title: Morbidity and mortality after surgery for cancer of the oesophagus and gastro-oesophageal junction: A randomized clinical trial of neoadjuvant chemotherapy vs. neoadjuvant chemoradiation.
abstract: OBJECTIVE
  To compare the incidence and severity of postoperative complications after oesophagectomy for carcinoma of the oesophagus and gastro-oesophageal junction (GOJ) after randomized accrual to neoadjuvant chemotherapy (nCT) or neoadjuvant chemoradiotherapy (nCRT).
  
  
  BACKGROUND
  Neoadjuvant therapy improves long-term survival after oesophagectomy. To date, evidence is insufficient to determine whether combined nCT, or nCRT alone, is the most beneficial.
  
  
  METHODS
  Patients with carcinoma of the oesophagus or GOJ, resectable with a curative intention, were enrolled in this multicenter trial conducted at seven centres in Sweden and Norway. Study participants were randomized to nCT or nCRT followed by surgery with two-field lymphadenectomy. Three cycles of cisplatin/5-fluorouracil was administered in all patients, while 40 Gy of concomitant radiotherapy was administered in the nCRT group.
  
  
  RESULTS
  Of the randomized 181 patients, 91 were assigned to nCT and 90 to nCRT. One-hundred-and-fifty-five patients, 78 nCT and 77 nCRT, underwent resection. There was no statistically significant difference between the groups in the incidence of surgical or nonsurgical complications (P-value = 0.69 and 0.13, respectively). There was no 30-day mortality, while the 90-day mortality was 3% (2/78) in the nCT group and 6% (5/77) in the nCRT group (P = 0.24). The median Clavien-Dindo complication severity grade was significantly higher in the nCRT group (P = 0.001).
  
  
  CONCLUSIONS
  There was no significant difference in the incidence of complications between patients randomized to nCT and nCRT. However, complications were significantly more severe after nCRT.
  The trial was registered in the Clinical Trials Database (registration number NCT01362127).
authors.affiliation: Division of Surgery, Department of Clinical Science Intervention and Technology, Karolinska Institutet and Centre for Digestive Diseases, Karolinska University Hospital, Stockholm, Sweden. Electronic address: fredrik.klevebro@ki.se.
authors.forename: F
authors.initials: F
authors.lastname: Klevebro
authors.affiliation: Department of Gastrointestinal Surgery, St Olavs Hospital, Trondheim University Hospital, Norway.
authors.forename: G
authors.initials: G
authors.lastname: Johnsen
authors.affiliation: Department of Paediatric and Gastrointestinal Surgery, Ullevål University Hospital, Oslo, Norway.
authors.forename: E
authors.initials: E
authors.lastname: Johnson
authors.affiliation: Department of Acute and Gastrointestinal Surgery Haukeland University Hospital, Bergen and Department of Clinical Medicine, University of Bergen, Norway.
authors.forename: A
authors.initials: A
authors.lastname: Viste
authors.affiliation: Department of Surgery, Umeå University Hospital, Umeå, Sweden.
authors.forename: T
authors.initials: T
authors.lastname: Myrnäs
authors.affiliation: Department of Surgery, Örebro University Hospital, Sweden.
authors.forename: E
authors.initials: E
authors.lastname: Szabo
authors.affiliation: Department of Oncology, Oslo University Hospital, Norway.
authors.forename: A-B
authors.initials: AB
authors.lastname: Jacobsen
authors.affiliation: Department of Oncology, Karolinska University Hospital, Stockholm, Sweden.
authors.forename: S
authors.initials: S
authors.lastname: Friesland
authors.affiliation: Division of Surgery, Department of Clinical Science Intervention and Technology, Karolinska Institutet and Centre for Digestive Diseases, Karolinska University Hospital, Stockholm, Sweden.
authors.forename: J A
authors.initials: JA
authors.lastname: Tsai
authors.affiliation: Division of Surgery, Department of Clinical Science Intervention and Technology, Karolinska Institutet and Centre for Digestive Diseases, Karolinska University Hospital, Stockholm, Sweden.
authors.forename: S
authors.initials: S
authors.lastname: Persson
authors.affiliation: Division of Surgery, Department of Clinical Science Intervention and Technology, Karolinska Institutet and Centre for Digestive Diseases, Karolinska University Hospital, Stockholm, Sweden.
authors.forename: M
authors.initials: M
authors.lastname: Lindblad
authors.affiliation: Division of Surgery, Department of Clinical Science Intervention and Technology, Karolinska Institutet and Centre for Digestive Diseases, Karolinska University Hospital, Stockholm, Sweden.
authors.forename: L
authors.initials: L
authors.lastname: Lundell
authors.affiliation: Division of Surgery, Department of Clinical Science Intervention and Technology, Karolinska Institutet and Centre for Digestive Diseases, Karolinska University Hospital, Stockholm, Sweden.
authors.forename: M
authors.initials: M
authors.lastname: Nilsson
mesh_terms: D000230:Adenocarcinoma / Q000601:surgery; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000601:surgery; D059186:Chemoradiotherapy, Adjuvant / Q000009:adverse effects; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D004938:Esophageal Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery*; D016629:Esophagectomy / Q000009:adverse effects* / Q000379:methods; D004943:Esophagogastric Junction / Q000473:pathology / Q000601:surgery; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008197:Lymph Node Excision; D008297:Male; D008875:Middle Aged; D009017:Morbidity; D020360:Neoadjuvant Therapy / Q000379:methods*; D009367:Neoplasm Staging; D009664:Norway / Q000453:epidemiology; D011183:Postoperative Complications / Q000175:diagnosis / Q000453:epidemiology* / Q000209:etiology; D012720:Severity of Illness Index; D013548:Sweden / Q000453:epidemiology; D016896:Treatment Outcome
chemical_list: D002945:Cisplatin; D005472:Fluorouracil
keywords: Neoadjuvant treatment; Oesophageal cancer; Oesophagectomy complications