Long‐term results of definitive concurrent chemoradiotherapy using paclitaxel plus oxaliplatin in unresectable locally advanced esophageal cancer: a prospective phase II trial

This prospective study aimed at assessing the efficiency and safety of concurrent chemoradiotherapy (CCRT) using paclitaxel (PTX) plus oxaliplatin (OHP) in unresectable locally advanced esophageal cancer patients. Between January 2006 and December 2010, 34 patients with unresectable locally advanced esophageal cancer were enrolled in this study. Radiotherapy was delivered with a daily fraction of 2.0 Gy to a total dose of 60 Gy over 6 weeks. Concurrent PTX (135 mg/m², d (1)) and OHP (130 mg/m², d (1)) were administered on Day 1 and Day 29 of radiotherapy. Of these patients, 76.5% completed the treatment course with a response rate of 73.5%, including eight (23.5%) patients with complete response and 17 (50.0%) patients with partial response. The median overall survival (OS) time was 23.7 months (range: 4.0–65.5 months) with 1‐, 3‐ and 5‐year OS rates were 64.3%, 36.6% and 25.8%, respectively. The median progression‐free survival (PFS) time was 21.2 months with 1‐, 3‐ and 5‐year PFS rates were 63.8%, 30.9% and 20.4%, respectively, During the CCRT course, the main grade 3 or greater acute toxicities were leukopenia (38.2%), esophagitis (14.7%), and dysphagia (11.8%), with late toxicity being infrequent. Although this study did not meet its primary endpoint, the application of CCRT with PTX and OHP in unresectable locally advanced esophageal carcinoma yielded satisfactory clinical outcomes and manageable toxicities.