"The value of this study is that it is the first to directly identify overall postoperative complications as a negative prognostic and potential mediating factor for survival in a randomized controlled trial comparing minimally invasive- and open surgery," Dr. Frederiek Nuytens of Hopital Claude Huriez, in Lille, France, told Reuters Health by email.
In a paper in JAMA Surgery, Dr. Nuytens and colleagues note that although radical resection is the mainstay of curative treatment, the approach is associated with a high rate of postoperative complications. HMIE can reduce these complications and may thus improve long-term survival.
To investigate further, the researchers conducted a post hoc analysis of the MIRO trial, in which 207 patients were randomized to HIME (laparoscopic gastric mobilization with open right thoracotomy) or to open esophagectomy. The median follow-up was almost six years.
Overall survival at five years was 59% in the HMIE group and 47% in the open esophagectomy group (hazard ratio, 0.71; 95% confidence interval, 0.48-1.06). Corresponding proportions for disease-free survival were 52% and 44% (HR, 0.81; 95% CI, 0.55 to 1.17).
There was no significant difference between groups in recurrence rate or location, but major intraoperative and postoperative complications (HR, 2.21) and major pulmonary complications (HR, 1.94) were significantly associated with decreased overall survival. There were similar findings for disease-free survival.
"These results," Dr. Nuytens said, "provide additional indirect evidence that minimally invasive esophagectomy could offer improved long-term oncological outcomes as compared to open esophagectomy."
Dr. Daniela Molena, co-author of an accompanying editorial, is not entirely convinced, telling Reuters Health by email, "The most important observation about this study is that sometimes we want the data to say more than they actually say and we add our interpretation rather than letting the data speak."
Dr. Molena, of Memorial Sloan Kettering Cancer Center, in New York City, added, "I am a strong proponent of minimally invasive esophagectomy and I really believe it is a great option for patients because it gives less pain and allows for faster recovery. Two previous randomized trials comparing totally minimally invasive (and robotic) esophagectomy to open esophagectomy have shown decreased perioperative morbidity and improved quality of life. However, they failed to demonstrate a survival advantage for the minimally invasive approach."
"The multivariable analysis in the MIRO trial also showed that the surgical approach was not an independent predictor of disease free or overall survival. The benefit of the hybrid approach on survival was likely related to the 10% higher number of pathologically node negative patients in this group versus the open group rather than the approach itself."
SOURCE: https://bit.ly/3uw07qH and https://bit.ly/3dH7yFt JAMA Surgery, online February 17, 2021.
By David Douglas
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