Patients with esophageal cancer who underwent a hybrid minimally invasive esophagectomy had a lower incidence of intraoperative and postoperative major complications than patients who underwent open surgery, according to results of a randomized, phase 3 trial published in The New England Journal of Medicine.
Further, the hybrid procedure did not appear to compromise survival over 3 years.
“Esophageal cancer is among the cancers with the most rapidly increasing incidence in the Western world,” Guillaume Piessen, MD, PhD, gastrointestinal surgeon in the department of digestive and oncologic surgery at Claude Huriez University Hôpital in Lille, France, and colleagues wrote. “Overall survival among patients with esophageal cancer remains poor ... [but] improvements in overall survival after esophagectomy have been observed in recent years because of centralization of practice to high-volume centers and the increased use of treatments involving multiple approaches.”
Researchers randomly assigned 207 patients (median age, 61 years; range, 23-78; men, n = 175) with esophageal cancer from 13 centers in France to undergo a hybrid minimally invasive esophagectomy (n = 103) or a transthoracic open esophagectomy (n = 104). The hybrid procedure included laparoscopic gastric mobilization and open thoracotomy.
A total of 152 patients underwent either neoadjuvant chemotherapy (n = 86) or chemoradiotherapy (n = 66).
Primary endpoints included intraoperative or postoperative complications of grade 2 or higher — according to the five-grade Clavien-Dindo classification system — within 30 days.
Median follow-up as assessed by reverse Kaplan-Meier method was 48.8 months (95% CI, 46.9-52.2).
Researchers observed 312 serious adverse events among 110 patients. A total of 37 patients (36%) in the hybrid surgery group experienced a major intraoperative or postoperative complication compared with 67 patients (64%) in the open surgery group (OR = 0.31, 95% CI; 0.18-0.55). More patients in the open surgery group (n = 31) had a major pulmonary complication than in the hybrid surgery group (n = 18).
Results showed 3-year OS of 67% (95% CI, 57-75) in the hybrid surgery group and 55% (95% CI, 45-64) in the open surgery group. Three-year DFS was 57% (95% CI, 47-66) with hybrid surgery and 48% (95% CI, 38-57) with open surgery.
Other endpoints, such as operative time and median length of hospital stay, appeared similar between the two groups.
“In parallel to previous findings regarding colorectal resection and gastrectomy, we found that a minimally invasive approach ... was associated with substantially lower morbidity, specifically pulmonary morbidity,” Piessen and colleagues wrote. “This result was most probably mediated by the reduction in surgical trauma, with less postoperative pain and a lower incidence of diaphragmatic splinting and thus less basal lung atelectasis and fewer major pulmonary complications.” – by John DeRosier
Disclosure s : The French National Cancer Institute funded this study. Piessen reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.