Hybrid Minimally Invasive Esophagectomy vs Open Esophagectomy in Esophageal Cancer
In a French phase III trial reported in The New England Journal of Medicine, Mariette et al found that a hybrid minimally invasive surgical procedure was associated with reduced postoperative complications vs transthoracic open esophagectomy in patients with resectable cancer of the middle or lower third of the esophagus.
Study Details
In the open-label multicenter trial, 207 patients were randomly assigned between October 2009 and April 2012 to the hybrid procedure (n = 103) or open surgery (n = 104). Surgical quality assurance measures included credentialing of surgeons, standardization of technique, and monitoring of performance. Hybrid surgery consisted of a two-field abdominal/thoracic operation (Ivor-Lewis procedure) with laparoscopic gastric mobilization and open right thoracotomy.
The primary endpoint was intraoperative or postoperative complications of grade ≥ II (major complication leading to intervention) within 30 days. Analyses were performed in the intention-to-treat population.
Complication Rates
A total of 312 serious adverse events were recorded in 110 patients. Major intraoperative or postoperative complications occurred in 37 patients (36%) in the hybrid procedure group vs 67 patients (64%) in the open procedure group (odds ratio [OR] = 0.31, P < .001).
After adjustment for age, sex, risk score, neoadjuvant therapy use, tumor location, histologic subtype, resection margin status, pathologic tumor and node stages, and trial center, the reduction in risk of major intraoperative or postoperative complications within 30 days in the hybrid procedure group remained significant (adjusted OR = 0.23, P < .001). A major pulmonary complication occurred within 30 days in 18% vs 30% of patients (OR = 0.50, 95% confidence interval [CI] = 0.26–0.96).
Overall survival was 67% in the hybrid procedure group vs 55% in the open procedure group at 3 years and 60% vs 40% at 5 years (hazard ratio [HR] = 0.67, 95% CI = 0.44–1.01). Disease-free survival was 57% vs 48% at 3 years and 53% vs 43% at 5 years (HR = 0.76, 95% CI= 0.52–1.11).
The investigators concluded, “We found that hybrid minimally invasive esophagectomy resulted in a lower incidence of intraoperative and postoperative major complications, specifically pulmonary complications, than open esophagectomy, without compromising overall and disease-free survival over a period of 3 years.”
Disclosure: The study was funded by the French National Cancer Institute. The study authors’ full disclosures can be found at nejm.org.
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