Abstract
e14502 Background: Patients (pts.) with advanced gastric cancer still have only limited treatment options. In our 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.Time to progression however was short suggesting resistancy to chemotherapy. Therefore in the current Gastric-3 trial we investigate sequential chemotherapy combined with bevacizumab. Methods: Oxaliplatin 85 mg/m2 biweekly (q2w) and irinotecan 125 mg/m2 q2w were administered for the first three months followed by docetaxel 50mg/m2 q2w for three months. Chemotherapy is combined with bevacizumab 5 mg/kg q2w until progression. Inclusion of 40 patients with histological proven unresectable and/or metastatic gastric adenocarcinoma is planned in a first line setting. For this abstract 19 patients have been evaluated: Median age: 65 years (range 26-81 years), PS 0: 13 patients, PS 1: 5 patients (1 patient not available), single metastatic site: 13 patients, multiple metastases: 6 patients. Results: Frequently reported adverse events (more than 20% of pts.) were predominantly grade 1 or 2 (90%) and included nausea (9/19), polyneuropathy (8/19), diarrhoea (8/19), fatigue (7/19), asthenia (4/19) and vomiting (4/19). There were 4 adverse events (AEs) grade 4, all in one patient, three consecutive cases of neutropenia and one leucopenia. There were 8 AEs grade 3 in 6 patients including thrombocytopenia, anemia, leucopenia, neutropenia, hydronephrosis, candidiasis, duodenitis with diarrhea and haematemesis (one case each). Conclusions: The combination of oxaliplatin and irinotecan with bevacizumab followed by docetaxel with bevacizumab is feasible and safe in advanced gastric cancer. Updated results will be presented during the meeting.
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