Preoperatieve chemoradiotherapie voor carcinoom van slokdarm of slokdarm-maagovergang*

To compare preoperative chemoradiotherapy followed by surgery with primary surgery in patients with potentially surgically curable cancer of the oesophagus or oesophagogastric junction. Multicentre randomized controlled phase 3 trial. Patients with potentially curable carcinoma were randomized for preoperative chemoradiotherapy (CRT) followed by surgery (n = 178) or primary surgery (n = 188). Patients in the CRT arm were treated preoperatively with 5 weekly courses of carboplatine and paclitaxel in combination with simultaneous external radiotherapy (41.4 Gy). Patients were followed up postoperatively; survival, relapse and complications were recorded during follow-up. The hazard ratio (HR) for the primary outcome measure (overall survival) was estimated using Cox-regression analysis. In the period March 2004 to December 2008, 366 patients were included and analysed. Three-quarters of patients suffered from adenocarcinoma. More than 90% of patients in the CRT arm received the full planned dose of chemotherapy and radiotherapy. There was no significant difference in postoperative complications or postoperative mortality between the two groups. A microscopically radical resection (R0) was performed in 92% of patients in the CRT arm versus 69% in the primary surgery group (p < 0.001). In the CRT arm 29% of patients had a pathologically complete response. The estimated 5-year overall survival was significantly better in the CRT arm than in the primary surgery arm (47% vs. 34% respectively; p = 0.003; HR 0.657). Preoperative chemoradiotherapy followed by surgery leads to a significant increase in survival in patients with cancer of the oesophagus or the oesophagogastric junction