Results of a phase II multicenter study of minimally invasive esophagectomy (Eastern Cooperative Oncology Group Study E2202)

Abstract

4516 Background: The incidence of esophagogastric adenocarcinoma (EAC) is increasing at an alarming rate in the United States. Definitive treatment may require a combination of surgery (esophagectomy), chemotherapy and radiation. Operative mortality rates after esophagectomy have been reported as high as 8–23% (NEJM 2003). Minimally invasive esophagectomy (MIE) may decrease morbidity and mortality. Previous single institution studies have demonstrated successful outcomes with MIE. The primary aim of this cooperative group protocol ECOG 2202 was to assess the feasibility of MIE in a multi-institutional setting. Methods: We conducted a prospective phase II trial with a two-stage design. Thirty-five patients entered the first stage, followed by an interim analysis. Next, the study continued to the second stage and full accrual. The primary endpoint was 30-day mortality. Secondary endpoints included complications, duration of intensive care unit (ICU) stay, lymph node (LN) count and clinical outcomes at 3 years. Results: We entered 106 patients (men 84%; women 22%; median age 64, range 36–83) into the study from 16 institutions in the United States (ECOG, CALGB, ACOSOG). Neoadjuvant chemotherapy was administered in 35 (33%) and radiation in 26 (25%). MIE was performed in 99 patients. Final pathology included high-grade dysplasia (n=11), and EAC (n=88). Complications included an overall 30-day mortality rate of 2% (2/106),. Other major complications included pneumonia (4.9%) and anastomotic leak (7.8%). Median ICU stay was 2 days; median LN count was 20. At a mean follow-up of 19 months, the estimated 3-year overall survival for the entire cohort was 50% (95% Confidence interval 35–65%). Stage specific survival was similar to open series. Conclusions: This phase II study demonstrates that MIE is safe and feasible in a multi-center trial, with low perioperative mortality rate and morbidity. Oncologic outcomes are similar to open esophagectomy. This is the first report of a multicenter trial of minimally invasive esophagectomy. No significant financial relationships to disclose.