F Klevebro1, G Johnsen2, E Johnson3, A Viste4, T Myrnäs5, E Szabo6, A-B Jacobsen7, S Friesland8, J A Tsai9, S Persson9, M Lindblad9, L Lundell9, M Nilsson9. 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 complicationsafter 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).
RCT Entities:
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).
Authors: Zuhair Ahmed; Jessie A Elliott; Sinead King; Claire L Donohoe; Narayanasamy Ravi; John V Reynolds Journal: World J Surg Date: 2017-02 Impact factor: 3.352
Authors: Tomoyuki Irino; Jon A Tsai; Jessica Ericson; Magnus Nilsson; Lars Lundell; Ioannis Rouvelas Journal: Langenbecks Arch Surg Date: 2016-03-09 Impact factor: 3.445
Authors: Fredrik Klevebro; Signe Friesland; Mattias Hedman; Jon A Tsai; Mats Lindblad; Ioannis Rouvelas; Lars Lundell; Magnus Nilsson Journal: Langenbecks Arch Surg Date: 2016-03-28 Impact factor: 3.445
Authors: M C J Anderegg; P C van der Sluis; J P Ruurda; S S Gisbertz; M C C M Hulshof; M van Vulpen; N Haj Mohammed; H W M van Laarhoven; M J Wiezer; M Los; M I van Berge Henegouwen; R van Hillegersberg Journal: Ann Surg Oncol Date: 2017-04-19 Impact factor: 5.344