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Quality assurance of surgery in the randomised ST03 trial of perioperative chemotherapy in carcinoma of the stomach and gastro-oesophageal junction(NCT00450203)

Research output: Contribution to journalArticle

Original languageEnglish
JournalBritish Journal of Surgery
DateAccepted/In press - 26 Feb 2019

Abstract

Objective: To describe adherence to ST03 trial surgical protocol and surgical outcomes in the trial.

Background

The U.K. MRC ST03 trial compared peri-operative epirubicin, cisplatin and capecitabine (ECX) chemotherapy with or without bevacizumab (B) in gastric and oesophagogastric junctional (OGJ) cancer. No difference in survival was noted between the arms of the trial. This study has reviewed the standards and performance of surgery in the context of the protocol specified surgical criteria.

Methods
Surgery and pathological clinical report forms have been reviewed to determine adherence to the surgical protocols, peri-operative morbidity and mortality and final histopathological stage for all patients treated on the study.

Results
Of 1063 patients randomised, 895 (84%) underwent resection; surgical details are available for 880 (98%). Postoperative assessment data are available for 873 patients; complications occurred in 458 (52%) overall of which 71 patients (8%) suffered complications deemed to be life threatening by the responsible clinician. The most common complications were respiratory (211 patients, 24%). The anastomotic leak rate was 118/873 (14%) overall; in those who underwent an oesophago-gastrectomy this was higher in the group receiving ECX-B (24% vs 10% ECX-B vs ECX). Pathological assessment data are available for 845 patients. In 82% of resections at least 15 nodes were removed and the median lymph node harvest was 24 nodes (IQR 17-34). In 49% of patients 25 or more nodes were removed. Histopathologically the R1 rate was 208/834 25% (R1 resection was more common in proximal tumours).

Conclusions
In the ST03 trial the performance of surgery met the protocol stipulated criteria. In the multicentre setting there has been a definite improvement in the outcome of surgery in comparison to previous experience in the UK.

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