Oxaliplatin, irinotecan and cetuximab in advanced gastric cancer: First results of a multicenter phase II trial (AGMT Gastric- 2

Abstract

15587 Background: Survival of patients (pts.) suffering from gastric cancer is still poor and treatment options for advanced gastric cancer are limited. In a previous phase II trial we could show that an outpatient combination of oxaliplatin and irinotecan was well tolerated and showed an objective response rate of 58% and a median overall survival of 9.5 months. In this multicenter phase II trial we tested this chemotherapy in combination with a cetuximab. Methods: Oxaliplatin 85 mg/m2 biweekly and irinotecan 125 mg/m2 biweekly were combined with cetuximab 400 mg/m2 loading dose and subsequent weekly 250 mg/m2. In 13 months 40 patients with histological proven unresectable and/or metastatic gastric adenocarcinoma and no previous palliative chemotherapy were treated. Median age: 64 years (range 20–80 years), male/female ratio: 24/16, PS 0: 17 patients, PS 1/2: 22 patients (1 unknown), single metastatic site: 22 patients, multiple metastases: 18 patients. Primary endpoint was response rate, secondary objectives were safety, overall survival and progression free survival time. Results: Frequently reported adverse events (more than 20% of pts.) were predominantly grade1 or 2 and included neutropenia (41% of patients), thrombocytopenia (20%), anemia (65%), nausea (53%), diarrhea (63%), alopecia (15%). Grade 3 and 4 toxicities included neutropenia in 7/40 pts., anemia in 4/40 pts., nausea in 2/40 pts., and diarrhea in 5/40 pts. 14 patients were taken off-study due to toxicity (allergic reaction, n=2). Sensory neuropathy occurred mostly as grade 1 and 2 in 45% of pts., in 2 pts. grade 3 neurotoxicity was observed. Acneiform skin rash grade 1/2/3 was reported in 30%/18%/8% of patients respectively. First efficacy data will be presented at the meeting. Conclusion: The combination of oxaliplatin and irinotecan with cetuximab is feasible and shows toxicity within the range of other polychemotherapy regimens. No significant financial relationships to disclose.