High pathological response rate in esophageal cancer after neoadjuvant radiotherapy (RT) and concomitant weekly chemotherapy with dose escalating of docetaxel (D)

4059 Background: dose-dense therapy should allow more frequent delivery of moderate doses over a short period with greater efficacy and lower toxicity than standard doses every 3 weeks. This neodjuvant phase I protocol was based on weekly D and cisplatin (P), continuous infusion (c.i.) of 5-FU and concomitant RT. The doses of D and RT were progressively escalated. Aims were pathological response rate and toxicity. Methods: from Oct 99 to Oct 03, 41 non metastatic pts (31 adenocarcinomas) were enrolled; median age was 61 yrs (47–76). Step 1: D and P 20 mg/m2 d 1,8,15 plus 5-FU 150 mg/m2 c.i. d 1–21. After one week rest, the same cycle was repeated at days 28, 35, 42 concurrently with RT (40 Gy). Step 2: D and P 25 mg/m2; 5-FU 180 mg/m2 days 1–21. Step 3: 5-FU prolonged to four weeks during RT (150 mg/m2 days 28–56). Step 4: D and P 25 mg/m2 added at day 49. Step 5: RT increased to 50 Gy. Step 6: D 30 mg/m2. Step 7: D 35 and P 25 mg/m2 added at day 56 and 5-FU prolonged to 5 weeks. Surgery was performed 4 t...