Perioperative chemotherapy in operable gastric and lower oesophageal cancer: Final results of a randomised, controlled trial (the MAGIC trial, ISRCTN 93793971)

Abstract

4001 Background: Epirubicin, Cisplatin and infused 5-FU (ECF) shows significant benefit in advanced oesophagogastric cancer, particularly locally advanced disease. This trial was designed to determine whether this effect translates into a survival advantage in operable disease. Methods: Patients with operable adenocarcinoma of the stomach, oesophagogastric junction or lower oesophagus were randomised to perioperative chemotherapy (CSC arm) or surgery alone (S arm). In the CSC arm, chemotherapy comprised three pre-operative and three post-operative cycles, 3 weeks apart, of E 50mg/m2 IV bolus, C 60mg/m2 infusion and 5-FU 200mg/m2/day continuous infusion. The trial was powered (2α=5%, 1-β=90%) to detect a 15% increase in 5-year survival (∼250 events required), with pre-planned analysis with another European trial of the same design, collectively giving ∼90% power to detect a 10% increase in survival. The latter trial closed early, therefore to increase power to detect a 10% increase from MAGIC alone, the fi...