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

• DOI: 10.1200/jco.2009.27.15_suppl.4516
• Publication Date: 2020-08-25T20:07:41Z
• Authors: J. Luketich; A. Pennathur; P. J. Catalano; S. J. Swanson; A. L. de Hoyos; M. A. Maddaus; N. Nguyen; A. B. Benson; H. C. Fernando
• Keywords: Esophagectomy; Clinical endpoint; Interim analysis

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