St. Vinzenz Krankenhaus Betriebs GmbH, Zams, Austria
Ewald Woell , Felix Keil , Josef Thaler , Birgit Gruenberger , Michael Hejna , Wolfgang Eisterer , Michael A. Fridrik , Franz Romeder , Richard Greil
Background: We could show efficacy of oxaliplatin and irinotecan as well as oxaliplatin, irinotecan and cetuximab in previous trials.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 and irinotecan 125 mg/m2 are administered biweekly (q2w) 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. Primary endpoint is response rate. 40 patients (pts.) with histological proven unresectable and/or metastatic gastric adenocarcinoma treated in a first-line setting are evaluated. Median age: 62.5 years PS 0: 26 pts., PS 1: 12 pts., missing: 2 pts.,single metastatic site: 25 pts., multiple metastases: 13 pts., missing: 2. Results: Frequently reported adverse events (more than 20% of pts.) were predominantly grade 1 or 2 and included diarrhea (72.5%), nausea (65%), emesis (50%), abdominal pain (50%), fatigue (47.5%), polyneuropathy (40%), neutropenia (25%), hypokalemia (22.5%), hypertension (22.5%). Grade 3 and 4 toxicities included neutropenia (25%), diarrhea (12.5%), ileus/subileus (10%), hypokalemia (7.5%), leucopenia (7.5%), anemia (5%), meningiosis carcinomatosa (5%). Objective response rate after 3 cycles was available in 31 patients: CR 1/31 (3.2%), PR 48.4%, SD 35.5%, PD 12.9%. After 6 cycles there were 14 evaluable patients with CR 2/14 (14.3%), PR 42.9%, SD 35.7% and PD 7.1%. Median progression free survival was 32 weeks, median overall survival was53 weeks. Progression rate or death was 34/40 (85%), mortality 29/40 (72.5%). Maintenance therapy was given in 12/40 pts. (30%). Median time on maintenance therapy was 17 weeks, range (2 – 77). Conclusions: The combination of oxaliplatin and irinotecan with bevacizumab followed by docetaxel with bevacizumab is feasible and active in advanced gastric cancer. Clinical trial information: 2008-006128-79.
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Abstract Disclosures
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