Meeting NewsPerspective

Hybrid minimally invasive esophagectomy reduces morbidity in esophageal cancer

MADRID — Hybrid minimally invasive esophagectomy reduced incidence of major morbidity compared with open esophagectomy for patients with esophageal cancer, according to long-term results from a randomized, controlled phase 3 trial presented at the European Society for Medical Oncology Congress.

“Hybrid minimally invasive esophagectomy allows for reduction of severe complications and reduction of major pulmonary complications without negative impact on oncological outcomes and [with] a trend to better survival,” Guillaume Piessen, MD, gastrointestinal surgeon at University Hospital C. Huriez in Lille, France, said during his presentation. “These findings provide strong evidence for the use of hybrid minimally invasive esophagectomy for patients with resectable esophageal cancer [and the procedure] should be considered as a new standard.”

More than half of patients who undergo open esophagectomy experience postoperative morbidity. Pulmonary complications are particularly problematic.

In the multicenter, open-label MIRO trial, Piessen and colleagues assessed the efficacy of hybrid minimally invasive esophagectomy.

The study — conducted at 13 centers between October 2009 and April 2012 — included 207 patients aged 18 to 75 years with resectable cancers in the middle or lower third of the esophagus.

Researchers randomly assigned 104 patients to transthoracic open esophagectomy and 103 patients to hybrid minimally invasive esophagectomy, an Ivor Lewis procedure that consisted of laparoscopic gastric mobilization and open right thoracotomy.

Investigators credentialed surgeons prior to patient enrollment, standardized techniques and monitored their performance during the trial to ensure surgical quality.

Thirty-day grade 2 to grade 4 postoperative morbidity — measured by the Clavien-Dindo classification — served as the primary endpoint. Thirty-day postoperative mortality, OS and DFS served as secondary outcomes.

Median follow-up was 48.8 months, and minimum follow-up for all patients was 3 years.

Intention-to-treat analysis showed patients who underwent the hybrid minimally invasive procedure experienced a significantly lower rate of major postoperative morbidity (35.9% vs. 64.4%; OR = 0.31; 95% CI, 0.18-0.55) and major pulmonary complications (17.7% vs. 30.1%; P = .037).

Patients assigned hybrid minimally invasive esophagectomy achieved higher rates of 3-year OS (67% vs. 54.8%) and DFS (57% vs. 48%).

“This represents an extremely important, well-designed and well-conducted study demonstrating that hybrid minimally invasive esophagectomy is an oncologically sound procedure,” Professor Ulrich Güller, MD, MHS, FEBS, faculty member in oncology and hematology at Kantonsspital St. Gallen in Switzerland, said in a press release. “Based on these results, the [hybrid minimally invasive approach] should become the new standard operating procedure for patients with mid- and low esophageal cancer.”

Güller also acknowledged Professor Christophe Mariette, MD, PhD, the first author of the MIRO trial, who died in July.

Mariette, surgical oncologist and professor of surgery at University Hospital of Lille in France, “was a model of a surgical scientist and an opinion leader in the field,” and his contributions to the MIRO trial were of “cardinal importance,” Güller said. – by Mark Leiser

 

Reference:

Mariette C, et al. Abstract 615O_PR. Presented at European Society for Medical Oncology Congress; Sept. 8-12, 2017; Madrid.

 

Disclosures: The French National Cancer Institute funded this study. The researchers report no relevant financial disclosures.

 

 

 

 

MADRID — Hybrid minimally invasive esophagectomy reduced incidence of major morbidity compared with open esophagectomy for patients with esophageal cancer, according to long-term results from a randomized, controlled phase 3 trial presented at the European Society for Medical Oncology Congress.

“Hybrid minimally invasive esophagectomy allows for reduction of severe complications and reduction of major pulmonary complications without negative impact on oncological outcomes and [with] a trend to better survival,” Guillaume Piessen, MD, gastrointestinal surgeon at University Hospital C. Huriez in Lille, France, said during his presentation. “These findings provide strong evidence for the use of hybrid minimally invasive esophagectomy for patients with resectable esophageal cancer [and the procedure] should be considered as a new standard.”

More than half of patients who undergo open esophagectomy experience postoperative morbidity. Pulmonary complications are particularly problematic.

In the multicenter, open-label MIRO trial, Piessen and colleagues assessed the efficacy of hybrid minimally invasive esophagectomy.

The study — conducted at 13 centers between October 2009 and April 2012 — included 207 patients aged 18 to 75 years with resectable cancers in the middle or lower third of the esophagus.

Researchers randomly assigned 104 patients to transthoracic open esophagectomy and 103 patients to hybrid minimally invasive esophagectomy, an Ivor Lewis procedure that consisted of laparoscopic gastric mobilization and open right thoracotomy.

Investigators credentialed surgeons prior to patient enrollment, standardized techniques and monitored their performance during the trial to ensure surgical quality.

Thirty-day grade 2 to grade 4 postoperative morbidity — measured by the Clavien-Dindo classification — served as the primary endpoint. Thirty-day postoperative mortality, OS and DFS served as secondary outcomes.

Median follow-up was 48.8 months, and minimum follow-up for all patients was 3 years.

Intention-to-treat analysis showed patients who underwent the hybrid minimally invasive procedure experienced a significantly lower rate of major postoperative morbidity (35.9% vs. 64.4%; OR = 0.31; 95% CI, 0.18-0.55) and major pulmonary complications (17.7% vs. 30.1%; P = .037).

Patients assigned hybrid minimally invasive esophagectomy achieved higher rates of 3-year OS (67% vs. 54.8%) and DFS (57% vs. 48%).

“This represents an extremely important, well-designed and well-conducted study demonstrating that hybrid minimally invasive esophagectomy is an oncologically sound procedure,” Professor Ulrich Güller, MD, MHS, FEBS, faculty member in oncology and hematology at Kantonsspital St. Gallen in Switzerland, said in a press release. “Based on these results, the [hybrid minimally invasive approach] should become the new standard operating procedure for patients with mid- and low esophageal cancer.”

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Güller also acknowledged Professor Christophe Mariette, MD, PhD, the first author of the MIRO trial, who died in July.

Mariette, surgical oncologist and professor of surgery at University Hospital of Lille in France, “was a model of a surgical scientist and an opinion leader in the field,” and his contributions to the MIRO trial were of “cardinal importance,” Güller said. – by Mark Leiser

 

Reference:

Mariette C, et al. Abstract 615O_PR. Presented at European Society for Medical Oncology Congress; Sept. 8-12, 2017; Madrid.

 

Disclosures: The French National Cancer Institute funded this study. The researchers report no relevant financial disclosures.

 

 

 

 

    Perspective

    The MIRO trial was a well-conducted surgical trial, and it was well powered with adequate accrual over a reasonable time frame. It is a proper validation of a new surgical technique.

    The primary endpoint was met, with major side effects being much less with the hybrid technique than the open technique. It’s logical that the preliminary complications were much lower in the hybrid group because, when you don’t open the abdomen, patients can breathe much better and have less pain. But does this new surgical procedure reduce the morbidity of the intervention only?

    Survival was a secondary endpoint. The study was not powered to show an OS advantage, but I’m sure if it included an additional 100 patients, it probably would have been positive.

    What are the causes of this potential OS advantage? Could it be because of the cleaner procedure? Possibly, but I doubt it. Could it be the relation between surgical morbidity and cancer prognosis, or oncotaxis? That could be. There are few data on oncotaxis in the literature, but two or three papers have suggested that the more complications patients have after surgery, the more prone they are to relapse.

    Could it be a significant difference in surgical mortality at 3 months or more? This information was not given to us. Usually, because of the improvements in ICUs, most patients are surviving 30 days, so more deaths are occurring later than 30 days.

    This study suggests that improvements in surgery might still improve the prognosis of esophageal cancer. These new techniques appear advantageous for patients, but if we really want them to become reality, the question becomes: Should we leave them to very specialized, high-volume centers?

    Data in cases like this show the more operations you do, the better you are. For esophageal cancer, and for certain other tumors, we may need to leave the ego behind, think more about the patient and restrict these cases to very specially designed centers.

    • Arnaud D. Roth, MD
    • Geneva University Hospital

    Disclosures: Disclosure: Roth reports no relevant financial disclosure.

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