LUGANO-MADRID – Patients requiring surgery for oesophageal cancer fare better after undergoing a hybrid minimally invasive oesophagectomy (HMIO) compared to an open oesophagectomy (OO), according to long-term results of the MIRO trial to be presented at the ESMO 2017 Congress in Madrid. (1)
Mature results of the phase 3 study, with follow-up to a median of 48.8 months, demonstrate that the reduced surgical trauma associated with a laparoscopic approach, does not cut corners on safety, said investigator Dr. Guillaume Piessen, from University Hospital C. Huriez, Lille, France.
“In addition to a 69% reduction in major intra- and postoperative morbidity, three-year overall survival was improved in the laparoscopic group, showing that it is an oncologically sound procedure,” he said.
While the survival difference between groups was not statistically significant, he called it “highly clinically relevant.”
MIRO enrolled 207 adult patients from 13 centres with with resectable cancers of the middle or lower third of the oesophagus.
They were randomised to undergo either HMIO or an OO.
At 30-days, major postoperative morbidity occurred in significantly fewer patients in the HMIO compared to the OO group (35.9% versus 64.4%, odds ratio [OR] 0.31, 95%CI 0.18-0.55; p<0·001).
At three years, there was also a trend in the HMIO group towards improved overall survival and disease-free survival (67.0% versus 55%, p=0.05 and 57% versus 48%, p=0.15).
Commenting on the trial, Prof. Ulrich Güller, from Kantonsspital St. Gallen, Switzerland said: “This represents an extremely important, well-designed and well-conducted study demonstrating that HMIO is an oncologically sound procedure and significantly reduces postoperative morbidity. Based on these results, the HMIO should become the new standard operating procedure for patients with mid and low oesophageal cancer.”
Güller added, “I think it is key to mention Prof. Christophe Mariette, the first author of this important trial, who sadly passed away one month ago. Prof. Mariette was a model of a surgical scientist and an opinion leader in the field, and his contribution to the MIRO trial was of cardinal importance.”
Notes to Editors
Please make sure to use the official name of the meeting in your reports: ESMO 2017 Congress
- Abstract 615O_PR ‘Hybrid Minimally Invasive vs. Open Esophagectomy for patients with Esophageal Cancer: Long-term outcomes of a multicentre, open-label, randomized phase III controlled trial, the MIRO trial” will be presented by Dr Guillaume Piessen during Proffered Paper Session 'Gastrointestinal tumours, non-colorectal 1' on Friday, 8 September 2017, 14:00 to 15:30 (CEST) in Barcelona Auditorium.
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Hybrid Minimally Invasive vs. Open Esophagectomy for patients with Esophageal Cancer: Long-term outcomes of a multicenter, open-label, randomized phase III controlled trial, the MIRO trial
C. Mariette1, S. Markar2, T.S. Dabakuyo-Yonli3, B. Meunier4, D. Pezet5, D. Collet6, X.B. D'journo7, C. Brigand8, T. Perniceni9, N. Carrere10, F. Bonnetain11, G. Piessen12
1Department Of Digestive And Oncological Surgery, Lille University Hospital, France, Lille/FRANCE, 2Surgery And Cancer, St. Mary's Hospital Imperial College Healthcare NHS Trust, London/UNITED KINGDOM, 3Biostatistics And Quality Of Life Unit , Ea4184, Centre Georges François Leclerc, dijon/FRANCE, 4Departement Of Digestive Surgery, Pontchailloux University Hospital, Rennes/FRANCE, 5Department Of Digestive Surgery, D'Estaing University Hospital, Clermont Ferrand/FRANCE, 6Department Of Digestive Surgery, Haut Leveque University Hospital, Bordeaux/FRANCE, 7Department Of Thoracic Surgery, North University Hospital, Marseille/FRANCE, 8Department Of Digestive Surgery, Hautepierre University Hospital, Strasbourg/FRANCE, 9Department Of Digestive Surgery, Institut Mutualiste Montsouris, Paris/FRANCE, 10Departement Of Digestive Surgery, Purpan University Hospital, Toulouse/FRANCE, 11Methodological And Quality Of Life Unit In Oncology (inserm Umr 1098), University Hospital Jean Minjoz, Besançon/FRANCE, 12Department Of Digestive And Oncological Surgery, Claude Huriez University Hospital, Lille/FRANCE
Background: Postoperative morbidity, especially pulmonary complications, affects more than half of patients after open oesophagectomy (OE). We assessed whether hybrid minimally invasive oesophagectomy (HMIE) reduces morbidity compared with OE.
Methods: We performed a multicentre, open-label, randomised controlled trial at 13 study centres between October 2009 and April 2012. Patients aged 18-75 years old with resectable cancers of the middle or lower third of the oesophagus were assigned by randomisation to undergo either transthoracic OE or HMIE. Surgical quality assurance was implemented through credentialing surgeons before enrolment, standardisation of technique and monitoring of performance during the trial. HMIE comprised an Ivor Lewis procedure with laparoscopic gastric mobilisation and open right thoracotomy. The primary outcome was 30-day grade II-IV postoperative morbidity as defined by the Clavien-Dindo classification. Secondary outcomes were 30-day postoperative mortality, overall and disease free-survivals. Analysis was done by intention to treat.
Results: We randomly assigned 104 patients to the OE group and 103 to the HMIE group. Sixty-seven (64.4%) patients in the OE group had major postoperative morbidity compared with 37 (35.9%) in the HMIE group (OR 0.31, 95%CI 0.18-0.55; p<0·001). Thirty-one (30.1%) patients in the OE had major pulmonary complications compared with 18 (17.7%) in the HMIE group (p=0·037). After of follow up of at least 3 years for each patient (median 48.8 months), the overall survival was improved in the HMIE group and at 3 years was 67.0% (95% CI 57% to 75.2%) compared with 54.8% (95% CI 44.8% to 63.8%) for OE (median not reached, p=0.054).
Conclusions: These findings show that hybrid minimally invasive oesophagectomy is an oncologically sound procedure, and reduces the incidence of major morbidity specifically pulmonary following oesophagectomy for cancer.
Clinical trial identification: Clinical trial information: NCT00937456
Keywords: morbidity, Minimally-invasive approach, randomized controlled trial, oesophageal cancer
Funding: the French National Cancer Institute INCa
Disclosure: All authors have declared no conflicts of interest.