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

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

Author information

1
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.
2
Department of Gastrointestinal Surgery, St Olavs Hospital, Trondheim University Hospital, Norway.
3
Department of Paediatric and Gastrointestinal Surgery, Ullevål University Hospital, Oslo, Norway.
4
Department of Acute and Gastrointestinal Surgery Haukeland University Hospital, Bergen and Department of Clinical Medicine, University of Bergen, Norway.
5
Department of Surgery, Umeå University Hospital, Umeå, Sweden.
6
Department of Surgery, Örebro University Hospital, Sweden.
7
Department of Oncology, Oslo University Hospital, Norway.
8
Department of Oncology, Karolinska University Hospital, Stockholm, Sweden.
9
Division of Surgery, Department of Clinical Science Intervention and Technology, Karolinska Institutet and Centre for Digestive Diseases, Karolinska University Hospital, Stockholm, Sweden.

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

PMID:
25908010
DOI:
10.1016/j.ejso.2015.03.226
[Indexed for MEDLINE]

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