525 SURGICAL MORBIDITY AND MORTALITY FROM THE NEORESII TRIAL: STANDARD VS. PROLONGED TIME TO SURGERY AFTER NEOADJUVANT CHEMORADIOTHERAPY FOR ESOPHAGEAL CANCER

Abstract

Abstract For carcinoma of the esophagus or esophagogastric junction the time to surgery (TTS) has traditionally been 4-6 weeks after completed neoadjuvant chemoradiotherapy (nCRT). However, the optimal timing is not known. A majority of previous non-randomized studies addressing this issue, have not detected any significant differences in complication rates comparing patients operated with standard TTS compared to prolonged TTS. The aim of this sub-study was to investigate if prolonged TTS after completed nCRT improves postoperative outcomes. Methods A multicenter clinical trial was performed with randomized allocation to standard TTS (4–6 weeks) or prolonged TTS (10–12 weeks). All patients received nCRT according to the CROSS regimen. Patients were enrolled between 2015–2019 from 10 University Hospitals in Sweden, Norway and Germany. The primary endpoint of this sub-study was overall postoperative complications defined as Clavien-Dindo grade II-V. Secondary endpoints included complication severity according to Clavien-Dindo grade IIIb-V, postoperative 90-day mortality and length of hospital stay. The study was registered in Clinicaltrials.gov (NCT02415101). Results In total 248 patients were randomized. There were no significant differences between standard TTS and prolonged TTS regarding overall complications Clavien-Dindo II-V (59.0% vs. 69.8%, P = 0.092) or Clavien-Dindo IIIb-V (31.6% vs. 35.0%, P = 0.603). Furthermore, there were no significant differences regarding anastomotic leak (P = 0.601), conduit necrosis (P = 0.524), chyle leak (P = 0.427), pneumonia (P = 0.548) or respiratory failure (P = 0.723). The 90-day postoperative mortality was 4.3% (5 patients) in the standard TTS, and 3.8% (4 patients) in the prolonged TTS arm (P = 1.0). Median length of hospital stay was 15 days in the standard TTS arm and 17 days in the prolonged TTS arm (P = 0.220). Conclusion The timing of surgery after completed nCRT for carcinoma of the esophagus or esophagogastric junction is not of major importance with regard to short-term postoperative outcomes.