Abstract
Background
Patients with localised oesophageal cancer are frequently offered neoadjuvant treatment and surgery, with the benefit of improved survival but an expected at least short term negative impact on quality of life (QoL). Minimally invasive surgical techniques may reduce the QoL impacts by reducing tissue damage. The ROMIO study compared hybrid with open oesophagectomy, to test the hypothesis that hybrid allows faster recovery whilst maintaining the survival benefit of surgery. We have previously reported no evidence of a difference in early complications or recovery of physical function. Here we present the results of the comparison of longer term QoL and survival.
Methods
A pragmatic multi-centre randomised controlled trial was conducted in nine UK cancer centres. Patients with localised adenocarcinoma or squamous cell cancer were selected by multi-disciplinary teams for oesophagectomy with or without neoadjuvant treatment. Patients were randomly allocated to laparoscopic abdominal surgery and thoracotomy (hybrid) or open oesophagectomy. Surgery was quality assured by provision of a protocol, pre-operative video assessment of the 40 participating surgeons, and intra-operative photographs of key surgical components. Here we report on survival, and patient reported outcomes measured using the EORTC QLQ-C30, over 2 to 3 years post-randomisation.
Results
At enrolment 469 (89%) of 527 participants had an adenocarcinoma, 371 (71%) had a clinically staged T3 or T4a tumour, 296 (56%) had clinically positive nodes, and 438 (83%) underwent neoadjuvant treatment. Kaplan-Meier estimates of survival at 24 months were 66% in the hybrid surgery group (95% confidence interval 60% to 71%) and 65% in the open surgery group (95% confidence interval 57% to 69%) with the difference between the two groups being consistent with chance. Preliminary analyses did not provide evidence of a difference in patient reported quality of life following the two surgical approaches.
Conclusions
In contrast to the previous MIRO study, the ROMIO study has not identified any differences between hybrid and open surgery in complications, short-term recovery of physical function, or survival and quality of life over two to three years post-randomisation. Both approaches remain common in UK practice, with ROMIO providing evidence of their safety. Potentially, a fully minimally invasive approach, as investigated in the ROMIO phase 2b substudy and the TIME study, is required to realise the potential benefits of minimally invasive approaches.
Patients with localised oesophageal cancer are frequently offered neoadjuvant treatment and surgery, with the benefit of improved survival but an expected at least short term negative impact on quality of life (QoL). Minimally invasive surgical techniques may reduce the QoL impacts by reducing tissue damage. The ROMIO study compared hybrid with open oesophagectomy, to test the hypothesis that hybrid allows faster recovery whilst maintaining the survival benefit of surgery. We have previously reported no evidence of a difference in early complications or recovery of physical function. Here we present the results of the comparison of longer term QoL and survival.
Methods
A pragmatic multi-centre randomised controlled trial was conducted in nine UK cancer centres. Patients with localised adenocarcinoma or squamous cell cancer were selected by multi-disciplinary teams for oesophagectomy with or without neoadjuvant treatment. Patients were randomly allocated to laparoscopic abdominal surgery and thoracotomy (hybrid) or open oesophagectomy. Surgery was quality assured by provision of a protocol, pre-operative video assessment of the 40 participating surgeons, and intra-operative photographs of key surgical components. Here we report on survival, and patient reported outcomes measured using the EORTC QLQ-C30, over 2 to 3 years post-randomisation.
Results
At enrolment 469 (89%) of 527 participants had an adenocarcinoma, 371 (71%) had a clinically staged T3 or T4a tumour, 296 (56%) had clinically positive nodes, and 438 (83%) underwent neoadjuvant treatment. Kaplan-Meier estimates of survival at 24 months were 66% in the hybrid surgery group (95% confidence interval 60% to 71%) and 65% in the open surgery group (95% confidence interval 57% to 69%) with the difference between the two groups being consistent with chance. Preliminary analyses did not provide evidence of a difference in patient reported quality of life following the two surgical approaches.
Conclusions
In contrast to the previous MIRO study, the ROMIO study has not identified any differences between hybrid and open surgery in complications, short-term recovery of physical function, or survival and quality of life over two to three years post-randomisation. Both approaches remain common in UK practice, with ROMIO providing evidence of their safety. Potentially, a fully minimally invasive approach, as investigated in the ROMIO phase 2b substudy and the TIME study, is required to realise the potential benefits of minimally invasive approaches.
| Original language | English |
|---|---|
| Number of pages | 2 |
| Publication status | Published - 18 Nov 2023 |
Bibliographical note
Conference abstract.Research Groups and Themes
- Centre for Surgical Research
- BTC (Bristol Trials Centre)
