogastric junction or lower oesophagus. Methods: 52 caucasian pts were included after documented resistance to 5-FU, cisplatin, oxaliplatin, irinotecan and/or doxetacel. Inclusion criteria were KPS ≥ 70, measurable lesions and adequate organ functions. Sunitinib was given 50 mg/day for 4 weeks with 2 weeks rest (4+2). In case of toxicity, dosage was reduced to 37.5 or 25 mg. Treatment continued until progression or non-tolerable side effects. Tumor assessments were performed after cycle 1, 2, 4 etc. Results: The analysis refers to 51 of 52 pts because 1 pt had no tumor and was thus excluded. Pts (median age 59 years, range 28-81, KPS 90%, gastric 69%, esophagogastric 21%, lower oesophagus 10%) were resistant to median 2 (range 1-6) ...