755 - Oxaliplatin, Irinotecan, Bevacizumab followed by Docetaxel, Bevacizumab in Inoperable Gastric Cancer. A Multicenter Phase II Trial (AGMT Gastric-3) of the Arbeitsgemeinschaft Medikamentöse Tumortherapie (AGMT)

Abstract

ABSTRACT Background In previous phase II trials (AGMT-Gastric-1 and AGMT Gastric-2) we could show efficacy of oxaliplatin and irinotecan as well as oxaliplatin, irinotecan and cetuximab in advanced gastric cancer. Time to progression however was short suggesting acquired chemotherapy resistance. To address this problem sequential chemotherapy combined with bevacizumab is investigated in the presented Gastric-3 trial. Methods Oxaliplatin 85 mg/m2 biweekly (q2w) and irinotecan 125 mg/m2 q2w are administered for the first three months followed by docetaxel 50mg/m2 q2w for subsequent three months. Chemotherapy is combined with bevacizumab 5 mg/kg q2w which is administered until progression. For this abstract 36 pt. with histologically proven unresectable and/or metastatic gastric adenocarcinoma treated in a first line setting have been evaluated. Median age: 62.5 years (range 26-80 years), PS 0: 25 patients, PS 1: 10 patients, missing: 1 patients, single metastatic site: 24 patients, multiple metastases: 10 patients, missing: 2. Results Frequently reported adverse events (more than 20% of pts.) were predominantly grade 1 or 2 and included diarrhea (25/36, 69%), polyneuropathy (17/36, 47%), nausea (17/36, 47%), fatigue (15/36, 42%), neutropenia (13/36, 36%), abdominal pain (11/36, 31%), hypokalemia (9/36, 25%). Grade 3 and 4 toxicities included neutropenia (6/36, 17%), diarrhea (3/36, 8%), hypokalemia (3/36, 8%), anemia in (2/36, 6%), leucopenia (2/36, 6%), thrombocytopenia (1/36, 3%), nausea in (1/36, 3%). Weight loss Grade 1 was initially documented in 1/36 pts., (3%). Objective response rate after 3 cycles was available in 25 patients: CR 1/25 (4%), PR 14/25 (56%), SD 8/25 (32%), PD 2/25 (8%). After 6 cycles there were 12 evaluable patients with CR 2/12 (16.7%), PR 5/12 (41.7%), SD 4/12 (33.3%) and PD 1/12 (8.3%). Median time to progression was 24 weeks, median overall survival was 48 weeks. Progression total was 12/36 (33%). Conclusions The combination of oxaliplatin and irinotecan with bevacizumab followed by docetaxel with bevacizumab is feasible and active in advanced gastric cancer. Disclosure All authors have declared no conflicts of interest.