In:
Diseases of the Esophagus, Oxford University Press (OUP), Vol. 32, No. Supplement_2 ( 2019-11-23)
Abstract:
To characterize oncologic surveillance protocols across European esophageal cancer centers and determine the independent impact of intensive surveillance on oncologic outcome. Background Emerging data demonstrate long-term survival after salvage interventions for local or oligometastatic recurrence after planned curative resection for esophageal cancer, providing rationale for postoperative surveillance. However, the impact of intensive surveillance on oncologic outcome and health-related quality of life (HRQOL) is unknown. Methods First, a survey of surveillance protocols across European esophageal cancer centres was undertaken (Phase 1). Then, an international multicentre study including consecutive patients who underwent surgery with curative intent for cTxNxM0 esophageal or junctional cancer from June 2009 to June 2015 was initiated (Phase 2). The estimated sample size of 4425, with 31% undergoing intensive surveillance, will provide 90% power to detect a 5% increase in 5-year overall survival (primary outcome measure). Secondary outcome measures include disease-free survival, incidence of oligometastatic recurrence, treatment strategies, and HRQOL. Subgroup analyses by age, histologic type and HER-2 status are planned. The study is registered on ClinicalTrials.gov (NCT03461341). Results For Phase 1, 27 centres across 13 European and North American countries participated. Centers undertook 52.3±17.1 esophageal cancer resections per year between 3.5±1.3 attending surgeons. The majority of centers utilized a standardized surveillance protocol for all patients (23, 85.2%). Routine laboratory investigations, nutritional profiling and tumor markers were assessed in 10 (37.0%), 9 (33.3%) and 4 (14.8%) of centers, respectively. 10 centers (37.0%) utilized routine postoperative surveillance computed tomography, of whom 3 (11.1%) also undertook routine postoperative PET-CT in follow-up. Surveillance endoscopy was performed in 7 centers (18.9%). Centers undertaking intensive imaging surveillance had fewer attending surgeons (P=0.036) but similar surgeon volume (P=0.832). Surveillance intensity was not associated with national health expenditure (P=0.733). For Phase 2, data for 4010 patients (31.1% intensive surveillance) from 18 centres across 9 European countries have been submitted to date, with results expected in September 2019. Conclusion The ENSURE study will provide the first appropriately powered evidence assessing the impact of postoperative surveillance strategies on oncologic outcome and HRQOL following potentially curative resection for esophageal cancer.
Type of Medium:
Online Resource
ISSN:
1442-2050
DOI:
10.1093/dote/doz092.66
Language:
English
Publisher:
Oxford University Press (OUP)
Publication Date:
2019
detail.hit.zdb_id:
2004949-3
