Neoadjuvant chemoradiotherapy did not improve resection rates or survival outcomes in patients with early-stage, locally advanced esophageal cancer.
Neoadjuvant chemoradiotherapy (NCRT) did not improve resection rates or survival outcomes in patients with early-stage, locally advanced esophageal cancer, according to results of a new phase III randomized trial. Compared with surgery alone, NCRT actually increased postoperative mortality rates.
Recent research has suggested that NCRT could provide benefit in esophageal cancer, but its effect in early-stage disease had not been well studied. The new trial, led by Christophe Mariette, MD, PhD, of University Hospital Claude Huriez Place de Verdun in Lille, France, included 97 patients who underwent surgery alone and 98 who received NCRT with cisplatin and fluorouracil followed by surgery; all patients had stage I or II esophageal cancer. Results were published online ahead of print on June 30 in the Journal of Clinical Oncology.
The NCRT group had a R0 resection (meaning, complete surgical resection) rate of 93.8%, compared with 92.1% in the surgery alone group (P = .749). The 3-year overall survival rates were 47.5% for NCRT and 53% for surgery alone, for a hazard ratio of 0.99 (95% CI, 0.69-1.40; P = .94). The median follow-up time for both groups was 93.6 months. No overall survival benefit was seen in any subgroup analysis, and multivariate analysis still did not show any differences in overall survival based on NCRT.
The postoperative mortality rate was higher in the NCRT group, at 11.1% vs 3.4% for surgery alone (P = .049). The trial was stopped for anticipated futility after an interim analysis showed neither treatment arm would likely achieve superiority.
In an email, Mariette noted that early esophageal tumors are rare, representing less than 20% of all esophageal cancers at diagnosis. This study, he said, rules out neoadjuvant chemoradiotherapy for those early-stage patients. “Surgery remains the cornerstone for patients with localized esophageal cancer.” Still, early-stage patients with nodal involvement could at least warrant discussions of the use of NCRT.
The median age of patients in this study was 57.8 years, and 85.6% were male. The bulk of patients (70.3%) had squamous cell carcinoma, while another 29.2% had adenocarcinomas. Most patients (90.8%) had a tumor site below the carina, and 75.4% had a WHO performance status of 0. There were no significant differences between any baseline characteristics.