Morbidity and mortality after surgery for cancer of the oesophagus and gastro-oesophageal junction: A randomized clinical trial of neoadjuvant chemotherapy vs. neoadjuvant chemoradiation

Eur J Surg Oncol. 2015 Jul;41(7):920-6. doi: 10.1016/j.ejso.2015.03.226. Epub 2015 Apr 8.

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).

Conclusion: 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.

Registration trial database: The trial was registered in the Clinical Trials Database (registration number NCT01362127).

Keywords: Neoadjuvant treatment; Oesophageal cancer; Oesophagectomy complications.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenocarcinoma / surgery
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Carcinoma, Squamous Cell / surgery
  • Chemoradiotherapy, Adjuvant / adverse effects
  • Chemotherapy, Adjuvant
  • Cisplatin / administration & dosage
  • Esophageal Neoplasms / drug therapy
  • Esophageal Neoplasms / radiotherapy
  • Esophageal Neoplasms / surgery*
  • Esophagectomy / adverse effects*
  • Esophagectomy / methods
  • Esophagogastric Junction* / pathology
  • Esophagogastric Junction* / surgery
  • Female
  • Fluorouracil / administration & dosage
  • Follow-Up Studies
  • Humans
  • Incidence
  • Lymph Node Excision*
  • Male
  • Middle Aged
  • Morbidity
  • Neoadjuvant Therapy / methods*
  • Neoplasm Staging
  • Norway / epidemiology
  • Postoperative Complications / diagnosis
  • Postoperative Complications / epidemiology*
  • Postoperative Complications / etiology
  • Severity of Illness Index
  • Sweden / epidemiology
  • Treatment Outcome

Substances

  • Cisplatin
  • Fluorouracil

Associated data

  • ClinicalTrials.gov/NCT01362127