Neoadjuvant Chemoradiotherapy Versus Chemotherapy for the Treatment of Locally Advanced Esophageal Adenocarcinoma in the European Multicenter ENSURE Study.

Autor: Elliott JA; Trinity St. James's Cancer Institute, Trinity College Dublin, and St. James's Hospital, Dublin, Ireland., Klevebro F; CLINTEC, Karolinska Institutet and Department of Upper Abdominal Diseases, Karolinska University Hospital, Stockholm, Sweden., Mantziari S; Lausanne University Hospital CHUV and University of Lausanne UNIL, Lausanne, Switzerland., Markar SR; Surgical Interventional Trials Unit, Nuffield Department of Surgery, University of Oxford, Oxford, UK.; Department of Molecular Medicine and Surgery, Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden., Goense L; Department of Surgery, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands., Johar A; Department of Molecular Medicine and Surgery, Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden., Lagergren P; Department of Molecular Medicine and Surgery, Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden.; Department of Surgery and Cancer, Imperial College London, St. Mary's Hospital, London, UK., Zaninotto G; Department of Surgery and Cancer, Imperial College London, St. Mary's Hospital, London, UK., van Hillegersberg R; Department of Surgery, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands., van Berge Henegouwen MI; Department of Surgery, University of Amsterdam, Amsterdam, The Netherlands.; Cancer Center Amsterdam, Amsterdam, The Netherlands., Schäfer M; Lausanne University Hospital CHUV and University of Lausanne UNIL, Lausanne, Switzerland., Nilsson M; CLINTEC, Karolinska Institutet and Department of Upper Abdominal Diseases, Karolinska University Hospital, Stockholm, Sweden., Hanna GB; Department of Surgery and Cancer, Imperial College London, St. Mary's Hospital, London, UK., Reynolds JV; Trinity St. James's Cancer Institute, Trinity College Dublin, and St. James's Hospital, Dublin, Ireland.
Jazyk: angličtina
Zdroj: Annals of surgery [Ann Surg] 2023 Nov 01; Vol. 278 (5), pp. 692-700. Date of Electronic Publication: 2023 Jul 20.
DOI: 10.1097/SLA.0000000000006018
Abstrakt: Objective: This study aimed to compare clinicopathologic, oncologic, and health-related quality of life (HRQL) outcomes following neoadjuvant chemoradiation (nCRT) and chemotherapy (nCT) in the ENSURE international multicenter study.
Background: nCT and nCRT are the standards of care for locally advanced esophageal cancer (LAEC) treated with curative intent. However, no published randomized controlled trial to date has demonstrated the superiority of either approach.
Methods: ENSURE is an international multicenter study of consecutive patients undergoing surgery for LAEC (2009-2015) across 20 high-volume centers (NCT03461341). The primary outcome measure was overall survival (OS), secondary outcomes included histopathologic response, recurrence pattern, oncologic outcome, and HRQL in survivorship.
Results: A total of 2211 patients were studied (48% nCT, 52% nCRT). pCR was observed in 4.9% and 14.7% ( P <0.001), with R0 in 78.2% and 94.2% ( P <0.001) post nCT and nCRT, respectively. Postoperative morbidity was equivalent, but in-hospital mortality was independently increased [hazard ratio (HR)=2.73, 95% CI: 1.43-5.21, P= 0.002] following nCRT versus nCT. Probability of local recurrence was reduced (odds ratio=0.71, 95% CI: 0.54-0.93, P =0.012), and distant recurrence-free survival time reduced (HR=1.18, 95% CI: 1.02-1.37, P =0.023) after nCRT versus nCT, with no difference in OS among all patients (HR=1.10, 95% CI: 0.98-1.25, P =0.113). On subgroup analysis, patients who underwent R0 resection following nCT as compared with nCRT had improved OS (median: 60.7 months, 95% CI: 49.5-71.8 vs 40.8 months, 95% CI: 42.8-53.4, P <0.001).
Conclusions: In this European multicenter study, nCRT compared with nCT was associated with reduced probability of local recurrence but reduced distant recurrence-free survival for patients with LAEC, without differences in OS. These data support tailored patient-specific decision-making in the overall approach to achieving optimum outcomes in LAEC.
Competing Interests: The authors report no conflicts of interest.
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Databáze: MEDLINE