Phase I study of matuzumab in combination with 5-fluorouracil, leucovorin and cisplatin (PLF) in patients with advanced gastric and esophagogastric adenocarcinomas

摘要: Background To evaluate the safety and tolerability of two different weekly doses fully humanized epidermal growth factor receptor (EGFR)-targeting monoclonal antibody matuzumab combined with high-dose 5-fluorouracil, leucovorin cisplatin (PLF) in first-line treatment patients EGFR-positive advanced gastric esophagogastric adenocarcinomas. Methods Patients were treated dose groups first cohort receiving 400 mg combination PLF. Based on observations next received 800 matuzumab. The study was conducted parts, phase A, designed to assess combination, B be a continuation for those benefiting from treatment. Treatment cycles 7 weeks each. Each patient they assigned at entry duration study. Results Fifteen enrolled into groups; n = 7; 8. All experienced least one adverse event (AE). No any serious AE which considered related Two grade 3 AEs possibly occurred 2 (13.3 %), both group. dose-limiting toxicity (DLT) observed maximum tolerated not reached. best confirmed overall response rate 26.7 %. Conclusion Matuzumab, PLF, demonstrated an acceptable profile modest anti-tumor activity.