By Gene Emery
(Reuters Health) - 9/1/2019
In patients with esophageal cancer, laparoscopic abdominal surgery combined with an open thoracotomy - i.e., hybrid minimally invasive esophagectomy - produces 77% fewer major complications than open esophagectomy without lowering survival, according to a study of more than 200 French patients reported January 9 online in The New England Journal of Medicine.
The major complication rate was 36% with the minimal technique versus 64% with the open procedure (P<0.001).
At three years, overall survival rates were 67% with minimal surgery versus 55% for open surgery, and disease-free survival rates were 57% and 48%, respectively. Those differences were not statistically significant.
Median follow-up was just under 49 months.
"We hope that the impact will be important in convincing surgeons that this approach is the new standard in esophageal surgery," coauthor Dr. Guillaume Piessen, head of the Department of Digestive and Oncological Surgery at Lille University Hospital told Reuters Health in an email.
"There's emerging data that there may be benefits to these minimally-invasive approaches. They do seem to improve the morbidity rates after a major operation," said Dr. Nader Massarweh, assistant professor of surgery at the Baylor College of Medicine, who was not involved in the study.
But Dr. Massarweh, a surgical oncologist who has studied trends in minimally invasive surgery, told Reuters Health by phone that the missing piece is whether, from a cancer treatment standpoint, the minimally invasive surgery will "translate to long-term improvements for these patients. Those data are yet to emerge."
He said the new results build on the 2012 TIME trial published in Lancet, which used minimally invasive surgery for both portions of the operation.
"This study is a bit more pragmatic in that not every hospital in the world is able to offer minimally-invasive approaches to both thoracic and abdominal surgery," said Dr. Massarweh.
Surgery significantly improves a patient's chances of survival at five years, increasing the odds from 10% to 15% to about 40% if the surgery is considered curative.
In the new open-label phase 3 trial at 13 medical centers in France, all patients had squamous-cell carcinoma or adenocarcinoma in the middle or lower third of their esophagus, with no nodal involvement and no metastases. Nearly half the patients were treated at Lille.
Overall, 110 of the 207 volunteers reported at least one serious adverse event and there were 312 such events altogether. Where the surgery was performed did not influence the risk of complications.
"After adjustment for age, sex, American Society of Anesthesiologists risk score, neoadjuvant therapy use, tumor location, histologic subtype, resection-margin status, pathological tumor and node stages, and trial center, we found that minimally invasive surgery was associated with a 77% lower risk of major intraoperative and postoperative complications within 30 days than open surgery," the researchers concluded.
They also found that hybrid minimally invasive surgery produced a lower 30-day rate of pulmonary complications. The rates were 18% with hybrid surgery and 30% with the more invasive technique.
"Other end points, including operative time and the median length of hospital stay, were similar in the two groups," the team reported.
Median overall survival was 52.2 months with hybrid surgery and 47.6 months with open surgery.
Minimally-invasive esophagectomy (MIE) in some form "accounts for 20% to 40% of resections and it's increasing," Dr. Piessen said, "but there is definitively room for improvement."
"These results won't convince the small proportion of expert surgeons performing totally MIE but will surely convince the vast majority of surgeons who still perform open esophagectomy, which represents 52.1% of operations in experts centers and probably more 60%-80% in study populations," he said.
SOURCE: https://bit.ly/2GXBOgo N Engl J Med 2019.