Phase II trial of cetuximab plus cisplatin and irinotecan in patients with cisplatin and irinotecan-refractory metastatic esophagogastric cancer.

Overview

INTRODUCTION: Cetuximab in combination with irinotecan has shown clinically significant activity in patients with irinotecan-refractory colon cancer. We evaluated the efficacy of cetuximab in combination with cisplatin and irinotecan in patients with metastatic esophagogastric cancer refractory to cisplatin and irinotecan. PATIENTS AND METHODS: Patients with disease progression within 3 months of treatment with prior cisplatin and irinotecan received weekly cetuximab and cisplatin/irinotecan for 2 weeks, followed by a 1-week rest period. The primary endpoint was objective response rate. Secondary endpoints included progression-free and overall survival. RESULTS: Sixteen patients were enrolled (87% with adenocarcinoma). The median prior exposure to cisplatin/irinotecan was 3.6 months. The addition of cetuximab to cisplatin and irinotecan was well tolerated and there were no unexpected toxicities. One of 16 patients treated on study experienced durable RECIST partial response lasting 10 months. The median progression-free survival was 1.4 months (range, 0.5 to 10 mo). CONCLUSIONS: The addition of cetuximab did not overcome irinotecan resistance in patients with metastatic esophagogastric cancer. Further investigation of this strategy in esophagogastric cancer is not justified. The limited activity observed for cetuximab is consistent with other studies evaluating single-agent cetuximab.